Agenda

08 October

09 October

10 October

08 October

05:00 PM
Welcome Reception

09 October

08:00 AM
Advanced EU MDR and CER Workshop
08:00 AM
New England Healthcare Executive Network Meeting
09:00 AM
CRAASH Barcelona Start-up Showcase
10:30 AM
Keynote - Jeff Karp
Keynote
11:30 AM
Exhibition/Luncheon
01:00 PM
Leveraging Data and Machine Learning to Accelerate Medtech Innovation
Ecosystem
01:00 PM
The State of R&D: Can Big Companies Innovate?
Tech
01:00 PM
The State of Strategic Investments from Large Companies
Investment
02:00 PM
Exhibition/Networking Break
03:00 PM
Innovation in Context
Ecosystem
03:00 PM
Collisions of Value
Investment
03:00 PM
Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch
Tech
04:00 PM
Securing Connected Medical Devices and Systems against Cyber Attack
Ecosystem
04:00 PM
Investment Panel - Hot Topics
Investment
04:00 PM
Combination Products 101
Tech
05:00 PM
Exhibition/Networking Reception
06:30 PM
Keynote Dinner - Stephen MacMillan (Hologic)
Keynote

10 October

07:30 AM
Networking Breakfast
08:00 AM
Devices Talk, Who’s Listening?
Keynote
08:45 AM
Exhibition/Networking Break
09:30 AM
MedTech Showcase
09:30 AM
Women's Health
Tech
10:15 AM
Robotics Panel
Tech
11:30 AM
Exhibition/Luncheon
12:30 PM
Keynote -Todd Pope and Campbell Rogers
Keynote
01:30 PM
MedTech Showcase
01:30 PM
Digital Disruption in Life Sciences - It Takes More Than Technology
Tech
02:30 PM
What To Do When Things Go Sideways
Tech
03:30 PM
Getting to the Exit
Investment
04:15 PM
Closing Keynote: Heidi Dhose
Keynote

Speakers

Stephen P. MacMillan
Chairman, President & CEO
Hologic
Dr. Jeff Karp
Professor of Medicine
Brigham and Women’s Hospital, Harvard Medical School
Sheila Talton
Founder, President & CEO
Gray Matter Analytics
Todd M. Pope
President & Chief Executive Officer
TransEnterix
Heidi Dohse
Sr. Program Manager, Founder
Google, Tour de Heart Foundation
Campbell Rogers
Executive Vice President and ​Chief Medical Officer
HeartFlow
Jeffrey H. Burbank
Founder and CEO
NxStage
Martha Shadan
Global Vice President, Marketing; President & CEO
Smith & Nephew; Rotation Medical
Meg Eckenroad
Vice President, Women's Health
Hologic
Christopher von Jako
CEO
Dynatronics
Jeff Wyman
Vice President, InVentures
Smith and Nephew Advanced Surgical Device Division
Susan A. Posner
Health Advances
Partner
David Dykeman
Shareholder and Patent Attorney
Greenberg Traurig
Peter Stebbins
Transactions Lead, Medical Devices
Johnson & Johnson
Dr. Omar Amirana
Senior Vice President
Allied Minds
Jeff Mann
Vice President
Deputy General Counsel at Cantel Medical
Alex De Winter
Managing Director
GE Ventures
Don Barry
External Innovations Lead
DePuy Synthes Companies
Ignacio Galiana, PhD
Program Manager, Soft Wearable Robotic Programs
Wyss Institute at Harvard University
Will Sutton
VP of Engineering & Technology
Minnetronix
James H. Boll
SVP, New Product Development, Cynosure
Hologic
Jim Biggins
Founder, President & CEO
Access Vascular
Theodoros Zanos
Assistant Professor, Neural Decoding & Data Analytics Lab
The Feinstein Institute for Medical Research
Marissa Fayer
Founder & CEO
HERHealthEQ
Kim Bridges Rodriguez
President & CEO
Acessa Health
Tom Calef
VP, Engineering
Activ Surgical
Paul Gudonis
Chairman & CEO
Myomo
Jonathan Gimbel
Director & CER Business Unit Lead
R&Q
Nancy Morrison
Director of Regulatory Affairs
R&Q
Barb Taylor
Director of Marketing
Portal Instruments
Jeff Champagne
Director, Business Development
MPR Product Development
AN
Artha Nafie
EU MDR Program Manager
Independent Consultant
Ronald Sills
TUV Rheinland – North America
Lead Auditor – Medical
Karen Corallo
Regulatory Attorney and Shareholder
Greenberg Traurig LLP
Trevor Chaplick
Corporate Attorney and Shareholder
Greenberg Traurig LLP
Mike Labbe
Director, R&D
Valtronic
Susan Bagen
Application Development Manager
Micro Systems Technologies
Jesse Wheeler
Neurotechnology Business Lead
Draper Laboratory
Paul Schultz
Head of Partnerships
Flex Digital Health
Renee M. Sullivan MD, FACC
Covance
Medical Director Cardiovascular, Metabolic, Endocrine & Renal
Michael Halpin
VP, Regulatory Affairs
Vericel
Chuck Brokish
Director of Business Development
Green Hills Software
Mark Boden
Senior Fellow Corporate Research
Boston Scientific
Anthony Moffa
Senior Director of Product Management for ThingWorx IIoT Platforms
PTC
David Parish
Healthcare Solutions
Google Cloud
Thomas Lutzow
Director of Human Centered Industrial Design
Ximedica
Adriel Desautels
Managing Partner & CEO
Netragard
Ayan Bhandari
Senior Human Centered Industrial Designer
Ximedica
Per Bergman
VP, R&D
Corindus Vascular Robotics
RD
Ryan Downs
VP, Partner
MPR
EC
Eric Claude
VP, Product Development
MPR
Chris MacDonald
Senior Director of Analytics Business Development
PTC

Sponsors

Green Hills Software
Platinum
Minnetronix Medical
Platinum
MPR Product Development
Platinum
Regulatory and Quality Solutions LLC (R&Q)
Platinum
Toxikon
Platinum
Valtronic
Platinum
Ximedica
Platinum
Greenberg Traurig
Diamond
Vaupell
Diamond
The MedTech Conference
Gold
Asahi Intecc
Gold
Compounding Solutions
Gold
CPSL Language Services
Gold
Design Standards Corporation
Gold
EXB Solutions
Gold
Goddard
Gold
Healthlink
Gold
M2D2
Gold
Medmarc
Gold
Propel PLM
Gold
PTC
Gold
The Qt Company
Gold
Velentium
Gold
Consulate General of Canada
Gold
Design Concepts
Gold
Medidata
Gold
Chiltern
Gold
MintzLevin
Gold
Boston UX
Gold
Accumold
Gold
NAGLREITER
Gold
NAMSA
Gold
Davis Companies
Gold
Celestica
Gold
Foster
Merchandise Sponsors
SalesForce4Hire
Merchandise Sponsors
Product Creation Studio
Merchandise Sponsors
KDB
WiFi Sponsor
RBC Medical
Merchandise Sponsors
S2N Health
Hospitality Sponsor
MassMEP
Hospitality Sponsor
Finnegan
Hospitality Sponsor
Additive Manufacturing Today
Media and Supporting Partners
Design World
Media and Supporting Partners
Digital Health Today
Media and Supporting Partners
Drug Delivery Business News
Media and Supporting Partners
Insight Exchange Network
Media and Supporting Partners
MassBio
Media and Supporting Partners
MassDevice
Media and Supporting Partners
Medical Design Briefs
Media and Supporting Partners
Medical Device Developments
Media and Supporting Partners
MEDInnovation
Media and Supporting Partners
Med Tech Directory
Media and Supporting Partners
Medtech Innovator
Media and Supporting Partners
Microwave Journal
Media and Supporting Partners
OCTane
Media and Supporting Partners
Prototype Today
Media and Supporting Partners
SEMDA
Media and Supporting Partners
Re-Work
Media and Supporting Partners
The MedTech Conference
Media and Supporting Partners
Compliance Online
Media and Supporting Partners
NE Healthcare Executive Network
Media and Supporting Partners
CIMIT
Media and Supporting Partners
AI Med
Media and Supporting Partners
Medgadget
Media and Supporting Partners
ReWork
Media and Supporting Partners
MassMEDIC
Media and Supporting Partners

Exhibitors

Accumold
Advamed
Alira Health
ALKU
Applied Marketing Science
Asahi Intecc
BBraun
BMP Medical
Boston UX
Celestica
Compounding Solutions
Consulate General of Canada
CPSL Language Services
Davis Companies
Design Concepts
Design Standards Corporation
Draper
EAG Laboratories
Enercon Technologies
EXB Solutions
Fang Consulting
Fisher Unitech
Forum Plastics
Global Lead Staffing
Global Prior Art, Inc.
Goddard
Green Hills Software
Health Advances
HealthLink
Intrinsic Imaging
Jordi Labs
Keystone
Legit
M2D2
MANTA
MedAcuity Software
Medidata
Medmarc
Minnetronix Medical
MPR
NAGLREITER
NAMSA
Polaris CM-Lockheed Martin
Promenade Software
PropelPLM
Proven Process Medical Devices, Inc.
PTC
Qosina
RCRI
Regulatory and Quality Solutions LLC (R&Q)
Steri-Tek
Task Micro-Electronics Inc.
Tegra Medical
The QT Company
Toxikon
UL
Valtronic
Vaupell
Velentium
WuXi AppTec
Ximedica
Back

Stephen P. MacMillan

Chairman, President & CEO
Hologic
Mr. MacMillan was named President and CEO of Hologic in December 2013 and appointed Chairman in June 2015.

Stephen P. MacMillan was Chairman, President and Chief Executive Officer of Stryker Corporation until February 2012. Mr. MacMillan joined Stryker in 2003 as President and Chief Operating Officer, was appointed CEO effective January 2005, and Chairman in January 2010.

During his 9 years at Stryker, revenues almost tripled from $2.8B to over $8.3B in 2011, and the company moved up over 200 spots on the Fortune 500 list while transforming the company’s quality, compliance, and manufacturing operations.

Mr. MacMillan began his career with Procter & Gamble in 1985 and later spent 11 years with Johnson & Johnson in both the U.S. and Europe, and became President of the joint venture between Johnson & Johnson and Merck.

In 2000, he joined Pharmacia Corporation’s Executive Committee, reporting to CEO Fred Hassan, where he oversaw five global businesses with revenues exceeding $2 billion.

Mr. MacMillan has also served on the Board of Directors of Texas Instruments, Alere Inc., and served as a member of President Obama’s Advanced Manufacturing Partnership. Mr. MacMillan currently serves on the Board of Boston Scientific and AdvaMed (the medical device industry’s trade association).

He received a Bachelor of Arts degree in Economics from Davidson College and is a graduate of Harvard Business School’s Advanced Management Program. He is married and has four children.

09 October

06:30 PM
Keynote Dinner - Stephen MacMillan (Hologic)
Keynote
Back

Dr. Jeff Karp

Professor of Medicine
Brigham and Women’s Hospital, Harvard Medical School
Dr. Jeff Karp is a Professor of Medicine at Brigham and Women’s Hospital, Harvard Medical School, Principal Faculty at the Harvard Stem Cell Institute, and an affiliate faculty at the Broad Institute and at the Harvard-MIT Division of Health Sciences and Technology (where he teaches to HST and MIT-Sloan business school students). His work spans the fields of drug delivery, medical devices, stem cell therapeutics, and tissue adhesives. He He has published >100 peer-reviewed papers (with >14,000 citations), has given >250 national and international invited lectures, and has >100 issued or pending national/international patents. Several technologies developed in his lab have formed the foundation for multiple products on the market and currently under development and for the launch of six companies that have raised over $100 Million in funding including Skintifique (a skincare company), Gecko Biomedical (a tissue adhesive company), Alivio Therapeutics (an inflammation targeting company), Frequency Therapeutics (a regenerative medicine company), Molecular Infusions (a cannabinoid company), and Landsdowne Labs (a child safety company). In 2014, Skintifique brought four consumer healthcare products to market that are sold in pharmacies throughout Europe and are globally available. In 2017, Gecko Biomedical received European regulatory approval (CE mark) for its first tissue sealant product and was recognized by Fierce Medtech as part of their Fierce 15 list of 2017. Frequency Therapeutics began human clinical testing in 2017 for its lead program to treat chronic hearing loss and just completed a successful Phase I safety study in Australia.

Karp’s laboratory has been funded by multiple companies, foundations, and governmental funding agencies, including the Bill and Melinda Gates Foundation, NFL, Johnson & Johnson, Phillips, Sanofi, UCB, NIH, DOD, US Army, Kenneth Rainin Foundation, Helmsley Trust, JDRF, Rheumatology Research Foundation, Coulter Foundation, Prostate Cancer Foundation, Brain Science Foundation, American Heart Association, Deshpande Foundation, Institute for Pediatric Innovation, Boston Children’s Hospital, Brigham and Women’s Hospital, the Government of India and the Government of Korea. Karp also won an internal Shark Tank award judged by Kevin O’Leary (from ABC’s Shark Tank).

Karp’s work has been published in several high impact journals, including six papers in the Proceedings of the National Academy of Sciences (including two cover features), four in Nature Nanotechnology (including a cover feature), three in Cell Stem Cell, one in Nature Biotechnology, one in Nature Methods, one in Nature Biomedical Engineering, one in Nature Protocols, four in Science Translational Medicine (including two cover features), one in Nature Communications, and two in Blood. Karp also has published a commentary in Nature and another in the New England Journal of Medicine.

Karp’s work has been discussed in hundreds of newspapers, online websites, television newscasts, and radio shows around the world, including CNN, ABC News, NBC, Boston Globe, Los Angeles Times, BBC, Discovery, National Geographic, The Atlantic, The Guardian, American Museum for Natural History, Popular Mechanics, and CTV Canada AM, among many others. Karp has also appeared multiple times on CBC’s Quirks and Quarks and NPR Science Fridays. Karp has given invited lectures in 14 countries outside of the US including Canada, Israel, Ireland, United Kingdom, Denmark, Japan, Korea, Italy, India, Colombia, France, Chile, Switzerland, and Germany.

Karp has received over 50 awards and honors. Boston Magazine recently recognized Karp as one of 11 Boston Doctors Making Medical Breakthroughs. The Boston Business Journal recognized him as a Champion in Healthcare Innovation and MIT’s Technology Review Magazine (TR35) also recognized Karp as being one of the top innovators in the world (three members from his laboratory have subsequently received this award). Karp is also a Kavli Fellow and was elected to the American Institute for Medical and Biological Engineering’s College of Fellows in 2013. His work has been selected by Popular Mechanic’s as one of the Top 20 New Biotech Breakthroughs that Will Change Medicine. He gave a TEDMED talk at the Kennedy Center in DC on bioinspired medical innovation, and since 2015 has been a member of the TEDMED Editorial Advisory Board. In 2015 and 2016, he received Breakthrough Awards from the Kenneth Rainin Foundation, and in 2015 was a commencement speaker in at the University of Toronto Faculty of Dentistry and Pharmacy. He also has served as a consultant to the Kenneth Rainin Foundation and the Crohn’s and Colitis Foundation on the topic of new technologies for Inflammatory Bowel Disease. He has deep consulting expertise with startups and Fortune 500 companies across a wide spectrum of areas, including drug delivery, medical devices, consumer healthcare products, and stem cell therapeutics.

Karp has had several notable scholarly achievements during his career. In 2010, Karp was asked to serve a two-year term to co-lead the Brigham and Women’s Hospital Regenerative Therapeutics Center (making him the youngest faculty at the Brigham and Women’s Hospital to direct a research center). He also received the Society for Biomaterials Young Investigator Award and the Coulter Foundation Translational Young Investigator Award. Additionally, he was a visiting professor at Oxford in 2014, presented the Nicholson Memorial Lecture at Composites of Lake Louise in 2015, presented two public lectures at the American Museum of Natural History in 2016, gave a Keynote Lecture at the Ontario Hospital Association’s 2017 Health Achieve conference, was a Plenary Speaker at the Tissue Engineering Society Europe conference in 2017, and was a Keynote speaker in 2018 at the combined meeting of the American Society for Peripheral Nerve, American Society for Reconstructive Microsurgery, and the American Association for Hand Surgery.

In addition to his research goals, Karp is dedicated to the career development of next generation bioengineers to work at the forefront of regenerative medicine. Karp was selected as the Outstanding Faculty Undergraduate Mentor among all faculty at MIT and he received the HST McMahon Mentoring award for being the top mentor of Harvard-MIT students. Karp strives to create an educationally conducive environment that fosters the development of scientific confidence. To date, 20 trainees from his laboratory have secured faculty positions (he currently has 4 faculty working in his lab who he promoted from postdoctoral positions) and several have transitioned into impactful careers in pharma, biotech, medtech, and venture capital. Karp dedicates significant time to inspiring the next generation through hosting multiple groups of grade school and high school children to his laboratory each year for lectures and hands on demonstrations (including those from the US, Japan, Sweden, and France), as well as through giving lectures at local and national schools, including schools in Massachusetts, Connecticut, Oregon, and Washington. For example, in 2017 he gave a lecture at the Talcott Mountain Academy in Avon CT (a school for gifted children). He also has been a speaker at the Global Youth Summit at Brandeis University for the past two years. Karp has also collaborated extensively with clinicians, basic scientists, engineers, and fellow bioengineers in the US and in India, where he co-directed an Indo-US Center for Nanobiotechnology, and was invited to help launch a new biomedical engineering program at the Pontifical Catholic University of Chile.

09 October

10:30 AM
Keynote - Jeff Karp
Keynote
Back

Sheila Talton

Founder, President & CEO
Gray Matter Analytics
Sheila Talton is an innovative global leader and Big Data strategist with over 30 years of experience in helping organizations increase value, build successful businesses within larger companies and expand into emerging markets. She is recognized for her expertise in developing bold initiatives, whether that is through public/private partnerships melding company strategies with governmental objectives, obtaining buy-in for consulting services within technology product companies, or breaking down silos to build services around products to create solutions that increase customer value.

Her experience in governance extends to corporate, civic and not-for-profit sectors; currently serving on the boards of Deere & Company (NYSE: DE), Wintrust Financial Corporation (NASDAQ:WTFC), OGE Energy Corp. (NYSE:OGE), Chicago’s Northwestern Memorial Hospital Foundation, The Chicago Network, the Chicago Shakespeare Theater, the Chicago Urban League and Sysco Corporation (NYSE:SYY). She served for 10 years on the board of the Rensselaer Polytechnic Institute, and for five years at Acco Brand Corporation (NYSE:ABD). She was a founding member and chairperson of the Information Technology Senior Management Forum, where she continues to serve on their advisory board. She also served on the Advisory Committee to the Board Selection Committee for Agenda, a Financial Times Company.

Ms. Talton has had significant tenures at many organizations that have pioneered the current technology environment (Cisco Systems, EDS, Ernst & Young) as well as founding a consultancy that was an early leader in communications network integration. Built significant businesses both within large enterprises and as independent start-ups, as well as new markets for companies moving into emerging countries.

Career milestones: Built Advisory Services Consulting Practice for Cisco Systems into a global, profitable organization. First Cisco executive to build Cisco’s China, Brazilian and Mexico’s globalization strategy, including private/public partnerships with the Chinese, Brazilian and Mexican governments. Created a $6 billion Solutions Consulting practice for EDS. Identified as a pioneer in the network integration consulting business as CEO of Unisource Systems.

Specialties: Big Data/data analytics Strategists and General Manager. Public/Private Partnerships in emerging markets, building services around product portfolios to extend product life cycles and protect profit margins and corporate governance.

10 October

08:00 AM
Devices Talk, Who’s Listening?
Keynote
Back

Todd M. Pope

President & Chief Executive Officer
TransEnterix
As President and Chief Executive Officer, Mr. Pope sets the company’s strategic vision and oversees its organic growth.

Mr. Pope has spent more than 25 years working in key leadership positions within the medical-device industry. Prior to joining TransEnterix, Mr. Pope served as worldwide president of Cordis, a multi-billion-dollar division within Johnson & Johnson’s medical-device sector. He previously held a number of leadership positions within Johnson & Johnson and Boston Scientific.

Mr. Pope has a special passion for managing emerging start-ups that have disruptive technologies with the potential to change the landscape of current standard of care.

10 October

12:30 PM
Keynote -Todd Pope and Campbell Rogers
Keynote
Back

Heidi Dohse

Sr. Program Manager, Founder
Google, Tour de Heart Foundation
In 1982 I was diagnosed with a rare arrhythmia and that was the beginning of my journey as a heart patient. I was one of the first AV ablations at University California San Francisco hospital in 1983 and have been 100% pacemaker dependent for over 30 years.

As a lifelong heart patient, I did not want to become a victim of heart disease. Instead I wanted to pursue my desire to become an athlete and competitive cyclist. After having open chest surgery in 2010, doing any kind of physical activity was a frightening idea. However, with the help of wearable devices and applications, I had the data I needed to get from the hospital bed to across the finish line of my first bike race. Since then I have competed in cycling events both domestically and internationally. My mission is to inspire others to do amazing things!

10 October

04:15 PM
Closing Keynote: Heidi Dhose
Keynote
Back

Campbell Rogers

Executive Vice President and ​Chief Medical Officer
HeartFlow
Dr. Rogers brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.
He received his A.B. from Harvard College and his M.D. from Harvard Medical School.

10 October

12:30 PM
Keynote -Todd Pope and Campbell Rogers
Keynote
Back

Jeffrey H. Burbank

Founder and CEO
NxStage
Jeff is NxStage’s Founder, Chief Executive Officer, and is a member of its Board of Directors. Jeff has over 20 years of in-depth management experience with companies developing, marketing and manufacturing products for End Stage Renal Disease patients. He has led NxStage since its inception, guiding it through all of its developmental phases to the successful initiation and rapid growth of commercial activities, its initial public offering, and the acquisition of Medisystems. Prior to founding NxStage, he co-founded Vasca, Inc., a company providing innovative implantable access devices, where he was the President and CEO, as well as Chairman of the Board. He gained significant renal industry experience during his nine years in the Renal Division at Gambro, Inc., with his last position as Director of Marketing and Advanced Technologies. During his career he has been an inventor on over 50 U.S. patents for medical devices.

Jeff received his BS in Industrial Engineering from Lehigh University.

10 October

03:30 PM
Getting to the Exit
Investment
Back

Martha Shadan

Global Vice President, Marketing; President & CEO
Smith & Nephew; Rotation Medical
Ms. Shadan joined Rotation Medical in 2013 as President & CEO with over 30 years of experience as a business leader in a variety of organizations. Rotation Medical, Inc. was acquired by Smith & Nephew plc in December 2017. Prior to joining Rotation Medical Martha was the President of the Trauma Division at Zimmer where she managed the P&L for the global business. Martha served at Covidien as VP/General Manager of Vascular Therapies and VP/General Manager BioSurgery and Sports Surgery. Other companies that have benefited from Martha Shadan’s experience and leadership include Bristol Myers Squibb Co. and Merck Millipore. Martha holds a M.B.A from Northeastern University, M.S. Biology, Michigan State University, and B.S. Biology, University of New Hampshire.

Ms. Martha Shadan is the Executive Chairwoman of the Board of Directors for a medical device start-up, IlluminOss. Ms. Shadan has served on the AdvaMed Board of Directors since 2017, the AdvaMed Accel Board of Directors since 2015. She was also a founding member of the Leadership Circle for AdvaMed’s Women’s Executive Network (WEN).

10 October

03:30 PM
Getting to the Exit
Investment
Back

Meg Eckenroad

Vice President, Women's Health
Hologic

10 October

09:30 AM
Women's Health
Tech
Back

Christopher von Jako

CEO
Dynatronics
Dr. von Jako was named CEO of Dynatronics in June 2018. He brings extensive leadership and experience in the global medical device market with over 25 years of focusing on development and commercialization of products to improve patient experience and outcomes. Most recently, Dr. von Jako was the President and CEO of NinePoint Medical, an advanced medical imaging GI company, where he successfully secured a significant strategic investment and long-term partnership with Merit Medical in May 2018. Prior to that, he served as President and CEO of NeuroTherm, a pain management business, until its acquisition by St. Jude Medical in August 2014. From 2010 until its divesture in 2013, Dr. von Jako was the President of ActiViews, a minimally invasive IR company. Earlier, he worked in senior executive roles of progressive responsibility with other leading medical device companies such as Integra LifeSciences, Covidien, Medtronic, and Radionics.
Dr. von Jako continues to serve as a board member of NinePoint Medical and nView Medical. He holds a PhD in Biomedical Sciences from the University of Pécs Medical School, a MS degree in Radiological Sciences and Technology from the department of Nuclear Engineering at the Massachusetts Institute of Technology, and a double BS degree in Physics and Mathematics from Bates College.

10 October

03:30 PM
Getting to the Exit
Investment
Back

Jeff Wyman

Vice President, InVentures
Smith and Nephew Advanced Surgical Device Division

09 October

01:00 PM
The State of Strategic Investments from Large Companies
Investment
Back

Susan A. Posner

Health Advances
Partner
Susan A. Posner co-leads the Medtech Practice Group at Health Advances, where she has worked on over 250 project engagements, with a wide variety of clients ranging from small start-ups to some of the largest public companies in the industry. Susan’s work with these companies has helped to optimize the value of products and technologies through extensive market and product evaluations, due diligence of M&A opportunities, and the development of strategies for sales and marketing efforts. Susan’s expertise includes women’s health and urology, critical care, surgical, and other physician office and hospital products. Susan has published articles in a number of industry journals and is a previous MassMEDIC board member.

Prior to joining Health Advances in 2000, Susan worked at Interneuron Pharmaceuticals, Inc. in the areas of business development, marketing, and product management. Susan’s high technology experience also includes Molten Metal Technology, Inc. Susan earned her BA in General Science with a minor in Business and Managerial Economics from Brandeis University.

10 October

03:30 PM
Getting to the Exit
Investment
Back

David Dykeman

Shareholder and Patent Attorney
Greenberg Traurig
David Dykeman, who co-chairs the firm’s global Life Sciences & Medical Technology group, is a registered patent attorney with nearly 20 years of experience in patent and intellectual property law. David’s practice focuses on securing worldwide intellectual property protection and related business strategy for high tech clients, with particular experience in life sciences, medical devices, nanotechnology, and information technology.

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
Back

Peter Stebbins

Transactions Lead, Medical Devices
Johnson & Johnson
Peter is Transactions Lead, Medical Devices, based at the Johnson & Johnson Innovation Center, Boston. In this role, he provides deal leadership in partnering with early stage companies across the medical device sectors.

Peter has been with J&J since a business school internship in 1990. He joined the JJIC in November 2016. His previous position was Vice President of Strategy for DePuy Synthes Orthopedics and Business Development for Codman Neuro. Prior to that, Peter held a series of VP positions in Marketing, Strategic Marketing and Business Development for Mitek Sports Medicine and Codman Neuro. He helped reposition Mitek from purely shoulder anchors to arthroscopy enabling solutions and to earlier intervention, exemplified by Orthovisc and Monovisc HA injections for OA. At Codman Neuro, he helped redefine their business by divesting the Instruments business unit and emphasizing neurovascular stroke intervention, exemplified by Micrus and Pulsar.

Before his stints in Ortho and Neuro, Peter spent the first half of his career in the Ethicon Surgery businesses, starting in Operations before going into Field Sales and into Marketing, including working in Scotland as Director of European Marketing for Ethicon.
Peter studied Chemical Engineering at Princeton on an ROTC scholarship before serving with US Army Forces in West Germany and attending Harvard Business School.

09 October

01:00 PM
The State of Strategic Investments from Large Companies
Investment
Back

Dr. Omar Amirana

Senior Vice President
Allied Minds
Dr. Omar Amirana leads the strategic direction and development of the Life Sciences portfolio and is currently the CEO of LuxCath, SciFluor and Biotectix. Omar previously served as Partner at Oxford Bioscience Partners, a Boston-based venture capital firm with ~$1B under management. There he led the Series A investment in nFocus Neuromedical (brain aneurysm therapy) which was sold to Covidien for ~$100M. Omar has served on a number of boards and is currently on the board of CardioFocus as well as the Ignition Awards Committee at BU. He has held varying operating roles in 5 startups as well as VP of Business Development at St Jude Medical (STJ). Omar is passionate about the beach, sports, and travel and enjoys spending time with his wife, baby daughter, and dog.

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
Back

Jeff Mann

Vice President
Deputy General Counsel at Cantel Medical

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
Back

Alex De Winter

Managing Director
GE Ventures
Alex is a Managing Director based in Boston and joined the team in 2013. Alex led investments in Labcyte, RainDance Technologies, Syapse, and Veracyte. He is focused on funding healthcare startups and helps build relationships between GE and innovation ecosystems on the East Coast. His portfolio spans precision medicine startups, including clinical diagnostics, life science instrumentation, bioprocessing, and data analytics. Prior to joining GE, Alex was a Partner at Mohr Davidow Ventures, specializing in healthcare and life sciences startups. Before Mohr Davidow, he was a Senior Scientist at Pacific Biosciences, working on systems integration for their Single Molecule Real Time DNA sequencing technology. Alex started his career as a scientist at 454 Life Sciences, where he worked on sample preparation and emulsion PCR for what became the first of the next-generation DNA sequencers. Alex has a PhD in Chemistry from Stanford University, an MBA from UC Berkeley, and degrees in English and Chemistry from Amherst College. He is a board observer at Labcyte, Nuvolo, andSyapse. Outside of work, Alex fancies himself an amateur lumberjack and enjoys gonzo cooking.

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
Back

Don Barry

External Innovations Lead
DePuy Synthes Companies
Don Barry is an External Innovation lead for DePuy Synthes where he evaluates technology and products for the Sports Medicine division. As an electrical and software bioengineer he has developed products for J&J, Hologic, DuPont, Medicept and was a founder and President of PointCare Technologies. Driving innovation that’s relevant to patient outcomes is a lifelong passion.

09 October

01:00 PM
The State of R&D: Can Big Companies Innovate?
Tech
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Ignacio Galiana, PhD

Program Manager, Soft Wearable Robotic Programs
Wyss Institute at Harvard University
Ignacio Galiana, PhD is a Staff Engineer and Program Manager for Soft Wearable Robotic programs at the Wyss Institute at Harvard University. He leads the soft exosuit projects in the Walsh Biodesign Lab where he is responsible for managing a multi-disciplinary team of staff engineers, functional apparel designers, experts in biomechanics, physiology and clinical collaborators to develop the next generation of soft wearable exosuits that can be worn like clothing to enhance human performance and protect against injury.

Galiana received his B.Sc. in Industrial Engineering, M.Sc. in Automation and Robotics and a Ph.D. in Automation and Control from Universidad Politécnica de Madrid in 2013 during his Ph.D. where he received multiple awards including the “best Ph.D. thesis in Europe on haptics” by the EuroHaptics society. His Ph.D. research focused on the development of human-machine interaction methods, and on the design and control of haptic devices for VR and Telerobotics. Following this, Ignacio Galiana was the technical lead for the Harvard team under the DARPA Warrior Web program to develop soft exosuits to enhance human walking performance.

10 October

10:15 AM
Robotics Panel
Tech
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Will Sutton

VP of Engineering & Technology
Minnetronix
Will Sutton joined Minnetronix in 2015 as Vice President of Engineering and Technology bringing more than 25 years of industry experience including research, development, innovation, manufacturing and commercialization. He is named inventor on four patents and has helped bring more than 100 products from concept to commercialization.

Will most recently served as Chief Operating Officer for California-based Hansen Medical, a medical robotics company. His experience also includes multiple executive positions in St. Jude Medical’s Atrial Fibrillation Division. At St. Jude, Will served as Vice President of program management and Site Manager for the Minnetonka operations before being named Vice President of Research and Development. He began at St. Jude as Director of Research and Development for cardiac surgery. Additionally, Will held executive, director and management positions at Vascular Solutions, Urologix, CR Bard and Abbott Labs.

Will earned both his Bachelor and Master of Science in Mechanical Engineering from Stanford University. At Stanford, his senior design project received the prestigious Gold Award from the National College of Engineering and Technology.


09 October

01:00 PM
The State of R&D: Can Big Companies Innovate?
Tech
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James H. Boll

SVP, New Product Development, Cynosure
Hologic
James Boll is the VP of R&D at Cynosure, a division of Hologic and has been with the company since 1993. James has 35 years’ experience in the medical laser industry and received his Masters of Engineering in Biomedical Engineering from the Renssalaer Polytechnic Institute and his Bachelor of Science in Biomedical Engineering from Boston University. His career began as an engineer at Wellman Labs. With this strong clinical background, he subsequently has designed and developed a wide range of lasers and delivery systems for medical applications in many specialties.

09 October

01:00 PM
The State of R&D: Can Big Companies Innovate?
Tech
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Jim Biggins

Founder, President & CEO
Access Vascular
After shadowing physicians in a Boston hospital and witnessing first-hand the delay in administering antibiotics to a severely ill patient due to infection risks from a catheter, Jim Biggins knew there had to be a better way. Leveraging his engineering expertise and experience with hydrogels, he applied those skills to found Access Vascular in 2015, with the goal of reinventing venous access. Jim has previously held engineering and new product development positions at Ocular Therapeutix, Boston Scientific and Medtronic. In these roles, he launched more than a dozen medical technology products from concept through commercialization. He also has been a partner in a venture creation group with responsibility for identifying opportunities, initiating companies and developing business strategies. Jim earned an M.B.A from Babson College and a B.S. in Plastics Engineering from the University of Massachusetts Lowell.

09 October

04:00 PM
Combination Products 101
Tech
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Theodoros Zanos

Assistant Professor, Neural Decoding & Data Analytics Lab
The Feinstein Institute for Medical Research
Dr. Theo Zanos received his Bachelor of Engineering degree in Electrical and Computer Engineering from the Aristotle University of Thessaloniki in Greece in 2004. In 2006 he received his Master of Science and in 2009 his Doctorate in Biomedical Engineering from the University of Southern California, Viterbi School of Engineering. His thesis, supervised by Dr. Vasilis Marmarelis, focused on developing novel machine learning and system identification approaches for Multi-Input Multi-Output hippocampal neural circuits.
In 2009, Dr. Zanos was recruited as a postdoctoral fellow by Dr. Christopher Pack to work at the Montreal Neurological Institute (MNI), McGill, in Montreal, Canada. At the MNI, he worked on high-channel-count primate electrophysiology, estimating correlations and connections between brain areas, detecting spatiotemporal patterns and predicting signals and behaviors based on data true models. He also worked on projects involving neurostimulation experiments that manipulate single neuron firing, intracortical oscillations, connectivity between brain areas and behavior and in 2014 he became a research associate at the MNI.
In 2016, Dr. Zanos accepted a position as an Assistant Professor at the Feinstein Institute for Medical Research, where he joined the Center for Bioelectronic Medicine as the head of the Neural Decoding and Data Analytics lab. The same year he was also appointed as Assistant Professor in the Department of Molecular Medicine at the Zucker School of Medicine, at Hofstra University.

09 October

03:00 PM
Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch
Tech
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Marissa Fayer

Founder & CEO
HERHealthEQ

10 October

09:30 AM
Women's Health
Tech
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Kim Bridges Rodriguez

President & CEO
Acessa Health
Kim Bridges Rodriguez brings nearly 20 years of medical device experience in cardiology, radiology, vascular surgery, neurology and women’s health.

Kim currently serves as the President and CEO of Acessa Health Inc., a privately held company, developing minimally invasive, uterine sparing solutions for women who suffer from symptomatic fibroids.

Prior to Acessa, she served at Spectranetics, as Senior Vice President of the Vascular Intervention business unit, which more than doubled US revenue under her leadership.Prior to Spectranetics, Kim has held several global vice president and management roles in sales, marketing, therapy development and general business management at companies such as Blockade Medical, Stryker Neurovascular, Concentric Medical, Johnson & Johnson, Guidant Corporation and ev3.

She received her Executive MBA at the University of Southern California Marshall School of Business and BS in Management from Pepperdine University.

10 October

09:30 AM
Women's Health
Tech
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Tom Calef

VP, Engineering
Activ Surgical
Tom is a highly accomplished medical roboticist and seasoned leader of engineering teams capable of developing breakthrough innovation in surgical robotics. Tom holds multiple patents in robotics and surgical devices and has an extensive track record of taking surgical robotic platforms to market, having managed multiple surgical robotics products through 510k approval.

Currently, was on the founding team of Activ Surgical, leverging technology developed at Childrens National Medical Center in Washington DC to create the first machine learning engine for surgical robotics. Activ is delivering innovative real time visualization and perception data to the surgical staff, enabling higher levels of confidence in even the most demanding procedures.

Prior to Activ, Tom was the Director of Advanced Robotics at Medrobotics, where he led the development and release of the first flexible surgical robotics platform .While at Medrobotics, Tom’s group was responsible for winning multiple design awards for innovation and product design of highly articulated surgical robotics. During his time there, he grew the Advanced Robotics group from 2 to 50+ employees including clinical, electrical, software, and mechanical engineering.

Prior to Medrobotics, Tom was a Systems Engineering Manager at RTS Life Sciences responsible for developing robotic platforms that were adopted across the pharmaceutical development industry and FDA. Tom started his career in robotics at Hatch Technology where he developed automation systems for multiple industries including DoD, Automotive, and consumer elect

Tom has a BS in Computer Engineering and a MS in Mechanical Engineering, both from the University of Massachusetts Dartmouth. Tom has extensive student mentoring experience while mentoring a local high school FIRST robotics team for 20+ years. He enjoys ocean activities such as fishing and boating with his wife, Auna and their 3 kids.

10 October

10:15 AM
Robotics Panel
Tech
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Paul Gudonis

Chairman & CEO
Myomo
Mr. Gudonis has been Myomo CEO for five years and has led the commercialization of the Company's portable home devices. Mr. Gudonis brings 30 years of experience in launching new technology-based products and services to Myomo. His career spans the fields of software, telecommunications, Internet services, and robotics. Mr. Gudonis served as President at FIRST robotics and as CEO of Genuity and Centra Software. Northwestern McCormick School of Engineering (BS) and Harvard Business School (MBA).

10 October

10:15 AM
Robotics Panel
Tech
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Jonathan Gimbel

Director & CER Business Unit Lead
R&Q
Jonathan Gimbel is Director at Regulatory and Quality Solutions (R&Q), an industry-leading regulatory and quality consulting firm that helps medical device and combination product companies bring safe and effective products to market… and keep them there. Jon has worked in the biomedical and medical device area for nearly 20 years, acting as a key member in a medical device startup, a consultant to a wide variety of medical device companies, and as a researcher on both academic and industrial projects. Having a thorough understanding of the ever-changing global regulations, Jon leads R&Q’s CER business unit and has been successful implementing regulations at multinational medical device companies: delivering business-balanced solutions for their business-balanced demands. Jon oversees clinical evaluations completed by R&Q and helps ensure compliance to MEDDEV 2.7/1 Rev 4. Jon also works with companies to develop strategies and plans to meet the new EU MDR requirements pertaining to clinical evaluations and post-market activities. Jon holds a Ph.D. in Mechanical Engineering and BioEngineering, and a Master’s degree in Mechanical Engineering, from the University of Pennsylvania. Jon received his Bachelor’s degree in the same subject from Penn State University.

09 October

08:00 AM
Advanced EU MDR and CER Workshop
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Nancy Morrison

Director of Regulatory Affairs
R&Q
Nancy Morrison has over 25 years of experience dealing with FDA regulated products in the pharmaceutical and medical device industry on both the Quality Assurance and Regulatory Affairs sides. As a quality professional, she has implemented GMP, QSR, and ISO 13485 compliant quality systems and led successful audits by FDA, Health Canada, Notified Bodies, TTB (Alcohol and Tobacco Tax and Trade Bureau), and many customers. As a regulatory affairs professional, she has experience in the pharmaceutical, cosmetic, and medical device industries with successful IND, NDA Supplement, Special 510k and traditional 510k submissions in the US with corresponding submissions in Canada and creation of technical files and design dossiers for the EU. Additionally, she has RAC credentials through RAPS that span US and the EU, which has equipped her with the skills necessary to be successful on projects relating to EU medical device regulations, specifically, ISO 13485 certification, technical files, design dossiers and Clinical Evaluation Reports.
Nancy has a proven track record for managing complex regulatory and quality projects to successful conclusion while meeting tight budgets and timeline targets. She has the skill to balance regulatory requirements with business priorities to offer multiple solutions to best fit the situation, whether for a small startup or an established, multinational company. Rather than allowing regulations to limit possibilities for her clients, she has the unique ability to use them to identify opportunities, ensure compliant processes, and anticipate changing circumstances to enhance effectiveness. Nancy is a strong team player that deploys exceptional verbal and written communication skills to build collaborative, long-lasting relationships with stakeholders to ensure the success of every project, product and business.

09 October

08:00 AM
Advanced EU MDR and CER Workshop
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Barb Taylor

Director of Marketing
Portal Instruments

09 October

04:00 PM
Combination Products 101
Tech
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Jeff Champagne

Director, Business Development
MPR Product Development
With a background in R&D and Marketing, Jeff Champagne has a decade of product development experience. Focused on Life Sciences but crossing over multiple industries including Biotech, Medical Device, Energy, Advanced Materials, Specialty Chemistry, Food & Beverage, and Consumer Products, Jeff helps clients to solve their biggest challenges by mediating discussions with subject matter authorities and engineering experts. Well versed in Connected Health, Intellectual Property Strategy, Stage-Gate Process for the development of product pipelines, Regulatory Affairs and Technology Transfer, Jeff is able to help guide clients in their efforts to commercialize new products and launch startup companies. Over the last 6 years, Jeff has been immersed in helping the most innovative companies in the world to make their product plans into tangible commercial products. With a Bachelor’s in Visual Communication Design and MBA focused on Market Strategy, both from the University of Hartford, Jeff brings a fresh perspective to clients’ product development projects.

09 October

03:00 PM
Collisions of Value
Investment

10 October

02:30 PM
What To Do When Things Go Sideways
Tech
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AN

Artha Nafie

EU MDR Program Manager
Independent Consultant

09 October

08:00 AM
Advanced EU MDR and CER Workshop
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Ronald Sills

TUV Rheinland – North America
Lead Auditor – Medical
MS in Biological Sciences – Southern Connecticut State University
BS in Biological Sciences – University of Connecticut

Ron has worked for over 25 years in the medical devices industry in various capacities: as a QA Manager for a leading endoscope manufacturer, a research consultant supporting medical device, pharmaceutical and life sciences companies in the areas of research & development, regulatory compliance and patent research, and as a Lead Auditor for a notified body. With TUV Rheinland, Ron has the Lead Auditor authorizations for many certification schemes for quality systems including EN ISO 13485:2016, ISO 9001:2015 and the MDSAP program, and the EU directives and regulations. He has specialty expertise in non-active medical devices as well as sterilization, biocompatibility, and clinical evaluation.

09 October

08:00 AM
Advanced EU MDR and CER Workshop
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Karen Corallo

Regulatory Attorney and Shareholder
Greenberg Traurig LLP
Karen C. Corallo is the former Director of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Drug Imports, Exports, Recalls, and Shortages. In this role, Karen authored and executed the Agency’s global drug imports strategy, managed operations and supervised staff, and spearheaded important drug policy initiatives for the Agency. Before that, Karen was Associate Chief Counsel in FDA’s Office of Chief Counsel, where she worked with the Department of Justice Consumer Protection Branch on enforcement matters involving all FDA-regulated commodities and with U.S. Attorneys’ Offices across the country on criminal enforcement matters. In addition to her government work, Karen was a commercial litigation partner for a global law firm and also served as in-house counsel at a Fortune 100 company.
Karen represents pharmaceutical, medical device, and food industry clients, advising them in litigation and providing counsel to businesses on administrative, regulatory, and enforcement matters.

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
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Trevor Chaplick

Corporate Attorney and Shareholder
Greenberg Traurig LLP
Trevor J. Chaplick focuses his practice on representing technology and growth companies, underwriters, private equity firms, and venture capital funds in a broad range of corporate and transactional matters, including mergers and acquisitions, public offerings, financings, as well as in general corporate and securities law matters.
Trevor has represented numerous public companies in merger and acquisition transactions, including: Access Health; Actel Corporation; Cypress Semiconductor; Glodon Software Co. Ltd.; InfoSpace; Intellon Corporation; Luna Innovations; Microchip Technology; and U.S. Web. Investors Trevor has represented in structuring private equity and venture capital financings include: Accuitive Medical Ventures; Andreessen Horowitz; Cargill Ventures; Carlyle Ventures; Core Capital; Draper Atlantic; Inflection Point Venture Partners; International Finance Corporation; Institutional Venture Partners; New Enterprise Associates; Novak Biddle Venture Partners; Paladin Capital Group; Storm Ventures; Valhalla Partners; Warburg Pincus; and WWC Capital.


Trevor has represented issuers, underwriters, and investors in numerous public offerings, including: @Home; Access Health; Anergen; Cell Genesys; CellNet Data Systems; ChannelAdvisor Corporation; Clarify; Coinstar; Eagle Test Systems; GlobeSpan; Intellon Corporation; Luna Innovations; Maxygen; Rudolph Technologies; SmartDisk; and Ventana Medical Systems. He has represented the following underwriters in securities offerings: Banc of America; Deutsche Banc Securities; Friedman Billings Ramsey; Goldman Sachs; Lehman Brothers; Merrill Lynch; Morgan Stanley; and Robertson Stephens.

Trevor has significant international experience, having structured public and private acquisitions and investments in many countries, including the UK, China, Denmark, Germany, India, France, South Africa, Switzerland, Belgium, and Canada. He has represented numerous companies in raising capital from institutional investors across many industries, including software, communications, the Internet, alternative energy, entertainment and media, semiconductors, healthcare, medical devices, and biotechnology.

Trevor was previously a partner with Proskauer Rose and was managing partner of its Washington, D.C. office from 2007 to 2014. Prior to joining Proskauer, Trevor was a partner with Wilson Sonsini Goodrich & Rosati (WSGR), where he founded and was managing partner of the firm’s first East Coast offices in Washington, D.C. and Virginia from 2000 to 2007. Before founding such offices, he spent many years practicing law in Silicon Valley with WSGR, where he also served on the firm's Operations and Strategy Committees. Trevor began his legal career at Latham & Watkins LLP in San Francisco. He is a CPA in the state of Virginia and worked in the financial services group of Arthur Andersen LLP in Washington, D.C. from 1985 to 1987.

09 October

04:00 PM
Investment Panel - Hot Topics
Investment
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Mike Labbe

Director, R&D
Valtronic
Mike Labbe is an experienced leader with over 25 years managing full life cycle development and commercialization of complex medical devices and technologies. He has managed R&D budgets of >$10M across electrical, software, mechanical, chemical, systems and test engineering teams. Labbe has experience with all phases of product development; clinical research and input, product and system architecture and requirements, detailed design, engineering testing, verification and validation, regulatory submissions, design transfer and ongoing product maintenance and updates.

09 October

03:00 PM
Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch
Tech
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Susan Bagen

Application Development Manager
Micro Systems Technologies
Susan Bagen has been Application Development Manager for Micro Systems Technologies, Inc. since 2014. Her current focus is on the development and manufacturing of advanced medical devices, particularly Class III implantable. She is involved in a number of technical development activities using novel biocompatible materials for in vivo and directly implantable devices for neurostimulation, diagnostic and therapeutic applications.

Prior to joining MST, Susan was Business Development Manager and Sr. Field Applications Engineer for i3 Electronics, formerly Endicott Interconnect Technologies, for 7 years. She began her career in a variety of process engineering development roles with Texas Instruments, and has extensive experience as a process and product engineering consultant focused on high reliability, high performance electronic packaging applications. She holds a Bachelor of Science degree in Chemical Engineering from Case Western Reserve University in Cleveland, Ohio and has 5 US patents. Susan is a registered Professional Engineer in the State of Texas. She has co-authored a number of technical papers, and also served as conference chair and on various technical committees for IEEE and IMAPS over the last 30 years.

09 October

03:00 PM
Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch
Tech
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Jesse Wheeler

Neurotechnology Business Lead
Draper Laboratory
Jesse Wheeler is the Neurotechnology Business Lead at Draper Laboratory, an advanced R&D company that is creating next-generation Biomedical Solutions. His interests include implantable micro-systems for medical therapies, biomimetic systems for efficient processing and control, and cybernetic systems that optimize cooperative interactions between biology and machines.

Jesse holds degrees in physics and biomedical engineering and conducted his doctoral research at Washington University in St Louis. Jesse’s doctoral work focused on closed-loop neural interfaces to restore movement and sensation of touch through neuroprosthetics and re-animation of paralyzed limbs. This body of work includes neuro-computational modeling, neuromuscular and skeletal dynamics, design of novel chronic neural interfaces, circuit design for closed-loop neural recording and stimulation, and development of co-adaptive algorithms for accelerating learning and cooperation between humans and machines.
As Draper Laboratory’s Neurotechnology Business Lead, Jesse manages a diverse portfolio of neurotechnologies. His biomedical work at Draper includes the development of next-generation medical implants with high-fidelity electrodes, responsive therapies, and wireless connectivity. Examples include a 320-channel closed-loop brain implant for treating neuropsychiatric disorders and a network of miniature wireless implants for restoring sensorimotor function to amputees. Jesse has also applied neurotechnology solutions to non-medical applications, which includes the development of cybernetic systems that use neural interfaces to achieve cooperative control between biology and machines.

09 October

03:00 PM
Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch
Tech
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Paul Schultz

Head of Partnerships
Flex Digital Health
Paul Schultz, Head of Partnerships, Flex Digital Health, has over 10 years of experience in the pharmaceutical, medical device and digital health industries. Paul started his career as a management consultant for the leading global life science consulting firm, Campbell Alliance (now Syneos Health) where he spent 4 years supporting global pharma and medtech clients, including leading numerous digital health initiatives. Paul then co-founded Nurep, a digital health startup with a vision of disrupting the $30B medical device sales rep market. Paul took Nurep from concept to clinical validation over 5 years in partnership with a large academic medical center and a leading medical device company while raising several million in funding from top early-stage investors. After Nurep, Paul was an entrepreneur-in-residence at Stanford StartX Med, the Stanford affiliated start-up accelerator, supporting their Med portfolio with strategic initiatives and partnerships. Paul is now the Head of Partnerships at Flex Digital Health, leading the partnership with Google in addition to other key strategic partnerships.
Paul holds a Master in Business and Science from Keck Graduate Institute, a member of the Claremont Colleges, and a Bachelor of Science in Biotechnology from Washington State University.

09 October

01:00 PM
Leveraging Data and Machine Learning to Accelerate Medtech Innovation
Ecosystem
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Renee M. Sullivan MD, FACC

Covance
Medical Director Cardiovascular, Metabolic, Endocrine & Renal
Dr. Renee Sullivan is board certified in Internal Medicine and Cardiovascular Disease and trained in Clinical Cardiac Electrophysiology.She is a Medical Director in the Cardiovascular, Metabolic, Endocrine, Renal therapeutic area at Covance.She joined Covance in December 2014 and in this role is responsible for providing medical and scientific expertise, consultation and leadership for project teams and site investigators; designing and reviewing clinical trial protocols; and performing medical monitoring for clinical research trials.She serves as a Covance medical expert in cardiovascular, cardiac electrophysiology and device-based therapeutics.

Prior to joining Covance, Dr. Sullivan worked in academic practice during which time she was involved in clinical research.She is an invited national and international speaker for Continuing Medical Education courses, invited lectures, and society conferences.She is a Fellow of the American College of Cardiology and has served on various American College of Cardiology committees at the state and national levels.She is a member of the Heart Rhythm Society, European Cardiac Arrhythmia Society, and American Heart Association.She has published in the areas of anticoagulation in patients with atrial fibrillation (with an emphasis on gender differences), arrhythmias, and cardiac implantable electronic devices.Dr. Sullivan completed a combined BA/MD program at the University of Missouri- Kansas City and completed her residency and chief residency in Internal Medicine and fellowships in Cardiovascular Disease and Clinical Cardiac Electrophysiology at the University of Iowa Hospitals and Clinics.

10 October

09:30 AM
Women's Health
Tech
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Michael Halpin

VP, Regulatory Affairs
Vericel
Mike joined Vericel in April of 2017 with over 28 years of regulatory, quality assurance, and clinical research experience with a variety of medical device, combination product, small molecule, biologic, and advanced therapy technologies. Prior to joining Vericel, Mike was with Sanofi and Genzyme Corporation; most recently as vice president, North American region regulatory head with responsibility for Sanofi Genzyme’s rare disease, immuno-inflammatory, multiple sclerosis and other business unit products. Mike has also served as vice president, regulatory affairs for Genzyme’s biosurgery division, with regulatory oversight of all biosurgery and cell and gene therapy products, including Carticel®, Epicel®, and MACI®. Prior to Genzyme, Mike held a number of regulatory, quality, and clinical affairs positions at several medical device companies, including Abbott/MediSense, C.R. Bard, and Abiomed. Mike received his master’s degree in biomedical engineering and bachelor’s degree in biochemistry from the University of Virginia.

09 October

04:00 PM
Combination Products 101
Tech
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Chuck Brokish

Director of Business Development
Green Hills Software

09 October

04:00 PM
Securing Connected Medical Devices and Systems against Cyber Attack
Ecosystem
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Mark Boden

Senior Fellow Corporate Research
Boston Scientific
Mark is a Senior Fellow in the Corporate Research Division of Boston Scientific.He has been at Boston Scientific for 15 years, working in the fields of Interventional Cardiology, Peripheral Vascular, Urology, Women’s Health, and Endoscopy.Prior to Boston Scientific, Mark worked on development and manufacturing of biosensors.He has a dual Ph.D. from UMass Lowell in Polymer Chemistry and Plastics Engineering and specializes in biomaterials, drug/device combination products, and early stage research into disease states.Current activities include Tech Scouting, establishing and maintaining University partnerships, managing Exploratory Projects, and membership on several University and Government Advisory Boards of interest to Boston Scientific.

09 October

01:00 PM
The State of R&D: Can Big Companies Innovate?
Tech
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Anthony Moffa

Senior Director of Product Management for ThingWorx IIoT Platforms
PTC
Anthony Moffa is Senior Director of Product Management for ThingWorx IIoT Platforms where he manages the Axeda product line and portions of the ThingWorx product line.
Prior to PTC he was with Becton Dickinson, helping them revitalize their remote diagnostic program, growing their install base by a factor of 13x’s in the first 12 months, ultimately saving the company more than the program cost.Anthony has also worked for Tyco International.
A graduate of Villanova University’s College of Engineering and a certified Lean Practitioner and Six Sigma Master Black Belt. He started his career as a manufacturing engineer in GE’s Aerospace Group but has spent a majority of his career designing, building, implementing and servicing diagnostic systems.

10 October

01:30 PM
Digital Disruption in Life Sciences - It Takes More Than Technology
Tech
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David Parish

Healthcare Solutions
Google Cloud

David Parish works on healthcare artificial intelligence in Google’s Cloud organization. An electrical engineer by training, he has spent a career in technology and business development for several different industries. He did scientific work in the early days of magnetic resonance imaging, where among other things he developed novel cardiac imaging techniques. He also developed wireless communications systems including pioneering signal processing techniques for “smart antennas” many of which have now become commonplace. More recently, David has applied machine learning to pharmacometrics and internet advertising and also worked on a training system for robotic surgery. He holds undergraduate degrees in mathematics and electrical engineering, a masters degree in electrical engineering, and a PhD in structural biology.

09 October

01:00 PM
Leveraging Data and Machine Learning to Accelerate Medtech Innovation
Ecosystem
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Thomas Lutzow

Director of Human Centered Industrial Design
Ximedica
Tom has been with Ximedica for nine years, and as Director of Human Centered Industrial Design, he generates extensive iterative design methodologies as well as guided materials research. When working with vendors he is solution-oriented, as he utilizes findings from bench testing, multi-sensory testing, and human factors research to guide the creation of new and highly specialized, bio-compatible materials for human subject use. He has created functional design solutions that marry the needs and perspectives of design, user research, engineering, and manufacturing, ultimately creating a harmonious cross-functional relationship between these inputs.  Tom is a key team member involved in developmentally focused research activities such as pre-clinical research activities, clinical trials, focus groups, and ethnographic interviews. Tom graduated from the Savannah College of Art and Design with a BFA in Industrial Design, and is Co-Chair of the Rhode Island chapter of the IDSA.

09 October

03:00 PM
Innovation in Context
Ecosystem
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Adriel Desautels

Managing Partner & CEO
Netragard

09 October

04:00 PM
Securing Connected Medical Devices and Systems against Cyber Attack
Ecosystem
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Ayan Bhandari

Senior Human Centered Industrial Designer
Ximedica
Ayan is a Senior Human Centered Industrial Designer at Ximedica. He uses systems level thinking to synthesize complex, multi-layered problems in the medical industry, to create usability driven solutions. This process requires a dynamic design skillset, collaboration with cross-disciplinary teams, and the ability to advise and guide a client through the medical development process.

Since graduating from Virginia Tech in 2013, Ayan has honed his skills at various start-ups and corporations, culminating at Ximedica. He mentors and advises at various colleges, and is the Co-Founder and CEO of nuway, developing safety equipment for passengers, on motorcycle taxis, in Uganda.

09 October

03:00 PM
Innovation in Context
Ecosystem
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Per Bergman

VP, R&D
Corindus Vascular Robotics
Per is the VP or Research of Development for Corindus, where he focuses on new product development and advanced technologies. Per has extensive experience in medical device product development, systems and software engineering, and program management. Over the last 7 years, Per has grown the Corindus R&D team to 20+ engineers in the disciplines of software, controls, mechanical, electrical, and systems engineering. Per has managed multiple products from inception through 510k, including the CorPath® GRX system for robotic assisted PCI.

Prior to joining Corindus, Per was the technical manager for neurodiagnostic devices at NEUROmetrix, developing point-of-care products for nerve conduction studies of neuropathies such as carpal tunnel syndrome. Prior to NEUROmetrix, he was the Systems Development Manager at DelSys where he worked on a variety of products and projects ranging from wireless sensors, embedded systems and software, toEMG assessment techniques.

Per has a MS in Mechanical Engineering from Royal Institute of Technology, Sweden, with focus on Mechatronics.

10 October

10:15 AM
Robotics Panel
Tech
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RD

Ryan Downs

VP, Partner
MPR

10 October

02:30 PM
What To Do When Things Go Sideways
Tech
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EC

Eric Claude

VP, Product Development
MPR

10 October

02:30 PM
What To Do When Things Go Sideways
Tech
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Chris MacDonald

Senior Director of Analytics Business Development
PTC
Chris joined PTC through the acquisition of Coldlight in May of 2015. Chris has been a leader and technologist in the Analytics space throughout his career. Through his work at companies such as Xerox, SAP, Oracle, Coldlight, and now PTC, Chris has helped companies across every vertical harness the value of data-driven innovation. Leveraging his expertise in purpose built IoT Analytics, Chris remains focused on unlocking potential opportunities in evolving data ecosystems using innovative technologies. In his current role as Senior Director of Analytics Business Development at PTC he has responsibility for both GTM Strategy and global Business Development of the ThingWorx Analytics capabilities.

10 October

01:30 PM
Digital Disruption in Life Sciences - It Takes More Than Technology
Tech
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Green Hills Software

Platinum
Green Hills Software is the largest independent embedded software provider. With the most safety and security certifications and the best track record for solving embedded problems, Green Hills Software has been leading the embedded world since 1982.
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Minnetronix Medical

Platinum
Minnetronix is a medical technology and innovation company with deep expertise in electronic and electromechanical devices. Founded in 1996, the company creates new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies. Minnetronix is FDA Registered and ISO 13485 Certified.
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MPR Product Development

Platinum
Every day, MPR’s motivated and talented engineering professionals make a difference in locations around the world. We’re working to solve energy shortages by helping to develop the next generation of technologies and improving the operations of existing power plants, and we’re applying advanced technologies to ensure cleaner air and water. MPR is developing innovative medical devices and biotechnology products that offer solutions to world health problems, and we’re on the frontier of smart technologies, developing innovative improvements to make critical systems more secure.
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Regulatory and Quality Solutions LLC (R&Q)

Platinum
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing balanced solutions and hands-on support that enhance the commercialization and post-market processes for medical devices.
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Toxikon

Platinum
Toxikon is a preclinical contract research organization. We contract and partner with biotech, pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.
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Valtronic

Platinum
We innovate and manufacture miniaturized and high-precision complex products for our worldwide medical device partners. Our customers are leading suppliers of active implants, medical-grade wearables as well as medical and portable medical equipment. Our activities also cover advanced industrial assemblies, another field where our expertise and sense for innovation are appreciated the world over. For over thirty years, we have helped hundreds of companies develop and produce Class II & III medical devices as well as advanced miniaturized electronic assemblies. Headquartered in Switzerland, our company spreads over three continents with design, development, industrialization and manufacturing sites in Switzerland, the United States and Morocco and employs more than 350 employees worldwide.
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Ximedica

Platinum
Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy.
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Greenberg Traurig

Diamond
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Vaupell

Diamond
Vaupell designs, engineers, and produces custom, high performance engineered plastic and composite components and assemblies for demanding applications. We are the global market leader in plastics components and assemblies for aircraft interiors while also serving the broader aerospace, defense, medical, and commercial markets. Vaupell provides engineered solutions to top tier OEM’s, market-leading growth companies, and promising start-ups. Collaboration with our customers in all phases of a the product life cycle results in the highest value solutions that reduce time to market, manage risk and control costs.
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The MedTech Conference

Gold
The MedTech Conference is your opportunity to connect with thousands of medical technology professionals in one place, at one time. Join us in Philadelphia for business development, innovative technology, and networking with 3,000+ policymakers, business executives and industry leaders.
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Asahi Intecc

Gold
Asahi Intecc develops, produces and sells guide wires, guiding catheters and balloon catheters which are medical devices indispensable for catheter treatment.With its excellent development capabilities and production technologies in the medical device field, Asahi Intecc has a high share not only in Japan but in the world as well.
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Compounding Solutions

Gold
We strive to help accelerate and simplify the product development and FDA approval process. We offer custom compounding to achieve a wide range of colors utilizing pigments listed under the FDA 21 CFR 73 Subpart D colorants exempt from certification in medical devices.
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CPSL Language Services

Gold
CPSL Language Services, is one of the longest-established LSP in the translation and localization industry, having served clients for over 50 years in a range of industries including: life sciences, energy, machinery and tools, transport, software, telecommunications, financial, legal, electronics and government. We are among a select number of language service suppliers that are triple quality certified, including ISO 9001, ISO 17100 and ISO 13485 for medical devices.
We offer a full suite of language services, -translation and localization, interpreting and multimedia & eLearning related services, such as transcription, voice-over and subtitling-. Based in Barcelona (Spain) and with production centres in Madrid, Ludwigsburg (Germany) Boston (USA) and a sales office in the United Kingdom, we offer language integrated solutions on both sides of the Atlantic Ocean, 24/7/365 timeline.

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Design Standards Corporation

Gold
For over 40 years, Design Standards Corporation has been manufacturing precision medical devices for many of the biggest health care suppliers. We specialize in design and manufacture of disposable and reusable medical devices and instrumentation.
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EXB Solutions

Gold
EXB Solutions, Inc. (EXB) is an engineering services company focused on systems engineering and testing for safety and mission-critical software and systems. We are a Service-Disabled Veteran-Owned Small Business (SDVOSB) in the aerospace, defense, medical, critical infrastructure, and high-tech marketplace with over 14 years of performance history
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Goddard

Gold
Our success is driven by an interdisciplinary development process that combines extensive and diverse engineering experience with manufacturable and creative industrial design solutions. We are the leaders in product design and engineering in the greater Boston area. Our logo reflects the culmination of a long research effort designed to distill the core values of our company. The gear exemplifies the technical precision of our engineers while the lower ring symbolizes the vision and innovation of our industrial designers. The center ring bonds the two disciplines together and represents our unique product development process. This proven recipe continues to give our clients the highest standard in on time and on budget product development.
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Healthlink

Gold
At HealthLink, our mission is to be the number one choice for life science manufacturing companies looking to outsource their logistics and back office services. We achieve this by reducing costs throughout the supply chain and consistently delivering the highest standards in service, quality and efficiency.
HealthLink currently serves more than 130 life science manufacturing clients. We specialize in:
  • Warehousing, Logistics & Fulfillment
  • Value Added Services
  • Reverse Logistics
  • Multilingual Customer Services
  • VAT Processing & Deferment
  • Finance & Administration
We are experts in the medical device, diagnostic, human tissue and pharma industry, supporting our clients’ growth in an ever-changing market. Whether you are growing rapidly, changing facilities or switching distribution channels, we seamlessly support your operations throughout the process, in your timeframe.
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M2D2

Gold
The Massachusetts Medical Device Development Center (M2D2) is a lifeline for the state’s smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and the UMass Medical School campuses of the University of Massachusetts.
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Medmarc

Gold
Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve. From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me, George Ayd (800) 356-6886, to discuss the cost of insurance coverage, what coverages are needed and when, for your business plan.
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Propel PLM

Gold
At Propel, we’re building modern cloud Product Lifecycle Management, Product Information Management and Quality Management software to help propel your digital transformation. Whether you’re at an established company dealing with potentially more nimble competitors, or you’re ramping a young startup and scaling your business, Propel’s cloud software can help.
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PTC

Gold
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The Qt Company

Gold
Qt Group is a global software company with a strong presence in more than 70 industries. QT is the platform of choice for medical devices, in-vehicle systems, industrial automation devices, and other business-critical application manufacturers. QT is used by major global companies and developers worldwide, and the technology enables its customers to deliver exceptional user experiences and advance their digital transformation initiatives.
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Velentium

Gold
Velentium offers world class expertise in software, usability, cybersecurity, electrical, and mechanical development for medical devices. Our decades of experience, solid program management and systems engineering will ensure the success of your product.
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Consulate General of Canada

Gold
The Trade Commissioner Service (TCS), part of the Government of Canada, is a network in 161 offices around the world and across Canada. Trade Commissioners provide Canadian business and innovation clients with practical advice, on-the-ground intelligence, and connections to help them achieve their global goals. Our team of nine Trade Commissioners in Consulate General of Boston work along sector lines and manages the CTA. Our priorities align with what New England has to offer and where Canada has strengths: life sciences, IT (AI, clean tech, digital health), agriculture (including food tech), consumer and retail, aerospace and defence, robotics and ocean technologies.Trade Commissioners work with businesses in New England by making connections to Canada, driving value and innovation to the region.
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Design Concepts

Gold
Design Concepts is a full-service product design and innovation consultancy with offices in Madison, Wisconsin, San Francisco and Boston. We design products, services and experiences that drive business success and improve people's lives. Our process has been tested and refined through the completion of more than 2,700 projects for over 400 clients. Our research, design and engineering services deliver world-class strategies, physical products, digital products and services to clients in the healthcare, commercial and consumer industries.
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Medidata

Gold
Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
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Chiltern

Gold
Covance® and Chiltern, a Covance company, make the drug development business of LabCorp. As the world’s most comprehensive drug development company, we are dedicated to advancing healthcare through a Designed Around You® experience and delivering Solutions Made Real®.

Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, we transform today’s healthcare challenges into tomorrow’s solutions. Information on our solutions can be obtained through our website at www.covance.com.


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MintzLevin

Gold
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Boston UX

Gold
Boston UX designs compelling touchscreen interfaces for high-impact embedded and connected medical devices. We pair intuitive interface design with expert engineering to create devices both beautiful and buildable.
Boston UX:
Helps you meet stringent FDA regulatory requirements
Defines the product features that will appeal to your customers
Applies Design Thinking best practices to create powerful designs
Creates UIs with engaging visual imagery and clever animations
Validates designs with real-world users to gain the insight needed to develop products of superior quality
Boston UX is part of the Integrated Computer Solutions family, a product-driven software company offering development, project management and consulting services.
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Accumold

Gold
Accumold® is a high-tech manufacturer of precision micro molded plastic components with part geometries from 5cm to less than 1mm in size. Processes include: insert molding, clean room molding and 2-shot molding. Materials include: PEEK, Ultem, LCP, and most engineered thermoplastics. Markets include: Micro Electronics, Medical, Micro Optics, Sensors and other emerging technologies.
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NAGLREITER

Gold
NAGLREITER Medical Device Development Organization (MDDO) is a trusted partner for concept incubation, design, development and manufacturing engineering services within the Medtech industry. NAGLREITER prides itself on providing world-class services and employing a uniquely flexible business model to do so. NAGLREITER’s ‘The Right Path. With You’ business philosophy exemplifies the company’s commitment to partnering with clients in any way they require to yield the best possible outcomes. Based in the Ft. Lauderdale area in Miramar, Florida, NAGLREITER partners with medical device companies within the U.S. and abroad
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NAMSA

Gold
NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world. NAMSA operates 13 offices throughout North America, Europe and Asia, and employs over 1,000 highly-experienced laboratory, clinical and consulting Associates.
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Davis Companies

Gold
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Celestica

Gold
A $6B global provider of product lifecycle solutions, Celestica drives enhanced quality and competitiveness for some of the world’s leading healthcare companies. We specialize in solutions for high-reliability applications from design and manufacturing through to delivery and after-market support. With focused expertise in complex electro-mechanical systems and ultra-high volume automated finished goods manufacturing for single use devices, Celestica helps our customers accelerate market entry, reduce total cost and advance healthcare technology to improve patient care. We also specialize in advanced solutions for surgical instruments, in-vitro diagnostics, and imaging and patient monitoring. Through our certified Healthtech Centers of Excellence network and enterprise-wide global quality system, we ensure flawless execution in compliance with the most rigorous quality standards.
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Foster

Merchandise Sponsors
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SalesForce4Hire

Merchandise Sponsors
SalesForce4Hire provides strategic commercialization, consulting, and recruiting solutions for medical device, diagnostics, biopharma, and information technology companies and their investors.   Our risk-sharing, Client-driven engagement model is non-disruptive and provides a seamless “plug and play” solution that easily integrates into the client company.

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Product Creation Studio

Merchandise Sponsors
Product Creation Studio is an integrated medical product design and engineering consultancy in Seattle. We work hard to deliver user-focused design powered by deep technical expertise. We supercharge our client's product development efforts by reducing time to market and providing an exceptional user experience for increased market success.
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KDB

WiFi Sponsor
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RBC Medical

Merchandise Sponsors
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S2N Health

Hospitality Sponsor
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MassMEP

Hospitality Sponsor
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Finnegan

Hospitality Sponsor
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Additive Manufacturing Today

Media and Supporting Partners
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Design World

Media and Supporting Partners
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Digital Health Today

Media and Supporting Partners
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Drug Delivery Business News

Media and Supporting Partners
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Insight Exchange Network

Media and Supporting Partners
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MassBio

Media and Supporting Partners
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MassDevice

Media and Supporting Partners
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Medical Design Briefs

Media and Supporting Partners
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Medical Device Developments

Media and Supporting Partners
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MEDInnovation

Media and Supporting Partners
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Med Tech Directory

Media and Supporting Partners
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Medtech Innovator

Media and Supporting Partners
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Microwave Journal

Media and Supporting Partners
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OCTane

Media and Supporting Partners
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Prototype Today

Media and Supporting Partners
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SEMDA

Media and Supporting Partners
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Re-Work

Media and Supporting Partners
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The MedTech Conference

Media and Supporting Partners
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Compliance Online

Media and Supporting Partners
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NE Healthcare Executive Network

Media and Supporting Partners
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CIMIT

Media and Supporting Partners
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AI Med

Media and Supporting Partners
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Medgadget

Media and Supporting Partners
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ReWork

Media and Supporting Partners
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MassMEDIC

Media and Supporting Partners
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Accumold

Accumold® is a high-tech manufacturer of precision micro molded plastic components with part geometries from 5cm to less than 1mm in size. Processes include: insert molding, clean room molding and 2-shot molding. Materials include: PEEK, Ultem, LCP, and most engineered thermoplastics. Markets include: Micro Electronics, Medical, Micro Optics, Sensors and other emerging technologies.
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Advamed

The MedTech Conference is your opportunity to connect with thousands of medical technology professionals in one place, at one time. Join us in Philadelphia for business development, innovative technology, and networking with 3,000+ policymakers, business executives and industry leaders.
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Alira Health

Alira Health simplifies the complicated journey that is the healthcare and life science product and corporate lifecycle. With us, you get a full spectrum of advisory support to help you overcome your strategy, execution, and innovation challenges from one dedicated partner committed to your best outcomes. We respect the journey that life science and healthcare innovators and market leaders must take. We’re committed to helping our clients arrive at their destination with confidence and a competitive advantage.

We’re on a mission to grow healthcare and life science innovation companies. Alira Health partners with clients to identify the best roadmap for advancement and goal realization. We provide the right financial, scientific, clinical, and marketing tools to empower their ideas, implement their strategies and succeed at every turn.
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ALKU

ALKU is a highly-specialized consulting firm that provides FDA Compliance and Remediation staff augmentation services exclusively within the Medical Device and Diagnostics industry. ALKU’s core competencies include Quality, Validation, Regulatory Compliance, and Project Management consulting services.
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Applied Marketing Science

Our expertise in medical products and healthcare comes from nearly thirty years of serving the world’s best-known companies, as well as emerging ventures, in medical devices, diagnostics, life sciences, pharmaceuticals and healthcare delivery. Our team has advised innovators in nearly every clinical specialty. Clients trust us to execute high-quality market research for healthcare markets that informs global product strategy, design and marketing decisions. We deliver actionable insights to help you better understand clinicians, administrators, payors and patients, leading to improved patient outcomes, more satisfied providers, and better financial returns. Rely onour expertsto create innovative medical products and distinctive patient and clinician experiences.
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Asahi Intecc

Asahi Intecc develops, produces and sells guide wires, guiding catheters and balloon catheters which are medical devices indispensable for catheter treatment.With its excellent development capabilities and production technologies in the medical device field, Asahi Intecc has a high share not only in Japan but in the world as well.
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BBraun

B. Braun’s OEM Division delivers complete contract manufacturing capabilities focusing on fluid administration and admixture products, kits, valves, catheters and interventional accessories. In-house services include product development, laboratory, design, prototyping, tooling, molding, validation, manufacturing, packaging, sterilization, quality control, private labeling, regulatory guidance and supply chain management services.
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BMP Medical

Biomedical Polymers, Inc. (BMP), a quality manufacturer of plastic consumables for research and medical diagnostics laboratories, announced today that it has received ISO® 13485:2003 certification for its Quality Management System for the manufacture of Medical Devices. In order to meet these requirements for certification, BMP upgraded its quality management system to assist in achieving increased efficiencies, higher performance, and reduced operational costs.
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Boston UX

Boston UX designs compelling touchscreen interfaces for high-impact embedded and connected medical devices. We pair intuitive interface design with expert engineering to create devices both beautiful and buildable.
Boston UX:
Helps you meet stringent FDA regulatory requirements
Defines the product features that will appeal to your customers
Applies Design Thinking best practices to create powerful designs
Creates UIs with engaging visual imagery and clever animations
Validates designs with real-world users to gain the insight needed to develop products of superior quality
Boston UX is part of the Integrated Computer Solutions family, a product-driven software company offering development, project management and consulting services.
Back

Celestica

A $6B global provider of product lifecycle solutions, Celestica drives enhanced quality and competitiveness for some of the world’s leading healthcare companies. We specialize in solutions for high-reliability applications from design and manufacturing through to delivery and after-market support. With focused expertise in complex electro-mechanical systems and ultra-high volume automated finished goods manufacturing for single use devices, Celestica helps our customers accelerate market entry, reduce total cost and advance healthcare technology to improve patient care. We also specialize in advanced solutions for surgical instruments, in-vitro diagnostics, and imaging and patient monitoring. Through our certified Healthtech Centers of Excellence network and enterprise-wide global quality system, we ensure flawless execution in compliance with the most rigorous quality standards.
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Compounding Solutions

We strive to help accelerate and simplify the product development and FDA approval process. We offer custom compounding to achieve a wide range of colors utilizing pigments listed under the FDA 21 CFR 73 Subpart D colorants exempt from certification in medical devices.
Back

Consulate General of Canada

The Trade Commissioner Service (TCS), part of the Government of Canada, is a network in 161 offices around the world and across Canada. Trade Commissioners provide Canadian business and innovation clients with practical advice, on-the-ground intelligence, and connections to help them achieve their global goals. Our team of nine Trade Commissioners in Consulate General of Boston work along sector lines and manages the CTA. Our priorities align with what New England has to offer and where Canada has strengths: life sciences, IT (AI, clean tech, digital health), agriculture (including food tech), consumer and retail, aerospace and defence, robotics and ocean technologies.Trade Commissioners work with businesses in New England by making connections to Canada, driving value and innovation to the region.
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CPSL Language Services

CPSL Language Services, is one of the longest-established LSP in the translation and localization industry, having served clients for over 50 years in a range of industries including: life sciences, energy, machinery and tools, transport, software, telecommunications, financial, legal, electronics and government. We are among a select number of language service suppliers that are triple quality certified, including ISO 9001, ISO 17100 and ISO 13485 for medical devices.
We offer a full suite of language services, -translation and localization, interpreting and multimedia & eLearning related services, such as transcription, voice-over and subtitling-. Based in Barcelona (Spain) and with production centres in Madrid, Ludwigsburg (Germany) Boston (USA) and a sales office in the United Kingdom, we offer language integrated solutions on both sides of the Atlantic Ocean, 24/7/365 timeline.
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Davis Companies

DAVIS Companies delivers staffing and workforce solutions to global Medical Device and Life Science companies. We leverage our 30+ years of industry experience and expertise to provide solutions for companies whose goal is to attract, engage and retain talent giving you a competitive advantage. We specialize in contract and direct hire professionals for all phased of the product development lifecycle including for Quality, Validation, and Project Management roles.
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Design Concepts

Design Concepts is a full-service product design and innovation consultancy with offices in Madison, Wisconsin, San Francisco and Boston. We design products, services and experiences that drive business success and improve people's lives. Our process has been tested and refined through the completion of more than 2,700 projects for over 400 clients. Our research, design and engineering services deliver world-class strategies, physical products, digital products and services to clients in the healthcare, commercial and consumer industries.
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Design Standards Corporation

For over 40 years, Design Standards Corporation has been manufacturing precision medical devices for many of the biggest health care suppliers. We specialize in design and manufacture of disposable and reusable medical devices and instrumentation.
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Draper

For more than 80 years, Draper has delivered new capabilities to support U.S. national security. In often challenging environments, when lives are on the line, your technologies have to work. Many of the tools and capabilities delivered for our national security customers may be applied to solve challenges in the commercial sector.
Draper’s Biomedical Solutions encompass neurotechnology, medical devices, rapid diagnostics, organ-on-chip systems, and cell therapy bioprocessing devices. By leveraging multidisciplinary expertise in microfluidics, microfabrication, image analysis, and other areas, we design, build and test working prototypes that make innovation real.
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EAG Laboratories

The critical advantage EAG brings to you is our exceptional range of multi-disciplinary scientific expertise. This enables companies like yours to utilize the power of EAG science across every stage of your product life cycle. This results in a seamless, holistic view of your entire initiative – bringing great efficiencies and product benefits that are far superior to a fragmented approach using different partners with disparate methods.
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Enercon Technologies

Enercon can help turn your ideas into profitable new products by offering comprehensive Product Development, Contract Manufacturing and value-added services. From state-of-the-art ISO-certified facilities in Maine, they can meet any or all of your contract manufacturing needs, from product design and engineering, through prototyping and volume manufacturing, to distribution, inventory management and service depot support.
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EXB Solutions

EXB Solutions, Inc. (EXB) is an engineering services company focused on systems engineering and testing for safety and mission-critical software and systems. We are a Service-Disabled Veteran-Owned Small Business (SDVOSB) in the aerospace, defense, medical, critical infrastructure, and high-tech marketplace with over 14 years of performance history
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Fang Consulting

Since 1999, Fang Consulting, Ltd. has provided specialized Regulatory Affairs consulting, Quality System consulting, Clinical consulting, as well as device fulfillment, primarily for the medical device industry. Our team is comprised of principal, senior and junior consultants who have a working knowledge of and expertise in the most current global regulations and certifications and work closely with global government agencies. Visit www.fangconsulting.com to learn more about our services.
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Fisher Unitech

At Fisher Unitech, we are changing the way companies innovate and create new products. We are one of the world’s largest technology provider of 3D design software tools and 3D printers. We are on the cutting edge of a changing and explosive technology. We make innovation possible and help to advance manufacturing with our solutions.

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Forum Plastics

FPL is an engineering company that prides itself on accomplishing extremely difficult programs in the custom mold design & build, injection, insert & micro-molding medical space. We also offer a wide range of complementary services around our molding; from sub-component sourcing to added value secondary operations (ie pad printing) to vendor managed inventory programs. We are a premier supplier offering top notch quality from prototypes(3D Printing) to full production services with our valued employees, operating in a world class ISO 13485:2018 facility.
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Global Lead Staffing

Source Consulting LLC is a consulting group, started with data driven and managing data with data metrics for various organization. We are based in Massachusetts and helping our trusted clients since 2005. We provide our clients with Medical Device consulting, R&D / Product Design/ Manufacturing / Quality and Regulatory Compliances / Remediation. We leverage our knowledge of current GxP requirements to provide cost-effective solutions to life sciences organizations. Our Vision is to providing world class technology services economically and exceeding Customer expectation on Quality & Time. Our Technical expertise in Regulatory , Quality and Engineering allowed our customers to maintain current state of compliance while bringing continuous innovation in products to ease patients life. We help our customer to ensure their product are MDR compliance to sustain the product in the market.
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Global Prior Art, Inc.

Leading law firms and companies choose Global Prior Art to empower well-informed, successful decisions surrounding patent litigation, product clearance (FTO) and planning, licensing and acquisition due diligence, IP portfolio construction and business opportunity assessment. Global’s technical specialists provide proprietary visualization tools that allow our clients to leverage critical information typically buried in thousands of patent documents. Global Prior Arts enables its legal clients to offer sound opinions based on comprehensive and accurate searches.
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Goddard

Our success is driven by an interdisciplinary development process that combines extensive and diverse engineering experience with manufacturable and creative industrial design solutions. We are the leaders in product design and engineering in the greater Boston area. Our logo reflects the culmination of a long research effort designed to distill the core values of our company. The gear exemplifies the technical precision of our engineers while the lower ring symbolizes the vision and innovation of our industrial designers. The center ring bonds the two disciplines together and represents our unique product development process. This proven recipe continues to give our clients the highest standard in on time and on budget product development.
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Green Hills Software

Green Hills Software is the largest independent embedded software provider. With the most safety and security certifications and the best track record for solving embedded problems, Green Hills Software has been leading the embedded world since 1982.
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Health Advances

Health Advances is a strategy consulting firm that focuses exclusively on the healthcare industry. We are scientists, clinicians, and business professionals who share a passion for supporting commercialization and driving adoption of innovations that improve healthcare. The firm employs ~150 full-time professionals to help clients realize growth opportunities worldwide for healthcare technologies, products and services. Our consultants partner with senior executives and investors on their highest-stakes strategic decisions. We not only understand the complexities of each technology and disease state, but also appreciate the client’s context within the entire healthcare ecosystem.
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HealthLink

At HealthLink, our mission is to be the number one choice for life science manufacturing companies looking to outsource their logistics and back office services. We achieve this by reducing costs throughout the supply chain and consistently delivering the highest standards in service, quality and efficiency.
HealthLink currently serves more than 130 life science manufacturing clients. We specialize in:
  • Warehousing, Logistics & Fulfillment
  • Value Added Services
  • Reverse Logistics
  • Multilingual Customer Services
  • VAT Processing & Deferment
  • Finance & Administration
We are experts in the medical device, diagnostic, human tissue and pharma industry, supporting our clients’ growth in an ever-changing market. Whether you are growing rapidly, changing facilities or switching distribution channels, we seamlessly support your operations throughout the process, in your timeframe.
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Intrinsic Imaging

As a full-service medical imaging core lab, we provide comprehensive services in support of Phase I-IV Clinical Trials and Class I, II, III Medical Device Trials. Our team consists of more than 80 full-time, board-certified, fellowship trained radiologists and more than 250 consulting radiologists and key opinion leaders. We have sub-specialization in all therapeutic areas including Cardiovascular, Metabolic & Pulmonary, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal, Neuroradiology and Oncology. More specifically, we provide comprehensive medical imaging core lab services including overall leadership, project management, imaging charter development, image acquisition protocols, imaging site qualification training and management, patient scan transfer and quality control and radiology review. We serve as the “central reader” during clinical trials.
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Jordi Labs

Jordi Labs was founded in 1980 to provide the highest quality analytical services, polymer-based HPLC columns and packing media in the industry. Today, we are worldwide leaders in extractable & leachables testing, particulates & residue analysis, polymer analysis and more. Jordi Labs provides contract analytical services with a special emphasis on chemical identification and liquid chromatography products. As a family company, we take pride in the production of all of our products and analytical service offerings. Customers in nearly all industries are currently using our columns and packing media products worldwide. It is our goal to help our customers overcome their analytical challenges by providing excellent products and personal assistance from our highly trained staff.
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Keystone

Keystone Solutions Groupis a West Michigan-based product development and medical device contract manufacturing company. Since 1997, the company has collaborated with customers around the world in the aerospace, automotive, and medical device industries to design, develop, test. and manufacture a wide range of products. Keystone’s operation is FDA registered and ISO13485:2016 certified and provides assembly, kitting, packaging, and sterilization management services for single-use disposable and reusable medical products.

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Legit

Legit is the AI-powered system of record for medical device R&D. The platform uses machine learning and proprietary natural language processing technology to deconflict and coordinate R&D projects and spend across enterprises, identify potential device defects at the ideation stage, predict how closely aligned R&D projects are with customer requests, and provide unprecedented realtime transparency into R&D spend and efforts.
Legit was created in 2016 in MIT’s Computer Science and Artificial Intelligence Lab and partners with Fortune 1000 medical device companies as well as early stage companies working in medical technology.
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M2D2

The Massachusetts Medical Device Development Center (M2D2) is a lifeline for the state’s smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and the UMass Medical School campuses of the University of Massachusetts.
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MANTA

Market leaders are continuously challenged by the search for new product opportunities and the logistics of rapid development to bring innovations to market. With over 25 years of product innovation experience, we are experts at evaluating technologies, identifying opportunities, managing development, and rapidly transitioning to effective production solutions. We meet user needs, solve complex ergonomic and engineering issues, and communicate brand sophistication to targeted markets.
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MedAcuity Software

MedAcuity is an ISO 13485-certified custom software engineering firm focused solely on supporting the MedTech industry. Its team of over 80 full-time, senior, Massachusetts-based engineering specialists works with clients on both strategic and tactical levels to clear the most challenging hurdles and accelerate the right products to market. Through its pragmatic“special forces”approach, MedAcuity offers clients unique, practical insight, and predictable, successful business outcomes. More information is available at www.medacuitysoftware.com.
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Medidata

Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
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Medmarc

Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve. From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me, George Ayd (800) 356-6886, to discuss the cost of insurance coverage, what coverages are needed and when, for your business plan.
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Minnetronix Medical

Minnetronix is a medical technology and innovation company with deep expertise in electronic and electromechanical devices. Founded in 1996, the company creates new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies. Minnetronix is FDA Registered and ISO 13485 Certified.
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MPR

Every day, MPR’s motivated and talented engineering professionals make a difference in locations around the world. We’re working to solve energy shortages by helping to develop the next generation of technologies and improving the operations of existing power plants, and we’re applying advanced technologies to ensure cleaner air and water. MPR is developing innovative medical devices and biotechnology products that offer solutions to world health problems, and we’re on the frontier of smart technologies, developing innovative improvements to make critical systems more secure.
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NAGLREITER

NAGLREITER Medical Device Development Organization (MDDO) is a trusted partner for concept incubation, design, development and manufacturing engineering services within the Medtech industry. NAGLREITER prides itself on providing world-class services and employing a uniquely flexible business model to do so. NAGLREITER’s ‘The Right Path. With You’ business philosophy exemplifies the company’s commitment to partnering with clients in any way they require to yield the best possible outcomes. Based in the Ft. Lauderdale area in Miramar, Florida, NAGLREITER partners with medical device companies within the U.S. and abroad
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NAMSA

NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world. NAMSA operates 13 offices throughout North America, Europe and Asia, and employs over 1,000 highly-experienced laboratory, clinical and consulting Associates.
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Polaris CM-Lockheed Martin

Polaris Contract Manufacturing, Inc., a wholly-owned subsidiary of Lockheed Martin, has been a provider of contract manufacturing for more than 25 years, servicing high technology customers across a diverse set of industries. We serve customers who have higher mix, medium volume requirements for mission critical printed circuit board (PCB) assemblies and full box build assembly. Our full-service manufacturing and component engineering, end-to-end customer order fulfillments, and trusted sourcing affiliation enables quick delivery and ensures reliable parts.
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Promenade Software

Promenade provides a full suite of software engineering services for medical devices and instruments. From firmware, device applications, cybersecurity, mobile apps and cloud, we have the expertise to efficiently help take our clients to market with exceptional quality. Our extensive code frameworks and tools facilitate and accelerate the development of your product while offering your engineering teams full control, visibility and accessibility to the instrument internals for development, test, and service.
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PropelPLM

At Propel, we’re building modern cloud Product Lifecycle Management, Product Information Management and Quality Management software to help propel your digital transformation. Whether you’re at an established company dealing with potentially more nimble competitors, or you’re ramping a young startup and scaling your business, Propel’s cloud software can help.
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Proven Process Medical Devices, Inc.

Proven Process Medical Devices(PPMD) is a contract engineering and manufacturing company solely focused on the medical device and life sciences industries.PPMD development teams utilize a well developed process to manage the whole life cycle of a product for very large OEM's and the many start-ups integrating exciting new technologies into cutting edge products.Our teams of mechanical, electrical, software and quality engineers design and build devices that assist clinicians to improvetheir patients healthcare outcomes. Our goalis to provide the expertise and capabilities that will drive our customers to success.
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PTC

PTC helps companies around the world reinvent the way they design, manufacture, operate, and service things in and for a smart, connected world. In 1986 we revolutionized digital 3D design, and in 1998 were first to market with Internet-based product lifecycle management. Today, our leading industrial innovation platform and field-proven solutions enable you to unlock value at the convergence of the physical and digital worlds. With PTC, manufacturers and an ecosystem of partners and developers can capitalize on the promise of the Internet of Things and augmented reality technology today and drive the future of innovation.
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Qosina

Stuart Herskovitz established his unique Qosina company in 1980 to serve medical device companies by providing stock components. Companies purchase from Qosina to eliminate the cost of tooling their own components and to receive immediate delivery from inventory. This particular approach is useful to companies of all sizes, but has proven especially effective for small to mid-range manufacturing companies, as evidenced by Qosina’s broad customer base cultivated over the years.
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RCRI

RCRI is a leading provider of strategic consulting and integrated clinical trial services to the medical device, IVD, biologics, and combination product industries. For more than a decade, RCRI has been turning medical product concepts into successful, revenue-generating businesses for clients worldwide. More than 450 companies – from entrepreneurial start-ups to Fortune 100 market leaders – have experienced the value of RCRI’s expert insights.
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Regulatory and Quality Solutions LLC (R&Q)

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing balanced solutions and hands-on support that enhance the commercialization and post-market processes for medical devices.
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Steri-Tek

Steri-Tek is the San Francisco Bay Area and Silicon Valley’s leader in E-beam sterilization and X-ray irradiation for complex products and sensitive materials. Steri-Tek offers irradiation sterilization services to the Medtech, Biotech and food/drug industries, academic institutions and technology businesses, for a variety of materials and combination devices including medical device, biologic, pharmaceutical, cross-linking/materials modification, and food/agricultural products.
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Task Micro-Electronics Inc.

TASK Micro-Electronics Inc. is a leading microelectronics manufacturing and engineering firm founded in 1987 specializing in the miniaturization, design & manufacture of custom microelectronic circuits. We take our clients designs and work with them to implement innovative electronic packaging solutions where SWAP (Size, Weight and Power) are important issues.
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Tegra Medical

Tegra Medical is focused exclusively on precision machining and contract manufacturing services for the medical device industry, producing components and assemblies for leading edge surgical and interventional companies. As an end-to-end solutions provider, our services range from prototyping to full production, and from components to finished medical devices. We also meet the need for wire and hypotubing shipped overnight. Tegra Medical has 220,000 sq. ft. of modern manufacturing space in Massachusetts, Mississippi and Costa Rica.
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The QT Company

Qt Group is a global software company with a strong presence in more than 70 industries. QT is the platform of choice for medical devices, in-vehicle systems, industrial automation devices, and other business-critical application manufacturers. QT is used by major global companies and developers worldwide, and the technology enables its customers to deliver exceptional user experiences and advance their digital transformation initiatives.
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Toxikon

Toxikon is a preclinical contract research organization. We contract and partner with biotech, pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.
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UL

The UL Life & Health Sciences division is dedicated to healthcare industry innovation. We help clients with their biggest challenges in regulatory management, market access, and connected device risk i.e. safety, security, usability, and interoperability. We ensure that medical devices are safe to deploy and use in an increasingly patient-centric and connected environment. UL brings decades of the most advanced technical, regulatory and clinical expertise to solve the toughest challenges in the market with the goal of improving access to advanced safe healthcare around the world. Our technical experts and biomedical engineers each average of over 10 years’ experience and are active members of industry standards writing and technical committees. Throughout the UL family of companies, we offer services that life and health sciences companies need for business success and improving patient outcomes.
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Valtronic

We innovate and manufacture miniaturized and high-precision complex products for our worldwide medical device partners. Our customers are leading suppliers of active implants, medical-grade wearables as well as medical and portable medical equipment. Our activities also cover advanced industrial assemblies, another field where our expertise and sense for innovation are appreciated the world over. For over thirty years, we have helped hundreds of companies develop and produce Class II & III medical devices as well as advanced miniaturized electronic assemblies. Headquartered in Switzerland, our company spreads over three continents with design, development, industrialization and manufacturing sites in Switzerland, the United States and Morocco and employs more than 350 employees worldwide.
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Vaupell

Vaupell designs, engineers, and produces custom, high performance engineered plastic and composite components and assemblies for demanding applications. We are the global market leader in plastics components and assemblies for aircraft interiors while also serving the broader aerospace, defense, medical, and commercial markets. Vaupell provides engineered solutions to top tier OEM’s, market-leading growth companies, and promising start-ups. Collaboration with our customers in all phases of a the product life cycle results in the highest value solutions that reduce time to market, manage risk and control costs.
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Velentium

Velentium offers world class expertise in software, usability, cybersecurity, electrical, and mechanical development for medical devices. Our decades of experience, solid program management and systems engineering will ensure the success of your product.
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WuXi AppTec

WUXI APPTEC LABORATORY TESTING DIVISION MEDICAL DEVICE PLATFORM

WuXi AppTec partners with medical device manufacturers, guiding you through the often complicated regulatory process to successfully execute your project. We have supported hundreds of thousands of devices with the strategies and testing needed to gain global market access, avoid costly delays and support changing requirements throughout a product’s lifecycle.
Whether your device requires minimal testing or a complex customized program, our team will outline and execute the optimal strategy necessary for regulatory compliance, leveraging decades of accumulated knowledge gained from hands on experience and serving on international standards committees.
WuXi offers a broad range of global services including:
  • Biocompatibility Testing,
  • Materials Characterization,
  • Package Validation & Testing
  • Extractables / Leachables
  • Toxicological Risk Assessment
  • Microbiology
  • Product & Environment Validation
  • Reprocessing
  • Regulatory Consulting Services
Above all, we stand behind our work—from test plans through clearance—responding to questions or other regulatory requests that may arise.
Your success is our success.
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Ximedica

Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy.
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Welcome Reception

05:00 PM 08:00 PM Pavilion

Join us for networking and cocktails at this reception for all sponsors and guests.
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Advanced EU MDR and CER Workshop

08:00 AM 11:30 AM Commonwealth

This is not your average training workshop. Get maximum value from your DeviceTalks Boston experience by taking an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. During this comprehensive morning workshop, RA/QA leaders from multinational medical device companies – along with preeminent RA/QA experts from Regulatory & Quality Solutions (R&Q) – will share invaluable tips, tricks, and lessons learned. You’ll absorb information firsthand from those who have seen what works… and more importantly, what doesn’t. After fully exploring EU MDR and CERs, you’ll emerge with an advanced skillset and newly developed strategies no matter where you are in the EU MDR transition process. Please see the agenda breakout for specific detail on each section.

A special note to small companies: this may not be on your radar, but it should be. Join us to learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020.

The workshop is hosted by industry-leading regulatory and quality consulting and engineering firm Regulatory & Quality Solutions (R&Q). R&Q helps bring more safe and effective medical devices to market for medical device and combination product companies.

Agenda Breakout
7:30 – 8:00am – Arrival, networking, coffee, and continental breakfast
8:00am – 9:15am – Transitioning from MDD to MDR Mega Session
9:25am – 10:05am – Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs
10:15am – 11:10am – Post-Market Surveillance Under EU MDR
11:10am – 11:30am – Closeout Q&A Roundtable

Note: Additional presenters/panelists will be added upon confirmation.

Session Detail
8:00am – 9:15am – Transitioning from MDD to MDR Mega Session
Presenters/Panelists:
Nancy Morrison, Director of Regulatory Affairs, R&Q
Artha Nafie, EU MDR Program Manager, Independent Consultant
Sarah Fairfield, Manager of Regulatory Affairs, Hologic

Here’s nearly everything we’ve learned from multiple implementations that impacts regulatory, quality, and clinical professionals. We’ll pull from our experience of successfully executing large- and small-scale EU MDR implementations and illustrate how it happens. From gap assessments of regulatory files and the QMS to the transition of technical documentation and pilot submissions to the notified bodies – it’s all here. This session will also cover portfolio planning as an input to your implementation plan, and how inputs are used to realign and reduce regulatory files, schedule remediation and file transition activities, and propose portfolio plan revisions that are extremely beneficial to the company considering the significant cost and resources needed to transition products to the EU MDR.

Prepare to return to your organizations inspired by real-world examples and ready to act, with recommendations for impacting the development of project plans, schedules, process, templates, portfolio plans, budgets, and more.

9:25am – 10:05am – Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs
Presenters/Panelists:
Jon Gimbel, Director and CER Business Unit Lead, R&Q

These are stories you’ll want to hear. MEDDEV 2.7/1 Rev. 4 and the new European Union Medical Device Regulation (EU MDR) have raised a lot of questions in the regulatory and clinical affairs communities. This panel will feature medical device manufacturers and device consultants who have had the opportunity to create CERs for products in a wide range of clinical specialties being submitted to a variety of notified bodies. Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process. From a strategy for finding data to establish equivalence to completion of state of the art analysis, the speakers have encountered plenty of obstacles… and found solutions. Speakers will discuss case studies featuring a multitude of challenges. For example, what should you do with a low-risk device that has no clinical data? And what about a device that will be up-classed from IIb to III? How much historical information do you need in your CER if this is its first review under the MDR? How will the new EU MDR impact your clinical evaluations? Attendees will return to their organizations with actionable ideas and recommendations to impact decisions and apply plans on how to address the requirements. 

10:15am – 11:10am – Post-Market Surveillance (PMS) Under EU MDR
Presenters/Panelists:
Nancy Morrison, Director of Regulatory Affairs, R&Q
Jon Gimbel, Director and CER Business Unit Lead, R&Q
Ronald Sills, Lead Auditor – Medical, TUV Rheinland – North America

What is ‘sufficient clinical evidence’ and what does it look like as part of PMS? The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address options for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally in this session, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes. The requirements seem to overlap with the CER requirements. How can you optimize your process to take avoid duplication of efforts? Are you really ready?

11:10am – 11:30am – Closeout Q&A
Presenters/Panelists:
All previous presenters and panelists

All presenters and panelists from the workshop will answer audience questions and engage in discussion.


Speakers

Jonathan Gimbel
Director & CER Business Unit Lead
R&Q
Nancy Morrison
Director of Regulatory Affairs
R&Q
AN
Artha Nafie
EU MDR Program Manager
Independent Consultant
Ronald Sills
TUV Rheinland – North America
Lead Auditor – Medical
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New England Healthcare Executive Network Meeting

08:00 AM 10:00 AM Marina 2-3

A meeting of the New England Healthcare Executives Network. Separate registration required
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CRAASH Barcelona Start-up Showcase

09:00 AM 11:00 AM Marina 1

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Keynote

Keynote - Jeff Karp

10:30 AM 11:30 AM Grand Ballroom A,B

Serial entrepreneur, inventor Jeff Karp joins us for a talk on his groundbreaking work. Karp is a Canadian–born biomedical engineer. He is a Professor of Medicine at Harvard Medical School, Brigham and Women's Hospital, and the principal faculty at the Harvard Stem Cell Institute and Affiliate Faculty at the Massachusetts Institute of Technology through the Harvard–MIT Division of Health Sciences and Technology. He is also an affiliate faculty at the Broad Institute.

Speakers

Dr. Jeff Karp
Professor of Medicine
Brigham and Women’s Hospital, Harvard Medical School
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Exhibition/Luncheon

11:30 AM 01:00 PM Galleria

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Ecosystem

Leveraging Data and Machine Learning to Accelerate Medtech Innovation

01:00 PM 02:00 PM Commonwealth

Speakers

David Parish
Healthcare Solutions
Google Cloud
Paul Schultz
Head of Partnerships
Flex Digital Health
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Tech

The State of R&D: Can Big Companies Innovate?

01:00 PM 02:00 PM Grand Ballroom C,D,E

With technology evolving at break-neck speeds, the medtech industry is on the look-out for the next major innovation. Leaders in medical device R&D will discuss how they come up with the breakthrough technologies of tomorrow.

Sponsored By:

Speakers

Don Barry
External Innovations Lead
DePuy Synthes Companies
Mark Boden
Senior Fellow Corporate Research
Boston Scientific
James H. Boll
SVP, New Product Development, Cynosure
Hologic
Will Sutton
VP of Engineering & Technology
Minnetronix
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Investment

The State of Strategic Investments from Large Companies

01:00 PM 02:00 PM Marina 2-3

Early-stage funding continues to dry up for medtech - but could strategic investment fill the void? We look to a panel of experts to discuss how young companies and first-time innovators can approach establish players in the medical device industry for financial help and guidance.

Speakers

Peter Stebbins
Transactions Lead, Medical Devices
Johnson & Johnson
Jeff Wyman
Vice President, InVentures
Smith and Nephew Advanced Surgical Device Division
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Exhibition/Networking Break

02:00 PM 03:00 PM Galleria

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Ecosystem

Innovation in Context

03:00 PM 04:00 PM Commonwealth


Sponsored By:

Speakers

Ayan Bhandari
Senior Human Centered Industrial Designer
Ximedica
Thomas Lutzow
Director of Human Centered Industrial Design
Ximedica
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Investment

Collisions of Value

03:00 PM 04:00 PM Marina 2-3

The concept of creating “collisions of value” is about high-potential start-up companies interacting with valuable partners along their journey. These companies could be large strategic partners, payers, OEMs, investors and more. “Collisions of value” can be planned or serendipitous.
Planned collisions include a formal email introduction or a business development director reaching out to mentor a start-up on how to get funded. It could be a start-up’s presentation to an industry group that sparks interest from a scout sitting in the audience.
Serendipitous collisions are similar interactions that happen more by chance — not by luck. This type of collision happens by putting yourself in the right place at the right time, and being fortunate enough to meet a new mentor or potential investor. Participating in an industry event where the world’s experts in a niche market gather, listening to a few of them speak, and then introducing your start-up to the speaker to get their reaction to the value propositions you are building into your business model is a great way to sharpen an entrepreneur’s tools.
Serendipity is an important ingredient in the success of any new technology’s path to market. There is an air of collaboration in the Boston Healthcare Ecosystem that is unique. Everyone is willing to make an introduction to a friend that needs help, an executive looking for that next role in their career, or investor who is searching for that next shiny new development project to get behind. Mentorship is an active and free-flowing currency in Cambridge. From lunch and learns to pitch competitions, and industry events, there is no shortage of high value events to fill your calendar. I would argue that this constant buzz of activities and chance encounters are just as important to the ecosystem’s success as are the many prestigious academic institutions and hospitals that call Boston home. From breakfast in the President’s Box at Fenway Park to a lunch Pitch Competition at the Harvard Club to dinner at Dean Kamen’s house, we have been immersed in this ecosphere for the last 10 years and there has never been a better time for Innovation in Boston than right now. Look at the last 3 quarters of investment in Medtech. Let’s look at some of the ingredients that make this such a special place. There are plenty of opportunities
During this two-part panel session and pitch round, BHA, MEDTECH, ARMI, MPR and M2D2 will provide real-world examples of how these “collisions” have resulted in mutually beneficial partnerships from executives themselves. You will hear best practices on how to navigate a partnership from both the big- and small-company perspective from some of the people who have successfully executed these agreements.
Then, in part two, start-ups will present elevator pitches specifically aimed at creating partnerships with strategic investors.
Moderator:
Jeff Champagne, MPR Associates

Panelists:
Mary Ann Picard, Associate Director, M2D2, University of Massachusetts Lowell
Win Thurlow, Executive Director of MedTech Association
Ziad Moukheiber, President of Boston Harbor Angels
James Power, Principal at Harvest Circle
Shayan Bhattacharyya, Director @bluehealthintelligence.com

Companies Pitching include
1. Purple Sun
2. Dynocardia
3. 149 Medical
4. Vitascan
5. Ms. United

Speakers

Jeff Champagne
Director, Business Development
MPR Product Development
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Tech

Overcoming Obstacles on Neuromodulation Medical Device Product Development and Launch

03:00 PM 04:00 PM Grand Ballroom C,D,E

Panelists will explore how they're overcoming obstacles in developing and launching medical devices for neuromodulation.

Sponsored By: 

Speakers

Susan Bagen
Application Development Manager
Micro Systems Technologies
Mike Labbe
Director, R&D
Valtronic
Jesse Wheeler
Neurotechnology Business Lead
Draper Laboratory
Theodoros Zanos
Assistant Professor, Neural Decoding & Data Analytics Lab
The Feinstein Institute for Medical Research
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Ecosystem

Securing Connected Medical Devices and Systems against Cyber Attack

04:00 PM 05:00 PM Commonwealth

A professional Hacker’s perspective on security

Green Hills Software and a-world-renowned professional hacker from NETRAGARD will define the cyber-threat landscape in healthcare and describe his experience penetrating hospital networks with a 100% success rate. Then we tell you about the proven technology that dissolves the attack surface and strengthens medical device and system security from the inside out.



Sponsored By:

Speakers

Chuck Brokish
Director of Business Development
Green Hills Software
Adriel Desautels
Managing Partner & CEO
Netragard
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Investment

Investment Panel - Hot Topics

04:00 PM 05:00 PM Marina 2-3

Experts from Greenberg Traurig host thought leaders from the world of investment, IP and product liability for a look at the pressing issues facing medtech in these mission criritical issues.

Speakers

Dr. Omar Amirana
Senior Vice President
Allied Minds
Trevor Chaplick
Corporate Attorney and Shareholder
Greenberg Traurig LLP
Karen Corallo
Regulatory Attorney and Shareholder
Greenberg Traurig LLP
Alex De Winter
Managing Director
GE Ventures
David Dykeman
Shareholder and Patent Attorney
Greenberg Traurig
Jeff Mann
Vice President
Deputy General Counsel at Cantel Medical
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Tech

Combination Products 101

04:00 PM 05:00 PM Grand Ballroom C,D,E

Companies developing combination products can find themselves facing an array of challenges in the clinical and regulatory landscape. Panelists will share their experiences in treading new ground with a world that bridges pharma and medtech.

Sponsored By: 

Speakers

Jim Biggins
Founder, President & CEO
Access Vascular
Michael Halpin
VP, Regulatory Affairs
Vericel
Barb Taylor
Director of Marketing
Portal Instruments
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Exhibition/Networking Reception

05:00 PM 06:30 PM Galleria

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Keynote

Keynote Dinner - Stephen MacMillan (Hologic)

06:30 PM 08:00 PM Grand Ballrom A,B

Hologic CEO Stephen MacMillan joins us for a discussion on the turnaround at the Beford, Mass.-based women's healthcare company

Speakers

Stephen P. MacMillan
Chairman, President & CEO
Hologic
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Networking Breakfast

07:30 AM 08:00 AM Ballroom Foyer

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Keynote

Devices Talk, Who’s Listening?

08:00 AM 08:45 AM Grand Ballrom A,B

Speakers

Sheila Talton
Founder, President & CEO
Gray Matter Analytics
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Exhibition/Networking Break

08:45 AM 09:30 AM Galleria

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MedTech Showcase

09:30 AM 11:30 AM Grand Ballrom A,B


Featuring 20 exciting startups from the Bay State's thriving medical device cluster. For nearly 20 years, this showcase has helped launched some of the most exciting companies in the Bay State and beyond.
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Tech

Women's Health

09:30 AM 10:15 AM Commonwealth

Panelists will explore the latest innovations in women's healthcare, as well as the regulatory and clinical hurdles unique to this field.

Speakers

Kim Bridges Rodriguez
President & CEO
Acessa Health
Meg Eckenroad
Vice President, Women's Health
Hologic
Marissa Fayer
Founder & CEO
HERHealthEQ
Renee M. Sullivan MD, FACC
Covance
Medical Director Cardiovascular, Metabolic, Endocrine & Renal
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Tech

Robotics Panel

10:15 AM 11:30 AM Commonwealth

What roles can, or should, robots play in the evolving world of healthcare? Panelists will share the latest trends in robotic-assisted surgery and shed light on other aspects of healthcare that robots are helping to make more efficient and safe for patients.

Speakers

Per Bergman
VP, R&D
Corindus Vascular Robotics
Tom Calef
VP, Engineering
Activ Surgical
Ignacio Galiana, PhD
Program Manager, Soft Wearable Robotic Programs
Wyss Institute at Harvard University
Paul Gudonis
Chairman & CEO
Myomo
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Exhibition/Luncheon

11:30 AM 12:30 PM Galleria

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Keynote

Keynote -Todd Pope and Campbell Rogers

12:30 PM 01:30 PM Grand Ballroom A,B

Speakers

Todd M. Pope
President & Chief Executive Officer
TransEnterix
Campbell Rogers
Executive Vice President and ​Chief Medical Officer
HeartFlow
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MedTech Showcase

01:30 PM 03:30 PM Grand Ballroom A,B

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Tech

Digital Disruption in Life Sciences - It Takes More Than Technology

01:30 PM 02:30 PM Commonwealth

As life sciences companies take advantage of the opportunities that come with sensors and other IoT data, they also encounter challenges in operationalizing the intelligence that can be generated.

A common misconception of technology adopters is that technology is the solution. Instead, they should see technology as a tool. Accelerating digital transformation requires people, process, and policy.

Technologies such as IoT and advanced analytics make it possible to gain insight into areas that were previously out of reach. However, in the end, the true value lies in the ability to provide useful insights that drive action within the organization. In this session we will discuss some of these variables and how they need to be factored into initial program design.

Join us on an IoT journey that takes life sciences companies from current states to desired outcomes, helping them understand their business with new insights, advance their processes, and ultimately outperform the competition.



Speakers

Chris MacDonald
Senior Director of Analytics Business Development
PTC
Anthony Moffa
Senior Director of Product Management for ThingWorx IIoT Platforms
PTC
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Tech

What To Do When Things Go Sideways

02:30 PM 03:30 PM Commonwealth

Everyone wants product development projects to go smoothly and predictably, but sometimes the best laid plans do not work out as expected. When needed technologies do not easily integrate, tough hardware or software bugs crop up, or failures happen in the field, forward progress is stalled. This is when "things go sideways." Join us to talk about how to turn projects around and get back on track. Root cause analysis, forensics engineering, cultural clashes, letters from the FDA, product development process improvement and technology failures will be discussed at length with subject matter experts. In this interactive session you can share your war stories, ask those tough questions and teach/ learn how to recover from the worst that can happen.

Speakers

Jeff Champagne
Director, Business Development
MPR Product Development
EC
Eric Claude
VP, Product Development
MPR
RD
Ryan Downs
VP, Partner
MPR
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Investment

Getting to the Exit

03:30 PM 04:15 PM Grand Ballroom A,B

What does it take to sell your medical device company and when should you do it? A panel of experts will share best practices and how to navigate potential pitfalls.

Speakers

Jeffrey H. Burbank
Founder and CEO
NxStage
Susan A. Posner
Health Advances
Partner
Martha Shadan
Global Vice President, Marketing; President & CEO
Smith & Nephew; Rotation Medical
Christopher von Jako
CEO
Dynatronics
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Keynote

Closing Keynote: Heidi Dhose

04:15 PM 05:30 PM Grand Ballroom A,B

Speakers

Heidi Dohse
Sr. Program Manager, Founder
Google, Tour de Heart Foundation