Medical Devices Summit 2018

Revere Hotel Boston, Boston, MA
March 26, 2018 - March 27, 2018

32 days left

In today's complex and regulation-driven market, the medical device industry is undergoing a time of immense change. Prominent industry thought leaders will share their strategies and technological advancements to help further your professional development.

Medical Devices Summit has developed a series of discussions for Manufactures, Regulatory, Compliance, Legal Entities, Software Companies, Suppliers and Consultants.

Current as of February 21, 2018


Continental Breakfast & Registration


Ice Breaker


Welcoming Remarks


Case Study: Developing the Medical Internet of Things (IoT): Hitachi’s Approach to Transformation Through IoT Innovation

Bjorn Andersson, Senior Director, Global IoT Marketing, Hitachi Vantara

Richard Roth, Director of Business Development and Medical Marketing, Advanced Technologies, Hitachi Cable America


What opportunities and complications exist with protecting IP and Patient Safety?


David Arney, Lead Engineer, MD PnP Program, MGH, Affiliate at Berkman Klein Center for Internet & Society, Harvard University


Elizabeth O’Brien, Vice President Intellectual Property, CVG, Medtronic


Morning Refreshment Break


Comparisons of Consumer Devices and Medical Devices – Examining Why They Share Technology but Have Opposed Cultures


Christopher Elliott, Chief Regulatory Officer, Leman Micro Devices SA


How Medical IoT and Advanced Connected Medical Devices will have the biggest technological impact on Healthcare

Venk Varadan, Co-Founder and CEO, Nanowear Inc.


Networking Luncheon


Roundtable Breakout


How Home Healthcare is Changing the Medical Device Game


Lonnie Adelman, CEO, iAssay Inc.


Tom Kramer, President and CEO, Kablooe Design


Ways to Incorporate Human Factors Engineering to Win in Device Development


Tom Kramer, President and CEO, Kablooe Design


Wenjing Wang, Regulatory Affairs Manager, Dentsply Sirona


Afternoon Refreshment Break


An Inside Look: How Does a Hacker Go About Tampering with Devices in a Clinical Setting?


Accelerating Speed to Increase Manufacturing Productivity of Medical Devices

Asmita Khanolkar, Manager, Manufacturing Engineering, CeQur Corp


Day One Closing Remarks


Continental Breakfast


Welcoming Remarks


3-D Printing Innovations in Medical Device Manufacturing


Ibraheem T. Badejo, Sr. Director, New Ventures, Johnson & Johnson Innovation Center


To Report or Not to Report: Best Practices for Submitting Changes in Medical Devices


Joel Kent, Senior Manager, Regulatory Affairs, GE Healthcare


Echo Yu, Regulatory Compliance Manager, IBM Watson Health


FDA Insights and Analysis: Complaints, Medical Device Reporting, Recalls and the Relationship between Contract Manufacturers and the Medical Device Firms

Stephen Smith, CDR, PA-C, Medical Device Specialist Investigator, FDA


Morning Refreshment Break


Exploring Challenges and Opportunities When Developing Cost Effective Pediatric and Adult Devices


Donald Lombardi, Chief Executive Officer, Institute for Pediatric


Full Product Lifecycle Traceability: Best Practices for Quality Risk Management


Michelle Jirak, Design Assurance Engineer & Manager, Phillips Medisize


Protecting and Licensing Inventions Developed from Government Funded Research


Ami Gadhia, Technology Transfer and Patenting Specialist, NIH


Closing Remarks


Conclusion of Summit

Revere Hotel Boston Common, 200 Stuart Street, Boston, MA, United States

Room Rate $235
*Room rates quoted above are subject to tax, which is currently 14.45%
  • Rooms are available only to those participants who are registered conference attendees.
  • Rooms will not be guaranteed without a credit card.
  • Rooms are allocated on a first come first serve basis. Room types/rates are subject to availability.
  • The name on the form will be the name of the guest room.

Registration Pricing

Standard Rate
Government and Academic Faculty* $195
Employees of Medical Device Manufacturers (Including Startups) $195
Service Providers / Vendors $1,895

*Subject to approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by conference producer. Opal Group reserves the right to allocate places and to refuse applications.

Sponsorship, Exhibition & Speaking Opportunities 212.532.9898
  • 3M
  • Abbott
  • Atlantic Council
  • Biogen Idec Inc.
  • Boston Scientific
  • Catchwind Innovations
  • CERT
  • Childrens Hospital
  • DermaClip US, LLC
  • GE Healthcare
  • Harvard Medical School
  • Innurvation
  • Johnson & Johnson Innovation
  • Kablooe Design
  • Medtronic
  • Minnetronix
  • Munson Healthcare
  • National Institutes of Health
  • Nicomatic
  • Nonin Medical Inc
  • Philips-Medisize
  • Roche Diagnostics GmbH
  • Smiths Medical
  • Starkey Hearing Technologies
  • U.S. Food and Drug Administration
  • University of Minnesota
  • Van Scoyoc Associates
  • Vascular Solutions
  • Vital Images/Toshiba Medical
  • ZOLL Medical
  • Are you an expert in the medical device industry? Share your thought-provoking, educational content with others in the field to assist medical device manufacturers to become more competitive in today's time-sensitive and regulation-driven market.

  • The Medical Devices Summit invites you to come present an informative session as a standalone presentation, case study, or as part of a panel discussion. This summit provides a peer-to-peer platform of industry thought leaders exploring proven strategies and technological advancements to maximize operational outcome and cost efficiency.

  • Deadline:September 30, 2017
    Email your proposal to

  • Submission Guidelines
    1. Speaker’s Full Name
    2. Speaker’s Title
    3. Speaker’s Company
    4. Speaker’s Contact Info (email, phone, location)
    5. Presentation Format
    6. Session Topic and Title
    *Please provide a brief description of the session (no more than 5 sentences) and a minimum of 3 learning objectives.

  • Topics Will Include:
    Full Product Traceability
    Design and Product Development
    Patenting and Licensing
    Internet of Things
    Compliance and Regulatory tools
    Disruptive Innovations
    3-D Printing
    Human Factors

  • Products Director, Regulatory Affairs
  • Software Engineer
  • Compliance and Regulatory Officer
  • Senior Systems Engineer
  • Senior Engineering Manager
  • Technical Project Manager
  • Product Development Manager
  • Principal Data Scientist
  • Director of Clinical Information Security
  • Site Quality Manager
  • Compliance Officer and Counsel
  • Product Security Architect
  • Quality Engineer
  • Quality Specialist
  • Sr. Director New Ventures
  • VP Engineering and Manufacturing
  • Product Security Program Facilitator
  • Research and Development Engineers
  • Patenting Specialist
  • Chief Product and Solution Security Officer
  • Principal Engineer