Events Calendar

As a member benefit, MassMEDIC holds an Annual Conference in May, an Annual MedTech Investors Conference in October and a series of informational programs throughout the year on a wide range of topics of interest to MassMEDIC members, including regulatory affairs, product development trends and reimbursement issues.

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  1. Jan
    31
    Tue

    1. Register
      Challenges and Best Practices for Patient Engagement and Behavior Change from Across the Stakeholder Spectrum
      8:30 am – 1:00 pm

      glucose-monitoring

      PRESENTED WITH

      SPONSOR

      The US approach to healthcare is shifting from transactional to outcomes-based. Increasing healthcare costs and a population that is both growing and graying have researchers and the media publicizing mobile health (mHealth) as a powerful “any time, everywhere” anodyne for healthcare quality and costs at the individual and population levels. The stakeholders in this solution span healthcare systems and payers; regulators; the tech, medical and pharmaceutical industries; care providers; employers; and at the center of this ecosystem are the individuals whose daily decisions and behaviors are the most critical factor in how they fare.

      Engaging people in their own “everywhere” health care, particularly for chronic disease patients, is vital for a true mHealth solution, and it goes well beyond the currently fragmented landscape of apps, wearables, rewards programs, secure data storage, and connectivity. The expert panel will explore varied perspectives on the challenges and best practices for patient engagement and behavior change from across the stakeholder spectrum. The panel will tackle subjects such as: the varying definitions of patient engagement; approaches to support and improve lasting engagement; tools for collecting data “anytime, everywhere” and the analytics behind making the data meaningful to patients and other stakeholders; and what the future may hold.

       

      AGENDA

      8:00 a.m.

      Registration / Continental Breakfast / Networking
       

      8:30 a.m.

      Welcome
      Lana Gladstein, Partner, Nutter McClennen & Fish

      Patient Perspective on the State of Patient Engagement
      Christina Roth, Chief Executive Officer and Founder, The College Diabetes Network

      Patient Engagement Technologies
      Professor Diane M. Strong, Director, Management Information Systems Program
      Foisie School of Business, Worcester Polytechnic Institute

      Challenges and Best Practices for Patient Engagement and Behavior Change from across the Stakeholder Spectrum
      Moderated by Alexa Konstantinos, Vice President – Consumer, Industrial & Medical, Battelle

      Panelists:
      Robert Jarrin, Sr. Director of Government Affairs, Qualcomm Inc.
      William F. Kennedy, Partner & Chair, Public Policy Group, Nutter
      Renee McInnes, CEO, Norwell Visiting Nurse Association
      Kathryn O’Callaghan, Assistant Director, Strategic Programs, Center for Devices and Radiological Health, U.S. FDA
      Justin Wright, PhD-Vice President, Drug Delivery Innovation, Drug Delivery and Device R&D, Eli Lilly and Company
      Christina Roth, Chief Executive Officer and Founder, The College Diabetes Network

      The Future of Patient Engagement
      John Brooks, III, Chairman, Cellnovo Group
       

      12:00 p.m.

      Networking Luncheon
       

      1:00 p.m.

      Program Concludes

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      8:30 am
      Challenges and Best Practices for Patient Engagement and Behavior Change from Across the Stakeholder Spectrum
  2. Feb
    3
    Fri

    1. Practical Application of the FDA’s Guidance on Postmarket Medical Device Cybersecurity
      12:00 pm – 1:00 pm

      massmediclogo     medacuitylogo_hires

       

      Present

      Practical Application of the FDA’s Guidance on Postmarket Medical Device Cybersecurity

       

      Join us for a free webinar on Feb 03, 2017 at 12:00 PM EST.

       

      Register now!

       

      With its recent release of its final guidance document, “Postmarket Management of Cybersecurity in Medical Devices,” the FDA has provided some guidelines, but also raised many questions. The intent of this webinar is to answer some of the most pressing, including:

      • What does it mean to comply with this guidance?
      • What potential considerations apply to new products vs. legacy products already in the market?
      • How far will this guidance take you in securing your devices?

      Invest an hour in a practical discussion of the FDA’s latest guidance in this critical area.

       

      Presenter: Jarman Joerres is a co-founder of MedAcuity, a software specialty engineering firm focused exclusively on MedTech software development. Over the past 25 years, Jarman has honed his proficiency in architecting and implementing cybersecurity solutions to protect client platforms from compromises such as PHI data breaches, intellectual property exposures, and unauthorized access to devices. Jarman earned his Bachelor’s degree from Northeastern University and his MBA from Boston University.

      After registering, you will receive a confirmation email containing information about joining the webinar.

      View System Requirements

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      12:00 pm
      Practical Application of the FDA’s Guidance on Postmarket Medical Device Cybersecurity
  3. Feb
    8
    Wed

    1. MassMEDIC Member, NAMSA, Hosts Webinar – Clinical Evaluation Reports (CERs): Global Benefits & The Impact of MEDDEV Updates to Manufacturers
      12:00 pm – 1:00 pm

      MassMEDIC Member, NAMSA, Hosts Webinar – Clinical Evaluation Reports (CERs):

      Global Benefits & The Impact of MEDDEV Updates to Manufacturers

       For program information and free registration, click here.

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      12:00 pm
      MassMEDIC Member, NAMSA, Hosts Webinar – Clinical Evaluation Reports (CERs): Global Benefits & The Impact of MEDDEV Updates to Manufacturers
  4. Feb
    10
    Fri

    1. Intellectual Property Considerations for Start-Ups – Spreading the Word Without Poisoning the Well
      12:00 pm – 1:00 pm

      massmediclogo

      choatehallstewartlogo

       

       

       

       

      present

      Intellectual Property Considerations for Start-Ups – Spreading the

      Word Without Poisoning the Well

       

      REGISTER HERE

      Intellectual property is of critical importance in the medical device industry, particularly for small pre-revenue companies that may not have other assets of substantial value. Unfortunately, in the case of patents, it is easy to either impair or even lose your rights to otherwise patentable inventions by disclosing them during fund raising talks, or during technical or scientific meetings. In this webinar, Larry and Brian will discuss ways to navigate these difficulties in the fund raising “dance” as well as basic IP considerations and strategies for efficiently protecting your company’s most valuable intellectual property on limited funds.

      Presenters:

      Laurence P. Naughton, Partner, Choate

       

      Brian Reese PhD, JD, MBA
      Counsel, Choate

      After registering, you will receive a confirmation email containing information about joining the webinar.

      Brought to you by GoToWebinar®
      Webinars Made Easy®

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      12:00 pm
      Intellectual Property Considerations for Start-Ups – Spreading the Word Without Poisoning the Well
  5. Feb
    16
    Thu

    1. Webinar: Asia – MedTech Market: 10 things you want to do and do not want to do to succeed in Asia
      12:00 pm – 1:00 pm

      February 16, 2017

      12:00 – 1:00 p.m.

      MassMEDIC and Pacific Bridge Medical 

      massmediclogo

       

      Pacific Bridge

       

      present

      Register here for this free webinar.

      This webcast will cover key issues as you grow your business in Asia. Topics will include – 1) determining the best business strategies, 2) determining the best regulatory strategies, 3) sourcing and local manufacturing opportunities, 4) how to pick CROs and do clinical trials, 5) due diligence for acquisitions and sales, 6) the pros and cons of the Trans Pacific Partnership (TPP), 7) building strong relationships and cultural sensitivity, among others. Asian case studies will be used to emphasize key points. There will be time for Q+A after the presentation is completed.

       

      ames gross

      Ames Gross, President & Founder, Pacific Bridge Medical

      Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named Mr. Gross one of the top 100 executives in the medical business.

      After registering, you will receive a confirmation email containing information about joining the webinar.

      Brought to you by GoToWebinar®
      Webinars Made Easy®

      +
      12:00 pm
      Webinar: Asia – MedTech Market: 10 things you want to do and do not want to do to succeed in Asia
  6. Mar
    2
    Thu

    1. FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs
      8:30 am – 10:00 am

      Presented by Michael Drues, Ph.D., President, Vascular Sciences

      For medtech companies working to bring their devices to market, ineffective communication with FDA often leads to time-consuming and costly delays. For example, the manufacturer assumes a classification or regulatory pathway for a new device that has not yet been established-only to learn later that FDA disagrees. One way to mitigate such problems is to take advantage of the FDA’s Pre-Submission Program.

       

      The ‘pre-sub’ program-an expansion of the pre-IDE program now collectively referred to as ‘Q-Sub’- allows manufacturers to request meetings regarding development and testing of devices currently under development and/or under regulatory review. Although CDRH issued guidance on the pre-sub program in February 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced.

      When used effectively, pre-subs can offer significant advantages to the manufacturer, such as getting their device to market sooner.  But if not managed properly, pre-subs can add tremendous burden to the manufacturer by increasing the time to market.  Knowing when not to use the pre-sub process is just as important as knowing when to use it.

      This seminar will use the case study approach, to present the pre-sub process in an interactive fashion including:

      • When should the pre-sub program be used and when should it not be?
      • How does the process work and what can the manufacturer expect?
      • When is it better to meet formally or informally? Should you meet in person or via teleconference? Should meetings take place verbally or in writing?
      • What info should be provided in advance and what should be provided during the meeting?
      • What happens after the meeting? How should the manufacture follow-up? Are the results binding?
      • Are there other ways to communicate with FDA beyond pre-subs and when should they be used?

      By Invitation – Free Registration – RSVP Here put Pre-Submission Meetings: Strategies for MedTech Entrpreeurs – March 2 in subject line.

       

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      8:30 am
      FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs

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