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. Feb
    24
    Fri

    1. Intellectual Property Considerations for Start-Ups – Spreading the Word Without Poisoning the Well
      1:00 pm – 2:00 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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      1:00 pm
      Intellectual Property Considerations for Start-Ups – Spreading the Word Without Poisoning the Well
  2. 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
  3. Mar
    8
    Wed

    1. MDMA – 2017 FDA Forum/510(k) Workshop (all-day)
      Mar 8

      MDMA – 2017 FDA Forum/510(k) Workshop

      March 8-9

      Palo Alto, CA

      More information here.

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      MDMA – 2017 FDA Forum/510(k) Workshop (all-day)
  4. Mar
    9
    Thu

    1. MDMA – 2017 FDA Forum/510(k) Workshop (all-day)
      Mar 9

      MDMA – 2017 FDA Forum/510(k) Workshop

      March 8-9

      Palo Alto, CA

      More information here.

      +
      MDMA – 2017 FDA Forum/510(k) Workshop (all-day)
    2. Next Generation Tactics for 510(k) Submissions- by Right Submission LLC
      12:00 pm – 1:00 pm
      +
      12:00 pm
      Next Generation Tactics for 510(k) Submissions- by Right Submission LLC
  5. Mar
    16
    Thu

    1. Register
      New Guidance for Combination Products
      8:30 am – 10:30 am

      As interest in developing innovative combination products continues to grow, industry has turned to FDA for additional guidance on how to navigate the differing policies and review procedures of the FDA Centers that regulate the product components and how to receive timely responses on issues such as requests for designation, pre-submission guidance, and primary jurisdiction.

      This program will also focus on several recent new guidances and rules intended to simplify the process as well as on new and ongoing initiatives at FDA and reactions from industry.

      AGENDA

      8:00                Registration/Coffee/Networking

      8:30                Welcome & Introduction

                             Combination Products – Overview
                              Linda Bentley, Member
                              Mintz Levin

                              Update on Guidance Documents and Implementation of 21st Century Cures Act Provisions
                              John (Barr) Weiner, JD. – Associate Director for Policy and Product Classification Officer
                              Office of Combination Products – FDA

                             Industry Perspectives on Combination Products Guidance Documents and Policies
                             Sharon Starowicz,  Director, Regulatory Policy Innovation,
                             Global Orthopaedics – Johnson & Johnson

                             Q&A

      10:30 a.m.     Program Concludes

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      8:30 am
      New Guidance for Combination Products
  6. May
    10
    Wed

    1. ipCapital Group13th Annual Thought Leadership Conference (all-day)
      May 10

      Information and registration can be found here.    Please contact Cori Stemmler for the registration passcode.

       

      Early bird discounted rates are available through February 28, 2017!

       

      Overview:  

      Business, technical, and legal professionals gather to collaborate on issues unique to innovation and intellectual property.  Unlike other conferences, our event is held in an intimate setting in which thought leaders may freely confer and collaborate. The interactive seminar-style presentations provide great relationship-building and networking opportunities between facilitators and attendees.  We will be hosting a dinner on the evening of May 10. The conference will be held the following day, May 11.

       

      Confirmed Topics for 2017:

      • “Monetizing IP – Past, Present, Future”
      • “Using Virtualized Innovation to Supercharge a Portfolio”
      • “Virtualized Innovation Process”
      • “Applied Creativity and Invention – Thoughts and Comparisons to Normal Corporate Inventing”
      • “Building & Managing a Trade Secret Program”

       

      More topics and speakers to be announced!

      For more information, please contact Cori Stemmler.

      +
      ipCapital Group13th Annual Thought Leadership Conference (all-day)
  7. May
    11
    Thu

    1. ipCapital Group13th Annual Thought Leadership Conference (all-day)
      May 11

      Information and registration can be found here.    Please contact Cori Stemmler for the registration passcode.

       

      Early bird discounted rates are available through February 28, 2017!

       

      Overview:  

      Business, technical, and legal professionals gather to collaborate on issues unique to innovation and intellectual property.  Unlike other conferences, our event is held in an intimate setting in which thought leaders may freely confer and collaborate. The interactive seminar-style presentations provide great relationship-building and networking opportunities between facilitators and attendees.  We will be hosting a dinner on the evening of May 10. The conference will be held the following day, May 11.

       

      Confirmed Topics for 2017:

      • “Monetizing IP – Past, Present, Future”
      • “Using Virtualized Innovation to Supercharge a Portfolio”
      • “Virtualized Innovation Process”
      • “Applied Creativity and Invention – Thoughts and Comparisons to Normal Corporate Inventing”
      • “Building & Managing a Trade Secret Program”

       

      More topics and speakers to be announced!

      For more information, please contact Cori Stemmler.

      +
      ipCapital Group13th Annual Thought Leadership Conference (all-day)

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