MassMEP Medical Device Development Series (Updated - New Dates!)

Date: October 12, 2022

Time: 9:00 am - 11:00 am

Category: Webinar

MassTech’s Chief Investment Strategist Ben Linville-Engler facilitates this three-part workshop series hosted by MassMEP.

Note the updated dates.

Medical Device Development Workshop - Three-Part Virtual Series Kicks Off on October 12.

The three-part workshop kicks off on October 12 from 9-11 a.m. and continues on October 19 and November 2.

Session 1: Architecting Trust

October 12, 9-11 AM

  •     Case Introduction – MA Manufacturing Emergency Response Team (MERT)

  •     Topics Covered – Crisis Response, Systems Thinking, System Engineering, Stakeholder Value Mapping, and Medical Device Product Lifecycle

Session 2: A Case for Quality

October 19, 9-11 AM

  •     Topics Covered – FDA Regulatory Pathways, Quality Management (ISO 13485), and Risk Management (ISO 14971)

Session 3: The Human Element

November 2, 9-11 AM

  •     Form-Function-Frequency, Stakeholder-Connected Value Statement, and Patient-User-Product Safety (IEC 62366 and IEC 60601-1)

Sessions tailored to:

  •     Production development, manufacturing, technical, or executive professionals interested in learning more about medical device development and commercialization;

  •     Entrepreneurs actively engaged in or considering a medical device startup; and

  •     Ecosystem partners interested in understanding more about how they can support medical device manufacturers and developers throughout the total product lifecycle.

Goals for the series:

  •     “Help those that are new to, or considering, medical device development understand more about the total product life cycle”;    

  •     “Introduce foundational concepts of FDA quality management and regulatory requirements and pathways”;

  •     “Provide those working in startups, or interested in engaging with startups, a roadmap and resources for further learning”;

  •     “Share application of systems thinking to multidisciplinary problem solving, model-driven engineering, design, and strategic decision making from MIT”; and

  •     “Connect attendees to share knowledge and experiences and enable professional networking.”


Medical Device Development Workshop - Three-Part Virtual Series Kicks Off on September 28th