• Creating a single active, collaborative, strategic brain that connects the CEO, leadership team, and every single person in a company.
• Giving the team a shared language and focused team results connecting strategy to execution.

10/12, 10/19 & 11/2

UPDATE!!!! Date Change!!

Join us for this three part workshop series for Medical Device Development. Do you as a Medical Device Manufacturer fall into one of the categories below? If yes, we will see you in September!

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

Medical Device Development Series:

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)

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
• Connect attendees to share knowledge and experiences and enable professional networking

Workshop facilitator: Ben Linville-Engler

Ben Linville-Engler is the Chief Investment Strategist and Program Executive at MassTech where he works across the agency’s divisions, funds, and programs to align investments with ecosystems needs, emerging technologies, and sector priorities in the Commonwealth’s technology and innovation economy. Ben provides organizational oversight for the agency’s Center for Advanced Manufacturing (CAM), MassCyberCenter, and the Massachusetts eHealth Institute (MeHI). Previously, he served as the Industry and Certificate Co-Director for MIT System Design and Management (SDM), where he first joined as a Fellow in 2016. He was awarded MIT's 2021 Collier Medal for COVID-19 response efforts with the MA Manufacturing Emergency Response Team. Prior to MIT, Ben worked for over a decade at Applied Medical, a vertically integrated surgical device and systems company; serving in Vice President roles in technology and product development, as well as engineering. He holds a B.S. in Mechanical Engineering from the University of Colorado – Boulder with and emphasis in Biomedical Engineering and a Minor in Biochemistry, and received a Master of Science degree in Engineering and Management from MIT through SDM.

To register to attend this event, you must register through the button below. When registering for this event, you are registering for the three (3)-part workshop that will be held virtually from 9-11 AM, October 12, 19 & November 2. This is the only registration link for this workshop.