About this Event
Getting a medical device to market means solving engineering, regulatory, and business problems at the same time, and the decisions founders make early often determine how smoothly (or painfully) the rest goes. This session walks through the path from early prototype to FDA clearance, with a practical look at how development and regulatory strategy fit together instead of being treated as separate tracks.
Who Should Attend
Startup and growth-stage founders developing medical devices, plus anyone supporting them, including advisors, investors, and ecosystem partners looking for a practical view of the device development process.
About Gene Parunak
Gene Parunak is the Managing Director of in2being, a Michigan based medical device development and regulatory consulting firm that helps companies take products from concept through prototype to FDA clearance.
SCALE-UP! SESSIONS
Scale-Up! Sessions is a recurring educational series presented by the Henry Ford + MSU Innovation Hub, offering practical guidance for healthcare entrepreneurs. Through expert-led workshops, presentations, and networking events, founders gain insights into topics such as clinical validation, commercialization, market access, reimbursement, venture investment, and strategic healthcare partnerships that help accelerate the development and adoption of innovative healthcare solutions.
ABOUT THE ORGANIZER
The Henry Ford + MSU Innovation Hub brings together the strengths of Henry Ford Innovations and the MSU Research Foundation to help healthcare innovators move promising technologies from concept to real-world adoption. By combining clinical expertise, entrepreneurial support, venture investment, and market-access partnerships, the Innovation Hub helps founders validate solutions, navigate complex healthcare environments, and accelerate commercialization.
PARKING INFORMATION & DIRECTIONS
This event will take place at The Mezz - Floor 2 of Michigan Central Station.
Please park in the Bagley Mobility Hub, 1501 Wabash Street. Parking is $5 for the first 30 minutes, with a $15 daily flat rate.
Enter Michigan Central from the East Entrance off 15th Street and check-in with the Front Desk at the east entry when you arrive. There is a free shuttle from Bagley Mobility Hub Welcome Center on the First Floor to the East Entry of Michigan Central.
Event venue & nearby stays
Michigan Central, 2001 15th Street, Detroit, United States
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