Navigating FDA Pathways for Digital Health Innovators
Build the Right Product—and the Right Path to Market
You’ve got a breakthrough idea for a connected medical device. Now comes the hard part: bringing it to market without tripping over FDA regulations you didn’t see coming.
Join us during a2Tech360's Ann Arbor Innovation Week for a candid, content-rich evening focused on how digital health teams can design smarter—and stay nimble—while navigating the FDA approval process. This is a rare chance to hear straight talk from experts who've been in the trenches of regulatory strategy, product development, and real-world innovation.
Whether you're working on embedded systems, digital therapeutics, or AI-enabled diagnostics, this event will arm you with insights to avoid costly missteps and accelerate time to market.
Featured Conversation (5:30–6:00 PM):
The Two FDA Tracks—Which One Are You On?
A practical, eye-opening conversation with:
Gene Parunak, Founder of in2being, a medtech product development and regulatory consultancy supporting 175+ projects across Southeast Michigan
Shawn Crowley, Co-CEO of Atomic Object and expert in digital product strategy
They’ll unpack:
Class I vs. Class II classifications—and what they really mean
How early product choices shape your regulatory future
Practical ways to balance speed, quality, and compliance
Where AI ambition meets FDA determinism
Networking & Refreshments (5:00–5:30 + 6:00–7:00 PM)
Connect with other founders, engineers, researchers, and investors shaping the future of health tech over local drinks, great snacks, and relaxed conversation in Atomic's open-concept downtown space.
Why Attend
Michigan’s life sciences and engineering talent run deep. But too often, critical insights into regulation, funding risk, and market entry are siloed. This event opens the door to:
Trusted FDA advice you’d normally pay a consultant for
Clear-eyed discussion of startup realities
A space designed to foster real community in health tech
Come ready to listen, learn, and make connections that move your ideas forward.