Why FDA Approval Isn’t the Finish Line for MedTech Startups

What does it really take for a MedTech startup to move from FDA approval to commercialization?

In this episode of MedTech Unboxed, Steve Maxson talks with Ryan Blasko, Vice President of The Mullings Group, about why regulatory clearance is no longer the finish line for early-stage medical device companies.

Ryan breaks down the importance of reimbursement strategy, market access, society adoption, commercial operators, quality systems, and simple product demonstrations that help investors, physicians, and strategic partners understand why a technology matters.

If you’re building, funding, advising, or commercializing a MedTech startup, this episode is a practical look at what needs to happen beyond the 510(k), the pitch deck, or the first technical milestone.

What you’ll hear in this episode:

• Why FDA approval is only one step in MedTech commercialization
• How reimbursement strategy affects funding, launch timing, and adoption
• Why startups need to build the economic story early
• The difference between pitching a company and building one
• Why commercial operators matter in early-stage boardrooms
• How simple product demos can help de-risk medical technologies
• What “simple isn’t shallow” means in MedTech sales and adoption
• Why quality systems, CDMOs, and partners can influence buyer confidence