Hardware Podcasts

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

Global Medical Device Podcast · 29 Nov 2024 · 33m · Episode 393

What this episode covers

Justin Bushko, president of Concise Engineering and founder of MedTech Man, discusses engineering strategies for medical device startups and established players, emphasizing the importance of 'prototyping with purpose' to mitigate high-risk areas like autoclave sealing and sterile electronics early in development. He explains how to balance innovation with cost by rigorously defining user needs, using formative usability studies with Key Opinion Leaders (KOLs) to kill 'nice-to-have' features before design freeze, and executing strategic pivots to reduce part counts and accelerate time to market. Bushko highlights the unique regulatory complexities of MedTech, including hidden requirements in standards like IEC 60601 and the evolving landscape of cybersecurity and FDA guidance, advising founders to build strong teams and leverage competitive benchmarking and reverse engineering to avoid reinventing the wheel.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Concise Engineering, Greenlight Guru, Arthrex, Stryker, Smith and Nephew, Conmed Limitech, BSI
Also
MedTech Man, FDA, IEC 60601

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