Hardware Podcasts

Knowing vs. Doing as Medical Device Professionals

Global Medical Device Podcast · 19 Apr 2021 · 31m · Episode 197

What this episode covers

John Kapitan, CEO of Kapstone Medical, joins host John Speer to discuss the gap between knowing and doing in medical device quality systems. Kapitan categorizes professionals into three buckets: the ignorant, the antagonistic, and the apathetic, arguing that quality is a mindset rather than just a compliance burden. He warns that pre-revenue startups often neglect quality documentation, which can severely damage valuation during M&A due diligence by strategic acquirers. Kapitan advocates for a pragmatic, modular approach to building quality systems, cautioning against over-engineering processes for small companies.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Kapstone Medical, Green Light Guru, Medtronic, Boston Scientific, J&J
Also
FDA, ISO 13485, 510(k)

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