Hardware Podcasts

How to Solve the Medtech Value Equation with Quality Data

Global Medical Device Podcast · 5 Dec 2019 · 32m · Episode 127

What this episode covers

Devon Campbell, founder of Prodct, LLC, joins host John Spear to discuss the 'Medtech Value Equation,' arguing that early-stage companies must integrate quality infrastructure with product development to maximize valuation and de-risk for investors. Campbell emphasizes that data integrity, reproducibility, and scalable processes are critical for generating trusted data, whether for regulatory submission or early commercial services. The conversation highlights the importance of a 'just-in-time' quality strategy that anticipates future needs like FDA 21 CFR Part 820 compliance and ISO 13485 without stifling early innovation.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Prodct, LLC, Green Light Guru
Also
Med Tech True Quality Stories, FDA 21 CFR Part 820, ISO 13485, EU MDR, 510(k)

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