Hardware Podcasts

Best Practices for Clinical Evidence Management

Global Medical Device Podcast · 22 Sept 2022 · 46m · Episode 281

What this episode covers

Keith and Kevin Kallmes, founders of Nested Knowledge, discuss the critical role of clinical evidence in medical device development, drawing on their experience building and selling a balloon catheter. They argue that entrepreneurs must validate unmet clinical needs through literature and clinician interviews before prototyping to avoid lack of product-market fit. The brothers detail their expensive early mistakes, including inadequate design history files and poor prioritization of navigability over robustness, which forced them to rebuild their device. They emphasize starting design controls at the concept stage and using pre-design validation to de-risk testing protocols before formal DV/DV.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Nested Knowledge, Marblehead Medical, Greenlight Guru
Tools
PubMed
Also
FDA, ISO 13485, 510(k)

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