Hardware Podcasts

Setting the Record Straight on Usability & Human Factors

Global Medical Device Podcast · 3 Nov 2021 · 36m · Episode 234

What this episode covers

Mike Drues, a regulatory consultant for Vascular Sciences, joins host Jon Speer to clarify the distinction between usability and human factors in medical device development. They discuss how engineers often fail to test devices on actual end-users, leading to design flaws, and argue that FDA regulations are inconsistent, requiring extensive testing for simple devices while ignoring complex ones. The conversation emphasizes that usability testing should be risk-based, distinguishing between formative testing during development and summative testing after design freeze. Drues highlights the importance of realistic testing scenarios and warns against the 'tick-box' mentality that ignores off-label use risks.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Products
Band-Aid
Also
FDA, 510 K

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