Hardware Podcasts

Why Biocompatibility Should be Addressed by Every Medical Device Company

Global Medical Device Podcast · 4 Nov 2020 · 48m · Episode 166

What this episode covers

Mike Drues of Vascular Sciences joins host John Spear to discuss the critical importance of biocompatibility in medical device development, emphasizing that every device, including software, must address it. They analyze recent FDA guidances on skin-contact devices and Nitinol, warning against misinterpreting 'least burdensome' approaches as excuses to skip testing. Drues highlights the dangers of relying on purchasing controls or labeling for risk mitigation, citing the gynecological mesh litigation as a cautionary tale, and stresses the need for objective evidence and early engagement with experts.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, FDA
Materials
Nitinol
Also
ISO 10993, 510 K

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