Hardware Podcasts

012 - "Asking then Seeing" with Sara Waxberg Mcnew

Let's Combinate · 22 Dec 2021 · 1h 16m

What this episode covers

Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Design Science, Eli Lilly and Company, Philips Healthcare, Baxter Healthcare
Also
Tufts University, ANSI/AAMI HE75:2009 (R2018), IEC 62366-1:2015, FDA

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