Hardware Podcasts

024 - "Operating Under Constraints "with Naveen Agarwal

Let's Combinate · 16 Mar 2022 · 1h 12m

What this episode covers

Naveen Agarwal, a PhD polymer scientist and quality management consultant at Creative Analytics Solutions, discusses operating under constraints, drawing parallels between his 1,500-mile running challenge and risk management in medical devices. He explains the distinction between post-market vigilance and surveillance, advocating for a customer-experience-focused approach to quality improvement that goes beyond regulatory compliance. Agarwal introduces the SNIP framework (Strength, New, Importance, Preventable) for data-based decision-making in post-market surveillance and argues that safety performance should drive innovation and reimbursement rather than just meeting baseline safety standards.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Creative Analytics Solutions
Also
ISO 14971, NIST, Malcolm Baldridge Award, Toastmasters, Operation Smile

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