# 024 - "Operating Under Constraints "with Naveen Agarwal

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-03-16
- Length: 1h 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/024---Operating-Under-Constraints-with-Naveen-Agarwal-e1eadka

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=0) Introduction: Naveen Agarwal and Creative Analytics Solutions
- [3:19](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=199) Running 1,500 Miles and Operating Under Constraints
- [18:33](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=1113) Career Journey: From Polymer Science to Quality Management
- [24:31](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=1471) Vigilance vs. Surveillance and Post-Market Data Analysis
- [38:35](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=2315) The SNIP Framework for Post-Market Surveillance Decisions
- [44:14](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=2654) Being Remembered: Truth, Honesty, and Consistency
- [50:25](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=3025) Safety as a Driver of Innovation and Reimbursement
- [56:58](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=3418) P1/P2 Probability Estimation and Common Implementation Issues
- [59:30](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal#t=3570) Malcolm Baldridge Award Appraisal and Toastmasters

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Creative Analytics Solutions (company)
- ISO 14971 (other)
- NIST (other)
- Malcolm Baldridge Award (other)
- Toastmasters (other)
- Operation Smile (other)

## Related episodes from other shows

- [#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey) (Global Medical Device Podcast)
- [Building a Culture of Quality](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-20-building-a-culture-of-quality) (Global Medical Device Podcast)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.