# 031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-05-04
- Length: 1h 19m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/031---The-Five-Stages-Of-Regulatory-Grief-with-Michelle-Lott-e1i19qm

## Summary

Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=0) Introduction: Michelle Lott and Lean RAQA
- [2:26](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=146) From Baxter Healthcare to Lean RAQA: Bridging the Gap
- [8:51](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=531) EU MDR Compliance: US Avoidance vs. European Reality
- [25:58](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=1558) Challenging the FDA: Masks, Guidance, and Consistency
- [30:07](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=1807) Regulations vs. Guidance: The Power of the Federal Register
- [41:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=2488) Auditing Intent vs. Letter: From Baxter to Lean RAQA
- [47:05](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=2825) Audit Preparation: Humanizing the Inspector
- [52:49](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=3169) FDA Inspections vs. Notified Body Audits
- [57:26](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=3446) Startup Regulatory Strategy: Avoiding the Train Wreck
- [1:00:40](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=3640) FDA Device GMP Advisory Committee: The Industry Representative Role
- [1:12:11](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott#t=4331) The Five Stages of Regulatory Grief

## Topics

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

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Lean RAQA (company)
- Baxter Healthcare (company)
- FDA (company)
- EU MDR (other)
- ISO 13485 (other)
- QMSR (other)
- 510(k) (other)
- Form 483 (other)

## Related episodes from other shows

- [Challenges for Regulatory Submission: EU vs. US](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (Global Medical Device Podcast)
- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)
- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)

## Citing this page

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