# Closing the gap between Regulatory and Development with Milton Yarberry

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2024-03-05
- Length: 51m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry
- Listen: https://agileembeddedpodcast.com/episodes/closing-the-gap-between-regulatory-and-development-with-milton-yarberry-8jPD8bw3

## Summary

Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS), discusses bridging the gap between engineering and regulatory teams in medical device development. He identifies key friction points such as process lag, software stacking, and the cognitive burden on developers, arguing that regulatory processes should be viewed as support rather than compliance burdens. Yarberry advocates for a 'regulatory concierge' model where regulatory staff handle administrative overhead, allowing engineers to focus on building safe and effective products through incremental, value-driven processes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=0) Introduction: Milton Yarberry and Integrated Computer Solutions
- [4:13](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=253) Defining the Gap: Native Characteristics and Workflows
- [18:25](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=1105) Complicating Factors: Process Lag and Software Stacking
- [26:36](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=1596) Solutions: Process Rollout and Mechanical Workflows
- [34:37](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=2077) The Cost of Slow Feedback Loops and FDA Submissions
- [39:43](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry#t=2383) The Regulatory Concierge Model and Cognitive Shifts

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- Integrated Computer Solutions (company)
- ICS (company)
- FDA (other)
- MDR (other)
- IEC 62304 (other)
- Squish (tool)
- Bluefruit (company)
- Misra (other)

## Related episodes from other shows

- [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)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (Global Medical Device Podcast)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [Meet a Guru: Ryan Behringer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-14-meet-a-guru-ryan-behringer) (Global Medical Device Podcast)
- [305: Humans Have a Terrible Spec Sheet (Repeat)](https://hardwarepodcasts.com/podcast/embedded-fm/2022-04-28-305-humans-have-a-terrible-spec-sheet-repeat) (Embedded.fm)

## Citing this page

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