# From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-05-04
- Length: 45m
- Episode: 258
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference
- Listen: https://podcast.greenlight.guru/episode/from-startup-to-industry-leader-live-recording-at-scbio-conference

## Summary

Shawn Regan, CEO and Co-founder of Rhythmlink International, discusses the company's 20-year journey from a bootstrapped garage startup to an industry leader in neurophysiologic monitoring devices. He details the strategic decision to pivot from reusable to disposable electrodes, the critical collaboration with the FDA to achieve the first MRI-cleared products, and the operational challenges of manufacturing in China. Regan also explains the recent decision to maintain MDD certification in the EU rather than transitioning to the more burdensome MDR, and how the company leverages its in-house capabilities for OEM partnerships with firms like Johnson & Johnson and Stryker.

## Chapters

- [4:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=294) Introduction: Shawn Regan and Rhythmlink's Clinical Origins
- [6:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=391) Bootstrapping Rhythmlink and the Reusable-to-Disposable Pivot
- [11:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=692) Early FDA 510(k) Clearance and MRI Collaboration
- [19:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=1181) Manufacturing in China and Contract Manufacturer Blackmail
- [27:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=1642) Failed Automation and Reshoring Decision
- [29:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=1770) EU Regulatory Strategy: MDD vs. MDR Cost-Benefit Analysis
- [33:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=2017) Supply Chain Disruptions and Inventory Management
- [39:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference#t=2348) OEM Partnerships and Leadership Evolution

## Topics

- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Rhythmlink International (company)
- Green Light Guru (company)
- Johnson & Johnson (company)
- Stryker (company)
- Synthes (company)
- SI Bone (company)
- Newvasive (company)
- SCBIO (other)
- FDA (other)
- SE Launch (other)

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- [S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda) (Being an Engineer)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [S1E35 Harley-Davidson, Device Reprocessing, & Keeping a High Level Perspective | Tim Rempfer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r) (Being an Engineer)
- [Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa) (The Hardware Story)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-04-from-startup-to-industry-leader-live-recording-at-scbio-conference. 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 Global Medical Device Podcast.