# 216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-12-03
- Length: 21m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/216---How-UAE-and-Singapore-Are-Redefining-Regulatory-Innovation-with-Stephen-ORourke-e3bq39n

## Summary

Stephen O'Rourke, founder of the consultancy Clarifi, discusses regulatory strategy for MedTech, biotech, and novel food startups navigating EU and US pathways. He highlights the hidden costs of regulatory failure, emphasizing the need for early engagement with agencies and the importance of UDI compliance across all departments. O'Rourke also explores emerging regulatory models in the UAE and Singapore, explaining how regulatory sandboxes and national initiatives are accelerating innovation, and shares insights from his run for the European Parliament on how policy is made.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=6) Introduction and Guest Welcome
- [0:29](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=29) The Hidden Costs of Regulatory Failure
- [3:45](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=225) Engaging with Regulators Early
- [5:26](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=326) Global Regulatory Models and Emerging Markets
- [10:05](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=605) Understanding UDI and Serialization
- [15:16](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=916) The Power of LinkedIn and Personal Stories
- [15:16](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou#t=916) Running for European Parliament and Policy Insights

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Marketing & brand](https://hardwarepodcasts.com/topic/marketing-and-brand)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

companies scaling up

## Mentioned

- Clarifi (company)
- Medtech Chopsticks (other)
- GUDID (other)
- EU MDR (other)
- UAE (other)
- Singapore (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)
- [#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth) (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)
- [Understanding the Value of a Medical Device Guru](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru) (Global Medical Device Podcast)
- [#357: The State of UDI Across the World](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world) (Global Medical Device Podcast)

## Citing this page

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