In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.
They discuss:
Key Topics
- The hidden costs of regulatory failure and how to avoid them
- Why early engagement with regulatory agencies is critical
- Global regulatory models, including emerging markets like China and the UAE
- A clear explanation of UDI and serialization
- How regulatory impacts extend beyond compliance teams
- The role of LinkedIn and storytelling in regulatory careers
- Steven’s experience running for the European Parliament and what it taught him about policy
Timestamps
- 00:00 Introduction and Guest Welcome
- 00:38 The Hidden Costs of Regulatory Failure
- 03:47 Engaging with Regulators Early
- 05:26 Global Regulatory Models and Emerging Markets
- 10:07 Understanding UDI and Serialization
- 15:16 The Power of LinkedIn and Personal Stories
- 17:11 Running for European Parliament and Policy Insights
- 21:18 Conclusion and Contact Information
Connect with Steven O’Rourke
Resources
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Stephen O’Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.
Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
