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When you hear the words Alzheimer's disease, what do you think of? The truth is, the picture most of us have of the disease is incomplete. Alzheimer's disease doesn't start when someone starts to lose their memory. It actually starts years – sometimes decades – earlier. The Rethinking Alzheimer's Disease Podcast is an engaging, narrative-style podcast miniseries for those curious or motivated to learn about Alzheimer’s disease. Perhaps you have a family member with Alzheimer’s disease, or ca ...
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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:
- 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
Website: https://clarifi.fi
LinkedIn: https://linkedin.com/in/sorourkde
Subscribe to Let’s Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.
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.
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