In this episode, we dissect the massive acquisition of Penumbra by Boston Scientific. We go beyond the financial headlines to explore the immense, unseen regulatory and logistical challenges that lie ahead as these two MedTech giants merge their global operations. This is not just a story of market consolidation; it is a case study in navigating the treacherous waters of international compliance.

The real challenge begins now: How does Boston Scientific integrate Penumbra's product portfolio across more than 30 international markets without disrupting sales or violating local regulations? We look at the specific hurdles they will face in the European Union, China, and other key regions, where a single misstep in transferring technical files or updating local representation could halt business for months.

Key Takeaways:

- Why did a cardiology leader pivot to acquire a neurovascular specialist?

- What are the critical differences in regulatory integration for the EU versus China?

- How do you manage the transfer of thousands of technical dossiers without costly errors?

- Could this merger actually delay new product launches in emerging markets?

- What happens to existing distribution contracts and local representatives post-acquisition?

- How will they consolidate two separate post-market surveillance systems?

- What are the hidden risks in aligning two different Quality Management Systems?

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