Bio Break: Core Facilities for Medical Device Development
In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss the critical role of specialized facilities in the successful development of medical devices. From testing laboratories to clean rooms, they explore the infrastructure needed to support innovation and ensure safe, effective products reach the market.
Drawing on their extensive experience in medical device development, they explain the various levels of containment and cleanliness required for different stages of development, as well as how these facilities are tailored to meet specific product needs.
Key takeaways from the episode include:
- Laboratory Safety and Containment: An overview of Biosafety Levels (BSL 1-4) and how they address varying risk factors, from basic research to handling highly infectious agents.
- Clean Room Standards: A guide to ISO classifications and their applications in medical device assembly and production.
- Facility Fit for Purpose: Understanding how to match the level of containment or cleanliness to your product’s development stage and regulatory requirements.
Joris and Nick highlight the importance of balancing safety, cost, and efficiency in choosing the right facility. For example, while BSL 2 laboratories are suitable for most diagnostic testing, clean rooms with ISO 8 or better standards are essential for assembling medical devices. They also touch on the scalability of facilities, emphasizing the need for spaces designed for preclinical and early clinical phases rather than full-scale production.
Through practical examples and clear explanations, this episode provides valuable insights into how core facilities enable successful product development. It’s a must-watch for innovators, engineers, and executives navigating the complexities of infrastructure requirements in the medical device industry.
Discover how the right facilities can streamline your development process and help you deliver safe, effective, and compliant medical devices to the market.
Core Facilities for Medical Device Development
Related Resources
Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle.
Nick Allan and Joris van der Heijden revisit one of StarFish Medical’s most successful Pathfinder journeys, showcasing how a bold research concept evolved into a fully realized clinical diagnostic device.
Nick and Joris explore one of the most dynamic early-phase services at StarFish Medical: the Pathfinder Program. If you’re a medtech innovator with a promising concept or prototype, Pathfinder helps you identify the right path forward—before you invest millions in development.
Nick and Joris explore the wide world of ablation technologies—unpacking how each approach works and what it’s best suited for.