FDA Regulatory Books and PCR Memoirs: End-of-Summer Picks with Nick and Nigel

Two men, Nick A. (left) and Nigel (right), sit at a white table, engaging in a lively and friendly conversation. Both wear checkered shirts and lavalier microphones, suggesting a filmed discussion or interview. Nick holds tissue samples in one hand and gestures animatedly, while Nigel smiles in response. Each has a white mug labeled with their name and a purple star logo. The background is a bright white, creating a clean and professional studio setting.
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FDA Regulatory Books and PCR Memoirs: End-of-Summer Picks with Nick and Nigel

Topic: Bio Break
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In this Bio Break episode, Nick Allan and Nigel Syrotuck share their end-of-summer reading list, featuring FDA regulatory books and PCR memoirs. From navigating regulatory hurdles to celebrating groundbreaking discoveries, their choices show how science reading can be both educational and entertaining.

FDA Regulatory Reading

Nigel highlights Innovation Breakdown, a book that examines the regulatory processes of the FDA. He explains that while the FDA ensures medical devices are safe and effective, the pathway to approval can be costly and complex. For innovators, this book illustrates both the challenges and safeguards within the FDA system.

PCR Discovery Through Storytelling

Nick’s pick is Dancing Naked in the Minefield by Kary Mullis. This memoir tells the story of polymerase chain reaction (PCR), a discovery that transformed molecular diagnostics. Mullis’s unusual personality and candid storytelling make the book as engaging as it is informative. PCR continues to influence lab testing worldwide, and Nick reflects on its lasting importance.

End-of-Summer Science Picks

Together, Nick and Nigel offer a mix of perspectives: FDA regulatory books that reveal systemic barriers and protections, and scientific memoirs that celebrate creativity and discovery. Their end-of-summer picks capture how reading can deepen our understanding of both process and innovation.

From FDA regulations to PCR breakthroughs, these end-of-summer reads show how science books can spark insight and inspiration.

Indirect ELISA explained with antibody model showing enzyme linked immunoassay detection

Nick and Nigel walk through how indirect ELISA works, why it uses two antibodies instead of one, and when this approach makes the most sense in real diagnostic workflows.

Smartwatch displaying heart rate and ECG-style waveform, illustrating the difference between wellness devices and medical devices in digital health regulation

Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.

Nick from StarFish Medical demonstrating antigen detection using a toy antibody model to explain how monoclonal antibodies bind antigens in ELISA diagnostics

Nick and Nigel break down the ELISA assay explained in simple, practical terms using everyday models.

Magnifying glass revealing cracks with the text “This gets missed,” illustrating hidden risks in medical device validation and real-world use.

Ariana Wilson sits down with Mark Drlik to unpack why reprocessing is often one of the hardest challenges engineers face during development.