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

  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.

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  How AI Affects the Project Manager Role?

  Project managers are on the front lines of rising complexity in medical device development. They sit at the intersection of vendor timelines, regulatory constraints, and engineering realities.

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  Medical GUI Design: Key Differences from Web Apps

  As a software engineer with experience in both web development and medical system software engineering, I’ve worked on projects ranging from consumer-facing web applications to medical device graphical user interfaces (GUIs).

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  What Is “Vibe Coding” and Should I Use It to Create a Medical Device?

  Many developers have tried using AI to generate code, often called “Vibe Coding”. Sometimes, the results are nothing short of amazing. Other times, the results are mixed, or worse.

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  Lessons from Real-World Device Testing

  Even the best-designed devices, prepared with careful simulations and usability studies, can behave very differently when used in actual clinical or emergency situations.

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  Organ Transplant Logistics in Device Design

  In this Before the Build episode, Eric Olson and Paul Charlebois dive into the importance of organ transplant logistics when designing effective medical devices.

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  The importance of a user-centered design approach to training: A case study

  The simplest and least expensive way to train users of medical devices is to ask them study the Instructions for Use (IFU) beforehand.

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  Touch It to Believe It: Cost-Efficient, Tangible Prototypes That Impress Users, Boards and Investors.

  In the complex world of medical device development, creating effective prototypes is more than just a creative exercise, it’s a regulatory necessity and a strategic imperative.

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  Medical Device Development: User Experience (UX), Human Factors (HF), and Industrial Design (ID) Unexpected Benefits

  User Experience (UX), Human Factors (HF), and Industrial Design (ID) each have a major impact on the success of new medical devices. Their influence is especially important during product definition and early phases of device development.

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