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  Bio Break: Surprising Innovations in Olfactory Drug Delivery

  In this episode of Bio Break, Joris van der Heijden and Nick Allan explore one of the most innovative approaches in drug delivery: olfactory drug delivery. This cutting-edge method targets the olfactory region of the nose, offering a direct pathway to deliver drugs into the brain while bypassing the blood-brain barrier. Unlike traditional intranasal delivery, this highly specialized technique uses neural pathways to achieve precise and effective results.

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  5 Regulatory Considerations For Developing a Combination Device

  A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.

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  Combination Product Regulation Basics

  This blog discusses the combination product regulation basics and explains how these types of products are regulated in the US and EU.

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  How Minimum Viable Products Deliver the Most Valuable Products (MVP) for Medical Device Development

  Achieve more accurate budgeting in medical device development by clearly defining the intent of the Minimum Viable Product (MVP).

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  Bio Break: Thanksgiving Traditions and Lessons for Medical Devices

  In this episode of Bio Break, StarFish Medical experts Joris van der Heijden and Nick Allan celebrate Thanksgiving by sharing a heartwarming and hilarious family tradition: preparing the perfect turkey. Through this tale of generations working together to create the iconic holiday meal, they uncover a surprising lesson that applies to medical device development and procedural design.

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  Bio Break: The Story of PCR and Taq Polymerase

  In this episode of Bio Break, Joris van der Heijden and Nick Allan continue their exploration of nature-inspired innovations, focusing on one of the most transformative breakthroughs in molecular biology: the polymerase chain reaction (PCR) and its key component, Taq polymerase.

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  Knowing the Limits for Successful Medtech Design Transfer

  In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.

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  Root Cause Analysis for Medical Device Development

  Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.

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  Bio Break: The Power of Continuous Analyte Monitoring

  In this episode of Bio Break, StarFish Medical experts Joris and Nick dive into the transformative concept of Continuous Analyte Monitoring (CxM) and its growing role in wearable medical devices. They discuss the value of tracking metabolic markers over time, as opposed to relying on static time-point measurements, and how this approach enhances precision in both diagnostics and treatment.

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