Bio Break

In this festive episode of Bio Break, Joris van der Heijden and Nick Allan bring a holiday twist to medical device innovation by discussing how modern technology could improve Santa’s health. Using a lighthearted analogy, they explore the challenges of managing conditions like diabetes and how advancements in drug delivery devices, such as Ozempic injection systems, could make a difference.

In this episode of Bio Break, Joris van der Heijden and Nick Allan explore one of the most critical challenges in drug delivery device design: shear stress. When designing systems for biologics and gene therapies, avoiding shear stress is essential to ensure the viability and activity of biomolecules like proteins, antibodies, and viruses.

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.

In this episode of Bio Break, Joris and Nick explore the fascinating ways microorganisms and nature inspire medical innovations, showing how these tiny organisms play an outsized role in advancing healthcare and biotechnology. From lifesaving antibiotics like penicillin to revolutionary technologies like CRISPR-Cas9, they dive deep into the surprising and transformative contributions of microbes to medicine, shedding light on their critical role in shaping modern science and improving patient outcomes.

In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss an advanced category of combination devices: drug activation devices. Unlike drug delivery devices that transport medication to specific locations, drug activation devices ensure the drug becomes active precisely where it is needed in the body, reducing systemic side effects and enhancing therapeutic effectiveness.

In this episode of Bio Break, Joris and Nick explore the increasingly important world of drug-device combination products, discussing what they are, why they matter, and the unique challenges associated with their development. As modern pharmaceuticals become more complex, the role of engineered medical devices in delivering these therapies safely and effectively has never been more critical.

In this episode of Bio Break, StarFish Medical experts Joris and Nick break down the key differences and similarities between clinical trials for medical devices and pharmaceutical products. As the conversation unfolds, they provide valuable insights into the distinct processes and challenges associated with these two types of trials, including the complexities of combination devices that bridge both worlds.

In this episode of Bio Break, Joris and Nick explore groundbreaking innovations in drug delivery systems, focusing on how advanced technologies are transforming the precision and effectiveness of medical treatments. From delivering medications to hard-to-reach areas like the brain to targeted oral delivery, this discussion highlights solutions that are redefining modern healthcare.

In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

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.

In this episode of Bio Break, StarFish Medical experts Joris and Nick explore the groundbreaking FDA clearance of the first over-the-counter continuous blood glucose monitoring system. This exciting development marks a significant milestone in the world of diagnostics and opens new possibilities for patient-centered healthcare.

Whether you’re in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It’s packed with practical advice and expert insights to set you on the path to success.