Bio Break

Nick and Joris explore the fascinating world of repurposing existing medical device technologies for new market sectors. As engineers and innovators, we often focus on creating brand-new solutions, but what about leveraging tried-and-true technologies to expand into untapped markets? This strategy not only opens doors to new revenue streams but also maximizes the potential of existing innovations.

Nick Allan and Joris van der Heijden tackle the fascinating challenge of targeted drug delivery. When administering drugs to specific areas in the body, how can we be certain they reach the intended target? Nick shares an exciting example involving an intranasal device designed to deliver drugs precisely to the olfactory cleft—an area located between the eyes.

Nick Allan and Joris van der Heijden dive into a critical concept in drug delivery and biopharmaceutical development: shear stress. Understanding shear stress, especially when dealing with delicate therapies like cell and gene treatments or mRNA vaccines, can have profound effects on drug viability and efficacy. Nick walks us through how shear stress is identified, measured, and mitigated during product design and development.

Nick Allan and Joris van der Heijden delve into the fascinating world of drug delivery systems, focusing on the innovative use of nebulizers. While traditional methods like pills and injections dominate the landscape, nebulizers offer a unique, efficient, and non-invasive alternative for administering medications.

In this special New Year’s episode of Bio Break , Joris van der Heijden and Nick Allan reflect on resolutions, persistence, and a 20-year journey to establish a new standard for biofilm testing in medical devices. Nick shares the story of his two-decade-long mission to develop a standardized test method for growing and monitoring biofilm on medical device surfaces.

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 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.

Joris and Nick 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.

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.

Joris van der Heijden and Nick Allan tackle an intriguing question: can alternative bodily fluids like sweat, saliva, or urine offer viable alternatives to blood sampling for medical diagnostics? While blood remains the gold standard for clinical testing, advancements in non-invasive sampling methods are opening new possibilities, particularly in wearable devices and at-home diagnostics.

Nick and Joris dive into the fascinating realm of biosensors, showcasing how nature’s biological processes inspire groundbreaking innovations in medical device technology. From jellyfish to fireflies, the natural world has provided invaluable tools that are transforming diagnostics and research.

Nick and Joris tackle a topic that’s more relevant than ever—raising funds for medical device development in today’s challenging financial landscape. With economic headwinds and cautious investors, startups and even established organizations face significant hurdles in securing funding. But there are ways to mitigate these challenges, and Joris shares strategic insights to align product development milestones with fundraising cycles.

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.

Nick and Joris explore two critical concepts: Limit of Detection (LOD) and Limit of Quantification (LOQ). These terms might sound similar, but their implications for clinical diagnostics and medical devices are vastly different. Whether you’re an engineer, researcher, or product developer, this video sheds light on why both LOD and LOQ are vital in ensuring the precision and reliability of diagnostic tests.

Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you’re a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.

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.

Nick and Joris dive into a common challenge faced by researchers and product developers: the use of pipettes in laboratory workflows and the need for alternatives in non-laboratory environments. From the precision of the trusty P200 pipette to innovative solutions like microfluidics, this discussion highlights the strengths and limitations of fluid handling tools in research and beyond.

Nick and Joris dive into the complex world of platform technologies in product development, exploring the pros and cons of this widely discussed concept. From in-vitro diagnostics to point-of-care instruments, the term “platform” often sparks excitement—and sometimes hesitation. But what does it truly mean to build a platform-based product, and when does it make sense?

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.