Bio Break: Drug-Device Combination Products

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Bio Break: Drug-Device Combination Products

Topic: Bio Break

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.

Joris begins by defining combination products as therapeutic solutions that combine a medical device with a pharmaceutical under a single regulatory umbrella. He explains why this approach, while more complex, is necessary for modern biologics, such as gene therapies, which require precise delivery to specific parts of the body—like the brain—where traditional methods fall short.

Key takeaways from the episode include:

  • Why Combine Drugs and Devices?: Combination products are often essential for biologics and viscous therapies, which require bespoke devices for controlled, targeted delivery. For example, wearable injectors allow patients to administer viscous drugs over long periods without discomfort or traditional syringes.
  • Regulatory Challenges: Combining a device and a drug introduces additional regulatory considerations, particularly aligning medical device development timelines with pharmaceutical clinical trial phases. Joris highlights how phase one trials often use off-the-shelf devices, but by phase two, the bespoke medical device must be integrated to validate both the drug and the device’s safety and efficacy.
  • Device Engineering for Precision Delivery: Nick illustrates the need for tailored devices that can handle challenges like viscous fluids, using honey as a relatable example. Such precision-engineered devices ensure therapies are delivered effectively, making the drug and device interdependent for success.

The conversation highlights how collaboration between pharmaceutical and medical device developers is critical to meeting clinical milestones and achieving regulatory approval.

This episode is essential viewing for developers, innovators, and healthcare professionals working on combination products. Discover how pairing medical devices with pharmaceuticals enables groundbreaking therapies and unlocks new possibilities for patient care.

Drug-Device Combination Products – Navigating Complexity

Two men sit at a table discussing the science behind freeze-drying. One of them holds a jar of freeze-dried coffee, illustrating the topic. The text overlay reads "The Science Behind Freeze Drying" in bold letters. A whiteboard with diagrams is visible in the background, reinforcing the technical discussion.

Nick and Joris dive into the fascinating world of freeze-drying, exploring how this process extends shelf life and maintains the integrity of various products—including reagents used in in vitro diagnostics and even instant coffee!

Two men, Nick and Joris, are seated at a table, engaged in a discussion. Both are wearing checkered shirts and have coffee mugs with their names on them. The background features a whiteboard with faint blue writing. The text overlay reads "Imaging for Targeted Drug Delivery" in bold, purple and black letters. The setting resembles a laboratory or office environment.

In this episode of Bio Break, Nick and Joris discuss the fascinating world of real-time imaging for targeted drug delivery. When delivering drugs to precise locations in the body, how do we ensure they reach the right spot? The answer lies in medical imaging technologies such as MRI, CT, and ultrasound, which play a crucial role in guiding complex drug delivery devices.

Two professionals discussing strategies for repurposing medical devices into new market sectors, sitting at a table with mugs featuring their names (Nick and Joris) and a star logo. The background is a blurred office or laboratory setting. The overlay text reads, 'New Markets Ahead! Repurposing Medical Devices,' in bold purple and black fonts, emphasizing innovation and market expansion.

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.

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In this episode of Bio Break, 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.