Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

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Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

Sector: Diagnostics
Topic: Bio Break

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.

Nick, drawing on his experience with medical device development, explains the critical distinctions between LDTs and In Vitro Diagnostics (IVDs). He provides insights into why these changes are happening and what they mean for developers working to bring innovative diagnostic tools to market.

Key takeaways from the episode include:

  • Understanding the Difference: LDTs are clinically validated tests performed in CLIA-approved labs but do not require FDA regulatory clearance, unlike IVDs, which are classified as medical devices.
  • The Shift in Regulation: The FDA is transitioning from selective enforcement to increased scrutiny due to the growing complexity and impact of LDTs, such as cancer diagnostics and genetic testing.
  • Implications for Developers: Nick explores how the new regulations add layers of oversight but also improve the safety, accuracy, and reliability of tests with far-reaching implications for patient care.

Joris and Nick discuss the broader industry impacts, including the challenges and opportunities presented by these regulatory changes. While some pushback is expected, they highlight how these steps are ultimately beneficial for innovation and patient outcomes, ensuring that advanced diagnostics meet higher standards of clinical utility and reliability.

This episode is essential viewing for medical device developers, diagnostic innovators, and healthcare professionals navigating the evolving regulatory landscape. Gain a clear understanding of how the FDA’s increased involvement in LDTs is shaping the future of diagnostics and how to stay ahead in this rapidly changing environment.

Laboratory Developed Tests vs. In Vitro Diagnostics

A laboratory or engineering workstation featuring a high-precision stereo microscope mounted on an articulated arm, positioned beside two computer monitors displaying 3D CAD models or imaging of a complex mechanical or biomedical device. The workspace also includes a keyboard, mouse, and a metallic container, all situated on a clean white desk in a dimly lit, modern lab environment.

In a sophisticated world of ever increasing complexity, we need our tools to evolve alongside us and assist in complex decision making, allowing us to understand the consequences of choices ahead. Computational Modelling and Simulation (CM&S) is emerging as an essential tool in building evidence for medical device development.

Three engineers are assembling or troubleshooting a large industrial or medical device prototype in a workshop. One person is seated in a wheelchair, another is standing behind the structure, and a third is kneeling on top of the machine for internal access. The workspace includes tools, laptops, electronic parts, and a large diagram of the device on the wall.

I routinely engage in the development of prototype medical devices. These prototypes typically incorporate at least one printed circuit board (PCB) installed within a plastic or metal enclosure, featuring numerous connections to external components through various connectors.

A laptop on a wooden desk displays a digital document icon on its screen. Beside it, bold text reads "Design History Files Explained," highlighting the topic of regulatory documentation in medical device development.

Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle.

Two colorful paper boats—one red and one yellow—float on a blue background with illustrated white waves beneath them. Bold text reads "From Idea to Impact," symbolizing innovation and progress in medical device development.

Nick Allan and Joris van der Heijden revisit one of StarFish Medical’s most successful Pathfinder journeys, showcasing how a bold research concept evolved into a fully realized clinical diagnostic device.