Bio Break: How to Successfully Pivot in Medical Device Development

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Bio Break: How to Successfully Pivot in Medical Device Development

Sector: Diagnostics

In the world of medical device development, unexpected challenges often lead to critical product pivots. In this episode of Bio Break, Nick and Joris discuss one of the most dramatic pivots they’ve encountered—transforming a lab-developed test (LDT) into a lateral flow assay to expand its market reach.

Initially, the client had a blood-based diagnostic test licensed for use in North America but wanted to serve global markets. Their original approach involved developing a blood spot sampling system, where patients would send dried blood samples by mail for lab analysis. However, after evaluating the logistics, the team proposed a game-changing pivot: converting the assay into a lateral flow test, making it more accessible and reducing the need for centralized lab processing.

This shift represented a major transformation—moving from a laboratory test requiring trained technicians to a rapid test that could be performed by users at home. This meant rethinking regulatory strategies, usability considerations, and product stability while maintaining diagnostic accuracy. The outcome? A scalable and commercially viable point-of-care diagnostic that opened new global opportunities for the company.

Pivoting in medical device innovation isn’t just about solving technical challenges—it’s about recognizing when to rethink market access, user needs, and business models. In this conversation, Nick and Joris highlight the key considerations when making strategic pivots and the lessons learned from adapting diagnostic technologies to new formats.

How to Successfully Pivot in Medical Device Development

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loved hand holding a blood vial in front of blurred Chicago skyline. Overlay text says ‘From vial… To Chicago?’ in bold white font on black background.

Each summer, the laboratory diagnostics showcase hosted by the Association for Diagnostics & Laboratory Medicine (ADLM) draws industry leaders to Chicago.

Thumbnail showing a vial of clear contrast agent on the left, with a red dotted arrow pointing to an X-ray image of a skull displayed on a tablet held by a person in a white coat. Overlay text reads “Not approved here?” in bold black and white text.

Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.

A disposable medical syringe is pointed toward a small pile of pennies, with a red dotted arrow connecting them. The text overlay reads, “So cheap. So complex.”

Despite costing just pennies, syringes pack an extraordinary amount of design and manufacturing complexity. From precision-molded barrels to breathably sealed packaging, these tools are more than meets the eye.

Jet Injector Drug Delivery - A gloved hand holds a syringe angled upward on a white background. A red dashed arrow curves upward from the syringe needle, pointing to empty space. Large black text on the left reads “Outdated?” suggesting a question about the relevance or currency of syringe-based technology.

Nick and Nigel dive into the world of jet injector drug delivery. This needle-free method, made popular in science fiction and real-world vaccines, is still used today.