Bio Break: From Concept to Clinical – Pathfinder Program Case Study

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Bio Break: From Concept to Clinical

Sector: Diagnostics
Topic: Bio Break
YouTube video thumbnail

In this episode of Bio Break, 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.

The story begins over a decade ago when a client approached StarFish Medical with a breakthrough breath diagnostic concept. Their research had identified a unique analyte detectable in breath samples that promised a much clearer and faster diagnosis than existing tests. But the concept was still in its infancy and needed structured guidance, funding, and technical grounding to become a real medical device.

This is where the Pathfinder Program came in. The client engaged StarFish Medical to map out the best route to commercialization. The team produced a 200-page Pathfinder report packed with competitive analysis, target product profile development, reimbursement strategy, and detailed intellectual property evaluations. The industrial design team contributed stunning photorealistic renders, which became key assets in investor presentations and helped secure critical early funding.

With a clear path defined, StarFish Medical moved forward with iterative prototyping. Initial functional mock-ups helped evaluate sensors and control systems, leading to a clinical-ready prototype used in preliminary trials. The device performed beautifully, validating the original hypothesis and paving the way for final development stages.

Years later, that device is now in market, delivering accurate diagnoses and changing patients’ lives. In fact, during a MedTech conference, a user of the device approached the StarFish Medical team to share how it had transformed their health and lifestyle.

This new Bio Break episode is a powerful example of how Pathfinder engagements at StarFish Medical accelerate medical device innovation. It’s about more than a report—it’s about unlocking ideas, de-risking decisions, and setting a strong foundation for MedTech success.

A gloved hand holds a COVID-19 lateral flow test in front of a white bathroom sink and tiled wall. Overlay text reads: ‘From ELISA to DIY?’ in bold white font on a black background.

Nick Allan and Nigel Syrotuck reflect on recent ADLM diagnostics innovation and how it has shaped the future of clinical testing.

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.