Bio Break: How to Successfully Pivot in Medical Device Development

Resources

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

YouTube video thumbnail
Gloved hand holds fluorescent liquid over a UV-lit surface with green glow and red arrow pointing to the light, captioned ‘See the Clean?

Fluorescent Soil Load Test

Nick Allan and Nigel Syrotuck explore a creative approach to visualizing cleaning validation using a fluorescent soil load.

Gloved hands insert a swab into a sealed vial beside a crossed-out O₂ symbol with the text “No Oxygen Allowed?” illustrating anaerobic sample collection.

Anaerobic Sample Collection Explained

Nick Allan joins Nigel Syrotuck to explore how anaerobic sample collection works and why it’s vital for studying bacteria that cannot survive in oxygen.

Thumbnail showing “First to Invent” with yellow exclamation marks transitioning via red arrow to “First to File” with a folder of patent documents, illustrating the shift in patent rules discussed in the Bio Break episode.

Patent Documentation Habits

Nick Allan and Nigel Syrotuck dive into the evolution of patent documentation habits in engineering and medical device development.

Thumbnail showing a medical sampling pipette with a red arrow pointing to a microscope under the text “Repurposed for Research?” illustrating medical device adaptation in scientific studies.

Device Repurposing in Research

Nick Allan and Nigel Syrotuck discuss device repurposing in research, sharing a story that blends microbiology, animal science, and engineering ingenuity.