Laboratory rigor, applied to medical devices.

Our approach

1. Diagnostics expertise

   White Coat Sciences was founded as a CLIA high-complexity molecular laboratory, and molecular diagnostics remains a current capability. Working inside a clinical laboratory teaches what a usable specimen requires: careful collection, controlled handling, and documented chain of custody. That experience is the starting point for our devices.

2. Device design

   We design devices from the laboratory back to the point of care. Each design begins with the clinician who orders the test, the person who provides the sample, and the laboratory that receives it, so the device fits the way care is actually delivered.

3. Development discipline

   Programs advance through defined stages, with requirements, design documentation, and regulatory planning appropriate to each device’s classification. We describe each program by its category and current status, and we make claims only when the evidence and the regulatory pathway support them.