Researchers at University Health Network (UHN) – the largest medical research network in North America – developed Freespect, a new method for locating and imaging subcutaneous tumours. A gamma-ray detection sensor is housed in a hand-held wand equipped with motion capture targets for a set of external cameras which localize the device in space. A clinician injects a gamma-ray emitting ink that attaches to a patient’s cancer cells, then uses the device to detect the cancer cells’ location and image the tumour using the motion capture system.
FreeSpect offers the possibility of a handheld alternative to expensive MRI machines – a system that clinicians can use at a patient’s bedside to reduce wait times, improve patient flow, and democratize access to medical imaging data. UHN’s researchers found evidence of the system’s clinical efficacy. They developed a prototype that worked, but FreeSpect needed a consumer-facing form factor that clinicians would want to use in practice.
The FDA’s CFR 820.30 design controls require that “devices conform to defined user needs and intended uses, and shall include testing of production units under actual or simulated use conditions.”
Faced with the task of producing production units without having completed validation studies, UHN’s researchers needed a design solution that would allow them to accommodate a variety of use cases without costs spiraling out of control.