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.  

The Insight

Form factor must accommodate divergent user preferences. Our user observation and feedback determined that clinicians had many different preferred ways to hold the device, none of which were accommodated by the initial prototype. 

This insight led to our modular design that allows clinicians to hold the Freespect like a “pointer”, a “stamp”, or a “paintbrush,” depending on preference – which maximizes the user’s precision and comfort with the device. 

Cortex Fundamental Deliverables

• Effective design at warp speed. Working under tight time constraints, our solution provided UHN researchers with an ergonomic, consumer-facing design that accommodates a variety of user preferences and technological constraints. 

• Flexible design for user validation. The device’s motion capture targets had to be mounted on top of the enclosure to remain visible to the camera system. Our design allows clinicians to easily modify the placement of these targets on the device to accommodate their preferred method of use. 

Key Tasks: 

• • User observation and ethnography
  • Concept development
  • Electronic enclosure design
  • Clay modeling
  • CAD modeling
  • 3D print modeling 

The Result

• Our flexible concept gave UHN researchers the ability to accommodate the different use cases needed in validation. This allowed them to avoid repeating the validation stage for multiple use cases to meet FDA’s CFR 820.30 design controls requirements — and brought us one step closer to low-cost, accessible MRI technology at the bedside.