Best Practice for Sensor-Based Digital Healthtech
What does it take to implement sensor-based digital health technologies effectively and safely at scale?
While their use in clinical research is on the rise, further clarity around best practice use is still required – with far-reaching implications for patient wellbeing and beyond.
As US Digital Medicine Society (DiME) Program Director and guest columnist for Med Device Online, Dr Jessie Bakker writes, considerations around patients’ ability to easily use a device is key when designing a product – and not just for safety reasons.
“Paying inadequate attention to the principles of user-centered design and usability engineering can have adverse consequences beyond product safety and effectiveness,” Dr Bakker reports.
“[This includes] the need for costly product redesign; delays in getting a product to market; sub-optimal product uptake and adherence resulting in missing or uninterpretable data; and the potential for increased health disparities resulting from a design process that does not account for diversity, equity, and inclusion.”
She notes two key challenges currently preventing optimal user-centred design and human factor studies for digital healthtech: inconsistent sector terminology, standards and regulatory requirements, and lack of clarity around best practices for user-centred design and human factors testing.
Part of DiME’s remit is to help provide solutions to such challenges, and has led to its development of the Verification, Analytical Validation, and Clinical Validation (V3) Framework for biometric monitoring technologies.
