Most medical devices rarely get headlines. From an injectable pen to a pulse oximeter to a programmable IV pump, and every other medical device you can imagine represent an integral part of healthcare. AND, each and every device requires thoughtful development and refinement, with a series of rigorous human factors testing eventually – hopefully – leading to FDA approval.

But why do both human factors testing AND user experience research? Isn’t a medical device’s technical performance, its innovative design, etc., enough to drive its success?

Human factors testing focuses on technical performance – does a medical device perform as designed.

Human factors testing broadly falls into two protocol-driven categories: formative testing assesses performance during device development; summative testing confirms a device meets performance criteria with results submitted to the FDA as part of its approval process.

A medical device may check all the boxes, functioning exactly as it is designed, with clear instructions for safe use – BUT fail to capture market share once it’s launched.

User experience research looks at a medical device using a wider lens that encompasses its perceived value, desirability, etc.

Let’s imagine a new medical device in development. Its designers, engineers, and advisory panel members have all contributed to its development, and its initial prototypes function just as envisioned. Everything is moving forward according to schedule.

BUT, no one has put it in the hands of the healthcare professionals who will use it in a clinical setting, so no one really knows… What will our customers think of it?

User experience research fills the gap between functionality and marketability.

Unlike human factors testing, there are less stringent protocols or standards to limit user experience research design or execution. Research can be designed as a series of quick qualitative “hits” with a few select healthcare providers to more structured, in-person global research in a simulated medical facility setting. Key business questions, and budget, will drive the research design.

What do we need to know?

These business questions will be as specialized as the medical device itself, and can include:

• How does this medical device measure up to what’s available now? What will be available when it’s ready to launch?
• Does the medical device address an unmet need or performance gap in current devices?
• Does this device…
  • Enhance safety for healthcare professionals and/ or patients?
  • Improve quality of care?
  • Make healthcare more cost-efficient
  • Reduce storage needs?
  • Decrease disposal costs by reducing waste?

These business questions do not need to be addressed simultaneously, especially if the device is early in development. For example, package design can wait until the device is closer to its final version, while key ergonomic factors (size, weight, etc.) should be explored with earlier prototypes.

And let’s consider a very important question: When should further device development be terminated?

Not all medical device concepts will reach the finish line for a myriad of reasons. Terminating development of a medical device unlikely to provide sufficient return on investment enables resources to be shifted to more promising medical device opportunities.

Strategic implementation of user experience research will aid manufacturers in making informed decisions throughout the medical device development process and will guide first steps in marketing strategies.