Wiklund’s Perspective: Digital Evolution of HFE for Medical Device Design and Development

The term opus is usually applied to a piece of music or another type of creative work. Today, our human factors team employs the term as an acronym, standing for Optimal Product Usability Suite (OPUS™). We use this term to describe our new creative work, a software platform for the application of human factors engineering (HFE) in the development of medical technology.

In early March 2022, we publicly launched OPUS™. A creative work of a non-musical nature, it includes HFE training modules, a framework for conducting HFE that should meet FDA and other regulators’ expectations, and many analysis and design tools and templates that facilitate various HFE tasks. Feel free to take a look at OPUS™. But, my commentary is not intended to be an advertisement. Rather, I want to reflect on a need for selected digitalization within the HFE medical space.

The application of HFE to medical technology is mushrooming, as I stated in last month’s perspective. Consequently, product development and consulting companies have had to evolve, sometimes organizationally and usually in terms of how they apply HFE.

More standardized HFE processes for medical device testing

HFE used to be practiced in somewhat of an ad hoc and “figure things out as you go” manner. There was a lot of variety in how one HFE specialist would apply HFE to medical technology compared to how others would. For example, I remember conducting a “final” usability test of a hemodialysis machine based on my own interpretation of the FDA’s HFE expectations. We didn’t even use the term “validation test” in the early 2000s, and test report content was whatever the specialist considered to be pertinent content.

Today, there is a very specific way to approach HF validation testing, with direct links established to use-related risk analyses leading, in turn, to the identification of critical tasks. Proper user population sampling is now important. Data must be collected, analyzed, and reported in specific ways. Therefore, companies have established standard operating procedures (SOPs) governing the actions of their internal HFE teams and consultants. Where practitioner judgment and preference used to guide the application of HFE, there are now rules. Also, a larger proportion of developers are employing HFE specialists or drawing upon HFE consultants to perform the required work.

Digitizing HFE tools and resources

The evolution, driven by increased demand for methodological consistency, has opened the door to digitalizing some aspects of applying HFE to medical technology. Functioning to a degree as a detailed SOP, this is what OPUS™ does for its users. The platform guides users through the HFE process so that developers ultimately have “checked all the boxes” as far as meeting regulators’ expectations is concerned. Importantly, OPUS™helps developers produce a truly safe, usable, and appealing product, thereby meeting regulatory and commercial imperatives. The intent is that when OPUS™ users “check the box,” they have truly done good HFE.

In closing, I admit to missing just a bit the “wild wild west” days when HFE practitioners had nearly full reign over how they applied their craft to medical technology. During those times (let’s say 1980-2000) you felt like a pioneer who could help to transform a company’s development process to be more user-centered. It was fun, but your opportunity to make a positive difference was uncertain. We’re better off today when HFE is being applied with far greater consistency to medical technology. Just as 3D modeling software has helped produce better cars and airplanes, digital tools and templates should help HFE practitioners do their best work ever. 3D anthropometric models have helped user interface designers create ergonomic workspaces. Similarly, tools that can be expected to evolve, like OPUS™, will help HFE practitioners move more swiftly and effectively through an HFE process that has become highly specialized to suit the regulated medical device (and combination product) industry.

Michael Wiklund is General Manager and Director, Human Factors Research & Design (HFR&D) at Emergo by UL.

• HFE user research for medical devices, IVDs and combination products
• Human factors design and prototype development support