Achieving regulatory compliance with a new device means more than checking boxes.

Milton Yarberry, Boston UX & Integrated Computer Solutions

In medical device development, quality management achieved through design controls can often be viewed as an “add-on” activity intended to check the regulatory boxes for the FDA. This practice happens at startups where founders are new to the esoteric religion of regulatory compliance, but also at Fortune 500 companies with storied medical device legacies.

While the circumstances might differ, the result is similar: Product risks are managed outside of a quality system, usually at the end and at disproportionate cost.

In such scenarios, prototyping early in the product development cycle typically happens as a means to get a jump on the project schedule and handle visible technical risks. As the prototype becomes more substantial, the line between the prototype and production code becomes ever less distinct. Fleshing out features gets priority over analysis and evolution of the prototype. Then, as an afterthought, the focus becomes “How do we check the boxes to make this compliant?”

This very natural evolution of work results in a quality system that adds no value. By contrast, correctly designed prototypes can feed and shorten development under design controls by reducing product evolution and cementing the product vision internally.

Iterate on key product issues

The prototyping phase is an opportunity to work on important product issues until reaching a clear and decisive vision. Giving short shrift to the study and revise steps in a build/study/revise cycle can introduce uncertainty later in the development process and cause disruptive change. Developing a high-fidelity prototype that leaves zero room for interpretation provides a direct path to product realization: “Make it exactly like this.”

This dynamic is especially true in the area of user experience (UX) design. Due to concerns about user error, the FDA released final guidance in 2016 on following appropriate human factors and usability engineering processes to improve the safety and efficacy of new devices

“User error is still considered to be a nonconformity because human factors and other similar tools should have been considered during the design phase of the device,” the agency said.

Companies that develop a high-fidelity prototype and do formative testing may avoid the problems associated with discovering user errors during late-stage testing. A high-fidelity user interface (UI) prototype not only reduces bumps in testing at the end of development, but it may feed each step of the design process.

Develop a refined prototype

A well-reviewed and refined UI prototype acts as a strong precursor to a cornerstone of design controls — the product requirement document (PRD). Feature interactions, operational modes, error states and safety features can all be uprooted and iterated with a fraction of the resources normally required under design controls. A UI prototype also accelerates the engineering and testing by providing precursors for design documents and test cases.

Get comfortable with the idea that, at this point, that you’re not developing software for the final product. You’re eliminating risks and unifying the product vision across your organization. This has strategic value beyond getting a jump on development.

The good news is that there is a range of rapid-prototyping tools and product frameworks available that enable fast and inexpensive prototyping. The best ones will have been applied in other medical devices, which makes them good candidates to accelerate development under design controls.

Milton Yarberry is the director of medical programs at Boston UX and Integrated Computer Solutions (ICS). He has more than 15 years of experience working with large and small medical device and IVD manufacturers.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.