We talk a lot about quality maturity in medical device companies. Why don't we talk about Human Factors maturity the same way?
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
What does human factors maturity look like in medical device development?
Human factors maturity means integrating user needs, risk reviews, design decisions, formative research, and post-market data across all development phases to improve safety. Rather than treating validation as a regulatory checklist hurdle before submission, mature organisations embed this mindset from the beginning, making regulatory evidence a natural outcome of good design.
Quality maturity gets a lot of attention in the medical device world. There are full programs and frameworks around it. FDA’s Voluntary Improvement Program is a good example. The idea is that quality is not just about passing audits or inspections. It is about building the systems and habits that keep getting better at making safe, effective products.
So why do we not talk about Human Factors maturity in the same way? Maybe it is time we do. There is a big difference between companies that simply run a Human Factors study because it is required and those that actually have Human Factors maturity built into the organization.
The first group does a validation study before submission because it is expected. This group usually starts with "What do we need for FDA?". The second group weaves Human Factors into design decisions, risk reviews, formative research, post-market data, and product strategy, from the very beginning, because they are trying to answer “What do we need to understand to make the device safer?”
When Human Factors is mature, the regulatory evidence is the result of doing the right work, not just a hurdle at the end. If anything, the checklist is secondary.
I think we need a clear vision of what Human Factors maturity actually looks like. Not just a new template or requirement, but an organizational mindset that connects users, risk, design, and real-world feedback in every phase of development.
Maybe that is the next step for our field, building our own maturity model so we can talk about progress in Human Factors the way we talk about progress in quality.