Regulators are not the problem for innovation
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
Does regulation slow down innovation in medical device development?
Regulation does not inherently slow innovation; delays happen when teams develop devices without understanding regulatory expectations. Leaving Human Factors until validation leads to reactive fixes and expensive surprises. Companies clear regulation more smoothly by identifying usability risks early, iterating designs, and treating human factors as an integral part of ongoing development.
I see a lot of early MedTech companies blaming regulators on social media for slowing down innovation. I don’t see regulation as the problem. The issue is starting development without really understanding what will be expected later. If you don’t design with those expectations in mind from the beginning, you are not being innovative, you are just building something that will struggle to pass.
In Human Factors, this shows up very clearly. By the time you are writing your validation report, the real work should already be done. That is not the moment to discover usability issues or start fixing gaps. If problems are still appearing that late, you are not doing usability, you are uncovering surprises, and those surprises get expensive very fast.
When Human Factors is pushed to the end, teams end up reacting instead of designing. The companies that move faster and get through regulators more smoothly do the opposite. They identify risks early, iterate early, and treat usability as part of development, not as a box to check before submission. At that point, regulators are not blocking innovation, they are just reflecting the quality of your process.