Timelines in Human Factors
Human factors is one of the top reasons medical devices run into problems with the FDA after an initial submission. Yet many MedTech teams, especially newer companies, still postpone it or treat it as…
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Process
Human factors fails most often for process reasons, not technical ones. These pieces cover how usability engineering fits into development planning, design controls and design history files.
Questions answered here
- What happens if human factors is delayed in medical device development?Postponing human factors in medical device development frequently leads to regulatory issues with the FDA. Because usability is directly tied to device design, late-stage fixes are not quick patches. They typically require interface redesigns, additional development, revised risk assessments, and further testing, resulting in substantial costs and severe project delays.
- What are the risks of hiring human factors experts late in medical device development?Hiring human factors experts after design lock leaves predictable use errors built into the system. Instead of shaping the device, late involvement forces teams into damage reduction. This frequently leads to costly redesigns, complicated instructions for use, weak risk mitigations, project timeline delays, and increased regulatory submission risk.
Articles on process
Hiring late HF experts
One of the biggest red flags in MedTech startups is hiring Human Factors experts only after the design is already locked. At that stage, the key assumptions have already been made, the workflows are f…