Author: Nick Benedetto
Medical device startups face a cruel irony: they need regulatory submissions to unlock funding, but comprehensive human factors validation requires resources they don't yet have, perhaps assigned to other tasks. This chicken-and-egg scenario forces companies into strategic compromises that can either accelerate or derail their development timeline. The solution lies in understanding that FDA expectations around human factors testing are more nuanced than many companies realize. Regulators want evidence that companies understand their human factors risks, not necessarily that they've validated every possible user scenario before initial submissions or even pre-sub meetings.
Effective MedTech design firms that understand human factors engineering should also understand their clients’ business needs. If a regulatory submission, regardless of its heft, unlocks a next round of funding, innovators would be wise to submit initial applications focused on one primary user group for human factors testing while immediately planning expanded studies for additional populations like nurses or home caregivers for example. This approach satisfies immediate funding requirements while demonstrating regulatory sophistication.
For emerging medical device companies, a phased approach to human factors engineering mitigates the inherent risk of going "all in" and missing the mark early in development. Rather than pursuing comprehensive validation across all user groups simultaneously, startups should focus on demonstrating efficacy with their primary user set first, launching with core functionality and adding advanced features like sensors or AI capabilities while generating revenue and investor confidence. This strategy allows companies to confirm user benefit and market demand before committing to multi-million-dollar development investments, as investors fundamentally want to see that the device delivers genuine value and meets real user needs.
The FDA's predictable 45-90 day response timeline for human factors submissions, regardless of complexity, creates additional strategic opportunities for well-planned companies to sequence their validation activities, initiating studies for secondary user groups while awaiting regulatory feedback on their initial submissions, thereby maintaining development momentum without overextending resources.
Effective human factors consultants understand both regulatory requirements and business realities. They should bring interdisciplinary expertise spanning engineering, regulatory affairs, manufacturing, and user research. Their role extends beyond identifying problems to helping companies prioritize solutions based on risk and resource constraints. The best HF partners help companies ask the right questions at FDA pre-submission meetings, avoiding vague inquiries that result in equally vague responses. They understand that their job is to break things systematically through human factors testing, then provide actionable paths to fix them ultimately resulting in a higher quality product with a lower risk of recalls and churn.
Our dedicated professionals are actively involved in fieldwork, undertaking numerous projects that provide unparalleled insights into user behaviors and needs. We collaborate with diverse user populations across a wide range of medical conditions and clinical environments, to fully understand the varied contexts of device use. Our expertise lies in effectively navigating the medical device human factors process per ISO / IEC 62366, ensuring exceptional user-focused outcomes and a successful regulatory submission.
“We can adapt to evolving needs of the customer, scaling work to match your needs,” Veranex Director of Human Factors Nick Benedetto says. “We can give you the always affordable, reliable Honda Civic in a feasibility study, then upgrade from there when the time is right for more intensive human factors testing. Pick it up, put it down then pick it back of on your schedule; a high value proposition especially for startups in the early stages of multi-year ventures.”
Whether you need focused testing for your primary user group or comprehensive validation across multiple populations, Veranex offers the regulatory expertise and business acumen to guide your path forward. Our human factors engineering services and integrated CRO capabilities provide the strategy, flexibility and scalability that medical device startups need.
Clinical trials represent one of the largest investments in medical device development, often consuming millions in resources and months of careful planning. The FDA doesn't require human factors validation before clinical trials, but this regulatory flexibility in applying human factors and usability engineering to medical devices can become a financial trap for unprepared companies. Yet many companies discover too late that inadequate human factors validation can derail even the most meticulously designed studies. When users struggle with device operation during trials, the ripple effects are immediate and costly: extended timelines, expanded participant pools, and compromised data integrity.