Prioritise Human Factors

Introduction

What is good for the user is good for you! Medical devices developed upon sound human factors work are not only safer and easier to use but also streamline your regulatory submission and create greater value for your product. Human Factors – often known as Ergonomics – is the safety and usability of the product going to market. It has been a presence in the regulatory landscape for over a decade, but both startups and well-established medical companies can struggle to integrate it into their strategy to yield the most value. Here are some of the common pitfalls I see, and how to avoid them. 

Misunderstanding Human Factors

Meeting your human factors needs is much easier when all parties understand what human factors is, and what it isn’t. Done well, human factors work supports and coordinates with engineering, design/UX, regulatory, legal, and market research. However, human factors should not be mistaken for any of these elements itself. In its raw form, human factors provides these teams with the information they need to make a usable and safe product. A human factors specialist may obtain this information either through established analytical methods, or empirically through various forms of usability testing. 

The most common misunderstanding I see is thinking a human factors specialist is a UX designer or engineer who will give you a finished product. Typical human factors outputs are reports, spreadsheets, and raw data – data that you can use to create a safe and usable product. Human factors data alone is also not designed to give you a green light, answering whether your product is, “ready”. A solid human factors foundation will make this decision easier, but ultimately this decision can only be made by your executives after they have weighed the risks and benefits of the current medical device design.

Medical Device Startup Struggles: Get a Regulatory Specialist

Building a company out of nothing is already a daunting feat. You are working hard to do everything correctly, but you don’t know what you don’t know. Involve a regulatory specialist early in a medical device development to tell you about some of the oft-missed lingo-ridden fine print, like human factors. All too commonly, the product is developed, instructions and packaging designed, the suppliers in place, and all the clinical results in a report ready to go to the FDA, and suddenly you’re hearing about this “human factors” thing for the first time. 

A human factors professional can conduct and analyse a full validation study for you, or your product may not need that much. There are many different pathways toward approval, and the regulatory specialist will get you on the right one. All the years, money, stress, it all comes down to this submission, so make sure you aren’t caught by surprise. Get a regulatory specialist, get a human factors professional, and get them talking.

When to Integrate Human Factors

Human factors is often labelled “the science of common sense” due to its connection with intuitive design, but rigorous human factors work will often uncover and address hidden risks that were not so obvious. Companies old and new often try to cut costs by making human factors the last checkbox on the submission. Not only does this put the whole submission at risk, but you miss out on the value that comes from applying human factors work from the beginning stages of medical device development. 

A product that is user-cantered even before concept development mitigates more use errors, which in turn translates to fewer costs due to redesign, retesting, and resubmission pre-market, and training programs, recalls, and litigation post-market. A product that is intuitive and promotes correct use will also result in more positive and consistent clinical outcomes for your patients.

How to Respond to FDA Human Factors Feedback Without Delaying Your Submission

Remember that feedback from the FDA is not a death sentence. It is not uncommon for the FDA to respond with a few concerns that can be addressed with clarification, minor tweaks, and a supplemental study or two. The only client I have ever had fail a submission was one who panicked when the human factors checkbox revealed their product was not perfect and then chose to ignore the facts instead of facing them. In the words of Douglas Adams, “Don’t panic”! I stress this because panic is reflexive and unchecked it will kill a product faster than anything else. 

Even the best designed products will have residual risk, so you should expect to see some use errors even in the validation study. Take a deep breath. The FDA wants to know what those risks are, they want to know you have tried to fix them, and they want to know why you think the benefits of the product outweigh those residual risks. A classic example is the scalpel. A scalpel’s residual risk is that it might cut somebody, but that is also precisely why it would benefit a surgeon trying to save somebody’s life. The FDA does not want a perfect, risk-free product as much as they want due diligence. 

How to Recover When Human Factors Is Introduced Late in Development

Perhaps you are reading this as a company that has, knowingly or not, missed the mark on due diligence: you skipped the regulatory specialist, you have not considered human factors, or you are ready to scrap your product because some of the results are less than perfect. I have seen my share of products that seemed like they were past the point of no return but made it through their submission by addressing these issues as soon as possible. 

Fix these problems as soon as you find them. A late fix is not ideal – it leaves a lot of value of human factors on the table – but you may be surprised what a human factors professional can help you salvage. If product redesign is no longer an option, targeted research and analysis can help smooth out more concerning use errors with less costly modifications to product labelling or packaging. A little information can go a long way toward positive patient outcomes. 

Takeaways

Make human factors part of your company culture and let it inform your teams as they work to develop your medical device. Mitigate what risks you can take, accept that there will be residual risks, and be prepared to make your case to the FDA for why those risks are acceptable. Integrate human factors into your strategy as early as possible for the maximum benefits to the product, your submission timeline, your budget, and your patient outcomes. Because again, what is good for the user is good for you.

References

• Food and Drug Administration, “Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff,” U.S. Department of Health and Human Services, Silver Spring, MD, 2026. 
• S. Pelayo, R. Marcilly and T. Bellandi, “Human factors engineering for medical devices: European regulation and current issues,” International Journal for Quality in Health Care, vol. 33, no. Supplement 1, p. 31–36, January 2021.  
• R. G. Bias and D. J. Mayhew, Cost-justifying Usability, 2nd ed., Elsevier Inc., 2005.  
• J. M. B. C. 2. D. M. Ann Kutney-Lee 1, K. H. Bowles, M. D. McHugh and L. H. Aiken, “Electronic Health Record Usability: Associations with Nurse and Patient Outcomes in Hospitals,” Med Care, vol. 59, no. 7, pp. 625-631, 1 July 2021. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.