2019年 6月 5日
Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers.
Dealing with medical device manufacturing companies, I’m often asked, “How much is this going to cost?” For a consumer of any service or product, this is a very important question to ask. Resources, time, and money in this case, are always limited, and we all must ensure efficient allocation of our companies’ resources. Spending on human factors services is no different.
I see a striking difference in how companies approach allocating resources to human factors services versus other investments. For some, it’s a need to meet a regulatory expectation. For others, human factor or usability engineering is a way of life embedded throughout the organization, involving elements of marketing (understanding users), software and hardware developers (designing with usability in mind), and regulatory (ensuring compliance).
When human factors engineering (HFE) and usability are viewed as investments, clients recognize the benefit of applying a robust user-centered approach to the design process. Understanding who your uses are, gathering user inputs, using those inputs to iterate the design, and then repeating the process creates a product that is not only safe and effective (a regulatory imperative), but is also satisfying to the user (a commercial imperative). User satisfaction will have a major impact on your market success. Keeping an eye on the commercial imperative helps maximize your return on your human factors investment.
Human factors practitioners are keen observers: whether performing ethnographic research (watching people do things) or conducting a formal usability studies, we’re leveraging the data we collect to offer opportunities to improve a device’s safety and efficiency, ultimately enhancing the user’s experience. Since regulators expect you as a manufacturer to incorporate human factors engineering into your development process, it’s important to create intrinsic value for that effort. This holds true whether you have an internal HFE team or you utilize independent HFE consultants.
On the flip side, I do occasionally get the “I need an HF validation study report to include in my filing” or “I just received an Additional Information request from FDA on my pre-submission--they want to review the HF protocol” question from a client. Or even worse, after a filing, a company needs an HFE/UE (usability engineering) report.
Within minutes of the conversation, it becomes clear that the firm had followed no formal human factors process, and that HFE was clearly an afterthought. Thankfully, as the requirement to meet FDA human factors guidance has penetrated the MedTech industry in the last decade, this issue occurs less frequently, but yes, it still happens to this day. At this point, a huge opportunity has been missed and there’s a risk that this could derail an entire MedTech project. HFE has now become an large expense.
According to a study done by Association for the Advancement of Medical Instrumentation (AAMI) in the early 2000s, AAMI found that applying a robust human factors process resulted in a cost-to-benefit ratio of 5:1 – 9:1. By any ROI measure, that’s a return on investment even Warren Buffett would be proud of.
While the regulatory goal of applying HFE is to reduce use-related risks, there’s a spillover effect that enhances the cost-to-benefit ratio by reducing business risk such as time-to-market delays, product returns, low sales, lost goodwill, and a high volume of support into your call center. These benefits are a direct result of having a well thought-out, user-centered design process that’s been validated by an integrated human factors usability engineering process.
Our best advice is to be sure to apply a human factors process early and often. Also very importantly, challenge your HFE partners to explore value engineering options during your device’s development stage to ensure the benefits of this process, and your investment are maximized.
Having a team-wide perspective on applying human factors will result in a faster time to market, improve user satisfaction, simplify your training requirements, reduce calls to your support center, reduce returns, reduce potential liabilities from harm, and improve sales. Now that’s a positive return on your HFE investment.
Mark Tavano is Sales Director at Emergo by UL's Human Factors Research & Design division.