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By Sam Sye

A key step in designing any human factors study is to define the intended user groups. User groups are determined by unique demographic characteristics that may impact how a particular user interacts with a given medical device. These characteristics may include age, gender, education level, medical literacy, prior experience with similar products, or any number of other factors. Every human factors study requires determining which of these characteristics are relevant, and subsequently, how these might be represented appropriately in a study.

At the surface, it is logical that study participants should be representative of real-life end users. How else could one determine if safety mitigations and product designs facilitate treating patients safely and effectively?

However, medical and pharmaceutical companies must wear many hats. On one hand, they have a responsibility to develop safe and useful products that promote health and alleviate suffering. On the other, as businesses, they also have a fiduciary responsibility to their stakeholders to remain profitable and efficient (thereby ensuring their continued ability to produce safe and useful products). On occasion, these two hats find themselves at odds with one another. Prohibitive costs and time to find/recruit rare user groups can make the difference between bringing a device to market (to desperate patients) early, or not at all. At what price, if any, can representativeness be purchased?

Coming from a business background myself, I know such ethical dilemmas can be deceivingly difficult to recognize and resolve. At a certain point, it becomes all too easy for a decision to be lost in numbers and spreadsheets. Humans, after all, are logical creatures. Anyone can become susceptible to making business decisions based on projected revenues, expenses, and profits. Finding representative test subjects is one of those things that doesn’t translate well into numbers. For instance, if intended users are not particularly tech-savvy or commonly attempt to use complicated devices without training, recruiting representative test subjects may decrease the likelihood of successful product testing and lead to cost- and time-intensive design changes. As a result, some companies want to test only participants who will successfully use their device, to improve product performance in the study. But now, for the logical mind in all of us, let me argue the rationale of representativeness.

At the end of the day, medical and pharmaceutical products are intended to help people. Testing with representative participants is one of the best ways to ensure your device is safe and effective for the actual end users. Disease does not discriminate between socioeconomic or educational strata. Neither should medical devices. Surgical tools need to be user-friendly for both right-and left-handed people. (After all, right-handedness is not a requirement for medical school admissions…yet). Similarly, someone with low literacy needs to be able to use their rescue inhaler just as well as someone with a PhD.

The perils of stacking the deck in your favor early on, can emerge after your product has come to market. Post-release use errors can cost millions in recalls, lawsuits and regulatory fines or fees, not to mention the potential impact on a company’s reputation. Taking positive (if costly) action in the short-term, can lead to long-term gains by bolstering consumer confidence and loyalty to your brand. For example, Johnson & Johnson’s proactive management of the 1982 Tylenol recall allowed them to turn a potentially disastrous event into a industry-defining example of responsible brand management and consumer protection. Merck’s philanthropic dedication to the development and distribution of Mectizan, a drug used to treat river blindness in West and Central Africa, gave the company a lasting reputation for corporate citizenship and social responsibility. The list of examples goes on.

It would be naïve to say that money doesn’t matter, because it does. Paying the bills and turning a profit ensures that there continue to be innovations in healthcare, and that services continue to be available to those who need it most. That said, these business decisions must be made in a context of delivering products that people need to live and thrive.

So, in conclusion…

Representative users? $1000s. Safe and effective medical devices? Priceless.