‘9 out of 10 dentists’ – the importance of user-centred design

10 Nov 2023 8min read

My spouse is a dentist – and she is quite indifferent to product design. Despite this, she recently found herself in an ideal position to compare the design of two competing products, while working alternate days in two separate dental clinics. Each clinic was kitted out with different equipment, meaning she was effectively enrolled in her own private comparative clinical study, able to assess the design and usability of each device. Mostly, she found she could adjust easily when moving from one set of equipment to the other, with one notable exception. For plaque removal, one clinic was equipped with a device which I’ll call Device A, while the other had, you guessed it, Device B.

These two devices ostensibly performed the same function: grinding and scraping plaque from teeth and sucking it out of the mouth – pretty standard dental techniques that most patients have experienced. Working with Device A, she found she could complete the plaque removal in 15-20 minutes, while Device B would require 30-40 minutes. That’s a significant difference, with Device B resulting in roughly half as many patients attended to across a day. Since dentists in France are paid per procedure – either by the patient, social security or insurance – this additional time spent has a very real impact on revenue.

When raising the issue with her peers, my spouse found that this was a common issue experienced with Device B, with most dentists preferring Device A by a significant margin. Deciding to take her investigation a step further, she went on to ask the manufacturer of Device B if they were aware of this potential flaw in their product. Their official line was that their device ‘provided a gentler experience for patients’. While this is a potential benefit, it is debatable as to whether this justifies such a difference in product performance. Likewise, some patients might prefer to spend as little time as possible in the dental chair, versus a longer, more comfortable experience.

This example highlights a common issue in medical device development – user-centred design is often not made a priority. One of the key reasons for this is due to what is required by the regulations.

Do regulators care about design?

Let’s shelve our dental story for a minute and think about a different stakeholder: the medical device regulator. For most of my professional life I have been attuned to the interactions between medical device manufacturers and regulators such as the FDA and EU notified bodies. I was trained on the idea that, above all else, regulators care about safety and efficacy.

Medical device regulations have largely been built on the back of safety scandals like Radithor (“certified radioactive water”), the Dalkon Shield, or recently the PIP breast implant fraud scandal, that encouraged the EU to tighten and strengthen regulations around post-market surveillance in the MDR.

When I picture a regulator, I think of someone who is above all concerned with preventing unsafe products from reaching the public. I imagine people who live and breathe the Hippocratic principle of “first do no harm”. People like Dr. Frances Kelsey of the FDA, who famously refused an application for Thalidomide and prevented a near disaster.

The risk of prematurely or wrongly approving medical products is still a valid concern in the industry. This was brought into acute focus on the frontlines of the race for Covid-19 treatments and vaccines, when regulators pleaded caution on products like hydroxychloroquine and vaccines, until enough clinical data could be obtained.

In contexts such as this, product design may often be seen as secondary, at least so long as it has no tangible impact on clinical safety and efficacy. The FDA even says as much in their Human Factors guidance document:

“While following [user engineering processes] can be beneficial for optimizing user interfaces in other respects (e.g., maximizing ease of use, efficiency, and user satisfaction), FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments.”

As shown in the diagram below, safety and effectiveness are the minimum regulatory requirement for device manufacturers to achieve. It is not surprising then that many device manufacturers focus only on this core regulatory priority in their race to market.

While safety is of course paramount in any medical application, this should not mean that usability and user-experience are sacrificed.

The importance of user-centred design

Before joining Team, I worked at a company that provided regulatory support services. For many of my clients, FDA approval or CE marking was considered the finish line, the point at which their device was deemed safe to market. In reality, regulatory approval should be seen more as a ticket to join the race – to continue building on and improving the product so that it truly meets user needs.

For a product to be successful, it needs to be commercially (and regulatory) viable, desirable and technically feasible. The focus should be on both safety and efficacy, as well as responding to users. It should be on gaining market approval while ensuring market adoption. Achieving these core qualities involves a careful process of ‘Design Thinking’ throughout your development and requires a detailed understanding of your users, your technology and the market you plan to sell in. See our articles on MedTech product design and front end innovation for a deeper discussion of the Design Thinking process.

While users such as my spouse may not be consciously aware of the careful design decisions that go into device development, they are certainly impacted by them. At its best, good design will improve the safety and efficacy of your product, in addition to providing a better experience for your end users in the areas that matter for them.

Ultimately, your device may be regulatory approved, but it will only be truly successful if it meets real user-needs. Even when they might not notice it.