The people using healthcare products are getting older. Are the products keeping up?
By 2030, one in six people globally will be aged 60 or over. By 2050, the number of people in this age group is expected to reach 2.1 billion.
In the UK, the change is even more tangible. The Office for National Statistics projects that the number of people aged 85 and over will more than double, from 1.75 million in 2024 to 3.6 million by 2049.
This is not simply a demographic story.
It is a product development challenge.
And potentially one of the biggest usability challenges facing MedTech.
Who are you actually designing for?
Think about the last medical device, diagnostic platform or digital health product your organisation developed.
Who was represented in the early user research?
Who tested the prototypes?
Who completed the formative usability studies?
And did those people genuinely represent the patients who will ultimately use the product?
A 45 year old product designer navigating an interface in a well lit usability lab is very different from an 82 year old patient using the same device at 10pm at home.
Their eyesight may be poorer.
Their hearing may be reduced.
Their dexterity may be limited.
They may have arthritis, tremor or reduced grip strength.
Their cognitive processing may be slower.
They may be taking several medications and managing multiple conditions.
And they may be anxious about getting something wrong.
Yet many healthcare products still appear to be designed around an idealised user with good vision, good dexterity and considerable confidence with technology.
Is that really your user?
The home is becoming part of the healthcare system
Healthcare is steadily moving away from hospitals and clinics.
Monitoring, diagnostics, rehabilitation and treatment increasingly happen in patients’ homes.
That changes the design challenge fundamentally.
The FDA explicitly identifies the user, use environment and user interface as the three major components that need to be considered in human factors and usability engineering.
For over the counter medical devices, it also highlights differences in users’ physical, sensory, cognitive and emotional abilities, including vision, hearing, tactile ability and health literacy.
So ask another question.
If your device is moving from a trained clinician to an elderly patient, has the product really been designed for the same job?
A clinician may use a device hundreds of times.
A patient might use it once a week.
A nurse may immediately understand an alarm.
A patient may interpret it as evidence that something has gone seriously wrong.
A clinician may recognise an icon instantly.
An older patient may simply not see it.
Moving a medical device into the home therefore requires more than simplifying the instructions.
It can require rethinking the product.
Accessibility is not a font size
There is a temptation to equate inclusive design with larger text, bigger buttons and greater screen contrast.
Those things matter.
But genuine inclusive design goes much deeper.
Consider a connected diagnostic device.
Can someone with reduced grip remove the packaging?
Can they insert a cartridge correctly?
Is there an obvious physical indication that it has engaged?
Can they distinguish between controls?
Can they read the screen without finding their glasses?
Can they recover easily from an error?
Does the interface clearly communicate what happens next?
Could they complete the task with reduced hearing?
Could someone unfamiliar with smartphones successfully connect the device?
And perhaps most importantly:
What happens when they do something you didn’t expect?
That last question is where human factors becomes particularly important.
Good medical device design should not simply make correct use possible. It should make incorrect use less likely.
Usability is increasingly a regulatory issue
This is not simply good industrial design.
IEC 62366-1 establishes a usability engineering process for analysing, developing and evaluating medical device usability as it relates to safety and use error.
The FDA has also strengthened its focus on human factors. Its August 2026 guidance, Applying Human Factors and Usability Engineering to Medical Devices, states that manufacturers should use appropriate human factors and usability engineering processes to maximise the likelihood that devices are safe and effective for their intended users, uses and environments.
A separate FDA final guidance issued in May 2026 provides a risk based framework for the human factors information manufacturers should include in medical device marketing submissions.
The direction is clear.
Understanding the user cannot be something that happens shortly before regulatory submission.
It needs to influence the product from the beginning.
Test the difficult users first
There is another way to think about this.
Instead of designing for the average user and subsequently adapting the product for older people, what if you deliberately started with the more demanding users?
Give the prototype to someone with reduced vision.
Give it to someone with arthritis.
Test it in poor lighting.
Test it with background noise.
Test it with someone who has never used the technology before.
Remove the carefully trained moderator and see what happens.
Where does the product fail?
Those failures are valuable.
Finding them during rapid prototyping might require a design change.
Finding them during validation can require a development change.
Finding them after launch can become a commercial or safety problem.
This is why Maddison believes human factors should not sit alongside product development.
It should actively drive it.
Better for older users often means better for everyone
There is also a commercial opportunity here.
Designing for ageing does not mean creating products that look like they were designed for elderly people.
Quite the opposite.
The best inclusive products remove unnecessary complexity.
Clearer information.
Better ergonomics.
More obvious controls.
Fewer steps.
Better feedback.
Easier error recovery.
More intuitive interfaces.
These improvements benefit almost everyone.
The objective should not be to design an “elderly version” of a medical device.
It should be to design a better medical device.
The questions MedTech leaders should be asking
Before the next design review, ask:
Are our intended users genuinely represented in our research?
Have we considered how ageing changes vision, hearing, dexterity and cognition?
Are we designing for the real use environment rather than the ideal one?
Are we relying on instructions to solve problems that should have been solved through design?
Have we tested the people most likely to struggle with the product?
What happens when a user makes a mistake?
Can they recover without assistance?
Could we remove a step rather than explain it?
And are human factors influencing our concept now, or are we waiting until validation to discover the problems?
If those questions are difficult to answer, that is precisely when specialist development support can create the most value.
Design for the population that is coming
The ageing population is sometimes discussed as though it were a future healthcare challenge.
It isn’t.
The users are already changing.
The care environment is already changing.
And regulatory expectations around human factors continue to evolve.
At Maddison, we work with MedTech teams to investigate difficult product challenges, understand real user behaviour and rapidly turn those insights into better concepts, prototypes, interfaces and products.
Sometimes that means working alongside an established development team.
Sometimes it means taking a difficult problem away from the core organisation and giving a focused multidisciplinary team the freedom to investigate it.
Either way, the objective is the same.
Find the usability problems early, solve them intelligently and design medical products around the people who actually have to use them.
Because the biggest question may not be whether your technology works.
It may be whether the person who needs it can use it.
References
- World Health Organization. Ageing and health. WHO, 2025. By 2030, one in six people globally is expected to be aged 60 or over, rising to 2.1 billion people by 2050.
- Office for National Statistics. National population projections. ONS, 2026. The UK population aged 85 and over is projected to increase from 1.75 million in 2024 to 3.6 million by 2049.
- US Food and Drug Administration. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff. August 2026.
- US Food and Drug Administration. Content of Human Factors Information in Medical Device Marketing Submissions. May 2026.
- IEC 62366-1:2015. Medical devices, Part 1: Application of usability engineering to medical devices.