Medical technology has long been shaped by institutions – and constrained by procurement cycles, regulatory pathways and clinical environments. These forces have determined not just what got built, but how it looked, how it was used and who it served.
But that model now has competition. A growing share of health innovation is moving out of hospitals and into everyday life. And as it does, the definition of a successful medtech company is changing.
Remote monitoring, at-home diagnostics and preventative self-care are no longer niche behaviours. Across the UK and Europe, people are engaging with their health in the same way they manage their finances or fitness – on demand, personalised and part of daily life.
This shift has been enabled by cheaper, more advanced technology, alongside post-pandemic growth in the health and wellness market. The UK alone now accounts for £165 billion of global demand, according to the Global Wellness Institute.
The direct-to-consumer pathway
Updates in medical device regulation changed the game for many medtech founders, making the regulatory landscape even more complex and costly.
To navigate this, many startups are building direct relationships with end-users first, by launching consumer products in lower-risk wellness categories. This way, they can build distribution, generate revenue, collect data and earn user trust before expanding into medical-grade features that require approval.
This allows companies to build momentum before taking on projects that fall under complex compliance requirements.
The model has been proven by the best. Healthtech company Withings, for example, built a large direct-to-consumer business before layering in medical devices. Apple has followed a similar trajectory with the Apple Watch, gradually adding regulated capabilities such as ECG monitoring to a mass-market device.
However, medtech founders, whether embarking on a staggered approach or looking to launch as a direct-to-consumer medical device from day one, should be aware of specific challenges.
Adoption is now a design problem
When products live in hospitals, usage is driven by protocol. At home, it’s driven by end-user actions and expectations.
After all, a device can be technically brilliant but still have stunted impact if people don’t want to use it. Friction, stigma and poor design become barriers just as real as regulatory ones.
There’s no shortage of devices that tick nearly every box on paper – clinically effective, innovative, even groundbreaking – but fall down on the one that matters most: whether people actually want to use them. Inhaled insulin device Exubera was a prime example – efficacious but its bulky, awkward design made it impractical in real life. CPAP machines remain the gold-standard treatment for sleep apnoea, yet have stubbornly poor adherence rates. Many patients stop using them due to discomfort and inconvenience. So, it’s clear clinical efficacy alone doesn’t guarantee real-world impact.
That’s why many newer health products increasingly resemble consumer technology. Blood pressure monitors take cues from wearables. Diagnostic kits borrow from skincare and beauty. Devices are designed to be worn and seen – not hidden away. They’re designed to be wanted, not just effective.
The influence of consumer brands is clear. In this model, experience is not an optional extra to clinical performance – it determines whether a product succeeds at all.
A different competitive set
Many founders still underestimate who they’re competing with. In a direct-to-consumer model, medtech startups are no longer just competing with other regulated devices, but with companies that have set the standard for user experience, storytelling and habit formation.
This reflects a broader shift in how people relate to their health. Traditional medtech focuses on intervention – diagnosing and treating problems once they arise. Consumer-led health is built around participation – continuous monitoring, optimisation and prevention.
That expands the market, and competition, significantly. Instead of serving only patients, these products target anyone interested in performance, longevity or quality of life.
What this means for startups
Scaling medtech companies is always going to difficult – and rightly so. So a consumer-led approach can offer a real alternative.
Direct-to-consumer distribution allows startups to bypass these slow procurement cycles and build relationships with users directly. It enables faster iteration and earlier revenue – often critical for venture-backed companies.
But it also raises the bar. Founders must build trust without institutional backing and compete on experience with global consumer brands.
The implication is clear – clinical innovation alone is no longer enough. Design, user experience and whether people actually want to use a product will be the deciding factors.
Founders need to ask themselves the following questions: how can the product be aspirational? What lifestyle does it enable? Is it aesthetically compelling? How does it appeal to today’s cultural trends?
Without some strong answers, it will be difficult to make the jump from a promising technology to a breakthrough product.
By Oscar Daws, Co-founder and Managing Director at Tone Product Design
