When a digital health project becomes a medical device. A story about the digital health market and regulations

Shades of the digital health

In simple terms, digital health solutions use technology to help improve people’s health and wellness. However, it’s a very broad and rapidly growing sector.

Wearables are conquering the world of eHealth

When speaking of digital health most people would think about wearables. Who hasn’t used or at least heard about fitness trackers, smartwatches, and wearable blood pressure monitors?

What makes a medical device?

I think it won’t come out as a surprise but whether a digital health solution can be referred to as medical depends on legal circumstances. Do you think you know what medical device really is? Let’s find out.

“Just” wearables or medical devices?

We associate them (wearables) with applications that help to keep is fit. There is a reason for that — they usually do. Just take Fitbit, Google Fit, or Apple Watch. They are accessible and at the same time non-engaging, often hands-free. Have you ever used Endomondo? You go for a run, take your smartphone, press one button, and when you come back all the data is on your screen. You are motivated to future exercises and happy about your progress.

Why choosing to go medical?

It may seem much more complicated and challenging. I won’t lie — it is. However, there are benefits that compensate for this demanding process.

  • The wearables market is crowded. Many devices simply don’t operate properly, hence strategy “But our device works, believe us!” is very risky.
  • Obtaining medical certification requires conducting clinical trials. It allows you to evaluate your device performance: in how many cases it’s truly effective and what conditions it helps to improve.
  • Image. Medical devices, with proven effectiveness, are more reliable and professional than non-certified wearables.
  • Medical certification = higher price, which brings you to a higher margin.


Let’s face it, both types of described devices positively influence people’s health. It’s not a matter of certification whether a device has the power to improve our lives. In reality, the difference between medical and non-certified devices lies in the term itself, scale, functions, and the complexity of the development process.



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Untitled Kingdom

Untitled Kingdom

Equality starts with technology. Untitled Kingdom offers product and software development services for MedTech and HealthTech solutions: www.untitledkingdom.com