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When does a digital health project become a medical device? A look at the digital health market regulations

Digital health is on the rise. And with the COVID-19 pandemic, the XXI century is catching up with patients’ needs and demands - and the numbers reflect this.

Research and Markets, for example, claims that the digital health market will reach a value of $223.7 billion by 2023, while Global Market Insights predicts $379 billion by 2024. And Grand View Research states that the digital health market size can be worth $509.2 billion by 2025. And all this data is from long before the pandemic “boom,” which means that these numbers will surely increase.

Whatever version we choose to believe, there is no denying that digital health will soon change how we see healthcare. But what does digital health really mean? What kind of devices can improve our well-being? How to classify them?

Table of contents:

Shades of the digital health 

Simply put, digital health solutions use technology to help improve people’s health and wellness. However, since it’s a very broad and rapidly growing sector, it’s not that simple.

On the one hand, we have watches that monitor heart rate or clothes equipped with sensors that measure various vital signs. They provide you with data you can analyze on your own to maintain a healthy lifestyle. On the other hand, there are bracelets that alarm emergency services when you have a heart attack. Not to mention robots, such as the da Vinci Surgical System - Robotic Assisted Surgery for patients.

Each of the mentioned devices is a part of the complex world of digital health. But what is the difference between them? Why is one described as a medical device and the others just as wearable?

Wearables are conquering the world of eHealth

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

But digital health isn’t only aimed at patients. Many big companies recognize the potential and want to contribute to this promising market. Apple, Samsung, and Google have already introduced their applications and wearables, noting significant success (more on that in a separate article Digital health on a big scale. Apple, Google, and Samsung know how it’s done).

However, wearable health technology isn’t a longing cure for cancer or a breakthrough like the penicillin invention in 1943. Its power lies else in prevention, not treatment. Wearables encourage behavior that reduces hospital visits and readmissions due to poorly managed personal health. According to Business Insider, 75% of wearables users agree that they help them engage with their health.

What’s even more inspiring, US consumer use of wearables increased from 9% to 33% in just four years. And (again) concerning recent circumstances, this number will surely grow. No wonder the wearable devices market is expected to reach more than $27 million by 2023 - a spectacular jump from almost $8 million in 2017. (Again, before-COVID-19-data.)

The relationship between wearables and medicine is undeniable. But can we always describe a wearable device using the term “medical”? What is a difference between medical or wearable device software development?

What makes a medical device?

Whether a digital health solution can be referred to as "medical" depends on legal circumstances.

As the official definition by the EU stands, a medical device is:
any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination" and "intended by the manufacturer to be used for human beings" for purposes of (among other things) "diagnosis, prevention, monitoring, treatment or alleviation of disease, [or of an] injury or handicap", or for the "investigation, replacement or modification of the anatomy or of a physiological process (…).

Sounds simple and logical, right? Well, there is more. When a device enters a specific market, it must be adjusted to the regulations of the country in question. In the case of the European Union, you will be interested in MDR (Medical Device Regulation). In the US market, you must meet the FDA (Food and Drug Administration) regulations.

The first step to obtaining the medical device status is classification - both in the EU and US markets. Then you know how expensive the development of the device will be and what exactly you will need to create it.

In the EU, it all comes down to getting CE marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. It defines what standards a device must meet to be introduced to the market as medical. In the United States, the inner workings are similar.

Is it difficult to obtain medical certification?

Theoretically speaking, no. But it varies depending on the project. The key is ensuring that a given digital health project does what a founder says it does. Simple as that. 🙂

The reason for all of this is obvious. Medical devices must be 100% secure - otherwise, they may not be authorized to enter a given market.
So, legally, are wearables and medical devices synonyms? No.
But does it mean that they cannot improve our health? Again - no.

“Just” wearables or medical devices?

With the term "medical device" comes greater responsibility. However, it is undeniable that even non-certified projects can improve our health.

We associate wearables with applications that help to keep us fit. There is a reason for that - they usually do. Take Fitbit, Google Fit, or Apple Watch - they are accessible, non-engaging, and often hands-free. Have you ever used Endomondo? You go for a run, take your smartphone, press one button, and when you return, all the data is on your screen. You are motivated for more exercise and can monitor your progress.

Medical devices, however, tend to focus on one problem - e.g. ovulation or heart attack prevention.
Developing such a device is a much more complex process due to all the regulations I've mentioned above. Such projects (often wearables) usually have more specialized functions.

Should you be interested, another Untitled Kingdom member covered the complexities of this development process in more detail, in a different blog post: What’s different in building a digital health application?

Why choose to go medical?

It may seem much more complicated and challenging. I won't lie - it is. However, some benefits compensate for this demanding process.

One of the Untitled Kingdom partners (never called them "clients") has chosen to develop the medical device after comprehensive market analysis and investor persuasion. Here are the reasons they shared:

  • The wearables market is crowded. Many devices simply don't operate properly. "But our device works, believe us!" is very risky.
  • Obtaining medical certification requires conducting clinical trials. It allows you to evaluate your device's performance. It's time-consuming, but in many cases, it's truly effective and helps you improve.
  • Self-Image. Medical devices with proven effectiveness are more reliable and professional than non-certified wearables.
  • Medical certification = higher price, which means 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.

In Untitled Kingdom, we believe that building a medical device is worthwhile. It takes time, effort, and specialized knowledge, but then, you can be sure the project is effective, secure, and needed.

You can learn more about Untitled Kingdom's approach to digital health projects or simply let's chat and exchange insights on the digital health market. 

By Piotr Zając

CEO at Untitled Kingdom. A guardian of Quality, Transparency and Family values. Responsible for showing his colleagues the meaning of life, what personal development is and how to be deeply joyful during work-work balance. A young daddy of Argus, The Polish Greyhound.