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

Digital health is on the rise. With the COVID-19 pandemic, patients’ needs, demands, and finally, the XXI century it couldn’t be any different.

The situation finds reflection in the numbers. Research and Markets, for example, claims that the digital health market will reach value at $223.7 billion by 2023, while Global Market Insights predicts $379 billion by 2024. In turn, Grand View Research, Inc. states that the digital health market size can be worth $509.2 billion by 2025. And it’s the data from long before the pandemic “boom”.

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

Photo by Bermix Studio on Unsplash

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.

On the one hand, we have watches that allow monitoring a heart rate or clothes equipped with sensors that enable us to measure various vital signs. You analyze the results they provide on your own, which helps you maintain a healthy lifestyle. On the other, there are bracelets that alarm emergency services when you have a heart attack. Not to mention robots, such as the da Vinci Surgical System.

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

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?

But digital health isn’t only a matter of patients. Many big companies recognize its potential and want to contribute to this promising market. Apple, Samsung, and Google have already introduced their applications and wearables, noting a significant success.

Learn more: 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 elsewhere — in prevention, not necessarily treatment. Wearables encourage behavior that reduces hospital visits and readmissions due to poorly managed personal health. According to Business Insider data, 75% of wearables users agree that they help them engage with their own health.

What’s inspiring, US consumer use of wearables increased from 9% to 33% in just four years. With recent circumstances, the number will surely continue to grow.

No wonder that the wearable devices’ market is expected to reach more than $27 million by 2023, which is 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 adjective “medical”?

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.

As the official definition by 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 (…).”

The definition sounds quite simple and logical, right? However, 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 U.S. 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 U.S. markets. Thanks to it you know how expensive the development of the device will be and what exactly you will need to create it.

In 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 in order to be introduced to the market as medical. In the United States, it works in a similar way.

Is it difficult to obtain medical certification?

Theoretically speaking, no. But in practice, every project is different. The key is to make sure it really 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.

The question arises: Are wearables legally always medical devices? Definitely not. Does it mean that they can’t improve our health? Again — not.

“Just” wearables or medical devices?

With the term “medical device” comes greater responsibility. However, it is an undeniable fact that even non-certified projects can improve our health and shape.

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.

What about medical devices? They usually 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. Note that those projects have usually more specialized functions. And yes, they are often wearables.

Learn more: What’s different in building a digital health application?

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.

One of the companies that we know has chosen to develop the medical device after comprehensive market analysis and investor persuasion. Here is why:

• 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.

Summary

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.

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

Learn more about our approach to digital health projects or simply chat with us to exchange ideas about digital health market.