The medical device industry has always been an important niche of the healthcare industry. In recent years though, as technology has developed and become even more important in medicine, the medical device industry has been gaining notoriety as its own industry.

But many people don’t know that much about the medical device industry, because the industry has been dominated by big, hospital-focused equipment that the average person didn’t need to know about.

Now, however, the medical device industry is expanding even as medical devices are getting smaller, more portable, more personal, and more focused on everyone involved in healthcare, not just medical professionals. As a primer on this long-standing and fast-growing industry, here are five things to understand about the medical device industry.

1. It’s growing fast

The medical device industry has been growing fast. It has experienced a 4.4% compound annual growth rate (CAGR) since 2015 and became a $450 billion-dollar industry in 2019. The pandemic slowed that growth rate down a bit in 2020, because global lockdowns halted production around the world. But even with a substantial slowdown in sales and manufacturing, it will still be around a $440 billion-dollar industry at the end of 2020.

As life and business begin to get back to normal, experts predict that there will be even faster growth in the industry. This prediction is an over 6% CAGR in 2021 and beyond to bring the market to over $600 billion by 2023. This is the kind of growth many industries only dream of, and there are no signs that this industry will slow down in the near future.

2. Software can be a medical device

One of the biggest drivers of the growth of the medical device industry is Software as a Medical Device (SaMD). As the name suggests, this is software that is used as a medical device without the need to be used with any other medical device. This article from Orthogonal explains how exactly to determine if something qualifies as SaMD.

Amazingly and importantly, SaMD takes the functionality of big machines and puts them in the palm of not only doctors but individual patients too. It makes medical devices cheaper, more portable, more accessible to the average person, and allows them to be updated and improved in real-time. It is a huge advancement that is driving the industry into the 21st century. 

3. Users are now the focus 

In the past, medical devices have been made to solve a problem. That has driven a lot of innovation, but the medical device industry has reached a point where that simply is not enough. The industry is big enough, mature enough, and has enough internal competition that medical devices now need to stand out and not deliver not only results but a great user experience as well.

There are so many medical devices out there and so many on the way, the best ones have to fight through a crowd and rise to the top. These devices do this by not forgetting about a great user experience. It is the best way to achieve wide-spread adoption in the healthcare world.

If these devices make either medical professionals or patients’ lives harder, they don’t stand a chance in the crowded marketplace. They need to make life easier, faster, or more convenient. This is why we are now seeing medical devices with such great user interfaces and user experiences across the board.

4. They are becoming more niche 

Medical devices used to be one-size-fits-all. Things like x-rays, CT scans, and MRI machines were and still are astonishing devices that can help a wide range of people in many ways receive better medical care and achieve better healthcare outcomes. Medical devices today though are going for niche acceptance. They want to target a very specific issue within a specific population and work well for that specific function.

This is especially the case with SaMD. These devices do things like calculate blood sugar and insulin levels for diabetics, monitor breathing in people with sleep apnea, or help optimize fertility drugs for people looking to get pregnant.

This trend will only continue in 2021 and beyond. Just as there is seemingly a podcast or a streaming service for every specific interest under the sun these days, so too will there soon be a dedicated medical device for every ailment and patient around.

5. The future is about security

While the first four items on this list are amazingly positive, this last point is a threat to the industry but also an opportunity. As more and more medical devices are using software or are entirely software-based, and many are connected to the internet, there is a potential for hackers to gain access. This access can be used to steal sensitive personal information or even to do harm to patients.

In some areas of the industry, technology and innovation are moving much faster than the security side of the development process. This is leaving some internet-connected medical devices woefully unsecure. This is an enormous problem that the industry must deal with going forward.

The good news is, they are currently dealing with it and making big strides. The industry overall recognizes the issue and is taking steps to correct it and fortify the devices against attacks. They are upping encryption and experimenting with newer secure technologies such as blockchain that will keep the very sensitive devices secure.


With these five things to understand about the medical device industry, you now have the basics of why the industry is so important in the world right now and how the industry will continue to be vital as it moves into 2021. The industry is growing, using software and medical devices, becoming more niche and user-focused, and grappling with security challenges. Chances are, medical devices will become a very normal part of your everyday life over the course of the next decade and beyond.