Any device intended for a medical purpose can be considered a medical device. These devices help medical professionals diagnose, treat, or monitor medical conditions. As the healthcare industry gets more advanced and technology progresses, more medical devices than ever are being used in the field.

In 2021, medical devices are more important than ever and are also more discussed, analyzed, and scrutinized than ever. This term can be used for a wide range of devices, making it confusing for someone who is not incredibly familiar with the industry. To help clarify what the field is and give some background about the most important aspects of the sector, here we provide you with seven points you should know about medical devices.

1. Medical devices come in all shapes and sizes

The application of the term medical device is very broad.

These devices can range from a simple thermometer, medical weight scale to something as complex and critical as a pacemaker. To determine the importance and risk associated with different categories of medical devices, the United States separates them into three classes.

Class I includes the least critical items, such as bandages, tongue depressors, and examination gloves. Class II is the next level up and includes more sophisticated – and potentially dangerous – equipment such as acupuncture needles powered wheelchairs and air purifiers. The final class, Class III is the most complicated and important. Devices classed in this level are such life-saving items as pacemakers, pulse generators, and defibrillators.

2. Production is highly regulated  

Medical devices provide critical information for medical professionals and patients.  In some cases, these devices even help keep patients alive. It is critical that these instruments are well-made and conform to all required specs in order to do the job for which each one is designed. For these reasons, the medical device industry is highly regulated.

The Food and Drug Administration (FDA) is responsible for regulating medical devices in the U.S. Strict quality control standards govern the medical device manufacturing process overall and, depending on the class designation of the device,  the FDA more heavily regulates the manufacture and operation of some devices than others. These standards are in place to help protect users and ensure that devices work in a safe and reliable way.

3. Software can be considered a medical device

One of the fastest-growing sectors of the medical device industry these days is software as a medical device (SaMD). SaMD is a complex designation; for more on the particulars of software as a medical device, this article from Orthogonal is a good SaMD primer. The two major defining features, though, are that the software provides a medical benefit and works independently of another medical device.

SaMD is changing the healthcare industry for both providers and patients. It is making healthcare more portable and more efficient. These devices also give patients more control over their own healthcare and provide medical professionals with more real-time data to help improve outcomes.

4. Security is More Important Than Ever

One of the big reasons medical devices are becoming more advanced and are offering more capabilities than ever is that many, like SaMD, are connected to the internet. This makes them easier to control and allows them to provide better, faster data, along with a host of other benefits. Unfortunately, it also makes them vulnerable to cyberattacks.

This makes cybersecurity a top priority for internet-connected medical devices. It is important that developers embed security features into the devices they create and that they keep the device’s software updated for the latest threats. It is also important that the user participates in this process. Downloading updates, registering devices, and reporting any malfunctions are all key pieces of cybersecurity.

5. User experience is key  

It used to be enough that a medical device provided a benefit that the medical industry needed. It didn’t matter exactly how the device accomplished this or how using the device affected the patients. Today, the medical device industry is highly competitive. Multiple devices can provide the same result, so these devices have to actively make life easier for both patients and clinicians.

On the medical professional side, the device needs to make the users’ life easier and allow them to do their job quicker and more efficiently. On the patient side, operating the device needs to be easy to understand and interacting with the device must be more convenient than other options. Making life better for all parties concerned is the only way medical devices can gain widespread acceptance these days.

6. They are constantly evolving

Medical devices are key components in the achievement of constant improvement in patient outcomes. This has been the case from the time of the invention of the stethoscope, which helped doctors better hear a patient’s heartbeat and breathing, to today when wearable technology allows patients to have a medical device on their wrist.

This evolution is a constant in the healthcare industry but, as in many other areas, technology has accelerated this evolution in the 21st century. Technology has made devices smaller, faster, more connected, and more cost-effective. This has improved the healthcare industry in many ways but also presents challenges to the industry that must be resolved in order to achieve continued progress.

7. The Medical device market is huge

In 2019, the medical device market grew to over $450 billion. It got there by experiencing a 4.4% compound annual growth rate (CAGR) between 2015 and 2019. Due to supply chain issues and production slowdowns caused by the COVID-19 pandemic, the market dipped slightly in 2020 to around $440 billion.

As the pandemic reaches its conclusion and both the world economy and healthcare industry get back to normal, growth in the industry is expected to again pick up and grow even faster than before. Experts predict that starting in 2021, the industry will grow at about 6% CAGR and bring the industry to over $600 billion by 2023.


As you can see, the medical device industry should only grow, both in size and in prominence in the coming years. Now that you know seven of the most essential details about the medical device industry, the conversations, and news about medical devices should make much more sense.