5 Things You Should Know About the Medical Device Industry

Within the medical industry are subsets of industries that deal with very specific aspects of medicine and healthcare. These other branches include industries such as the pharmaceutical and biotech industries. The medical device industry also falls under the umbrella of the medical sector but is an industry of its own.

The medical device industry deals specifically with the equipment and technology that medical professionals use to diagnose and treat patients. A medical device refers to anything used in patient care from stethoscopes to MRI machines and other machines and tools used to assist medical staff and patients.

For a closer look at this industry within an industry, we will examine some of its most vital basics to help you get a better understanding of what the industry includes and what challenges and opportunities it  faces. Here are five points you should know about the medical device industry.

1. It’s heavily regulated

Medical professionals use medical devices to help keep people healthy, nurse them back to health or, sometimes, to make a critical difference in a life or death situation. These devices are used in such important ways, it is vital that they work safely and correctly when operated by a healthcare provider.

To help ensure the highest quality functioning of medical devices, federal governments heavily regulate the medical device industry. In the U.S., these regulations fall under the purview of the Food and Drug Administration (FDA) which enforces a system of Quality System Regulations (QSRs). In Europe, medical devices must follow the International Organization of Standardization’s ISO 9000 standards and receive a CE mark.

No matter what standard a medical device must meet, the idea behind the standards is the same. These regulations are made to ensure that the production of the devices meets required health, safety, and environmental protection standards. This helps protect everyone involved in the process as well as the end-users.

2. Software can be a medical device

The category of medical devices used to only include hardware, devices or machinery physically present in a medical facility. The category has evolved in recent years and now includes software as well. Software as a Medical Device (SaMD) is now a major part of the medical device industry.

To be classified as a medical device on its own, software must provide a medical benefit and do so independently of any other medical device. It is often confused with the software that is used to run medical devices, but that is a different class of software known as Software in a Medical Device (SiMD). SaMD is run by general technology such as mobile devices, wearable devices, computers, or tablets. Orthogonal has a more thorough look at exactly how to determine what qualifies as SaMD and what doesn’t.

SaMD provides many benefits that traditional medical devices don’t bring to the table. These devices make healthcare more portable, more affordable, and more accessible to more people. This has been a great addition to the medical device category in recent years and one that should drive growth in the sector for years to come.

3. The technology is always evolving

A major hallmark of the medical device industry is that it is always evolving, changing and, usually, getting better. Medical devices are continually developing, which is how we got from the magnifying glass to the microscope to X-rays to ultrasounds to the CT scan and MRI to virtual and augmented reality.

Software, both in and as a medical device, has made the speed of innovation even faster in medical devices. Software allows for fast feedback loops where users can give developers feedback in real-time. Developers can then make the necessary adjustments and improvements and release a software update that can be downloaded to solve the issues that previously existed.

4. It’s a large and growing industry

The global medical device industry was a $425 billion industry in 2018 with an approximately 5.5% compound annual growth rate (CAGR).  It was expected to reach over $500 billion by 2022 and over $600 billion by 2025. Those numbers are impressive in their own right but with the onslaught of the global COVID-19 pandemic in 2020, those numbers now seem small.

The pandemic has supercharged the need for and the adoption of new medical devices in a way that experts never predicted. From medical device shortages in hospitals dealing with COVID to the need for distance medicine and the rise of telehealth, the pandemic has fundamentally changed the medical device industry, making it even more important in healthcare than ever before.

While the exact financial impact of the pandemic on the medical device industry is not yet known, it is safe to assume the sector grew by much more than the expected 5.5%. That, coupled with the fact that the steady growth of adoption of new devices in the industry skyrocketed in 2020, points to the belief that by 2025, the industry will far surpass the previously predicted $600 billion mark.

5. Security is more important than ever

One factor has led to the growth and success of the medical device industry so that many medical devices are now part of the Internet of Things (IoT). This is the internet-connected world of devices that are able to communicate wirelessly with other devices and technology.

Although this has been a great development that, in many respects, has made medical devices more efficient and effective, it is also an opportunity for bad actors to hack into these devices and steal sensitive medical and financial information.

For each medical device that is connected to the internet, cybersecurity is a top priority. As we get deeper into the 21st century and questions of privacy and safety become more prominent, medical device safety is helping lead that discussion. The need for security, like many other things, has been exacerbated by the global pandemic because hackers have used this as an opportunity to strike overworked and overwhelmed targets.


The medical device industry is complicated and ever-evolving. Significant aspects of the industry that you need to know about, include:  regulation, software, innovation, financial growth, and security. These are just a few of the underlying factors that make the industry so interesting and complex.

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