Connected Medical Devices - The Ultimate Guide

What are “connected medical devices?”

When talking about devices and other products, the word “connected” is often used interchangeably with “smart.”

Though “connected” and “smart” devices offer similar functionality, there is a key difference that separates “connected” from “smart” products in the medical device realm.

Within the medical device industry, “smart” is used to describe devices that can transmit and/or receive data over the internet (e.g., a smart watch that uploads a patient’s heartrate data to the cloud).

“Connected medical devices,” however, are devices that can transmit and/or receive data to/from another device or the internet (e.g., a heartrate monitor that transmits a patient’s heartrate data to a physician’s tablet via Bluetooth®).

As you probably noticed, these two terms are not mutually exclusive—a device can be both “smart” and “connected” or only “smart” or “connected.”

How many connected medical devices are there?

In 2014, Statista estimated that there would be over 50 billion connected devices—from TVs to smartphones—in use by 2020.

As you may recall from our previous post, the number of devices within the IoMT is expected to exceed 20 billion in the near future.

Though we may not know exactly how many connected medical devices exist, we do know that the number is high and is expected to keep climbing as connectivity technology continues to improve.

In fact, MarketsandMarkets estimates that the medical device connectivity space will achieve a compounded annual growth rate of over 25% between 2020 and 2025.

How can medical devices be wirelessly connected?

This is one of the questions we’re commonly asked when partnering on a connected device project.

There are three primary ways a medical device can be wirelessly connected to another device: Wi-Fi®, Bluetooth®, and radio transmission.

Wi-Fi®

With the rise of consumer health products like the smart watch, “Wi-Fi®” tends to be the word that comes to mind when the term “connected medical device” is mentioned.

Medical devices connected via Wi-Fi® provide a variety of benefits: data can be uploaded/download from the cloud, the device can be updated remotely, physicians can access the device/data without having to be in the same room as the patient, etc.

Though still in a relatively early stage, Wi-Fi® connected medical devices show great promise in expanding the IoMT.

Bluetooth®

The Bluetooth® concept for connecting products has existed since 1989.

Since that time, Bluetooth® connectivity has become a common (if not expected) feature of consumer and industrial devices alike.

Medical devices are no exception.

Within the world of medical devices, Bluetooth® is used to connect devices over a short distance.

For example, one prosthetic company uses Bluetooth® to connect its intelligent knee prosthetic to an app on the patient’s phone so that the prosthetic can be calibrated and monitored.

Radio Transmission

Using radio frequency to transmit data dates back even further than the use of Bluetooth®.

Radio transmission technology has evolved by orders of magnitude since Warren G. Harding became the first president to address the nation via radio.

Radio frequency identification (“RFID”) technology, for example, is used in everything from building security (e.g., RFID-enabled key cards) to limiting the reuse of single-use devices.

Within the medical device space, radio frequency has been used to connect short-range devices for years.

In fact, the first wireless pacemaker sent data from the pacemaker to a transmitter via a radio frequency band.

The data was then relayed to the physician via the internet.

What are some of the engineering challenges related to developing connected medical devices?

Connecting one device to another creates a plethora of challenges.

Connecting a device to a network of devices, like the internet, is like opening Pandora’s box.

Though there are many potential challenges an engineering team may face bringing a connected medical device to market, we’re going to focus on the three we hear about most often: data accuracy/integrity, security, and compatibility.

Data Accuracy/Integrity

How does a physician know that the data being collected by the device is accurate?

How does a physician know that the data, after being collected, is being transmitted without corruption/error?

These are two problems that the fields of computer science and telecommunications have been grappling with for the better part of a century (to understand, replace “physician” with “person making a decision”).

The first question is being addressed by the development of better sensor technology and the incorporation of systems like consensus protocols.

The second question has been a focal point of information theorists and engineers like Richard Hamming and Irving Reed, who are known for their pioneering work with error-correcting/detecting codes.

Medical device engineers must be aware of potential data collection and transmission errors and build systems that can mitigate the risk of inaccurate data being communicated and used to make healthcare decisions.

Security

What happens if your medical device is hacked?

As the IoMT grows, the threat of potential cyber attacks grows with it.

In fact, the Department of Homeland Security recently issued a warning about a bundle of vulnerabilities known as “Ripple20” which could impact millions of medical devices.

The FDA has also warned of a vulnerability in Bluetooth® technology known as “SweynTooth” that could compromise Bluetooth® Low Energy medical devices.

Regardless of how a medical device is connected, engineers must be aware of potential cybersecurity vulnerabilities so that they can mitigate the risks of attack and/or compromise.

Compatibility

How do you ensure that your device will connect to the network it needs to at the moment it is needed?

Many medical devices, especially those in the operating room, must connect and interact with devices and equipment that are not manufactured by the same company.

Wi-Fi®, Bluetooth®, and radio transmission technology all utilize different standards that change over time.

When developing connected devices, engineers must be aware of the connectivity standards used in the marketplace so as not to build a device that is incompatible with the network of devices with which it must connect.

Additional Resources

As you can see, the IoMT has opened up a world of possibilities for the medical device industry.

Developing a connected device, however, can be difficult—which is why we recommend working with an expert.

If you’d like to learn more about the future of medical devices, download our free ebook.

Wi-Fi® is a registered trademark of the Wi-Fi Alliance®.

Bluetooth® is a registered trademark of Bluetooth SIG, Inc.