Key takeaways:
Medical devices are used by millions of people in the U.S. every day. All medical devices are regulated by the FDA.
Digital health is leading the change for medical devices with many people now connected to apps on smartphones. These devices are sometimes referred to as digital health devices.
Digital health devices can help people treat or monitor health conditions, such as diabetes, migraines, and pain conditions.
Chances are high you’ve used many medical devices in your life without realizing it. Ever use a thermometer to check for a fever? Used a breast pump? How about covered a minor cut with a bandage? These are all medical devices — formally called consumer medical devices by the FDA.
In recent years, there’s been a change to some consumer medical devices. As technology has advanced, these devices have too. Even some commonplace devices, such as blood pressure and blood glucose (sugar) monitors, have received digital upgrades. These new technologies have been used to create “smart” consumer medical devices (also called digital health devices).
What is a consumer medical device?
Many people typically think of a medical device as something used in a hospital or clinic. And that's not wrong. Items like X-ray machines or pacemakers are medical devices that are used or placed in a healthcare facility.
However, there are many devices that can be used at home. These devices can be used at healthcare sites, but they’re also meant for general consumer use without a medical professional’s supervision. These are often reviewed by the Home Health Care Committee, a division of the FDA.
There are many examples of consumer medical devices on the market, such as:
Home pregnancy tests
Blood glucose monitors
Home blood pressure monitors
Home transcutaneous electrical nerve stimulation (TENS) units
What is digital health?
Over the past decade, we’ve seen the rise of new technologies for healthcare that use software to empower people in making decisions about their health. This is often called digital health.
Digital health is a broad term that refers to many products, including:
Using an app to monitor or track your health data
Wearable devices, like smartwatches
Virtual reality (VR) devices that can help treat some medical conditions
Talking to a healthcare professional (HCP) through a telehealth service
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How is digital health changing consumer medical devices?
The rise of digital health products have put pressure on the FDA not only to review traditional devices, but also next-generation medical devices. These new devices can do things that we haven't been able to in the past. One example of this is a pill-shaped camera that can be used to perform an endoscopy at home.
The FDA has since changed their policies to evaluate certain apps and software the same way other medical devices are reviewed. Just like traditional medical devices, these next-generation devices must have clinical evidence to back up effectiveness, safety, and accuracy.
Examples of digital health devices
There are many examples of digital health consumer medical devices available on the market. Many include taking traditional medical devices and connecting them to the internet. This can allow a device to share data with an app on your phone or with a HCP. Some people also refer to these products as digital health devices.
Some examples of digital health devices include:
Connected Bluetooth thermometers
Smartwatches with built-in electrocardiograms (ECG or EKG) to detect abnormal heart rhythms, such as atrial fibrillation
Continuous glucose monitoring (CGM) devices
Connected blood pressure devices
Electrical nerve stimulation devices for migraines
Smart inhalers for lung conditions, like asthma
What are the benefits of digital health technologies?
There are several potential benefits to using digital health technologies, including:
Helping to personalize healthcare decisions for each individual
Helping people and their HCPs monitor health conditions better in between appointments
Allowing people to better insight into their overall health
Helping people to better advocate for their health needs
Helping people access their HCPs faster or more easily
Lowering overall health costs for both people and their healthcare team members
Collecting health data and maintaining health records more efficiently
What areas of healthcare are being most impacted by digital health solutions?
Many digital health companies are focusing on health conditions that many people in the U.S. face on a daily basis. Companies are looking to make their products more accessible to these people. Focusing on these conditions could potentially reach and impact millions of people across the country.
Current areas of focus include conditions like:
Pain conditions
We’re even finding research that’s trying to see if certain digital health devices previously found only in healthcare facilities can be moved into people’s homes. One notable example is the development of portable dialysis units for people with advanced kidney disease. This would make it so people don't have to go to a clinic multiple days a week. They’d be able to have this procedure done at home instead.
The bottom line
Medical devices are used every day by millions of people in the U.S. More and more of these devices are being upgraded with new technology. These upgrades allow the devices to connect to smartphones to track and manage health data. Many people refer to these devices as digital health devices. The information these devices collect or provide can be used to help people and their healthcare professionals better monitor their health conditions.
The digital health medical device market is expected to keep growing. Keep in mind that these newer medical devices are reviewed for safety and effectiveness by the FDA just like traditional devices.
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References
Butcher, C. J. T., et al. (2022). Digital healthcare: The future. Future Healthcare Journal.
Gura, V., et al. (2016). A wearable artificial kidney for patients with end-stage renal disease. JCI Insight.
National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Upper GI endoscopy.
Teoli, D., et al. (2023). Transcutaneous electrical nerve stimulation. StatPearls.
U.S. Food and Drug Administration. (2018). Non-invasive blood pressure (NIBP) monitor guidance.
U.S. Food and Drug Administration. (2018). Software as a medical device (SaMD).
U.S. Food and Drug Administration. (2021). Home health and consumer devices.
U.S. Food and Drug Administration. (2022). How to determine if your product is a medical device.
U.S. Food and Drug Administration. (2023). Consumers (medical devices).
U.S. Food and Drug Administration. (2023). Home use devices.
U.S. Food and Drug Administration. (2024). Product classification: First aid kit without drug.
