With each passing year, technology continues to rapidly advance. The 21st century has seen the rise of mobile devices and the exponential growth of technology in all fields. Technology is now part of our everyday life and it is only fitting that the field of medicine would emulate this. Medical devices are a rapidly growing subset within the field of therapeutics. A multitude of new products have been approved by the FDA in the past decade with 23 new devices approved in 2022 thus far. Medical devices have the potential to improve patient outcomes and limit the ever growing medication burden on national healthcare systems.
What are Medical Devices?
“Medical devices” refers to a wide range of products used in the diagnosis, treatment or prevention of a disease. The FDA defines a medical device as an apparatus used in the treatment of a disease that is recognized by the USP and does not achieve its primary purpose through chemical action. In other words, medical devices are not medications but rather use other means to affect the structure or function of the patient’s body. These devices range from continuous glucose monitors to external bone growth stimulators that use ultrasound signals to encourage growth. Many new medical devices are tailored to manage hard-to-treat diseases such as migraines, ADHD and diabetes where management with conventional medicine has previously been inconsistent. Wearable devices that track heart rate, oxygen saturation and ECG readings are already a popular accessory. These devices may soon gain approval to be used in conjunction with digital therapeutic software to manage an individual’s health needs.
Examples of Recently Approved Devices
DyAnsys: A PENS (percutaneous electrical neurostimulation) device placed behind the ear that administers continuous pulses of a low-level electrical current over several days to treat diabetic neuropathy
AccelStim Bone Growth Stimulator: Delivers an ultrasound signal through the skin to encourage bone growth in fractures that are not healing on their own. 20-minute daily sessions used with standard therapy help shorten the healing process
Senza Spinal Cord Stimulation (SCS) System: An implanted, rechargeable spinal cord stimulation system used to treat chronic and hard-to-treat pain in the limbs and trunk as well as diabetic neuropathy
What is Their Place in Therapy?
Medical devices have afforded exciting advances in disease management. They provide alternatives to traditional treatment and offer medical interventions that are tailored to each patient’s needs. These devices provide prescribers with different therapy options that may be used after conventional therapy fails or before a high-risk medication is attempted. For instance, the Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first device approved for treating adolescents with ADHD. With this device, children with ADHD may not need to take stimulants, which is the current standard of practice. The device is used during sleep and may ease the burden of managing the condition with controlled substances. Migraines are another disease state that can be hard to manage with conventional medicine. Novel treatments for pain may offset the use of habit-forming analgesics such as opioids. Devices used in pain management have the potential to improve quality of life as well as limit dangerous adverse events associated with controlled substances. Many devices have already been approved for the treatment of migraines and many over the counter devices have also been developed. Nerivio is an example of a wearable device that uses integrated digital therapeutics software controlled by a smartphone to treat migraines that have already started with electrical neuromodulation. Devices provide new solutions for disease treatment and the integrated software allows for data tracking that can be used for efficacy studies and disease management decisions. Medical devices are becoming increasingly common in clinical practice guideline recommendations and have the potential to change medical therapy from a primarily chemically based intervention to a mixed approach tailored to the patients needs.
- Center for Devices and Radiological Health. (n.d.). How to determine if your product is a medical device. U.S. Food and Drug Administration. Retrieved September 6, 2022, from https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
- Center for Devices and Radiological Health. (n.d.). 2022 device approvals. U.S. Food and Drug Administration. Retrieved September 6, 2022, from https://www.fda.gov/medical-devices/recently-approved-devices/2022-device-approvals
- Aronson, J. K., Heneghan, C., & Ferner, R. E. (2020). Medical Devices: Definition, Classification, and Regulatory Implications. Drug safety, 43(2), 83–93. https://doi.org/10.1007/s40264-019-00878-3
- Sverdlov, O., van Dam, J., Hannesdottir, K., & Thornton-Wells, T. (2018). Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development. Clinical pharmacology and therapeutics, 104(1), 72–80. https://doi.org/10.1002/cpt.1036
- Devarasetti, H. (2022, July 15). DyAnsys receives US FDA approval for First Relief neurostimulation device. Medical Device Network. Retrieved September 21, 2022, from https://www.medicaldevice-network.com/news/dyansys-fda-first-relief-neurostimulation-device/
- Center for Devices and Radiological Health. (2022, May 31). AccelStim Bone Growth Stimulator – P210035. U.S. Food And Drug Administration. Retrieved September 21, 2022, from https://www.fda.gov/medical-devices/recently-approved-devices/accelstim-bone-growth-stimulator-p210035
- Center for Devices and Radiological Health. (2021, August 17). Senza Spinal Cord Stimulation System – P130022/S039. U.S. Food And Drug Administration. Retrieved September 21, 2022, from https://www.fda.gov/medical-devices/recently-approved-devices/senza-spinal-cord-stimulation-system-p130022s039
- Burch R. (2021). Preventive Migraine Treatment. Continuum (Minneapolis, Minn.), 27(3), 613–632. https://doi.org/10.1212/CON.0000000000000957