New technologies and breakthroughs in areas like skin treatment and sports medicine are constantly fueling growth in the medical device industry. New products mean new risk exposures, which is why it’s important for insurance professionals to understand the regulations governing medical devices, the different types of classifications, and other factors that may impact product liability coverage policies.
Here are some of the main medical device categories that are currently experiencing significant growth, and what you need to know:
Fitness Trackers, Smartwatches, and Other Wearable Devices
Increasing consumer awareness of the importance of health monitoring, along with technological advancements such as improved sensor accuracy, longer battery life, and enhanced connectivity with smartphones and other devices is fueling an explosion of digital health solutions.
These wearable health technologies are regulated as medical devices by the FDA, which ensures they meet safety and performance standards, and provide accurate health metrics.
LED Light and Laser Therapy Devices
LED light and laser therapy devices are increasingly being used in a clinical setting, as well as being sold for at-home use. Depending on the wavelengths of the light or laser beams being emitted, these devices can have a variety of different uses. These may include:
- Anti-aging and skin rejuvenation
- Acne treatment
- Reducing inflammation
- Repairing tissue and promoting healing
- Pain relief
Ice Baths and Cryotherapy Chambers
Brief but intense cold exposure is believed to provide various health benefits, including reduced inflammation, pain relief, improved circulation, faster muscle recovery, increased energy levels, and enhanced overall well-being, which is why an increasing number of athletes, celebrities, and wellness enthusiasts are turning to cryotherapy and ice bath treatments. The risks associated with these treatments generally come from staying in too long, which is why the FDA recommends using the devices with the supervision of trained professionals, and why a big part of assessing risk exposure involves the safety guidelines for the devices and the settings they are being used.
Electrical Stimulation Devices
An increase in the prevalence of chronic pain conditions due to an aging population combined with advancements in technology is driving market growth for electrical stimulation devices. In addition to managing pain, these devices are often used in rehabilitation settings to improve strength, mobility, and function. There are two main types of electrical stimulation devices: Transcutaneous Electrical Nerve Stimulation (TENS) devices and Neuromuscular Electrical Stimulation (NMES) devices. Both are highly regulated. Risk exposures can vary depending on the type of device, the and the setting they are designed to be used in.
Related: Product Liability Coverage for Medical Device Manufacturers
Work With Medical Device Insurance Experts
With fast-paced changes in technology driving innovation in the medical device industry, and a complex web of regulatory and compliance issues, it helps to have a trusted team of experts on your side. At Admiral Insurance, we understand the risk exposures associated with emerging medical device industry markets and technology, and can help find custom solutions for your medical device clients.
Our dedicated national underwriting team at Admiral has exceptional expertise in health, nutrition, and lifestyle products. We understand the risk exposures and can provide our brokers with coverage solutions. Admiral Insurance Group provides that expertise to our wholesale brokers, and their retail brokers. If you are a retail agent or broker, locate an Admiral wholesale partner. If you are a wholesaler, contact us about becoming a premier partner.
Products and services described above are provided through various surplus lines insurance company subsidiaries of W. R. Berkley Corporation and offered through licensed surplus lines brokers. Not all products and services may be available in all jurisdictions, and the coverage provided by any insurer is subject to the actual terms and conditions of the policies issued. Surplus lines insurance carriers do not generally participate in state guaranty funds and insureds are therefore not protected by such funds.