Miniaturization and mobility are two key trends impacting the design and development of new healthcare and wellness products. Health consumers are becoming increasingly more interested in monitoring their own vital signs and other conditions, and patients are transitioning to communication with their caregivers virtually via telehealth procedures. As a result, there are expectations for increasing connectivity between digital apps, sensors, compact medical devices and apparel.
As the rate of innovation increases in the healthtech space, the line between low-risk wellness products and those that are subject to higher-risk regulatory submission and review (products classified as medical devices, drugs, biologics, dietary supplements, foods or cosmetics) can appear blurred and leave manufacturers unsure about necessary product development precautions. Wellness products are generally limited to encouraging healthy lifestyles. Apps that track fitness, diet, sleep, stress, sexual function, self-esteem and other lifestyle qualities fall into this less-regulated category. Additionally, some wellness devices are used to help monitor associated lifestyle risk factors commonly associated with certain chronic diseases and conditions like heart disease, high blood pressure, and type 2 diabetes.
UL Solutions engineers stay current on global regulatory expectations in order to ensure that the appropriate type of product evaluation and safety testing is performed per the product classification.
For FDA guidance on wellness devices, please visit their web page.
Comprehensive healthtech product testing and certification
By leveraging our global testing facilities and digital solutions, coupled with decades of relevant expertise in both medical devices and consumer electronics, we are able to localize our services and deliver a personalized approach to solve your healthtech compliance challenges Our team wants to understand your product and business needs to help address the business challenges you face today and will confront tomorrow.
We can customize solutions to meet your needs. Our knowledge from the design and development stages, through manufacturing and delivery, will help you avoid costly errors to get your products through the development pipeline.
The UL Mark can empower your wellness product to convey consumer health trust
The UL Mark is a trusted and recognized symbol of safety for consumer devices. Market entry to the United States and health and wellness retail inclusion for healthtech product depends not just on meeting safety requirements but also readily conveying consumer confidence.
- We have certified consumer and medical product testing laboratories around the world, and our reports and certifications are recognized and accepted globally for comprehensive market access.
- UL Solutions is the world leader of IECEE CB schemes evaluating conformance to related electrical standards.
- We have helped to set more than 1,600 Standards defining safety, security, quality and sustainability.
- We offer comprehensive testing and certification services, and our engineers work with you throughout the entire production life cycle.
- We have an FDA-recognized consensus Standard, UL 2900, for cybersecurity.
Our engineers work with standards committees, such as Association for the Advancement of Medical Instrumentation, American National Standards Institute, IEC and government bodies.
One emerging area of product performance new healthtech manufacturers should be aware of is interoperability with other software products, especially popular virtual assistants using artificial intelligence. In addition to providing essential safety and security testing, UL Solutions can also issue a UL Verification Mark. In this service offering, UL Solutions will test your product to your specific device claims verifying product features. Manufacturers of nonmedical general wellness wearables may also be interested in pursuing a UL IoT Security Rating.
UL Solutions offers product safety and performance tests for the evolving healthtech category are designed to help mitigate risk and accelerate getting your consumer wearables and wellness technologies to market. We can help minimize common risks associated with wellness wearables and other consumer health products including toxicity (skin irritation), battery failure, and cybersecurity (threat of personal health data being misplaced or hacked).
We provide services to test your products for:
- Electrical safety
- Cybersecurity and IoT
- Electromagnetic compatibility (EMC) and wireless certification
- Interoperability and usability
- UL Marketing Claim Verification
We offer an array of services in safety, performance and compliance testing for manufacturers, designers, developers, retailers, marketing teams and regulatory managers. Our expertise allows us to thoroughly investigate healthtech software, materials biological characterization and evaluation, along with data and expertise to manage your product and supply chain. Some of the important areas we analyze include:
- Cybersecurity and IoT evaluation (UL 2900 series of Standards)
- Regulatory and safety compliance (including ANSI, AAMI, IEC, FDA, FCC)
- Wireless connectivity, interoperability, app functionality and testing
- Chemical policy development and management