Considerations for Wearable Device Development
Healthcare is among the fastest-growing segments of the $13 billion wearables market, due to the overwhelming need to monitor diseases and aging populations. Medical wearables, galvanized by new technologies, will not only offer more patient convenience, but also the capability to reduce medical costs and improve the delivery of medical services. Wearable medical devices are devices that can be adhered, ingested or surgically implanted.
Wearable Medical Devices can eliminate the need for expensive in-hospital monitoring, provide early detection and diagnosis, and make it easier for people to assess their wellness. Additionally, wearable medical devices can alert health professionals to various problems and signal changes in patient status.
The four types of wearables below are listed in the order of complexity and risk. The FDA treats the types of devices differently as they increase in risk:
•passive monitors: these devices monitor and alert
•surveillance devices: these devices report data
•diagnostic devices: these devices make decisions
•therapeutic devices: these devices make decisions and provide treatment
Although wearables promise new opportunities, they also pose challenges, especially in regards to protecting the privacy and confidentiality of patients. Cyber security threats must also be addressed. The digital format of data from wearable devices is vulnerable to data breaches, especially when the wearable device is linked with a smartphone, tablet, or computer.
The design and development of wearable medical devices must consider patient comfort as well as ease of use. These factors determine how the electronics are configured and what type of materials is used to fabricate the components. Other factors to consider are:
•How does the device need to function electronically?
•Will the devices include wireless interfaces?
•At what intervals does it need to collect data?
•How is that data stored?
•How is the data protected?
•What adhesives will be utilized?
•Will the device be exposed to water?
•What cleaning methods will be employed?
•How will power be supplied?
Wearable devices must be bio compatible. ISO 10993 - Biological evaluation of medical devices requires the manufacturer of the device to perform bio compatibility testing, generally using the services of a third-party vendor.
Other standards apply. For any wearable device used in the patient’s home, there are two guidance documents that apply; the IEC standard 60601-1-11 - Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications and the FDA document Draft Guidance for Industry and Food and Drug Administration Staff, Design Considerations for Devices Intended for Home Use.
Regarding electromagnetic compatibility (EMC), wearable medical devices fall into the same category as other devices intended for use at home, the governing standard is IEC 60601-1-2 - General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
In addition, wearable medical devices must co-exist with other radio systems, including other wearable devices (including implantable devices) and medical devices in clinical setting or home.
Wearable medical device product development promises to flourish, supported by innovation in battery technology, materials science, and wireless communication.