The future of medical devices is moving to wearables. After the Pandemic the world is even more ready to bring wearables, specifically low-cost patches vs integrated fabrics, into day-to-day medical activities. However, with anything healthcare, there are regulations and requirements that wearables must meet to be adopted. Unlike most other industries, startups and new product development teams are faced with the "hurry up and wait" process. The regulation and certification processes are not only rigorous, but can add unexpected delays to the device development, which can close the window of opportunity for the device being considered. This session explains ways to mitigate the risk and shorten the time it takes to get through medical regulations and certifications. This includes manufacturing and material considerations for FDA and ISO compliance, like using materials and process that are already approved, or exploring alternative options to avoid unnecessary certification processes. Challenges with adoption are far from over even after a device has passed through the gauntlet of regulations. A wearable device must offer a significant advantage that traditional medical devices cannot. In this session the audience will be challenged with material, design, and manufacturing considerations that often are not investigated until it is too late. Material considerations will include breakdown of the layers of a wearable, the challenges of sticking to skin, and end use of the wearer with examples of questions to consider when developing your wearable. Design considerations will include comparing bill of material to end use application for reduction in components or alternative material options, as well as feasibility for manufacturing at scale. Manufacturing considerations will include information on printing and converting process options for manufacturing the layers of wearables, especially moving as many processes to roll to roll for cost and labor reductions. Sustainability considerations will also be addressed for materials, design and manufacturing of wearable medical devices.
