Wearable technology has quickly evolved from simple fitness accessories into devices that monitor health conditions from the home. This shift has raised expectations around comfort, usability, and aesthetics, while also demanding more attention to regulatory requirements and material performance.
Our very own Kelly Wessner, Vice President of Sales, shares her insights on how consumer medical wearables are changing, how regulations influence design, and why material choices have become a central part of product development.
The wearable health market is expanding quickly. How can companies tell the difference between a consumer wellness device and a regulated medical device?
The distinction is rooted in intended use, product claims, and risk level. Devices that track general wellness indicators such as steps or sleep typically stay in the consumer category. Once a product begins monitoring a specific condition, supporting diagnosis, or influencing treatment decisions, it becomes a regulated medical device. Many companies start in the wellness category to move quickly, although added features or data interpretation can shift the product into the medical space faster than expected. Planning for that possibility early helps teams avoid costly pivots.
What changes once a wearable enters the medical device category?
The development process becomes more structured and more documentation heavy. Materials must be traceable and supported with regulatory data. Long term supply continuity becomes essential. A material change that would be simple in consumer electronics often requires significant revalidation once the product falls under medical regulation. For this reason, OEMs benefit from defining documentation needs, supply strategies, and compliance pathways early in development. Speed without a clear regulatory plan often leads to delays.
Why has usability become such an important performance factor for medical wearables?
Patients are now the primary users. If a device is uncomfortable, visually intrusive, or difficult to operate, people will not wear it consistently, and this affects data quality. Patients also compare medical wearables to consumer electronics they use every day, which raises expectations for comfort, aesthetics, and ease of use. Usability has become a core requirement rather than a secondary consideration.
Continuous glucose monitors are often seen as a strong model for wearable design. What can other products learn from them?
Continuous glucose monitors show how engineering and user experience must work together. These devices must stay attached for several days while avoiding irritation. They must balance adhesion strength, breathability, and comfort during removal. Real world user feedback has guided improvements in adhesive materials, device shape, and device weight. Other wearable categories can gain the same benefits by studying how devices perform during everyday life rather than relying only on controlled test environments.
As wearables become smaller and include more sensors, how does this influence material choices?
Materials serve functional roles that go far beyond providing shape. A housing may need to protect delicate electronics, support wireless communication, provide durability during daily wear, and enable miniaturization. Every material choice involves tradeoffs. A material that improves protection might interfere with signal performance. Because of this, materials must be selected early and in close coordination with the electronics and sensing strategy.
What challenges arise when scaling production from pilot builds to full manufacturing?
Scaling introduces new challenges related to consistency, documentation, and supply continuity. Materials that work well in small batches must also perform reliably at higher volumes. Any change in formulation, sourcing, or processing can affect validation. This makes early planning essential. It is important to define change control, align with suppliers, and plan for backup materials before production ramps. Rework at scale is costly and slow.
What should companies prioritize earlier in the design process when developing next generation consumer medical wearables?
Teams should integrate regulatory expectations, usability goals, and manufacturing flexibility at the start rather than later. Addressing these factors too late often leads to redesigns or delays. Companies should also build flexibility into materials and production strategies so devices can adapt to regulatory changes, new technologies, and shifting production regions. When engineering, regulatory, supply chain, and manufacturing groups align early, development moves faster and more smoothly
Ready to bring your next wearable device to market with confidence? Formerra can help you choose the right materials, navigate regulatory needs, and build a supply strategy that supports long term success. Connect with our team to accelerate development and create wearable solutions that perform reliably in the real world.
