Maximizing the Effectiveness of Internal Wear Studies for Medical Wearable Devices: Practical Tips and Insights

Importance of Wear Studies for Medical Wearables

Wearable medical devices, from glucose monitors to ECG patches, are becoming integral to modern healthcare. However, their performance depends on a functional and comfortable user experience, which is where internal wear studies come into play. These studies replicate real-world conditions, helping to identify potential issues such as adhesive failure due to sweat and high or prolonged activity, discomfort caused by the device's design or materials, and pain or skin damage upon removal.

Wear studies play a role in selecting the design of the wearable device, but also in selecting the material that comprises the device. For example, if a medical device is made from a low surface energy material, wear studies can reveal some of the challenges of using such material, prompting developers to adjust their material choices, improve its adhesive formulation or adapt the device’s design. 

Challenges identified during internal wear studies can prevent major setbacks which delay projects. For a wearable device to function effectively, it must adhere to the body for the duration of diagnostic or therapy.  

For example, if the device fails to adhere to a patient during activity or excessive sweating, it can prompt further design and development to ensure that the product will remain in place.  By simulating such scenarios, internal wear studies generate crucial data on durability, skin reactions, adhesive performance, and overall device reliability, which are critical to understanding the design compromises.

How to Conduct an Effective Internal Wear Study

Based upon our vast experience with conducting internal wear studies, Avery Dennison Medical experts have developed a checklist detailing the steps involved in planning and executing such studies. To ensure wear studies lead to actionable insights, the process must be methodical. Setting a well-defined scope for the study is essential, focusing on a few key variables at a time. This controlled approach allows developers to refine results progressively, improving each test cycle.

For instance, a wearable device may be tested under various conditions such as different body placements or varying levels of physical activity. By narrowing the scope (for instance by testing adhesive strength on one specific body part), developers can pinpoint specific benefits and/or challenges. Avery Dennison Medical’s experts emphasize the importance of trial and error during this stage, allowing engineers to test their hypotheses and verify assumptions about how the device works on the body.

Using a consistent control product across multiple tests helps provide a baseline for comparison. Any differences in wear or performance can then be attributed to changes in test conditions, ensuring more reliable results. In some cases, the results can vary testing in the winter versus the summer. Overall, the product performance can change and a control product will vary with the overall results.  

Wear studies become manageable and provide clear, actionable data when the scope of the study is well defined and narrow. Based upon Avery Dennison Medical’s vast experience in conducting internal wear studies, it is recommended to limit the variables while refining the testing. While it is often difficult to limit the variables and there is a desire to test multiple items at the same time, it is often challenging to decouple those variables when reviewing the wear study data results.

What to Take into Consideration for Internal Wear Studies for Medical Wearables

Essential aspects to take into consideration when conducting internal wear studies for medical wearables, include adhesive-related issues, the reproduction of real-world conditions, and balancing between functionality and user comfort.

Adhesive-related issues: Pain upon removal and device fall-off are two of the most common problems identified in wear studies. Adhesive strength is often compromised due to environmental factors like excessive sweat or shear forces from body movement. To mitigate these issues, Avery Dennison Medical’s experts recommend developers to:

• Test for adhesive placement, size, and shape: Different areas of the body and varying levels of skin tension can impact the performance of adhesives. Testing across diverse conditions, when possible, helps identify the most effective configurations.

• Iterate based on feedback: Not all adhesives work equally well for different users, so incorporating real-time feedback from wear study participants is key to refining adhesive formulations.

• Advancements in adhesive technology: New adhesives are being developed to balance aggressive sticking power with skin-friendliness.Those adhesives may be softer but still stable enough to extend wear time while minimizing discomfort. Testing these advancements in real-world scenarios ensures they meet the required needs in terms of functionality and comfort.

Real-world conditions: Factors like heat, moisture, and sweat can degrade adhesive performance. While accelerated tests (for instance by using a sauna to simulate sweating) provide quick feedback, they do not reflect real-world conditions. Effective wear studies simulate these variables in controlled, long-term tests, ensuring that adhesives perform as expected under normal usage. There is a growing emphasis on incorporating real-world conditions and limiting variables in testing: medical design companies prioritize studies that reflect actual usage patterns more accurately.

Balancing device functionality with user comfort: When developing a medical wearable, functionality (staying securely on the body) and user comfort (ease of wear and removal) must be carefully balanced. Internal wear studies guide this process, helping developers understand the limits of adhesive performance without sacrificing user experience. Engineers must accept some trade-offs during this process, recognizing that there will always be outliers in user reactions to adhesives. The goal is to minimize these outliers and maximize overall comfort. 

Developers are also expanding the population cross-section in wear studies to account for diverse patient groups. This approach provides more representative data, ensuring that products cater to a broader user base. Internal wear studies allow companies to strike a balance between adhesive strength and skin comfort. By testing on a wide demographic, developers can better understand the design trade-offs for their target end-user base. 

One of the significant challenges developers face is ensuring the device works across a range of skin types and medical conditions. For instance, a device designed for both pediatric and geriatric patients, needs to account for the fragility of elderly skin and the rapid changes in children’s skin. A comprehensive wear study would test the device on various skin types to ensure broad applicability.

Internal Wear Studies Are Important

Internal wear studies are essential in the development of medical wearable devices. They allow developers to fine-tune critical elements such as adhesive strength, material choice, and user comfort, ensuring that devices perform reliably across various conditions. By following a structured and focused approach, medical product designers can derive actionable insights from their studies, ultimately improving the device’s success in the marketplace.

For companies looking to stay competitive in the medical wearable industry, conducting thorough, well-designed internal wear studies for product design and development is not just recommended but essential for product refinement and user satisfaction.

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