Wearable medical devices are a treasure in a perfect world full of promises for monitoring and treating a range of ailments, including heart conditions, diabetes, Parkinson’s disease, managing pain relief, and more, so says Dr. Diana Eitzmen, director of agile commercialization at 3M’s Critical & Chronic Care Solutions Division.
Wearables are devices that let patients be monitored by their caregiver outside of the hospital. However, these devices don’t usually last a lifetime, and a “long-term” device can be challenging to develop, given the nature of the skin. Dr. Diana explains, “Skin is multilayer, and the stratum corneum layer of the epidermis sheds cells and replaces itself in 14 days, the epidermis layer thins as you age and loses hyaluronic acid — it is an at-risk surface and the skin of neonates isn’t fully developed”.
Recently, Dr. Diana did a talk on MD&M East 2017, where she pointed out that wearables can reduce the barrier function of the skin by taking off skin layers, and that tension blisters are also a possibility, particularly when the adhesive tapes securing the devices are stretched prior to application to the skin.
Medical adhesives related to skin injuries can put patients at risk of infections, and Medical adhesive-related skin injury (MARSI) can be more likely among immunocompromised patients.
As a healthcare giver, you need to be sure that you won’t be putting your patient at risk.
There has been a trend towards the development of products that can reduce the number of times a patient would need to go back to the hospital or doctor for treatment, which means improving their life. Medical device developers are trying to reach a 7-day or 14-day wear time so the patient has to think about the device as little as possible.
In order to help manufacturers develop longer-wearing products with minimal risk, many internal clinical studies, with an institutional review board to look at the wear time of its medical adhesives, and tests are already being made to determine which solution would be the most feasible.
A study evaluating adhesive samples placed on patients’ backs produced a fair number of candidates for 7-day wear times that 3M advanced for a 21-day study. The procedure was simple. If the samples did not fall off in 10 days, the patients would be taken to evaluate their skin for health, pain upon removal, wear time and lift. If an adhesive had more than 80% of samples attached with less than 20% lift, it was considered a “positive” result. These studies were also made with mock devices that patients wore on the chest and abdomen.
One of these 3M’s experimental silicone formulations reached 7 days, while acrylates reached 14 days. It was noted that silicones allowed patients to peel off devices and reapply them.
Dr. Diana believes that medical wearables would initially be applied by clinicians and then patients would be instructed on how to perform their subsequent applications. In addition to some of the applications mentioned earlier, these devices could also be used for temperature and pulse monitoring wellness products, and much more.
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