A Medical Device Designer’s Guide to the Pitfalls and Blind Alleys of Sticking to Skin
Skin is a challenging substrate and the requirements an adhesive must fulfill to hold your device to it safely provide a myriad of opportunities to fail. The most obvious failure is, of course, your device falling off before the end of its mission, whether that was securing a drug delivery device for a few hours or a monitoring device for two weeks. A device falling off could mean a patient is not getting the treatment or collecting the data they need…and it leaves them thinking “this device failed” while holding a device with your company’s name on it, figuratively or literally.
Finding an adhesive that sticks well enough, long enough is only the first challenge. Imagine: Your device stayed securely attached for the prescribed time and removed without damaging the skin it was stuck to… but the skin is swollen and moist because the combination of device and tape trapped moisture against the skin. Known as maceration, this swelling of the epidermis by trapped moisture weakens it, leaving it more prone to skin stripping and damage.1 Maceration signals insuffcient breathability (letting moisture out and oxygen in) beneath your device.
Adhesive failures should never ruin a medical device developer’s day, because guarding against them is part of tape development. Adhesive developers strive to test their products against every common combination of material and process, yet inevitably someone pairs a stick-to-skin tape with a device assembly that wasn’t tested with that tape.
There is no shortage of potential pitfalls in the selection of the right adhesive for your wearable device. Working with a guide versed in the landscape of challenges with the experience and tools to
help you overcome them can save time, money and frustration.
Reference
- White R.J., Cutting K.F. (2003). Interventions to avoid maceration of the skin and wound bed; British Journal of Nursing.
For more information, download the whitepaper, “Science of Skin: A Medical Device Designer’s Guide to the Pitfalls and Blind Alleys of Sticking to Skin”.
Related Articles
-
“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters.”
-
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
-
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
-
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
