The skin is the largest organ in the body. This represents the largest opportunity to adhere various devices, patches and dressings to heal, deliver treatment and monitor the body’s activity. With the evolution of adhesives in the last 25 years, the skin has become a critical portion of the overall system to treat, medicate and measure. Every person’s skin is different. Race, ethnicity, gender and age play a factor, as does each individual’s biology. The same bandage could have a radically different result if the skin is sweaty or if the season has changed from summer to winter.
So, what IS the best adhesive to stick to skin? There is not one, universal answer. It depends on whether the adhesive needs to remain on the skin for one week, deliver medicine, hold a digital device or go over an open wound. Each of these applications requires vastly different features in an adhesive; each will also require a variety of rigorous testing.
So, on exactly what should we test?
The same adhesive measured on two different individual’s skin can produce up to a 40% variance in peel adhesion (we know, we’ve performed these tests many times). If there is such a large discrepancy between individuals, what do you substitute as a substrate to perform testing? Some options include cadaver skin, HDPE, or stainless steel. Yes, stainless steel has been proven to provide the most consistent testing results versus these other options. See the FDA study.
Chemsultants has been trusted by some of the largest medical device and pharmaceutical companies in the world to research, test, and manufacture skin contact adhesives. Our knowledge depth is so strong, we literally teach the class on it - AWA Events
We can provide support in the development of your products and also be your independent lab that provides COA or COC documents to you for contract manufactured skin contact products. Being an FDA registered medical device manufacturer, Chemsultants is ISO 9001, ISO 13485 and cGMP compliant. We fully understand the requirements for documentation regulation in your field.