A true point of differentiation in today's medical design industry is the same as it was generations ago—what supplier can deliver a consistent, quality product, ensuring peace of mind for the design engineer, while protecting both the bottom line and, more importantly, the company's reputation. Following are several specifics to consider when evaluating options for an adhesives supplier.
- Application diversity—Does the application require gentle removal (from sensitive skin) or aggressive hold (for extended wear)?
- Range of adhesive properties—A company may need to address a variety of products and it shouldn't settle for a "one size fits all" solution. Seek a partner that can offer several adhesive properties, such as quick tack, gentle peel off, breathability, shear strength, and clean removability.
- Flexibility—It is impossible to predict what challenges will be presented from one day to the next. A supplier needs to offer significant flexibility when it comes to custom-matching adhesives to foams, films, fabrics, and more.
- Tried and true—Perhaps most importantly, the supplier's products should be tested according to ISO 10993-5/-10 standards for cytotoxicity, skin irritation, and skin sensitization.
- Reliability—A supplier that offers all the above but cannot deliver product in a timely fashion is of little value. A good measuring stick is a lead time of three to five days.
- Expertise—It is important to have a trusting relationship with the supplier's sales team; however, it is even more important to trust the people that stand behind them. Does their passion, expertise, and "you-first" mentality extend to the production floor? Ask the sales team for a tour or request to participate in a production meeting to get a better feel for who is actually producing the product.
Look at Tomorrow—Today
Medical device manufacturers need to evaluate how its current supplier approaches a customized product? Is its selection of facestocks and adhesives limited? Is it willing to look beyond current "on the shelf" stock? It is imperative that a supplier not only meet these basic requirements, but offer more.
Customization is the result of an unforeseen opportunity. However, in the case of new applications, the market has recently been altered and demands new solutions. Case in point is the baby boomer generation. As the population ages, the demand for skin-friendly products designed for sensitive skin is increasing. It is important to team with a supplier that has a deep queue of medical-grade adhesives that can support the industry's changing demands. A few examples of what should be considered include a smooth, silky removal; conformance to geriatric skin-types; and patient comfort from initial contact to pain-free removal.
Review the Bottom Line
- Long lasting adhesives—Choose a supplier that has an excellent range (ideal is seven to 30 days) to help reduce the number of bandage and patch changes required for a patient.
- Dynamic characteristics—The supplier should offer an adhesive line that is as diverse as the patients who will be treated. Consider ethnicity, gender, age, area of the body, and lifestyle.
- Certified quality—Be sure that the supplier chosen offers adhesives that have met the strict guidelines of ISO, FDA, and cGMP. Failing to do so could result in adhesive failures that cost a company later down the line.
- Be direct—It's no secret that direct skin is critical. Consider that there are an estimated 500,000 surgical site infections (SSI) each year in the U.S. A significant number by any means, but multiplied when the resources to attend to and heal those infections are considered. The adhesive alone can directly impact this number. Working with a quality adhesive allows for a safe, firm adhesion in drape-to-drape and drape-to-patient applications, which helps lower the risk of SSI and provides a significant performance advantage over competitive materials. In addition, promoting total direct skin contact ensures accuracy in monitoring and testing that requires electrical conductivity.
For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com or MACtac at www.mactac.com.