Resin suppliers are playing a larger role in enabling medical device OEMs to contain costs, meet evolving regulations, and increase patient comfort and safety.

In addition to typical datasheets and computer-based slide presentations, resin suppliers are providing hands-on, interactive tool kits that contain a wide array of actual medical devices molded in multiple materials. Such kits are allowing designers to see and feel the differences between materials to help facilitate the most appropriate decisions possible.

The benefits to a design company and its OEM customers are myriad. Waste is avoided by selecting the most appropriate material at the beginning stages of the design process, while costs are contained because late-stage (or even last-minute) material changes are less likely to occur. Finally, patient comfort and safety are enhanced, because discoloration, cracking, and other issues are avoided, allowing a device to be perceived positively by patients throughout its usable lifespan.

Changing regulatory environment

While managing costs continues to be a significant driver for medical device OEMs, so, too, is the changing regulatory environment, which directly affects the decision-making process for medical device design companies. For example, under future regulations, hospital-acquired infections will not be covered by Medicare and Medicaid, meaning hospitals will have to bear those costs if they occur. As a result, hospitals are adopting more stringent methods to minimize the potential for these types of infections, including frequent application of increasingly stronger disinfectants to medical devices. Some disinfectants can have an adverse effect on those devices, such as increased potential for stress cracking.

Medical device OEMs are relying on design partners for counsel regarding compliance with device fitness-for-use requirements as they relate to changing regulations. As a result, designers need to have a clear understanding of the specific attributes of the materials they have at their disposal, in order to effectively execute a high-quality design that will meet those requirements.

But it also bears mentioning that making the correct decision regarding a material at the beginning of the design process is more important than ever for designers, to avoid cost overruns due to late-stage changes, and resultant customer frustration. For years, designers have relied on technical data sheets from resin suppliers to gauge a material's toughness, sterilization stability and chemical resistance, or computer-based presentations that provide case-by-case technical information related to the application under development.

However, some resin suppliers have realized that a more effective way to help designers make the right choice the first time is to provide a means for them to see and feel the differences between materials. That realization prompted Eastman Chemical Company to develop a mobile toolkit contoured specifically to the needs of the medical design community.

Medically focused toolkits

While materials toolkits themselves are not entirely new, the concept of an exclusively medically focused toolkit that compares the technical attributes of actual devices made of multiple material types is an innovation with significant ramifications for medical device design companies, and the rest of the value chain. In development of the Eastman Medical Interactive Toolkit, Eastman Chemical Company conducted tests of its Tritan copolyester versus three materials used in medical device design: lipid-resistant polycarbonate; general-purpose polycarbonate; and general-purpose acrylic.

Testing culminated in a distinct variety of common medical device types contained within the toolkit that can be viewed and handled by designers during the research process. Those device types include: sterilized step chips, chemical resistance plaques, spiral flow comparisons, double-dosing cup, needle hub, tensile bars, I-beam test samples, and luers with tubing.

ARTICLE FOCUS:

• Why interactive toolkits
• Toolkit contents
• Benefits