Ronald C. Lilly
Adhesives with enhanced performance characteristics and associated converting and assembly processes are enabling constant advances in medical device design. For example, adhesives with the flexibility to withstand dynamic loads and the stresses of natural body movement have been developed for use in homecare devices that are applied to the body. To learn more about these and other bonding issues, we spoke with Ronald C. Lilly, president and founder of Alltis Corp.
An innovative business consulting and interim management partner, Alltis has extensive knowledge of adhesives, including pressure-sensitive adhesives, coatings, substrates, and applications, as well as related converting and distribution channels.
There has been much talk lately about the development of adhesives with enhanced performance characteristics. Since your company has expertise in the use of adhesives in medical products, I was wondering if you could tell us how these materials are affecting device design?
Ronald C. Lilly, president, Alltis Corp: There have been many developments in adhesives technology that have made the materials more process and substrate friendly and improved their durability. Low-intensity UV-curing adhesives are one example. Some manufacturers offer adhesives that fluoresce under UV light to ensure that they are precisely dispensed and fully cured.
More-flexible adhesives have been developed in response to homecare devices that are applied to the body and must endure the stresses of natural body movement. This causes stress on the adhesive bond line, unless the cured adhesive has the flexibility to withstand this dynamic load. Many new thermoset medical adhesives, and even a few cyanoacrylates, have increased flexibility for consideration in these new applications.
Advances have also been made in thermoformable process-friendly pressure-sensitive adhesives (PSAs). Many applications use PSAs, which can be preapplied, as opposed to liquid adhesives. Some of the new medical PSAs can be preapplied to one substrate, such as foam, and thermoformed into a finished subcomponent, which simplifies processing and assembly. In the wound-care sector, new acrylic and silicone PSAs have enabled the development of extended-wear products that are also easier to remove than previous iterations.
Are converting and assembly processes keeping pace with developments in the materials realm?
Lilly: Yes. We are seeing increasingly integrated converting, assembly, and packaging operations. Innovative medical converters are incorporating design assistance, as well as component assembly and packaging, into their precision converting role. Converting and die cutting tolerances have also improved to complement the miniaturization of new devices.
Generally speaking, what effect has contract manufacturing had on new device development?
Lilly: Contract manufacturing has allowed OEMs to control costs, particularly at scale-up and high-volume levels. In addition, the integrated expertise of some contract manufacturers provides a one-stop shop for design, molding, assembly, packaging, and distribution. These combined benefits add up to faster market entry and improved profitability, and provide the OEM with greater versatility in new product strategies.
How early in the design phase should companies seek the involvement of third parties?
Lilly: Materials suppliers and consultants, who can complement product development, scale-up, and product launch, should be involved early in the process. Of course NDAs would be required, but once that has been agreed to, the collaboration becomes part of the development process. Suppliers who successfully contribute to the OEM's product growth will become trusted members of the team. A collaborative approach enables the OEM to leverage the combined experience of the OEM/supplier/consultant team to reduce time to market of new and unique products.
What trends do you see in the next 5 to 10 years for new device applications and the materials processes required?
Lilly: Mobile patient monitoring is a developing application niche that provides more-senior users with the benefit of home monitoring. These sensor applications require skin-friendly extended-wear PSAs, flexible/breathable film substrates, printed electronics technology, and a price tag adapted to a medical disposable product. This provides additional opportunities for suppliers who can integrate product design, conductive printing, precision converting, packaging, and distribution.
Other growing consumer applications include improved wound management products with skin-friendly PSAs and extended-wear iontophoretic devices, both of which have similar requirements for extended-wear adhesives and films. There will also be more and more demand for companies with the expertise to process these materials into a finished package.
Ron Lilly has more than 30 years' experience in sales, marketing, and business development for the healthcare, food packaging, contract manufacturing, and specialty adhesives markets. He is president and founder of Alltis Corp., an innovative business consulting and interim management partner with expertise in sales development, technical marketing, market research, product development, and project validation for specialty service and manufacturing companies. Alltis has extensive knowledge of adhesives (including PSAs), coatings, and substrates as well as the converting and distribution channels that customize these materials for unique applications. For more information about the company, view its listing in the online Consultants Directory or go to the firm's Web site at www.alltis.com.