Made to measure: When off the shelf won’t do

Neal Carty, Vancive Medical Technologies, discusses how early collaboration on material selection can lead to bespoke adhesives — a path that may save some headaches in the long run

As functional demands on medical devices become more complex, device developers may struggle to find standard, off-the-shelf adhesives that can help them achieve their desired product performance requirements. This article guides developers through some basic considerations to keep in mind during material selection and when partnering with a supplier to get it right the first time.

Product development engineers live in a world of accelerating timelines, shrinking resources and impossible expectations. And they thrive on it. Delighting their customers and fueling their next record-breaking quarter is what drives them, and they know that winning means using every tool available to be leaner and more innovative in their work. 

Custom doesn’t have to mean slow

When designers need to specify adhesive materials, the thought of going down a path of customization may sound daunting.  Under the pressure of an aggressive project schedule, intuition says that an “off the shelf” choice will be faster and simpler.  But this is not always the case. An optimal solution to a specific problem often requires some degree of customisation, and it’s important to consider that not every custom product involves the creation of brand new chemistries. There are many cases in which existing adhesives and materials can be combined in new ways.

In other words, a materials supplier may be able to ‘mix and match’ different backings, release liners or adhesive types to achieve the desired performance. By doing so, the device developer can walk away with an adhesive product uniquely specialised for a certain end use, without reinventing the wheel. Certainly, there are also cases that call for development of a completely novel adhesive chemistry, and this can require a closer R&D partnership to co-engineer a solution. Either way, it’s good to engage with suppliers early and leverage their knowledge and experience to solve a particular development problem or achieve a desired clinical outcome.

Early collaboration and open innovation

More medical device businesses are embracing the theory of open innovation as a means to reap the rewards of proactively seeking and incorporating input from experts outside of their own organizations. This can apply to the selection of custom adhesive materials during medical device design and development.

A fundamental tenant of open innovation, as explained by one of the movement’s forefathers, Henry Chesbrough, executive director of the Center for Open Innovation, Haas School of Business, University of California, Berkeley, is  that: “…firms can and should use external ideas as well as internal ideas, and internal and external paths to market, as the firms look to advance their technology.”(1)  In other words, firms can and should leverage the entire universe of resources that is available to advance their goals, not just the ones they have in-house.

When device developers and their supply chain partners undertake a design challenge from this perspective, they seek answers from sources who hold the greatest expertise in a specific area. For example, medical device design engineers who need adhesive materials to enable multi-day or multi-week wear times on the skin will benefit from going straight to the suppliers who know the world of possibilities and have the accumulated experience of solving similar problems across a wide array of different applications. In turn, those suppliers should be seeking input from their raw materials suppliers. Each node of the supply chain has the potential to add a new perspective to the conversation. Without this first-hand advice, designers and developers can miss out on key advances and answers that could shorten their development times and help their product perform better for the patient.

Avoiding the ‘shotgun’ approach

In the rush to get products to market, sometimes development teams will request myriad material samples and embark on a program of brute-force experimentation to achieve a desired outcome. This can be referred to as the ‘shotgun’ approach in that companies’ parallel-path testing of a wide array of materials.  Sometimes this is effective, but it can quickly sap precious resources and by short-circuiting a process of thoughtful design it can also lead to suboptimal solutions. Often, design engineers can save considerable time and effort by first talking with materials suppliers about their end goals. For instance, it may be very straightforward for a supplier to make changes to an adhesive tape construction: eliminating layers, changing chemistries, or using innovative techniques to give it greater breathability, stronger hold or better conformability — or even something as simple as a different color. By communicating about the end use application early in device development, all parties have an opportunity to avoid designs that are unnecessarily complex or costly.

Optimising diverse expertise

Just as the best medical devices and materials are ultimately fit for a specific purpose, the different teams, partners and individual contributors who develop them serve unique roles toward the end goal. For example, wearable device developers need deep knowledge of process engineering to ensure designs can readily scale up to high-volume manufacturing levels. They need polymer and materials science experts to help them achieve the desired wear time, a conformable hold and comfortable release from the skin when it’s time to remove the device. Biochemical engineering and physiologic expertise is essential to ensure proper functioning of complex biometric systems, such as for glucose or cardiac monitoring and drug delivery. Electrical engineering is crucial for understanding device battery life, wireless communication and many other core functions.

Whether it’s wearables or wound care, tapping into insights from different subject matter experts can have a big impact on product development. Particularly within the medical device industry, good engineering must go hand-in-hand with an in-depth understanding of the regulatory environment. For example, a medical materials supplier with deep materials science experience in the medical market and a working knowledge of global regulations may be able to help a device developer save time and effort by recommending design approaches that operate within allowable regulatory boundaries.

In conclusion, when supply chain partners pool their resources and diverse talents, they can tap into a wealth of multidisciplinary expertise. If off-the-shelf solutions are insufficient to achieve target outcomes, an open innovation approach may prompt device makers and materials suppliers toward custom adhesive development. When this option is explored early, it can help device developers to solve problems better and deliver new patient solutions in an even more efficient way.

Footnote (1): Henry Chesbrough, “Open Innovation: The New Imperative,” as cited on the Open Innovation Community’s website