A better life

“Our customers know what drug they want to release, at what rate and for how long,” he continues. “That is their expertise. Our expertise is knowing the right polymer carrier for an application or how to modify a design or manufacture a component to maximize the performance of a drug-eluting device. We support customers in making the correct polymer selections for manufacturability and produce the data needed to advance their product concepts.”

 

Although Trelleborg’s work in any one polymer is not unique, its offering and knowledge of a broad range of polymer types is.

 

“Our background in silicone was a fantastic foundation for our drug-eluting solutions,” Fletcher says. “What I am excited about now is our push to continue to expand our expertise in other polymers. For instance, we’re sharpening our knowledge in bioresorbable polymers, materials that safely break down in the body, which are a better fit for shorter-term drug delivery applications providing roughly six months of delivery. We’re also beginning to work in biodurable materials other than silicone, ones that can withstand implantation into the human body, such as ethylene vinyl acetate and ones that offer advantages such as lower processing temperatures.”

 

Fletcher points out that he does not see Trelleborg as selling products. “Instead, we provide capabilities that accelerate the development process for our customers’ future devices,” he says. “In the early stages of programs, we’re a full-service development partner, and then we can scale up projects for clinical trials and high-volume commercial production.”

 

Drug-eluting devices are also commonly classified as combination products. The implant containing the active pharmaceutical is a drug product and is often paired with a medical device to facilitate delivery to a patient. This comes with some challenges.

 

Fletcher explains: “When we have these two elements – the drug product and medical device – the US Food and Drug Administration (FDA) regulates the device as a combination product. This is a nuance to the regulatory path, and our customers appreciate our support in helping them navigate to approvals.”

 

Additionally, much of the focus early in drug-eluting programs is making sure the drug will perform. “In just about every one of these programs, we prove the drug product works and then there is always a sprint to develop the companion drug delivery device,” he says. “This is where Trelleborg’s background in medical devices allows us to quickly put together a supply chain, leveraging our network of facilities, to produce what’s needed to bring that element of the project online as well.”

 

Looking to the future, Fletcher predicts that more and more implantable drug delivery applications will emerge. “Currently, the pharmaceutical industry still tends to lean quite heavily toward delivering their drugs via a pill, and if that doesn’t work, they explore injectables,” Fletcher says. “This is changing, and we’re seeing activity in new types of applications. I believe, as more drug-eluting products reach the market, more companies will consider these delivery methods. Trelleborg is very well set up to serve those customers.”