For surgeons, it is undeniably important to see exactly what they are doing. With the help of a small hand-held medical suture pen, a doctor can apply a line of surgical glue to the edges of a wound and seal it, replacing the need for traditional stitches.
A top medical device OEM came to Nolato GW with the need to create a delivery system for their new suture glue. Nolato GW started developing this with a polypropylene body in a thermoplastic urethane bulb, as the bulb’s requirement was for the surgeon to break the ampule to start the flow of the glue, and then allow the tip of bulb to apply the glue to the wound site.
Tactile and visual requirements were key, and after many design iterations, the solid thermoplastic urethane did not allow any visualization of glue in the bulb, and it was much too stiff for the surgeon’s preference. This was discovered at the end of the development and tooling cycle, and the program was about to be canceled.
As a potential solution, Nolato GW Silicones offered a more flexible Liquid Silicone Rubber (LSR) replacement to the solid thermoplastic urethane for the bulb. Several iterations were prototyped to find the perfect shape and tactile feel.
“Our LSR engineers began questioning the design and material choices,” says Mark Hammond, General Manager of Nolato GW Silicones. “We developed a new version of the device with an optical-grade silicone to increase the surgeon’s control over the application of the glue during operations.”
GW then recreated the transparent silicone component in a GW-built 16 cavity LSR mold at a cost comparable to the thermoplastic mold, and the manufacturing process was re-validated according to medical requirements. The project was then successfully launched.
The silicone bulb design has been so successful that the volumes have escalated beyond any original expectations. Today, Nolato GW is making both the silicone bulbs and the thermoplastic bodies in their Royalton, Vermont Manufacturing and Technology Center, where the combination of technologies in one location have been ideal for the customer.
“Our customer was extremely pleased that from one facility, we have delivered a high-quality medical device made of two completely different thermoplastic and silicone materials, and at a very competitive price,” comments Hammond. “Today, we have manufactured several millions of this product, with both a satisfied customer and satisfied surgeons as a result.”