Count Spectrum Plastics Group (Alpharetta, Ga.) among the medical device industry suppliers adding capabilities and expertise in order to add value to what they provide their customers.
Long gone are the days when medtech contract manufacturers simply made orders to spec. As four recent case studies out of Spectrum highlight, it’s all about branching out and finding ways to save medical device companies money.
Here are four ways Spectrum has been able to up its game with customers in recent years:
1. Taking a lead on standards
A Spectrum Plastics Group company, formerly known in the market as Xeridiem Medical Devices, was an early leader in the Global Enteral Device Supplier Association (GEDSA) — an industry alliance seeking to address the fact that the same Luer connector was in use for several different medical tubing purposes. The resulting ISO 80369-3 standard spurred the innovation of a new connector under the trade name ENFit that is specific for enteral feeding. ENFit is meant to ensure that only devices intended for nutritional delivery connect with the corresponding tubing, preventing potentially deadly and costly situations.
Industry adoption for ENFit is at 25%, according to Spectrum, where company officials expect full adoption by 2020.
2. Engineer-to-engineer collaboration
A prominent manufacturer of negative pressure wound therapy devices moved from manual to automated assembly, according to Spectrum. The multi-lumen, extruded tubing components — which had a tendency to spiral, curve and stretch during manufacturing — could no longer be inspected and skillfully manipulated by the assembly team.
Spectrum Plastics Group’s engineers collaborated directly with the customer’s engineers to align tubing extrusion and automation even though both processes occur in separate locations. Spectrum engineers came up with a host of savings for the customer:
- They created a tighter spec to remove memory from tubing, which cut waste by 5%;
- Their global footprint meant they could hold inventory for an 80% savings;
- Their returnable packaging reused boxes and pallets for a total savings of $70,000 per year.
3. Employing a variety of capabilities
A well-known manufacturer of fluid administration sets was planning to start the manufacturing process for an upcoming product. Already a longtime supplier of medical tubing to the customer, Spectrum was able to persuade the customer that it could become the complete contract manufacturer of the fluid administration sets, from mold making to device assembly.
Spectrum Plastics Group helped the customer transition the manufacturing and assembly of finished devices to Spectrum’s Reynosa, Mexico facility. The move helped the customer gain back 10,000 square feet of space that could be dedicated to the new device. It also reduced the overall cost of goods by a fifth.
4. Being expert and nimble
A global leader of structural heart delivery system therapies had a vendor who was not keeping pace when it came to making several iterations of prototypes for a new, multi-lumen, deflectable catheter for a transcatheter mitral valve. A Spectrum Plastics Group company, Apollo Medical Extrusion Technologies, stepped in and got the project done within six months, according to Spectrum.
“Apollo’s ability to work fast with remarkable accuracy quickly achieved the performance characteristics required of the catheter, and delivered units ready for studies weeks ahead of the other team,” said Mike Schultz, VP and CTO at Apollo Medical Extrusion Technologies.
“It’s a complicated delivery system that can take more than a year of development, but we were able to get them from concepts to design in six months because of our expertise in engineering and design,” Schultz said.
Apollo was also small enough to be nimble, even as it was supported by the overall expertise at Spectrum Plastics Group. “We offer agility and efficiency without sacrificing quality and experience, for a dependable and repeatable solution delivered at scale,” Schultz said.
The second generation of the catheter had an added level of complexity: The five-lumen deflectable catheter required a braided reinforcement to enhance performance. Apollo was able to draw on specialized polymers that add a certain degree of flexibility to the reinforcement offered by various braided materials, driving a 25% performance improvement and a 30% reduction in cost.