Caroline Lee, Account Representative, Mintz & Hoke04.11.18
Bringing a medical device to market can take years and requires expertise from several different perspectives and sources. From research and development to material selection and regulatory considerations, there are many parts of the process. When it comes to manufacturing the device, components of the finished product also come from a variety of sources before it is assembled. In some cases, parts of the device are outsourced to a manufacturer with a niche capability or area of expertise to streamline efficiencies and improve margins.
In other cases, selecting a contract manufacturer with a varied set of capabilities—from component manufacturing to complete device assembly—is far more beneficial. This was the case when a well-known manufacturer of fluid administration sets was planning to start the manufacturing process for an upcoming product. With a number of products already being manufactured at this facility, adding a new product on the floor was proving difficult. Faced with the possibility of outsourcing the manufacture of legacy products to make room for newer, higher-margin devices, the company sought an alternative solution. The company needed a trusted, full-service contract manufacturing partner.
Spectrum Plastics Group had been a longtime partner of this manufacturer, providing medical tubing components for fluid administration sets. Regularly delivering extruded medical tubing manufactured to precise, larger diameter specifications required for fluid administration sets, Spectrum Plastics Group created consistency in product and a valuable relationship with the manufacturer. Nurturing that relationship became mutually beneficial when the manufacturer needed additional supportin the form of contract manufacturing.
Recognizing that Spectrum Plastic Group’s expertise and rigorous internal acceptance standards are also applied to all processes, the manufacturer selected the company to do more than manufacture components. In addition to manufacturing the medical tubing, Spectrum Plastics Group is now the complete contract manufacturer of the fluid administration sets, from mold making to device assembly.
Tom Flannery, director of business development for Spectrum Plastics Group explained how the manufacturer was able to shift the perspective of the supply partner as a component provider to full-service contract manufacturer. “We understood the pain point. The business climate for manual assembly is challenging, with policy initiatives that favor bulk, commoditized healthcare as opposed to patient- and outcome-focused care. Manufacturers, like healthcare providers, are trying to provide as much as possible, to as many as possible, for the lowest possible cost.” He continued, “That is why finding a contract manufacturing partner becomes so important. We become your partner from R&D stages to manufacturing components and finished devices to sterilization and packaging, and even managing the complicated and ever-changing regulatory environment.”
Transitioning the manufacturing and assembly of the finished device to Spectrum Plastics Group’s Reynosa facility in Mexico, the company aided in streamline the manufacturing process, helping the manufacturer gain back 10,000 square feet of space that could be dedicated to the new device. In addition, the overall cost of goods was reduced by 20 percent and the partnership came together much faster than anticipated, moving from the audit to the first purchase order in just 90 days.
The Spectrum Plastics Group Reynosa facility specializes in OEM plastic components, subassemblies, finished sets, coiled dispensers, contract manufacturing and folding drapes. The facility features 50,000 square feet of space, 20 assembly lines, 10 molding lines and an in-house tooling center with ISO 9001 and ISO 13485 certifications.
In other cases, selecting a contract manufacturer with a varied set of capabilities—from component manufacturing to complete device assembly—is far more beneficial. This was the case when a well-known manufacturer of fluid administration sets was planning to start the manufacturing process for an upcoming product. With a number of products already being manufactured at this facility, adding a new product on the floor was proving difficult. Faced with the possibility of outsourcing the manufacture of legacy products to make room for newer, higher-margin devices, the company sought an alternative solution. The company needed a trusted, full-service contract manufacturing partner.
Spectrum Plastics Group had been a longtime partner of this manufacturer, providing medical tubing components for fluid administration sets. Regularly delivering extruded medical tubing manufactured to precise, larger diameter specifications required for fluid administration sets, Spectrum Plastics Group created consistency in product and a valuable relationship with the manufacturer. Nurturing that relationship became mutually beneficial when the manufacturer needed additional supportin the form of contract manufacturing.
Recognizing that Spectrum Plastic Group’s expertise and rigorous internal acceptance standards are also applied to all processes, the manufacturer selected the company to do more than manufacture components. In addition to manufacturing the medical tubing, Spectrum Plastics Group is now the complete contract manufacturer of the fluid administration sets, from mold making to device assembly.
Tom Flannery, director of business development for Spectrum Plastics Group explained how the manufacturer was able to shift the perspective of the supply partner as a component provider to full-service contract manufacturer. “We understood the pain point. The business climate for manual assembly is challenging, with policy initiatives that favor bulk, commoditized healthcare as opposed to patient- and outcome-focused care. Manufacturers, like healthcare providers, are trying to provide as much as possible, to as many as possible, for the lowest possible cost.” He continued, “That is why finding a contract manufacturing partner becomes so important. We become your partner from R&D stages to manufacturing components and finished devices to sterilization and packaging, and even managing the complicated and ever-changing regulatory environment.”
Transitioning the manufacturing and assembly of the finished device to Spectrum Plastics Group’s Reynosa facility in Mexico, the company aided in streamline the manufacturing process, helping the manufacturer gain back 10,000 square feet of space that could be dedicated to the new device. In addition, the overall cost of goods was reduced by 20 percent and the partnership came together much faster than anticipated, moving from the audit to the first purchase order in just 90 days.
The Spectrum Plastics Group Reynosa facility specializes in OEM plastic components, subassemblies, finished sets, coiled dispensers, contract manufacturing and folding drapes. The facility features 50,000 square feet of space, 20 assembly lines, 10 molding lines and an in-house tooling center with ISO 9001 and ISO 13485 certifications.
