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Plastics Today, September 2015

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Medical Technology 28 global PlasTics RePoRT 2015 PlasTicsToday.coM ing lower part costs, because cycle times, labor and assembly operations are reduced. To take some of the guesswork out of molding parts, more companies are embracing scientific molding, a move that is encouraged by many custom- ers. "It's an asset in precision molding operations, in general," says Reiss. GW Plastics has developed expertise in sci- entific molding, "which requires strong processes and methodologies, and that meshes well with the healthcare market," explains Reiss. A data-based process, scientific mold- ing is defined by MRPC (Butler, WI), a custom manufacturer of silicone, medical rubber and thermoplastic components and assemblies, as a methodical set of experiments to develop a process. It involves understanding the nature of the material that is being molded and its preferred molding conditions, MRPC Vice President of Engineering Jeff Randall told sister brand MD+DI. By understanding the material's preferences, behavior, and response to process inputs, a manufacturer can optimize the mold- ing process and produce the most consis- tent part possible, says Randall. While the use of scientific molding is not as widespread in the medical field as it is in other sectors, the smart money is on its growing adoption. Increasingly, customers will want to see that in your toolbox. All of the molders we spoke with also stressed the importance of provid- ing an array of services. For Witkowski, the evolution of smart devices that inte- grate sensors and sundry electronics, has made the synergy between Nypro and Jabil—the latter acquired the former in 2013—a tremendous asset. "We've come a long way from injectors with no elec- tronics. Now, devices communicate with cell phones, injectors store data about how much medication you took and when," says Witkowski. Suppliers need to be able to provide support for those applications, he explains. "OEMs don't want to go to 10 different suppliers for that expertise and spread their resources across the globe." Reiss sees demand for an array of services growing year after year as OEMs tighten resources. "Expertise in innova- tion, product design, material selection and so forth are increasing requirements, and that calls for significant engineer- ing resources on the part of the contract molder," says Reiss. The question of certification Some medical molders who make a vir- tue of not having ISO certification. It adds cost and complexity to the process, an administrative burden that is not entirely justified, they say. Most medical molders beg to differ, however. "The level of quality required depends on the application and the level of risk," says Welch. "Medical tubing may have a much lower risk than a complete plas- tic device that is made up of 14 or 15 parts and may even contain some metal inserts. But, generally speaking, without the appropriate certification, you are lim- iting your potential customer base. It's on their checklist—ISO 13485 is always required by our customers," says Welch. Adds Reiss: "ISO 13485 is the big- gest precursor for entering the medical molding market. The standard dictates a consistent, methodical approach. I don't see how you can expect to be taken seri- ously without it." it's easy to stub your toes on local business customs Although Prism Plastics, an injection molding company headquartered in Ches- terfield, MI, is certified to ISO 13485, it proudly proclaims that it does not have a quality department. "Our company philosophy is that everyone on our staff is in the quality department," says Gerry Phillips, Vice President and co-founder. "Responsibility and accountability for quality is shared by everyone. By the time you get to parts inspection, it's too late." A global footprint The medical technology sector is a global industry, and for contract molders with global ambitions, regionalization and prox- imity to customers is key. Phillips-Medisize says it's all about leaving options open for OEMs. "In China, the 80/20 rule applies," says Welch, meaning that 80% of what is made there, stays there for local con- sumption. "We have facilities in Western Europe, but also in the Czech Republic, as a low-cost option for the EU market. Likewise, we have facilities in Wisconsin, as well as Mexico. It's all about having low- cost options within the same geography." A global presence may be necessary if the customer has design centers in offshore locations, says Witkowski. "It's important in the front-end development process, because you want to be nearby to facilitate communication. But it's not as critical in the full production stage," adds Witkowski, "given the supply chain logistics that are available today." Witkowski does offer some sage Nypro and Jabil offer cleanroom injection molding of liquid silicone rubber.

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