Onshoring your Medical Device Injection Molding

Onshoring your Medical Injection Molding is the RIGHT thing to do. The economic financial crisis of 2008 gave cause for American Original Equipment Manufacturers (OEMs) to take a deeper look into their business models.
They studied alliances with business partners & suppliers, looking for ways to streamline processes, lessen expenses and re-gain profitability for stakeholders.

With uncertainty came the shift of outsourcing medical injection molding and assembly processes to overseas manufacturing companies in an effort to reduce costs, assets and overhead. China, India, Mexico and Brazil were the top four that benefited from this trend. China was the largest recipient despite their reputation for lower quality and dirty, unsafe work environments in their medical injection molding facilities. As a result U.S. manufacturing lost jobs, some plants closed, and angst was felt amongst suppliers that had projects pulled from their factories simply based on cheaper pricing.

It only took OEM’s a few years to figure out that their decisions to follow the trend meant something other than obtaining positive results. Serious issues began to plague their businesses in other ways unforeseen:

Lead Times = the length of time it took from purchase order placement to product receipt ended up being much longer than originally anticipated. Lengthy transportation time by cargo ships and even air transport took its toll - each with its own exhaustive international paperwork and shipping procedures.

Intellectual Property (IP) Issues = everyone knows that patent/copyright infringement & reverse engineering is rampant overseas. Stolen product designs later sold in a medical device market are cause for high concern. Device failure from a product that appears to have been manufactured from a global device maker, but indeed was not, could ruin that company’s reputation and cause millions of dollars in financial damage. As a contract manufacturer, Polymer Conversions Inc. signs non-disclosure agreements (NDAs) as well as confidentiality agreements, before they work with product designs, to exemplify their commitment to the customer’s right to privacy.

Cultural differences, language barriers & lack of technology = unless these overseas suppliers have English speaking employees or the OEM hires a translator to make sure their critical specifications are met for medical injection molding, the supplier has little chance at keeping the business it just pulled from the U.S. manufacturing sector.Medical device manufacturing must have complete document & process/design control, and full understanding of what the customers’ expectations are for their final products and its end users. Any misinterpretation of critical specifications at any point in the manufacturing process, and it could mean costly mistakes that could also impede time-to-market. A lack of robotics, in-house tooling and engineering expertise, as well as a lack of scientific injection molding knowledge, makes for an unattractive long-term partnership. Polymer Conversions, however, thrives in these specialized areas and has a no-risk, comprehensive and fully documented transfer tooling program to keep your products on-track for market entry.

Quick flexibility = for an American-based company to outsource its processes outside of the United States, it must deal with the challenge of slow reaction times to changes in production requirements or tool revision changes during early stage validations. Polymer is incredibly flexible and quick to respond when it comes to a customer’s increased production runs, tooling/part dimensional changes, or emergency pull-in requests. Everything is handled by a highly skilled, cross-functional team so that no detail is left untouched.

Strict Quality Management System (QMS) = some overseas suppliers tout that they use a QMS and follow procedures, but most are found to be quite inadequate once an OEM has visited them to do an in-house audit of their medical injection molding facility. To keep costs low, they cut corners and have poor record retention and document control, which is unacceptable to the medical device industry in the U.S. Any OEM that does not do its due diligence to audit a new foreign supplier (or even a domestic one) and keep vigilant during the entire length of their business together, is risking product quality/safety, a visit from the FDA, a failure in the field, and a ruined reputation.

This just scratches the surface of the extensive list of issues facing OEM’s today. Although China’s economy and medical device quality has seen a bit of an uptick, there are still many issues to be addressed before they can be considered a true solution to bottom-line profitability. Mexico will always be used for low cost labor but their volatile environment, lower quality and lack of ability to keep up with the expertise and technology of the U.S., will still keep them as a less-than optimal selection. Polymer Conversions, Inc. believes Western New York lends itself to an ideal manufacturing corridor. It’s close to the Canadian border, Eastern seaboard, Buffalo/Niagara Int’l. airport, can easily service the entire country, and as of 2014 is 15 minutes away from a new medical innovation center located at the University of Buffalo (UB). There are no tsunamis, hurricanes, typhoons, mudslides, floods, earthquakes, etc. that effect the Orchard Park, NY location. They also have a formal written Disaster Plan should anything out of the ordinary occur.

The OEM’s focus should now be shifted to supplier consolidation, reducing the base to only a select strategic few. Only those manufacturers, like Polymer with true full-service capabilities, the ability to stay technologically advanced, and who are highly committed to the strict standards of the FDA and ISO, will win new business returning to the States.

Polymer Conversions, Inc. is a world-class, full service contract manufacturer that focuses on medical injection molding, tooling, engineering and value-added post-molding services. Their Validated Product & Process Monitoring System linked to every injection molding machine captures real-time SPC & provides accurate & retrievable document control for each batch produced, proving highly repeatable and reproducible throughout the product’s life cycle.


PCI opens Silicone Injection Molding facility

The new facility, opening October 1, 2014 will offer precision Silicone Injection Molding services focused on the tight tolerance components required by high-tech OEM’s and start-ups in the Healthcare, Aerospace & Electronics industries.
Located just minutes from PCI, SILIKON Technologies will utilize the latest advances in processing, equipment and automation to deliver the high quality and precision capabilities customers require. SILIKON will also have an ISO 13485 quality management system, strict process controls, and full commitment to advanced manufacturing methods. Customer satisfaction, a high level of product performance, and broad-based knowledge will lay the foundation for the company’s growth.
Director of Silicone Operations, Patrick Meheran (pmeheran@silikontechnologies.com), and Sales contact Ryan Case (rcase@silikontechnologies.com, cell 716-713-4889) are ready and waiting to discuss exciting new opportunities with your team.
For more information, please visit: www.silikontechnologies.com


Medical Contract Manufacturing in Western New York

MedTech, the leading voice of bioscience and medical technology (Bio/Med) in New York State, today released its 2014 Bio/Med Industry Report, Bio/Med Breakthroughs: Advancing New York State’s Innovation Economy, at MEDTECH 2014. The report is sponsored by the National Grid, the Workforce Development Institute (WDI), NYSEG and RGE.

According to the report, pharmaceutical preparation, in-vitro diagnostic substance surgical appliance and supplies manufacturing as well as life science commercial research and development are emerging subsectors in Western New York, where employment rose by 4 percent between 2007 and 2012.

Responses and numbers indicate workforce and talent development is a major strength for Bio/Med in New York State. Western New York and the neighboring Finger Lakes region are the most-targeted area for recruiting bioscience talent. The Rochester Institute of Technology, University of Rochester and the University of Buffalo are the top three education pipelines in New York State.
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(via http://www.medtech.org/)


Custom Injection Molder helps inventor successfully market device

A new product and a new partnership are leading to success for custom injection molder Polymer Conversions Inc. and its customer, SensGard LLC, maker of hearing protection devices. Rob DiNardo and Greg Post, co-founders of SensGard LLC in Fairport, NY, obtained an exclusive license from Syracuse University to manufacture, market, and sell a technologically advanced hearing protection device developed by Jozef Zwislocki, a former Harvard Fellow from Switzerland, former professor at Syracuse University, and research fellow who founded the Institute for Sensory Research. Zwislocki maintains an office at Syracuse University.

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(via http://www.plasticstoday.com/)


Silicone Injection Molding now offered by Polymer Conversions

Polymer Conversions Inc. launched a sister company for silicone injection molding, SILIKON Technologies LLC., with the opening of its facility on Oct. 1, 2014.

The SILIKON Tech building is located about three miles away from Polymer Conversions, said Patrick Meheran, director of silicone operations at SILIKON.

The 3,750-sq.-ft.-facility will offer precision silicone injection molding services that are focused on the tight tolerance components aimed at the health care, aerospace and electronics industries.

Polymer Conversions saw a niche for a silicone molder that could replicate its thermoplastics validation process. That's where the idea of Silikon Technologies emerged.

Silikon expects to place somewhere up to five machines in this facility over the next five years, but currently has an Arburg all-electric 110-ton machine, a GraCo fluid automation pump system and Frigel chillers.

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(via http://www.rubbernews.com/)


Full-Service Contract Manufacturer exemplifies opportunities for WNY

Bioscience and medical technology (Bio/Med) companies are taking advantage of numerous opportunities in New York State, where support for the industry has led to recent growth.

Buffalo-based Polymer Conversions, a full-service contract manufacturer specializing in clean room manufacturing for the healthcare industry, recently expanded its clean room manufacturing capabilities by adding an additional 22,000 square feet to their headquarters in Orchard Park. They excel with products such as enteral feeding pumps, disposable syringe components, hearing protection devices, drug delivery systems and ear, nose and throat devices. They also recently established Silikon Technologies LLC, a new sister company created to support customers’ needs for silicone injection molding in the healthcare, aerospace and electronics industries.

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(via http://nybiomedreport.com)


Merger of Innovation and Expertise Results in Growth for NYS Companies

Rob DiNardo and Greg Post, co-founders of Fairport, N.Y.- based SensGard LLC, were ready to take their hearing protection business to the next level, marketing the ZEM hearing protection device to a global audience. Financial and manufacturing barriers existed until a meeting with Ben Harp, chief operating officer for Polymer Conversions, Inc., opened the way, pairing the ZEM product with a funding program through the University at Buffalo’s Center for Advanced Biomedical and Bioengineering Technology (UB CAT). SensGard has now moved to a new level of production and is prepared to meet the expectations of a more demanding client base.

From Concept to Production
While investigating business prospects, DiNardo and Post, friends and coworkers since 1990, received an alumni magazine from Syracuse University with an article about technology transfer. “University researchers and professors come up with patentable ideas or products,” explained Post, “but then they’re at a fork in the road. They either have to take that patent and start a business or put the idea on a shelf. Universities recognized the problem and started technology transfer departments to help the professors find homes for the technology.” With backgrounds in business development and marketing, Post and DiNardo might not invent a product that would become the basis of a business, but in this situation, the technical expertise was already in place.

At a conference in upstate New York for universities with technology transfer departments, DiNardo and Post took the first step toward their new company. “We had a great conversation with the technology transfer director from Syracuse University,” said Post. “He sent us to a database on the school’s website, with a listing of available opportunities.”

Discounting some products as unlikely due to financial or regulatory complications, DiNardo and Post were intrigued by a new technology in hearing protection that allowed harmful sounds to be reduced while maximizing the ability to understand speech in a noisy environment. A professor had developed a working prototype, but the device had not yet moved into production.

Seeing the opportunity, DiNardo and Post worked for six months to research the industry, potential competitors, and the current market need. “The more we looked into it,” Post explained, “the more we realized there had been no new innovations in forty or fifty years.” The new business partners licensed the technology in March of 2004 and made the first SensGard ZEM hearing protection device sale in July of 2005. Four years later, they were ready for the next step.

New York State Collaboration
In the Fall of 2008, Harp and DiNardo attended a vendor meeting where they had been asked to present their companies’ qualifications to a potential customer. After the event, Harp began a conversation about the SensGard product, its current production facility, and where the company was in the business cycle. “I learned they were in production with another vendor with development tools,” Harp said. “Their business plan was aggressive, however, and they were getting close to thinking about the next iteration of tooling. I introduced them to Polymer and our capabilities.”

Polymer Conversions, Orchard Park, N.Y., is an injection molder, specializing in the engineering and production of thermoplastic products for electronic, medical, and industrial markets. “We visited Polymer’s facility and realized what a good manufacturer they were in terms of production capabilities and quality,” DiNardo explained. “We knew that if SensGard was going to start doing business with Fortune 500 companies, we needed to step up and meet more stringent quality requirements. Polymer was a good fit for us.”

Polymer provided an estimate for the tooling required to move SensGard ahead. “It was difficult for us to commit to that cost,” said DiNardo. “We didn’t have the volume yet to justify the expense, but we needed their capabilities to bring on larger customers. Ben had a connection with a potential funding source and he presented us as a New York State company with an interesting product.”

Harp had worked with Marnie LaVigne, the director of business development for UB CAT, on previous projects. UB CAT is a program of UB’s New York State Foundation for Science, Technology, and Innovation, housed at the Center of Excellence. “UB CAT has matching funds available for innovative NYSdriven products that are designed here, developed here, and manufactured here,” stated Harp. “I talked to Marnie about this young company that was not totally prepared to go to production tooling, and introduced the possibility of a subsidy so that SensGard could invest in new tools.”

UB CAT encourages university-industry collaboration, with an emphasis on helping New York State-based businesses gain a technological advantage over their competition. Along with funding, UB CAT also provides R&D resources, business development assistance, and workforce development programming. Funding is available through a grant process that evaluates the potential economic impact for the state, the project’s technical merit, and the availability of matching funds from the requesting company, among other criteria. DiNardo and Post submitted a proposal to UB CAT and, under the guidance of Donald Henderson, Ph.D., UB professor in the Department of Communicative Disorders and Sciences, the UB CAT program was able to support the development project.

Beyond Development Tooling
DiNardo and Post committed to the new tooling in May of 2009 and Polymer’s engineering team stepped in. “The tooling used for initial production of the ZEM device was development tooling, made of softer steels and less durable than what is needed for high-volume manufacturing,” Harp stated. “Polymer built high-volume-capable tooling and in the process, used our engineering resources to fine-tune aspects of the product design.”

One such modification was made to the ZEM headband. The original headband consisted of four separate pieces, two of which needed to be joined through ultrasonic welding. By applying Polymer’s design capabilities, the headband was reduced to two pieces, eliminating the necessity for welding, simplifying assembly, and improving production efficiency.

Polymer Conversions has invested in both manufacturing technologies and its employees in order to provide its customers with an edge. The facility has both Class 100,000 (ISO class 8) and Class 10,000 (ISO class 7) clean room molding capabilities, a fully staffed two-shift tool room, and secondary operations which include decorating, assembly, custom automation, and packaging capabilities. The company’s employees are focused on improving designs and processes, while helping customers to become more knowledgeable about the molding and manufacturing process. The result is high-quality parts that meet or exceed the customer’s requirements.

Polymer produced 100 samples of the hearing protection device in November of 2009, with the first production run completed in early February of 2010. SensGard has since ordered another 6,000 units. “Polymer enables us to go to first tier companies to pitch the ZEM,” said DiNardo. “These companies are not going to buy our product unless they first visit the production plant and verify the quality standards are in place. Polymer allows us to be a viable player in any area because of its quantity capabilities, quality standards, and production models.”

To the Next Level
DiNardo and Post are cognizant that the partnership with Polymer Conversions and the matching funds provided by UB CAT have moved SensGard and the ZEM hearing protection device onto a new playing field. “When you start a business, you start at zero,” Post said. “We had money to get us off the ground, we had revenue, and we were operating at break even. But to get to the next level, we needed additional resources.” Polymer stepped into that breach, providing high-volume manufacturing capabilities, engineering expertise, and stringent quality standards that exceeded SensGard’s previous capacity. “Now we can pitch this product to anybody in the world without worrying about meeting objections,” stated DiNardo. “We feel comfortable with Polymer.”

By Dianna Brodine


Conceptual Development of a Device for Oral Hygiene in Individuals with Special Needs

NYSCEDII worked in collaboration with Oral Health Innovations (now Orius Innovations), Buffalo BioSciences, PreSource Technologies and Polymer Conversions, Inc. (PCI) on the development of a dental cleaning device. The project focused on the development of a device that can autonomously clean a complete set (upper or lower) of teeth at a time.

 

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(via http://www.plasticstoday.com)


Polymer Conversions Partnership Boosts SensGard Production

Merger of Innovation and Expertise Results in Growth for NYS Companies

April 15, 2010 – Orchard Park, N.Y. – Polymer Conversions, Inc. and SensGard LLC, with support from the University at Buffalo, have successfully partnered to increase production capabilities for the ZEM hearing protection device.

Rob DiNardo and Greg Post, co-founders of Fairport, N.Y.-based SensGard LLC, were ready to take their hearing protection business to the next level, marketing the ZEM device to a global audience. A meeting with Ben Harp, COO for Polymer Conversions, introduced the injection molder’s capabilities to a small NYS company ready for expansion.

Financial barriers existed until DiNardo and Post learned of a funding program from University at Buffalo’s Center for Advanced Biomedical and Bioengineering Technology (UB CAT), a program of UB’s New York State Foundation for Science, Technology, and Innovation, housed at the Center of Excellence. UB CAT encourages university-industry collaboration, with an emphasis on helping New York State-based businesses gain a technological advantage over their competition. Under the guidance of Donald Henderson, Ph.D., UB professor in the Department of Communicative Disorders and Sciences, the UB CAT program was able to support the development project with matching funds that provided an incentive for SensGard to proceed with the Polymer Conversions partnership.

“The tooling used for initial production of the ZEM device was development tooling, made of softer steels and less durable than what is needed for high-volume manufacturing,” Harp stated. “Polymer built high-volume-capable tooling and in the process, used our engineering resources to fine-tune aspects of the product design.”

Polymer produced 100 samples of the hearing protection device in November of 2009, with the first production run completed in early February of 2010. SensGard has since ordered another 6,000 units. “Polymer enables us to go to first tier companies to pitch the ZEM,” said Rob DiNardo, co-founder of SensGard. “These companies are not going to buy our product unless they first visit the production plant and verify the quality standards are in place. Polymer allows us to be a viable player in any area.”

Since 1979, Polymer Conversions, Inc. has specialized in highly technical, tight-tolerance medical devices, medical components, biometrics devices, and gearing parts. The Orchard Park, N.Y. technology center is fully equipped with Computer Integrated Manufacturing (CIM) systems that apply 6 Sigma principles to injection molding presses ranging from 28 to 390 tons. The center includes a clean room molding area, a full service tool room with mold making capabilities, and secondary operations such as decorating, assembly, custom automation, and packaging capabilities.