OEE Leads to SMART Solutions at PMC

Overall Equipment Effectiveness (OEE) is – at its most simple – a measurement of manufacturing productivity. Developed as a tenet of lean manufacturing, the aim of OEE is to provide metrics that can be used to improve a manufacturing process.

Three components provide data when assessing OEE, as described at www.oee.com. The first is availability, which measures whether the process is running as scheduled. The second factor, performance, assesses whether maximum manufacturing speeds are reached. Quality, which counts defects, is the third component.

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PMC SMART Solutions triples its medical manufacturing space in Indiana

Global medical device supplier announces new expansion and hires to accommodate continued growth

SHELBYVILLE, Ind. — PMC SMART Solutions, a leading global manufacturing company with operations in Shelbyville, Ind., is undergoing the final stages of a $5 million expansion project that will triple its current medical manufacturing space.

The expansion, which is scheduled to be ready for manufacturing in April, is designed to accommodate the significant growth the company has experienced in medical device contract manufacturing, according to Lisa Jennings, President and CEO of PMC SMART Solutions.

The company also has been hiring new employees in engineering and operations to manage increases in new programs and production of finished disposable devices.

“We are excited about the expansion and new team additions to PMC SMART Solutions,” Jennings said. “Our company’s growth can be directly attributed to our team’s commitment to continuous innovation, world-class quality and on-time delivery.”

PMC’s excellence in customer service has been recognized with numerous accolades, including the prestigious Bosch Global Supplier Excellence Award. “Our employees consistently perform beyond client expectations,” Jennings said. “And the expanded medical manufacturing space strengthens our ability to continue that legacy of success.”

Along with the expansion of medical manufacturing spaces, including Class 8 clean room manufacturing, the project includes new equipment, office space and employee amenities. PMC is investing in equipment for injection molding, including implant and micro-molding, and automation and sterile packaging for finished disposable devices.

“Our continued growth would not be possible without the tremendous support of the Shelbyville community,” said Jennings, referring to collaborations with Mayor Tom DeBaun, Brian Asher, executive director of the Shelby County Development Company and Shelbyville City Councilmembers.

“It’s been a great partnership since we opened our doors in 1973,” she said. “Shelbyville is a friendly place to do business. We’re looking forward to growing with the community.”

The medical devices sector has been a significant area of growth for PMC, which recently entered into contracts with major global companies that specialize in ophthalmic surgery and surgical navigation.

Plastics Business: The View from 30 Feet

Business gurus often talk about the view from 30,000 feet – the big picture that provides a look at overall operations. Perhaps, however, the focus should be on the view from 30 feet – a close-up of specific processes and procedures that make an impact now.

Read more.

PMC SMART Solutions receives Bosch Global Supplier Award

PMC SMART Solutions, LLC has been honored with the “Bosch Global Supplier Award 2015” from Robert Bosch GmbH. PMC received the award in the Plastics-Injection Molding category, for their work supplying Bosch with plastic components and assemblies for steering, fuel and electrical systems in the U.S, Mexico, and Europe. In all, Bosch has given awards to 58 elite suppliers from eleven countries, all of which were hand-selected from a pool of 35,000 total candidates. This is the 14th time that the supplier of technology and services has given out the global supplier award. By presenting this award, the company recognizes outstanding performance in the manufacture and supply of products or services – notably in the areas of quality, costs, logistics, and innovations. “The Bosch Global Supplier Award honors our top suppliers, who play such a key role in Bosch’s success,” said Dr. Volkmar Denner, chairman of the Bosch board of management, at the award ceremony in Stuttgart. “Our suppliers are important partners in helping us shape the connected world. We want to work with them to develop beneficial solutions for our customers.” The theme of this year’s award ceremony was: “Power of partnership – connected intelligence”.

In 2014, the Bosch Group’s purchasing volume came to some 25 billion Euros. Europe still accounts for the lion’s share, at roughly 60 percent of the global purchasing volume. Outside Europe, procurement is centered on China, the U.S., and Japan.

About PMC SMART Solutions, Manufacturing Technology that Saves Lives
Founded in 1929, PMC SMART Solutions is headquartered in Cincinnati, Ohio, with locations in Shelbyville, Ind.; Detroit, Mich.; Guanajuato, Mexico; and Wiesau, Germany. PMC has a strong history of creating plastic-based products in highly-regulated markets and is a contract manufacturer for 10 of the top global Tier 1 automotive manufacturers and seven of the world’s largest medical device OEMs. PMC is a certified women-owned business by the Women’s Business Enterprise National Council (WBENC). For more information, visit www.pmcsmartsolutions.com.

For more information, send email to [email protected].

Medical Device Summits Case Study – PMC SMART Solutions & Arthrocare

Norman Gordon
Vice President, R&D
ArthroCare

ArthroCare has done around USD 300,000 worth of business with a solution provider from the marcus evans Medical Device R&D Summit, according to Norman Gordon, Vice President, R&D, ArthroCare.

A delegate at two Medical Device R&D Summits, Gordon said: “When I am searching for vendors, the Summits are useful for assessing the marketplace. Although we were looking for new vendors, it is very possible that we would not have met or ended up working with PMC LLC if we had not attended the Summit.”

Since your last Summit, you have been working with PMC LLC on a new project. How did this relationship develop?
We do a lot of work with a material that is difficult to mold, which not many companies in the US have the expertise and experience that is required to do it well. We had one vendor for all our molds and were satisfied with them. However, when we had a hard look at our risk management plans, we realized that we were single-sourcing some expertise and production capabilities, and needed to find new vendors.

We met PMC LLC at the marcus evans Summit and got a feel for their capabilities and which industry partners they work with. They seemed to be a pretty good fit with our needs. Thus, we had them quote competitively with the other vendor, and decided to work with them.

The contract value was around USD 300,000. Over the next few years, as we generate revenue for our company, we will probably purchase some additional components from PMC and place orders for new molded parts.
Although we were looking for new vendors, it is very possible that we would not have met or ended up working with PMC LLC if we had not attended the Summit.

How do the Summits help you find vendors? How efficient and effective do you find the one-on-one meeting format?
They allow you to cut to the chase quickly. The vendors get a chance to present themselves to folks that they might not otherwise have access to, and delegates get an understanding of their capabilities that they might not have otherwise sought. The meetings can be very valuable.

Every few years, the marcus evans Summits help me see the most recent advances in project planning, interact with folks facing similar challenges and hear how they have solved problems. It is definitely time well spent. When I am searching for vendors, the Summits are useful for assessing the marketplace.

Are you planning to work with any other solution providers you met through marcus evans?

With one of the other vendors, we have identified an overlap in their machining capabilities and some of the parts we make on a regular basis, so we are keeping in touch to possibly utilize their services when we are at that point in the product development cycle. We certainly will bring them in when we get started on some new projects, late summer or fall 2013.

To access more marcus evans Success Stories, please visit the website: http://casestudies.marcusevans.com

Contact: Sarin Kouyoumdjian-Gurunlian
Press Manager, marcus evans, Summits Division
Tel: +357 22 849 313 / Email: [email protected]

For more information about marcus evans Manufacturing Summits visit:
www.medicalmanufacturingsummit.com/casestudy

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BRAVING NEW WORLDS – SMART BUSINESS MAGAZINE

Lisa Jennings translates PMC SMART Solutions’ strengths into a new market venture.

For additional information, click here.

For more information, send email to [email protected].

PMC’s Jay Haverstraw touts metal-to-plastic conversions

WESTLAKE, OHIO (Sept. 5, 3:30 p.m. ET)

The benefits from metal-to-plastic part conversion cuts across all parts of the health-care industry, from device makers, doctors, hospitals and patients, according to Jay Haverstraw of PMC LLC.

“It’s really predominately cost drivers, but there’s a bunch of side benefits to the other players in the food chain, so to speak,” said Haverstraw, technical sales manager at PMC, a Cincinnati-based injection molder, in a recent presentation at the Plastics in Medical Devices 2012 conference in Westlake.

Check out his presentation in this online video.

Founded in 1929, PMC is an injection molder and contract manufacturer that serves the medical, commercial electronics and transportation markets.

The Plastics News-sponsored conference was held June 11-13.

For more information, send email to [email protected].

Medical Plastics: The Innovative Beat Goes On

Society of Plastics Engineers
Plastics Engineering
April 2011

Strong and Flexible Implants

In the late 1990s, polyetheretherketone (PEEK) was first used for implants. PEEK-based spinal spacers were used to hold vertebrae upright after disk removal. Unlike titanium, PEEK parts didn’t eventually subside into bone, and they allowed visualization of the bone surrounding the implant in X-ray or CT images.

These advantages and others have led to many more PEEK-based implants. Marcus Jarman-Smith is a technology leader at Invibio Ltd., which has been making PEEK-OptimaR polymer for over a decade. He says that in addition to spinal implants, the material holds clear benefits for knee-replacement and hip-replacement parts. PEEK parts don’t produce the health concerns associated with the metal against metal wearing of traditional hip replacements. The strength of Invibio’s bearing grade, MotisR, means it can be used alone to make hip-replacement cups instead of combining a metal cup with a polymer liner. The resulting thinner cup requires the removal of less bone. In addition, polymer parts flex and pass on stress to the bone rather than focusing the stress on the implant. This transfer of stress helps bone maintain strength and means that damage is less likely to occur.

“Because of the polymer’s high strength and bearing properties, it is starting to be looked at more for trauma applications,” says Jarman-Smith. He says that PEEK has a high strength-to-weight ratio and allows more flexing than metal plates and nails used to repair a broken arm or leg. If the patient is a child, or if the patient develops an infection, plates or nails may have to be need removed, which is difficult with metal because it tends to bind to the bone, whereas PEEK doesn’t. The QuantumTM Humeral Composite Nailing System from N.M.B. Medical Applications Ltd. was the first PEEK intramedullary nail to gain FDA approval (March 2010). The nail is made of Invibio’s EndolignR, a composite of continuous carbon fibers in a PEEK-Optima polymer matrix.

For future developments and applications, the company is considering options such as combining PEEK with additives that help it bind better with bone or encourage bone growth. “We also want to see if we can use it to make scaffolds or porous PEEK parts that can support tissue and allow tissue to grow inside and regenerate,” says Jarman-Smith.

Although PEEK has many advantages for medical implants, it can be difficult to mold in a clean-room environment because of its high melt temperature. PMC SmartSolutionsTM has been implementing new ways to handle this challenge. The company, founded in 1929, entered the medical molding market four years ago. It specifically focused on long-term surgical implants made of materials such as PEEK because of the potential growth in this market.

“Consistency is very important for implants,” says Lisa G. Jennings, president of PMC SmartSolutionsTM. Using heat-transfer oils for mold-temperature control can potentially cause product contamination. Electric cartridge heaters are subject to temperature problems that can affect product consistency because they cannot control the mold’s surface temperature in a tight window across a part and often have hot and cold spots along their length. Cartridge heaters are also unable to remove heat from the mold if it becomes too hot.

Thus, PMC examined using pressurized water for precise mold-temperature control. Pressurized water can be heated to temperatures as high as 400°F. The company partnered with Single Temperature Controls of Charlotte, North Carolina, USA, which sells temperature-equilibrium systems that pump water through the mold at a set temperature. Heat is transferred to the mold if the water is hotter than the mold and removed from the mold if the opposite is true.

In PMC’s experiments, it found a 44.2°F variance in mold temperature with electric heating and only 5.0°F variance with the water-heated system. The effects from this variance could be seen through a 0.003-inch increase in part shrinkage and average 18.5% reduction in relative crystallinity in the same parts produced using the electric-heated molds.

The pressurized water system has allowed the company to make complex parts of PEEK and other high-melt temperature plastics. For example, it has made insert-molded porous metal parts for orthopedic implants. “We were among the first to use high-pressure water to control mold temperature for making medical-device implants in a clean room,” Jennings says. Since PMC shared its data showing the benefits of using water to control mold temperatures, other companies have followed its lead in using this technology. The complete white paper is available on www.pmcsmartsolutions.com.

For more information, send email to [email protected].

PMC’s Jennings discusses implantable-device markets

Plastics News Report
WESTLAKE, OHIO (May 19, 5:10 p.m. ET)

At the recent Plastics in Medical Devices conference in Westlake, several speakers touched on an emerging trend: implantable devices. Lisa Jennings, president of PMC LLC in Cincinnati, shares lessons learned in her 15 years’ experience with injection molding such products.

In this brief video clip, Jennings describes strategies for serving the implantable sector including partnering with supplier companies, as well as information about some of the most promising markets for implantable products.

Jennings is a fourth-generation owner of PMC, an 80-year-old injection molder and contract manufacturer serving the medical, commercial electronics and transportation markets.

Under her guidance, the Cincinnati firm has become a leader in supplying implantable and non-implantable medical devices and surgical instrumentation. In addition to its Ohio headquarters, PMC also operates a production facility in Shelbyville, Ind., as well as joint venture plants in Mexico and Germany.

For more information, send email to [email protected].

Preparation needed to enter medical market

By Frank Esposito | PLASTICS NEWS STAFF

WESTLAKE, OHIO (April 20, 1:40 p.m. ET) — The medical device market can be a rewarding one for plastics processors, but it’s not a market you can wander into and hope to succeed.

The volume of requests for medical projects is growing at Parker Hannifin Corp., a Cleveland-based manufacturing giant that uses engineering resins, fluoropolymers and urethanes in its seal products. But Dale Ashby — vice president of technology and innovation for the firm’s sealing and shielding group — said that those increased requests bring with them a lot of work in material selection, as well as part production.

“The main question that every customer has is : ‘How long can I expect this product to last in my application?’ “ Ashby said at the Plastics in Medical Devices conference, held April 12-14 in Westlake.

“We need well-defined expectations of performance from our customers to make predictions on seal life,” he added. “Modeling is very important. It’s step No. 1 in proving useful life. Tools and modeling continue to improve, and OEMs have more knowledge than ever before.”

Parker, a supplier to many major OEMs, rang up sales of more than $10 billion in 2009. The firm employs 62,000 at almost 300 plants worldwide.

Parker made a big move in the medical field in 2008, when it created a new medical systems division in its seals group. The new division was based on six businesses — five in California and one in Indiana — that Parker had acquired from HTR Holding Corp. Those businesses make plastic and elastomeric components for medical devices such as intravenous equipment, drug-infusion pumps, respirator hoses and catheters sold directly to OEMs. The group performs injection molding, rapid prototyping and similar services.

Ashby said that in material selection, it’s important for processors to consider physical properties such as elasticity and lubricity, and mechanical properties such as flex resistance and toughness. In thermal properties, processors need to be aware of melt flow index and thermal conductivity; while in electrical properties, surface resistivity and arc resistance can impact material choice. Chemical resistance to solvents and cleaning solutions also plays a role.

Injection molder PMC LLC of Cincinnati is among the ranks of firms that successfully have entered the medical field in recent years. But even for PMC, doing so took a pretty big leap of faith, according to President Lisa Jennings.

“We bought the equipment for medical molding, had a clean room ready and did sample molding before we even had a customer,” she said at the event. “But based on our evaluation of what PMC is capable of — making millions of parts at 0 PPM quality levels — we determined that medical was a good niche for us.

“We had best-in-practice standards that weren’t available to most of the medical device group.”

PMC also “had to develop a medical culture” that was different from automotive and other markets it had participated in over the course of its 81-year history.

“We needed to consider all areas of our business and manufacturing systems,” said Jennings, who is also a fourth-generation owner of the firm. “For clean-room classification, we had to create an environment to insure that implant molding is controlled and consistent.”

“We learned that having the right processing equipment is the foundation for repeatable processing of implantable polymers. We also learned that customer validations are custom and are up to interpretation.”

PMC — which operates plants in Indiana, Mexico and Germany — now produces medical items used in orthopedics, sports medicine, spinal care, cardiovascular care and drug delivery. PMC’s medical products are based on polyetheretherketone (PEEK), thermoplastic polyurethances and ultra-high-end bioabsorbable and bioresorbable resins, which are used in implants and other devices.

“Some of these materials can cost from $125 a pound to thousands of dollars per pound, so there can’t be any material wasted,” Jennings said. “That’s a huge consideration.”

For more information, send email to [email protected].