WESTLAKE, OHIO (July 3, 1:25 p.m. ET) — All parts of the health-care industry — device makers, doctors, hospitals and patients — can benefit from metal-to-plastic part conversion.

“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 Jay Haverstraw, technical sales manager at PMC LLC, a Cincinnati-based injection molder, in a June 12 presentation at the Plastics in Medical Devices 2012 conference in Westlake.

Haverstraw cited two case studies where medical OEMs switched from metal to plastics and saved money, plus enjoyed other benefits.

In one example, an orthopedic targeting guide, the OEM was able to switch from a $300 titanium part to a $20 injection molded device.

“The payback was pretty quick,” he said.

In the other case, the maker of an orthopedic cannulated guide was able to switch from a $400 titanium part that had chronic quality issues to a $15 plastic part.

Just those cost savings made the conversion worthwhile, especially in today’s health-care environment, Haverstraw said. Cost pressures from insurance companies and the government are making price a critical issue for OEMs.

“Obviously it makes driving every bit of cost out of your product critically important at this point,” he said. “At the end of the day, it’s improving the bottom line.”

But plastics have other big advantages in the medical-device sector. For example, OEMs benefit from being able to mold insignias or colors into products.

Hospitals gain by being able to use disposable devices that are easier and cheaper to manage than metal devices.

Using disposable devices also helps to cut down on the spread of infection — a critical issue for hospitals.

“One of the biggest issues facing the surgical center sites is control of infectious disease. Post-operative infections are a major problem, obviously a significant liability and a hazard to the patient,” he said.

“Taking the burden away from hospitals of having to manage re-sterilization of devices is a huge benefit,” he said.

Doctors benefit by being able to use lightweight devices that reduce fatigue and are easier to control, especially using soft-touch polymers.

Patients gain because plastic devices can be biocompatible, less toxic and with no metal particulate issues.

“A lot of you know, because it’s been very well-publicized, some of the issues obviously with metal-on-metal devices, specifically with hip implants. With plastics that’s a non-issue,” he said.

Plastics can be versatile too — for example, a plastic part can be made from a polymer that can be reabsorbed by the body.

“There are just endless possibilities and patient benefits,” he said.

In applications such as orthopedics, spinal, arthroscopic/sports medicine, cardiovascular, tissue biopsy, and more, the company produces components for implantables, handheld surgical instruments, and finished medical electronic devices – both sterile and non-sterile, Class 2 and Class 3. PMC also provides complex assembly and sterile packaging (thermoform and pouch) and manages sterilization for finished devices.

To meet some of these tough manufacturing requirements, PMC must continuously adapt and improve. This is why company leaders have developed a rigorous system they call SMART (Scientific Manufacturing Assures Reliable Throughput). SMART is a scientific approach that PMC applies to every aspect of product/project development and manufacturing. It focuses on following the value stream from material receipt through delivery to customers, enabling the company to deliver, with consistency, complex, hyper-precision components, and assemblies.

DESIGN, ENGINEERING

The depth of experience PMC has in its technical staff is essential to its SMART approach. The company provides frontend
design and engineering support to customers, often working with them in the early concept stage. Services include design for manufacturability to help optimize products for lean, cost-effective manufacturing. It also provides manufacturing engineering services as customers consider scalability and multiple manufacturing options.

PMC engineers use ProEngineer in house, but also work with models from all of the major software programs.

The company has a dedicated Director of Process Innovation to work on both proprietary processing technologies for new applications, and to help solve the most challenging molding applications for customers. PMC’s engineering staff also brings together product design, mechanical, manufacturing, and tooling engineering team members.

FACILITIES, MATERIALS

PMC invests extensively in state-of-the-art facilities to meet the precise demands of medical devices, including a Class 100,000 cleanroom, ISO 13485:2003 certification, and FDA Good Manufacturing Practices compliance at its plant in Shelbyville, IN.

The company also works with a variety of advanced materials, including:

• PEEK – Unfilled and filled polyetheretherketone;
• Bioabsorbables – Lactide, Polylactide, Polyglycolide, and Lactide/Glycolide copolymers;
• TPU – Thermoplastic Polycarbonate Urethane;
• PPSU – Polyphenylsulfone; and
• ABS and PC – Acrylonitrile Butadiene Styrene and Polycarbonate.

ADVANCED EQUIPMENT
PMC uses present processing challenges as well as high material costs, making efficient, exacting processing equipment a must.

“When materials cost thousands of dollars per pound, every fraction of material savings we can achieve is important,” says PMC President Lisa Jennings.

Working closely with the PMC team to address the unique needs of their sophisticated operation, Milacron Plastics Machinery has supplied Roboshot all-electric injection molding machines.

PMC deploys a total of six Roboshot’s – two 33-ton, one 110-ton, two 165-ton, and one 380-ton. Lowell Green, director of manufacturing, PMC mentions several ways the machines from Milacron support the ultra-precise molding:

• Customizing input/output signals and controls for new applications;
• Quick troubleshooting with robust controls;
• Shot-to-shot consistency;
• Fast startup – for example, a new eight-cavity, hot runner stripper plate tool running consistently after just five shots; and
• Shot size flexibility.

The greater control of shot size, allows PMC to use injection rather than extrusion for very small implantable parts, and also use much less material, according to Jennings.

Perhaps mot importantly, the machines are capable of achieving tolerance levels as low as 15u to 25u – one of the many reasons Milacron has become PMC’s provider of choice for new horizontal injection-molding purchases.

“We partner with Milacron because they help us optimize repeatability and precision control of all molding functions,” Green says.

Today, Milacron continues to apply its all-electric expertise technology to configure the machines for PMC’s challenging applications, while ensuring maximum uptime and productivity.

“We are running 24 hours a day, so when we need something serviced, it is critical that it be done immediately.” Jennings says. “The reliability of both our machines and our manufacturing partners is important, and we get that with Milacron.

PMC
Cincinnati, OH

Molding medical devices is a high-end business that has proven more resistant to economic swings and to foreign competition than some other plastics markets. On the other hand, there are significant barriers to entry: challenging technical and regulatory standards, highly demanding customers, and a host of well-established competitors. But that’s not enough to discourage all newcomers. Coming from a base in automotive and electronics, PMC, LLC decided to break into medical molding four years ago. It aimed straight for the most exclusive sector—long-term surgical implants. Taking a fresh look at how things are done in this field, PMC pursued innovative technology overlooked by competitors. This technology promises both cost and quality advantages, living up to PMC’s motto: “Smart Solutions.”

PMC has been family owned and operated since it was founded in 1929. The headquarters office in Cincinnati was formerly a molding plant dedicated to thermoset brake boosters. Today the company focuses on engineering thermoplastics and has around 200 employees and a 70,000-ft2 plant in Shelbyville, Ind., with 40 injection presses of up to 400 tons. It also has a joint-venture plant in Mexico.

In 2007, PMC decided to go after surgical devices and implants for orthopedic, spine, cardiology, and other uses. PMC invested over $2 million in two years to build a Class 100,000 clean room at Shelbyville and install three all-electric presses—two Fanuc Roboshot machines of 33 and 110 tons and a 75-ton Nissei with a vertical clamp. The new PMC Medical division achieved registration to the ISO 13485:2003 medical quality system in late 2008.

A BETTER WAY TO HEAT MOLDS
For making auto parts of PPS, PPA, PEI and other high-temperature resins, PMC uses hot-oil to control its mold temperature. But oil is not desirable for a clean room, so PMC, like all other U.S. medical molders, uses electric cartridge heaters in molds for its PEEK surgical implants, which require temperatures around 400 F. Zoned heating with electrical heaters requires expensive controls on each mold, says Robert Langlois, PMC’s executive director of technology. What’s more, cartridge heaters tend to burn out and thermocouples fail on a regular basis. More important, says Langlois, cartridge heaters tend to have hot and cold spots along their length. And they have no means of removing heat, so cycle times for larger PEEK medical components tend to be fairly long—up to 15 min.

Last year, Langlois contacted a Single Temperature Controls, Charlotte, N.C. (www.single-temp.com), to find out more about its high-temperature, pressurized-water mold-temperature-control units (TCUs). Langlois found Single to be the only source of hot-water TCUs capable of PEEK’s 400 F mold temperature.

Like hot oil, pressurized hot water requires no mold thermocouples and it adds or removes heat as needed. However, the idea of high-pressure hot water scares some people. But Langlois notes that steam escaping from a pinhole leak dissipates so quickly that it’s harmless just 6 in. away.

Langlois ran a head-to-head comparison of hot-water and electrical heating with a test mold for PEEK plaques. He found that hot water reduced shot-to-shot mold-temperature variation by 75%. More important, Langlois said hot-water heating reduced temperature variances along the length of the 5-in. plaque by almost 90%, from 44.2° F with electric heat to 5° F with hot water. That decreased dimensional variation along the part by 50%. Lab analysis confirmed that the larger mold-temperature differentials produced variations in crystallinity along the part, resulting in shrinkage differences and molded-in stresses.

Langlois hopes hot-water heating can cut cycle times for large PEEK parts from 15 min down to 3 min. He also expects lower tool maintenance costs and simpler setup than with electric heaters.

Plastics News Article, December 15, 2009

Injection molder PMC LLC continues to expand its medical business with the addition of a new 75-ton all-electric Nissei press.

“We are fortunate that in an otherwise flat economy, our medical device business is experiencing an accelerating growth trend,” said Lisa Jennings, president of the company’s medical unit, in a news release.

Cincinnati-based PMC jumped into medical molding about three years ago, and it built a Class 100,000 clean room at its plant in Shelbyville, Ind. With the new Nissei press, the company has now spent in excess of $3 million in the plant, equipment and resources.

Jennings said the company has added nine new customers in the past six months.

PMC, which was founded in 1929, molds and assembles devices for orthopedic, spine, cardiovascular, electrosurgical and other applications. The new Nissei vertical press will give the company the ability to insert mold delicate components for implantable and non-implantable medical devices, said Mike Scarpa, PMC’s vice president of operations and engineering.

PMC touts its SMART (Scientific Manufacturing Assures Reliable Throughput) method, which it says goes beyond conventional cavity-pressure monitoring to include all other aspects of injection molding and secondary operations. Jennings said the methodology helps meet growing demand for lower-cost disposable devices.

PMC also does manufacturing in San Jose Iturbide, Mexico, and Wiesau, Germany.

Plastics News Article, February 2, 2009

With an investment of $2 million over the past two years, PMC LLC is building its PMC Medical division to add more medical device work. “Our medical business is growing significantly. The rest of the business is holding steady with the economy,” said Lisa Jennings, president of PMC LLC, in a recent telephone interview.

PMC Medical recently gained ISO 13485:2003 certification and is targeting the surgical device and implantable biomaterial markets. Its products are used in orthopedic, spine, cardiology and other applications.

The company, which is headquartered in Cincinnati, put up a Class 100,000 clean room along white room space at its manufacturing plant in Shelbyville, Ind. It has also installed two all-electric Milacron Roboshot presses — with clamping forces of 33 and 110 tons — and the company plans to add another in 2009.

“We are in process of exploring Class 10,000 for some implantable devices,” she said.

Shelbyville has 70,000 square feet of space and includes a tool room. Overall, it has 40 presses, ranging up to 400 tons.

Lowell Green, the company’s director of manufacturing, served as the general contactor in the construction of the clean room. He designed a clean room that is modular and expandable.

The company has focused in the past on commercial electronics and automotive work. It specializes in high-temperature specialty materials, such as polyetheretherketone. It also has done many metal-to-plastic conversions.

Jennings said PMC’s work with high-temperature materials, insert molding and assembly has led to enquiries about medical work. She said the company’s systems and processes have been valuable assets in adding the new work.

PMC stresses its quality systems and has a proprietary PMC Smart Solutions system.

She said that moving into medical work meant hiring experienced staff and also adding extensive training.

“Our approach at PMC was to develop all these things and build a resume before approaching the medical community,” said Jennings, who is the fourth generation family member to lead the company.

Jennings’ great-grandfather Ed Gerdes founded the company in 1929 with Joe Merke. Her father, Thom Gerdes, is currently chairman.

PMC also does manufacturing in San Jose Iturbide, Mexico, and Wiesau, Germany.