With other markets taking a nosedive, medical devices are still in high demand. But don’t rush to make the switch to this segment until you know exactly what’s involved.
Clariant Masterbatches’ medical product lines have been developed because the medical and pharmaceutical industry requires an unconventional approach.
The Tech Group and its parent company West Pharmaceutical both designed and now manufacture the ConfiDose Auto-injector drug delivery device.
Medical device manufacturing is a specialty niche with unique requirements. And while the future for this market looks bright given the aging Baby Boomer population, with it comes a lot of regulatory issues, costly capital investment and resources, and associated risks for manufacturers.
Steven Duckworth, global head of marketing, Consumer Goods Segment for Clariant Masterbatches Div., says that underlying growth for medical devices and pharmaceutical packaging is extremely high. “Even with the recession, there are specific drivers such as growth in diabetes, a more elderly population, new treatments, and higher personal priority for healthcare in developing regions,” he says.
Market research firm Frost & Sullivan said in a 2008 report on the medical device market that the market’s R&D efforts “have to match the pace of innovations across all segments of treatment, as hospitals are looking to reduce surgery and recovery times and offer surgeons better treatment options.” Surgeons generally welcome innovations that lead to a better quality of life for patients, the report said, as long as “the medical device companies can convince them of the superior clinical outcomes of their products.”
It continues, “The medical device industry has witnessed dramatic shifts from highly invasive surgical procedures to minimally invasive surgical techniques. These methods offer patients reduced pain and discomfort, easing the burden on the healthcare setting. This shift has also helped decrease the number of inpatient procedures and the wait time for surgeries. Even segments currently involving invasive approaches are likely to witness a transition toward decreasing invasiveness. Such trail-blazing inventions in the medical device market have a huge influence on the entire healthcare industry, and hence the U.S. economy.”
With product recalls a major issue in today’s global marketplace, medical devices are particularly subject to them, as most stem from documented deaths related to the devices. That risk can sometimes put suppliers on the hook as well as OEMs, which is why many molders are reluctant to enter the medical device market, leaning instead toward noncritical medical disposables.
Frost & Sullivan’s report notes that incidents of device-related deaths and the subsequent recalls “have cost the market dearly, since eroding customer confidence and disinterest in a therapy have impeded device penetration and market expansion. Using the most cost-efficient materials is a critical component in the design of medical devices in order to ensure affordable healthcare technology. Moreover, it would be impracticable to monitor a device’s performance for seven to eight years before product launch.” Consequently, manufacturers must rely on projections and assumptions, which may not provide an accurate analysis of product reliability.
Another challenge in the manufacture of medical devices is the material. Eric Resnick, VP and GM for The Tech Group’s Medical Device unit (Scottsdale, AZ), says one of the latest problems with materials is the complaint against bisphenol-A (BPA). The Tech Group, a West Pharmaceutical Inc. subsidiary, has been a manufacturer of healthcare products and medical devices for more than two decades, serving many of the major medical OEMs.
Although BPA has not been an issue yet with the products his company makes, there are other hurdles, Resnick says. “We are seeing supply agreements that stipulate that we have no ingredients with animal origins. A lot of that has to do with what’s actually getting into these materials. As a maker of drug delivery devices, this is extremely important. Our suppliers let us know what’s in the materials—we’re running mostly Delrins, PCs, GF materials, and silicone agents.”
As a part of West Pharmaceutical, The Tech Group now manufactures proprietary products such as the ConfiDose, which alters the game a bit from what custom molders are typically used to. (See sidebar at imm.plasticstoday.com for more on this.) “We’re now specifying the material, which makes it our issue rather than someone telling us what material to use,” Resnick says. “It has to be the right material.”
Two primary tests on polymer materials for drug delivery devices are “extractable” and “leachable,” which involve a lot of upfront testing. The next blockbuster drug could have a negative reaction to the plastics in the drug delivery system; therefore, a lot of effort goes into these studies. If the polymer’s chemicals leach into the medicine, it could have an adverse affect on the patient. For example, says Resnick, in a pulmonary drug delivery system, any plastic used in the drug path, or in the air path through which the drug passes in cloud or mist form, must go through extractable and leachable testing. “With pulmonary devices becoming more common, the FDA is looking more closely at the plastic,” Resnick says. “We do all of that testing on all delivery systems through West’s laboratory services. And the tests are getting more stringent. We used to be required to do the extractable and leachable tests on the initial product. Now, every material lot needs to be tested. Our vice president of QA notified us of this change a few months ago.”
Some resin producers and suppliers also perform materials testing for their medical-grade materials. Clariant Masterbatches, for example, pretests its raw materials to reduce the risk of biocompatibility problems as a medical device company tests a device during its very extensive and expensive development and registration process.
When your material disappears
Another challenge that medical molders confront is the continued consolidation in resins being offered. “We just got hit with another one a couple of weeks ago,” says Resnick, “but we have good contact with our partner, PolyOne. They’ll tell us when a material is being eliminated and offer to help us find alternatives. These projects are difficult and don’t add value, while consuming significant resources.”
PolyOne (Avon Lake, OH) helps provide The Tech Group with alternatives and West runs the testing needed to get FDA approvals. “Typically a new material requires stability trials to revalidate the material,” says Resnick. “Also, we need to know the horizon for ordering the material—how to store it so there are no adverse conditions that degrade the material. All this becomes a project in itself.”
PolyOne realizes the extensive testing and approval process that medical device companies must go through. To help medical device molders with material obsolescence or discontinuance issues, it has a program that provides guarantees of availability. Steve Schlegel, the company’s healthcare marketing manager for specialty engineered materials, says, “Trilliant HC healthcare compounds carry a commitment to formulation lockdown, no cospec materials, and FDM/GMP processing. This protects our customers from having to reapply for regulatory approvals, and also supports the initial approval process.”
Innovative design has become a critical part of medical device products. Mike Treadaway, VP and GM of The Tech Group’s Healthcare division, says that one of the major drivers of innovative design is “developing devices that are more user-friendly and allow self-administration either through injection or inhalation, and make it easier for the patient to use the device. There’s a lot of R&D being done on products within various market segments on the need for an intuitive and easier-to-use device,” he states.
While some new products being developed and put onto the market continue to come from the major medical device makers, Treadaway says that many of the innovative products are coming out of the incubators of startup companies. That gives firms like The Tech Group an opportunity to help these startups with front-end design-for-manufacture, and with molding and mold manufacturing technologies that optimize the product and the cost to produce it.
“Much of our work involves some design, but most has to do with taking what a designer has come up with—the product’s appeal to and functionality for the patient—and determining if it’s manufacturable at the right cost,” Treadaway says. “We work with customers’ designers on two primary issues: First, can it be made, and second, can it be made at the lowest possible cost?”
Duckworth says that additives play an important role in device design and manufacturing as well. “[They] become important to help the functional performance of the devices and their reliability,” he adds. “For example, we have products developed to improve lubrication of catheters or reduce the force required to operate devices, or prevent jamming of devices. We have permanent antistatic agents to reduce clinging of powders.”
So, you want to be a medical device molder
Many injection molders currently serving markets that are slumping (think automotive) are beginning to recognize the value of diversification, and the mantra of many has become, “I want to get into medical molding.” It’s easier said than done.
The medical industry, while it may look like a stable, high-volume segment, is a tough market to enter. The barriers are primarily regulatory, and Good Manufacturing Practices (GMPs), cleanrooms, and the high cost of compliance restrict many molders from gaining entry.
Treadaway says that a major misconception in the molding community is that big money is to be made in medical devices. “The reality is that the pricing pressures are just as heavy in medical as in automotive or consumer products,” he says. “Be careful what you wish for.”
While molded components for nearly all markets require quality, on-time delivery, and best cost, meeting those requirements in medical device molding is much different from other markets because of compliance issues, Treadaway explains. “The overall company culture requires a different mindset for employees who need to understand the medical device manufacturing business.”
Molding medical device or healthcare products tends to require more resources. Treadaway says the trend The Tech Group sees in healthcare products manufacturing is customers wanting to subcontract more and more of the value-added services. That means an increase in the resources that molders must provide to ensure that regulatory compliance issues are strictly adhered to. “In the medical or drug delivery device business, you have risk factors involved. Someone’s life depends on manufacturing GMPs, so molders in this arena tend to be more conservative.”
West’s ConfiDose exhibits new approach to developing drug delivery system
West recently announced its newest product, the disposable ConfiDose Auto-injector System, which is being manufactured in The Tech Group’s device facility in Tempe, AZ. The ConfiDose system eliminates preparation steps and automates injection of drugs, providing patients with a sterile, single-use disposable system that can be used easily at home.
The ConfiDose auto-injector system incorporates a 1-ml-long, affixed-needle, prefilled syringe format that can be used with either a glass or Daikyo Crystal Zenith syringe. Additionally, the ConfiDose system has a clear viewing window for full visibility of the drug content and quick dose inspection before and after use. With the press of a button, a needle automatically extends to deliver a precise dose of medication before retracting. After use, the needle is permanently and completely shielded within the system, averting the risk of needle-stick injury and making the system safe for disposal. The needle remains hidden, helping to reduce anxiety among patients who fear needles. There are multiple visual, audible, and tactile cues to aid the user, which make using the system easy and intuitive.
West Pharmaceutical Services’ dedicated design facility in Athens, TX worked in tandem with engineers at The Tech Group in Scottsdale, AZ to design the ConfiDose auto-injector system. The Tech Group’s Medical Device division is responsible for manufacturing and assembly of commercial quantities of the ConfiDose system.
Eric Resnick, VP and GM for The Tech Group’s Medical Device division, adds that with respect to design engineering, the industry has moved from the concept of Six Sigma to design for Six Sigma, and then to designing outsources of variation or waste. “That’s been a 10-year discussion,” says Resnick. “Now the FDA is catching on to Quality by Design (QBD), and we’re hearing a lot more discussion on this. The FDA is targeting the pharmaceutical industry to develop safe pharmaceuticals along with the delivery device, so they’ve rolled in the device-manufacturing guys as well. These combination products, as they are called, make the delivery device just as important as the drug being delivered because they work in combination.”
For West and The Tech Group, that means the company tests the combination products together rather than independently, and then determines the process to ensure it’s done right. “I’ll look at both Six Sigma and formally creating the process to manufacture both device and the drug because we’re serving the GMPs and the QSR [Quality System Regulations],” Resnick says.
Polymers have come into the spotlight of late, primarily PVC and those containing BPA, such as polycarbonate and epoxy. In June 2008, Rep. Rosa DeLauro (D-CT) urged the FDA’s Science Board to expand its inquiry of BPA to include medical devices, according to the FDAnews Device Daily Bulletin (June 26, 2008). DeLauro also called on the board to identify all medical devices containing BPA, as Health Canada (Canada’s federal department of public health) has done.
DeLauro says a review of bottles and food containers falls short. “The potential risks posed to patients by BPA leaching from medical devices, especially implantable ones, would be very significant,” said DeLauro in a letter to Frank Torti, the principal deputy commissioner and chief scientist at the FDA. “I strongly urge you to expand your request [for information] and have the Science Board also assess the safety of BPA in medical devices.””
On Oct. 15, the FDA announced that it wants help in identifying which medical devices, drugs, and other products it regulates contain BPA. The agency said it wants details on medical devices containing BPA that are in direct contact with tissue, blood, and skin, such as implants, catheters, and most dental devices. The FDA would also like information on products with BPA that have indirect contact with patients, such as components of blood pathway circuits and respiratory tubing circuits. Companies had until the end of 2008 to comment on which FDA-approved products contain BPA.
Clariant Masterbatches’ Duckworth says that while there is “concern,” these issues are not necessarily of “greater concern” to medical device manufacturers. “It is more accurate to say that there is increasing awareness of requirements coming from legislation and guidelines. This growing understanding leads companies to take different approaches towards risk assessment,” he says. “Some recent statements from the FDA are leading companies to look more closely at the materials they use and what is in those materials. There is also a much greater awareness of product safety in general, not just in medical devices.”
Cultivating a medical device mindset
About a year ago, The Tech Group took greater measures to ensure that the culture of manufacturing drug delivery devices for pharmaceutical is maintained separately from its healthcare division, which molds surgical products. “There are enough subtle differences in customer requirements that we’ve established those two businesses in separate facilities,” says Treadaway. “We’ve also segregated our consumer divisions with designated plants serving the consumer markets.”
“People underestimate how difficult it is for employees to switch gears to serve multiple markets out of one facility. People tend to drift toward the highest level of requirements, which means that resources might be used on issues that not every market requires. While all parts might require high levels of quality, the differences in documentation, GMPs, and regulatory requirements make medical device molding a whole different ball game.”