All it takes is a look at U.S. demographics to understand why many molders and moldmakers are pinning their hopes for new business on the medical disposables market. Baby boomers, those of the post-WWII population surge that have produced “booming” demand for cars, houses, and many other things for the past 40 years, are entering the twilight of old age. Will that result in a booming demand for medical devices, products, and disposables?
Analysts say “yes!” The Freedonia Group (Cleveland, OH) offers up some market research supporting this forecast in a number of areas, reporting that U.S. demand for disposable medical supplies will increase 4.9% annually to more than $70 billion in 2011. The best growth opportunities are anticipated in devices such as dry powder inhalers, prefilled syringes, and blood glucose test strips for diabetes monitoring. While hospitals will remain the largest market for disposable medical supplies, the home healthcare market will grow faster as consumers broaden preventive medicine and self-treatment activities to save out-of-pocket health care costs.
These opportunities will come due to expanding numbers of home dialysis, IV, and respiratory therapy patients. Additionally, said Freedonia’s report, “improvements in design and efficacy are increasing the range of prefilled inhalers, prefilled syringes, and transdermal patches approved for direct patient use.” Gains will be led by these high-value-added drug delivery devices. Based on demand value, drug delivery, catheterization, and related products will remain the largest group of disposable medical supplies, with demand expected to increase 5.7% annually to nearly $35 billion in 2011.
The increasing incidence of chronic respiratory conditions, coupled with the need for safer and more effective therapies, will keep demand for inhalation drug delivery systems advancing favorably, to $21.9 billion in 2012 from $8.0 billion in 2002.
Demand for plastics for medical disposable applications is expected to approach 5 billion lb in 2012, due to a greater use of disposable medical products and sterile packaging materials, as well as the use of materials capable of withstanding intensive sterilization, says a Freedonia report on medical plastics. Demand for commodity plastics is expected to rise 2.3% yearly to 4.3 billion lb in 2012, valued at $4.6 billion. Leading commodity resins include PVC, PP, PE, and PS.
Engineering plastics accounted for 11% of the total volume of medical plastics in 2007, but a much higher 27% of total value, resulting primarily from the significantly higher price of engineering plastics compared to commodity resins. Demand for engineering plastics is expected to expand 5.2% annually to 630 million lb in 2012, reaching nearly $2 billion. Advances will be based on needs for higher-performing materials in surgical instruments, diagnostic testing, drug delivery, geriatric care, and preventive medicine.
However, said Freedonia’s report, the best opportunities are anticipated in surgical and medical instruments, while faster growth is expected in surgical appliances and supplies. Polycarbonate will remain the leading engineering resin with the best growth prospects, based on expanded needs for high clarity, impact resistance, and other enhanced performance properties.
High-tech automation for high-volume disposables
Following a trend toward increased automation in markets such as disposable medical products, where cycles are fast and volumes high, Waldorf Technik GmbH & Co. KG of Engen, Germany opened a facility in Chicago to serve its North American customers with engineering and aftersales service. Waldorf Technik Inc. provides complex automation systems, primarily for the medical disposables market.
The U.S. division’s president, Taras Konowal, says an efficient process uses automation not just to take the part out of the mold, but also to do something with it. Cavity separation can be used to track each cavity, and vision systems look for flash. “In products such as pipettes we look at the bottom wall thickness and concentricity of the openings, and in products such as test tubes, we do high-voltage leak testing to spot cracks or voids,” explains Konowal. “We can put a probe into each test tube and it shoots a high-voltage signal into it. If there’s a crack in the bottom or a short shot, it reads high, indicating a crack or opening. The process is done inline right out of the molding machine.
“In many cases, companies were molding parts, putting them in bulk containers, and then sending them downstream for assembly or labeling and quality control, so they’d end up assembling three or four different components, testing it, and throwing out the whole component if it was bad,” he explains. “Now, it’s 100% quality checked at the press, and then sent to packaging, knowing the parts are 100% good.”
Waldorf Technik will be at NPE (booth W119054) and it also will be showing a pipette system with camera-proofing technology at Engel’s booth (S24000).
Disposable solutions in the medical pharma market
Providing cost-effective solutions is at the forefront of serving the medical and pharmaceutical disposables markets. Like most other markets, OEMs in medical and pharma disposables need to reduce costs to manufacture, and the moldmaker can provide some unique manufacturing solutions that include robotics and other automation.
Plastics Engineering & Development Inc. (PEDI; Carlsbad, CA) is a custom molder and contract manufacturer that specializes in medical and biomedical devices, and has recently developed a customized film insert molding process for producing a pharmaceutical diagnostic tray. Using a 120-ton Sumitomo press with a Yushin robot, PEDI molds a 384-well tray for biological testing. Human cells and pharmaceutical drugs are placed in the tray wells for research and development. To manufacture the tray, plastic is molded onto the film in a Class 100,000 cleanroom. The critical requirements for this application include flatness of the tray and film clarity.
Jack Sparacio, PEDI’s president, says the new tray was designed to take the place of glass testing equipment. “It’s disposable and has good optical quality,” he says. “The reason it was important to go to PEEK is that the customer wanted to get away from washing, sterilization, and reusing the glass because that’s expensive.”
Sparacio says that while the medical and biomedical market has been “somewhat insulated from the economic debacle” the country is experiencing, there are still concerns about where healthcare is headed. “There’s always a need for innovative products,” he says. “One big thing is the blood-borne infection MRSA, and anyone who has a product that can help solve a problem such as that has a significant opportunity.”
Despite the challenges in this industry, there are also key opportunities for the innovative and solutions-oriented. And while some molders and moldmakers warn against making medical disposables a panacea for what ails plastics, PEDI’s Sparacio says, “If you’re in plastics, medical is the place to be.”
Creative solutions wanted
A good example of advances in creative solutions for surgical disposables is a series of new products for Arthrex, a Naples, FL medical device OEM, in conjunction with B&M Precision (Ruskin, FL), which provided the metal components, and Somerset Plastics Co. Inc. (Middletown, CT), which supplied the creative design, built the molds, and molds the parts. The three companies were recently recognized with a medical device excellence award for Arthrex’s newest surgical products, Clear Cut Oval Burrs, Clear Cut Round Burrs, and Clear Cut SLAP Burrs. These single-use, rotary instruments provide flush cutting and dual-suction pathways for precise resection of target bone, while maintaining visibility during arthroscopic shoulder and knee surgery.
Cliff White, owner of Somerset Plastics, says that the company, which was founded by his father, has been in business for 30 years, and is known for being able to think outside the box when it comes to unique solutions. “It’s actually pretty clever,” says White. “It’s been tried a few times but nobody could figure out how to do it until we came up with a workable design.”
Until the new design, the tools used in arthroscopic surgery to remove bone were made of metal, and the problem with that was that the doctor can’t see through the hood piece to the cutting end, explains Ken Adams, engineering manager at Arthrex, who originated the concept. “We had gone through a number of iterations trying to figure how to make this metal piece in a transparent material so the doctors can have better visibility during surgery,” says Adams. “We were able to work with Cliff and Somerset, and dial in how the hood would attach and what material we would use.”
Sabic supplied its Lexan HPS, a gamma-sterilizable medical material that turns clear after sterilizing rather than yellow, as many plastics are prone to do. “It was definitely a collaboration between the three of us to get the design to accommodate the metal tube insert that’s molded into the hood, and it resulted in a good product for Arthrex,” Adams says.
Tech Mold Inc. (Tempe, AZ), a custom mold manufacturer for the medical and pharmaceutical disposables market, also developed a creative solution—a coining process—for its Fortune 500 customer’s redesigned test plate. The purpose of these test plates is to reduce the amount of time it takes to get a new drug on the market by 100-fold, because the test plates permit 384 tests simultaneously, with each cell being read individually to provide greater speed-to-market for new pharmaceuticals.
The outer edge of the redesigned 3-by-5-inch test plate is either black or white, and the area under the center of the plate containing the wells that hold the testing solution is a clear polystyrene that is coined in the mold to achieve the best results. Coining involves holding the mold open farther than needed, shooting the plastic, and then closing the mold on the material, which then coins or squeezes the plastic to a specified wall thickness that is thinner than traditional injection molding can achieve. This process contributes to improved optical clarity. The wall thickness of this clear material is less than 0.015 inch, which allows light to pass through properly and test accurately during the diagnostic stage. It is the center section of the product that contains 384 wells and covers 70% of the part.
Tech Mold then developed the complete molding automation cell in-house and shipped the cell to the customer after total qualification of both the mold and the process, working closely with press maker Arburg and the robotics manufacturer. “We felt the only way to achieve 100% success was to develop a fully integrated cell: mold, molding press, and robotics,” says Craig Oestreich, Tech Mold project manager. “We helped review, define, and develop the requirements that were necessary.”
Tech Mold has since made a similar small-volume, shorter-height test plate mold that runs in the same integrated molding system. This new part has two interchangeable hot manifolds to accommodate product changes. It can either be run as one color (white or black) for reflective diagnostic tests or as a two-shot system (black with a clear lens or white with a clear lens) for through-lens diagnostic testing. This provides the customer with the ability to produce four distinct products from one mold. —firstname.lastname@example.org