Frank Celia05.03.06
Not So Raw Materials
Rising Costs, Higher Demand and Tighter Tolerances Force Raw Materials’ Suppliers to Improve Refinement
Frank Celia
Contributing Writer
Biomet’s next generation platelet concentrators use a CYROLITE Med 2 acrylic-based compound. The material selection was critical due to the precise tolerances and expansion rates required in the centrifuge. Photo courtesy of CYRO. |
Today’s materials vendors also face increasing resource costs as a result of skyrocketing demand from formerly third-world countries experiencing rapid industrial growth. Paying for fuel to produce intense heat—which plays some part in almost all materials processing—takes its toll, especially in wake of Hurricane Katrina. But those in the materials industry say it is worth tackling these challenges because, more so than almost any other industry, the medical field offers huge potential for future growth.
To be around for that future, companies with the skills and persistence to stay the course have developed partnership relationships with their customers, continually improved their processing methods and embraced (or invented) the latest technological innovations with wholehearted gusto. Following is a look at some of the field’s trials, trends and success stories.
Team Efforts
Servicing customers means catering to their needs, and if you can figure out what your customers need before they do, so much the better. That is the aim of CYRO Industries, a Rockaway, NJ manufacturer of acrylic polymer products, often used in injection molding.
Periodically, engineers and specialists from the company meet with representatives of their clients in what they call “innovation workshops,” during which the two groups share opinions. “The basic idea,” said CYRO Medical Market Specialist Holger Tinz, “is to meet with our customers and review their needs and our products to see where everything fits in. If they have a demand for a plastic not yet available, maybe we can develop such a product.”
All the new products CYRO introduces to the market are the result of company employees interacting with CYRO customers and trying to determine what they need, according to Technical Manager Peter Colburn. He recalled one customer that needed a compound with better radiation stability for products that would undergo radiation sterilization, which was becoming more popular for hospital applications. “We went to work and developed a product that was more radiation stable—CYROLITE GS-90 [an acrylic based multi-polymer molding compound],” Colburn said.
Such innovations can have long-range effects that go beyond merely strengthening the vendor-client relationship. CYRO recently developed Vu-Stat, an inherently anti-static transparent acrylic polymer that is being used in the manufacturing of spacers for inhalers commonly used to deliver asthma drugs. Due to the material’s anti-static properties, less of the drug compound gets stuck in the spacer of the inhaler, enabling more efficient dosage delivery. These small efficiencies, repeated over thousands of doses, could wind up saving the manufacturer and consumer a great deal of money over time. Colburn noted that even insurance carriers and public health funding could benefit from such innovation.
To achieve success in the materials field today, this kind of give-and-take with customers is all but essential. NuSil, a silicone manufacturer based in Carpinteria, CA, constantly receives requests for new products—everything from new kinds of silicones with non-sticking molecules to septa for implantable drug delivery pumps that self-seal after being pierced with a syringe needle.
Silicone is often an important component of drug delivery systems, explained Mark J. Paulsen, NuSil’s product director for healthcare materials. The drug may be contained in a reservoir of silicone, which, in the case of a transdermal patch, also may be acting as the adhesive.
“Somebody may be working on a drug delivery device for female hormone replacement or incontinence,” Paulsen explained. “And, the company wants us to modify the polymer to have greater control over the rate at which the drug passes through our silicone and into the body. This is a big area right now, and one at which we excel.”
Shrinking Devices
Raw materials manufacturers also find they play a major role in furthering the trend of device manufacturers creating minimally invasive medical products, which are getting smaller all the time.
David G. Niedermaier, director of sales and marketing for Fremont, CA-based Nitinol Devices and Components (NDC), acknowledged the trend toward smaller devices. “Everyone is looking for tighter tolerances, better dimensional control and more consistent mechanical properties,” he said. NDC manufactures nitinol, a metal comprised of almost equal parts nickel and titanium. This alloy is extremely elastic, with an elastic strain range of about 7% (most other metals cannot bend 1%).
Nitinol is commonly used in consumer items such as cellular telephone antennae and the flexible wires on spinning lures used in sport fishing. The material is gaining popularity in the medical field for use in wires and tubing.
“Where we see a push is in smaller tubes,” Niedermaier noted. “Then, if the customer wants it laser cut or shape set, doing that in a small tube is very difficult.”
Often, if the laser-cutting challenge can be met, the next problem is how to clean and inspect the part. “Some of these features are so fine that you can’t handle the part in a typical fashion, and new ways have to be found,” Niedermaier noted.
Silicone manufacturers face this challenge as well. When a device becomes smaller, the silicone used in it must be made stronger to do the same job. For example, a pacemaker’s lead wires that run from the battery to the heart are insulated with silicone, said NuSil’s Mark Paulsen. “There is a big push to make these wires smaller and smaller and, hence, to make the silicone tougher and tougher,” he explained.
This trend is considerably prominent in laparoscopic surgery, for which surgeons are creating smaller incisions and, at the same time, needing instruments to perform additional functions.
Ceramics are popular materials for laparoscopic surgery because they are stiff enough to maintain dimensional stability in miniature components with extremely thin walls. Such tolerances sometimes are not achievable with metals or plastics.
“The parts get more complicated,” noted Jim Schienle, general sales manager for medical products at ceramics component manufacturer CoorsTek in Golden, CO. “The tolerances get more exacting, the applications may be more exacting…New clients can sometimes go pretty far down the road before they realize they have designed something that cannot be manufactured.”
The company sometimes has to tell a potential new client that a design cannot be manufactured—out of any material, at any price.
Aside from future advances in nanotechnology, there are practical limits to how small some devices can get. Loren R. Alberico, president of G&L Precision Die Cutting, Inc., San Jose, CA, noted that in his business, in vitro diagnostics testing, lateral flow devices were about 7-mm wide 15 years ago, whereas many are 4 mm, and Alberico does not believe they can get much tinier. “The human eye still needs to be able to read the reaction line,” he said.
Processing
With customer pressure to keep costs as low as possible, material suppliers are continually looking for efficiencies in processing to make up the cost difference with the rise of fossil fuel and natural gas prices.
In the metals industry, prices are being driven up by sharp increases in demand from countries such as China and Brazil, whose economies are growing at a feverish pace—in China’s case, at 10% annually.
Companies such as NDC spend a lot of time and energy streamlining their processing but are reluctant (for proprietary reasons) to state specifics. “We have done little mundane things—better equipment, better control over parameters,” said Niedermaier. “Things like dies and speed…a whole host of little things.”
Improving consistency is always a plus. NuSil’s Mark Paulsen noted his company’s use of an on-line system that allows employees to view an entire lot history record on any given silicone product and see which way its physical properties are trending.
“Another way of reducing variability in your product is simply to make more of it at a given time,” he added. “We have made great strides in increasing the lot sizes of our standard products.” In some cases, he said, they are as large as 6,000-lb lots.
Given current fuel costs, perhaps one of the most forward-looking strategies for improved processing is to develop ways to reduce the need for heating materials. This tactic is being pursued by makers of the newer hot melt adhesives, which do not require heat treatment in ovens, as do other adhesives.
The skipped step will be a key to future success, according to G&L’s Alberico, whose company purchases large volumes of adhesives and who believes hot melts are a thing of the future. “Some are out there now, and I think they are going to continue to get better and better. The big energy savings will help control costs,” he said. “We are certainly looking into it.”
The Future
Makers of nitinol expect the market to stay competitive for the next few years. The material has been around since the 1960s, but was not used in cardiovascular stents until the late 1990. Now, more OEMs are becoming familiar with it and are discovering its advantages over other metals.
For example, nitinol’s lack of magnetic signature allows devices made from it to be compatible with MRI exams. “For us, it is really an exciting time,” said Niedermaier. “The whole industry is just emerging.”
In the world of silicone, NuSil receives consistent requests to make its product more hydrophilic and reduce surface drag. Paulsen believes the industry will achieve these goals by developing new base polymers.
Among the many medical device sectors, orthopedics is one that has attracted the attention of plastics, metals and ceramics suppliers. Already a booming specialty, orthopedics is believed by many to be a long way from peaking.
At 78 million, the Baby Boomers comprise one-third of the US population, and the technological advances made in the field will benefit this population enormously in the near future.
Despite a host of challenges, material suppliers feel this is an optimum time to be serving as the foundation for an industry that offers terrific growth potential and provides invaluable services to humanity.
Frank Celia is a freelance healthcare writer based in the Philadelphia area.
Materials and Processing Services Providers
The following directory lists suppliers who provide materials and processing services to the medical device industry.
Boston Centerless
11 Presidential Way
Woburn, MA 01801
Phone: (800) 343-4111 (toll free); or
(781) 994-5000
Fax: (781) 994-5001
Web: www.bostoncenterless.com
E-mail: info@bostoncenterless.com
Materials: Stainless steel, titanium, PEEK, medical alloys.
Services: Precision grinding, cutting, bar end chamferring, straightening, heat treating, lapping.
Comments: Boston Centerless is a leading supplier of precision ground bars with incomparable consistency of roundness, straightness and size tolerance.
Clariant Masterbatches
85 Industrial Drive
Holden, MA 01520
Phone: (508) 829-6321, x2509
Fax: (508) 829-2118
Web: www.clariantmb.com
E-mail: george.pape@clariant.com
Materials: All compounds and colors.
Services: Color masterbatches and additives, compounding, material development, reinforcement filling, stabilization.
Comments: We custom formulate all ETPs, TPEs to color/appearance or performance needs.
Command Medical Products, Inc.
15 Signal Avenue
Ormond Beach, FL 32174
Phone: (386) 672-8116
Fax: (386) 677-7781
Web: www.commandmedical.com
E-mail: sales@commandmedical.com
Contact: Stephanie McGee
Materials: PVC, EVA.
Services: Contract manufacturer offering: R.F. welding of bags, ultrasonic welding, solvent & adhesive bonding, tip forming, eye punching, assembly, packaging, sterilization.
Comments: ISO 13485 facility. Also have new facility for assembly and packaging located in Managua, Nicaragua.
CYRO Industries/Degussa
100 Enterprise Drive
Rockaway, NJ 07866
Phone: (800) 631-5384
Fax: (973) 442-6117
Web: www.cyro.com
Materials: Advanced medical-grade acrylic compounds and alloys from antistatic polymers to lipid and chemical resistant grades.
Comments: CYRO received the 2005 Frost & Sullivan Technology Leadership Award in the field of medical plastics for pioneering the development and market launch of innovative technologies.
DLE, Inc., Diagnostic Laminations Engineering
2613-B Temple Heights Drive
Oceanside, CA 92056
Phone: (877) 353-4968
Fax: (760) 407-4202
Web: www.dleinfo.com
E-mail: sales@dleinfo.com
Contact: Duane Lawson
Services: Slitting, laminating, die cutting, printing, assembly, packaging.
Comments: DLE provides specialized converting services with a focus on delicate membrane, thinfilm, non-woven and cellulose materials for custom lateral-flow, vertical flow and other diagnostic components. The company’s technical assistance spans design, development and manufacturing.
Filtrona Extrusion, Inc.
PO Box 720 / 170 Bartlett Street
Northborough, MA 01532
Phone: (508) 393-2553; (800) 527-3926
Fax: (508) 393-5690
Web: www.filtronaextrusion.com
E-mail: MassSales@filtronaextrusion.com
Comments: Precision thermoplastic medical extrusions produced in a pyrogen controlled Class 100,000 cleanroom. FDA registered ISO 9001-2000 and ISO 14001 certified. Capabilities include: SPC documentation, on-line measurement, in house Wire EDM Cad/Cam system, single and multi-lumen tubing, reinforced high pressure tubing, co-extrusions, custom profiles, secondary operations and sub-assembly. Specializing in medical grade custom flexible and rigid tubing, our USP Class VI materials include: PVC, Non-DEHP, PE, PP, PU, HIS, radiopaque and PVC alternatives. Servicing medical OEMs and contract manufacturers for over 45 years.
Jamak Fabrication Inc.
1401 North Bowie Drive
Weatherford, TX 76086
Phone: (800) 395-2625, x5250
Fax: (817) 594-8324
Web: www.jamak.com
E-mail: papa@jamak.com
Contact: Pam Parkinson
Materials: Silicone.
Services: Extrusion, liquid injection molding.
Comments: Jamak Fabrication is a custom silicone fabricator. We offer silicone extrusions and molded components manufactured in a Class 100,000 Cleanroom. Liquid injection molded silicone handles for dental and surgical instruments.
Kent Elastomer Products, Inc.
1500 St. Clair Avenue
Kent, OH 44240-0668
Phone: (800) 331-4762 (toll free); or
(330) 673-1011
Fax: (330) 673-1351
Web: www.kentelastomer.com
E-mail: info@kentelastomer.com
Contact: Cindy Harry
Materials: Natural rubber, latex tubing, thermoplastic elastomer tubing, PVC tubing, free-band tourniquets.
Medefab
81 Turnpike Road
Jaffrey, NH 03452
Phone: (603) 532-5656
Fax: (603) 532-5921
Web: www.medefab.com
E-mail: info@medefab.com
Comments: Medefab Inc. is a single source, full service, FDA-registered, ISO-certified medical product contract manufacturer. Capabilities include tubing extrusion, insert and loose-piece molding, assembly, printing, hot-stamp marking, finishing operations and packaging. Disposable components and products are manufactured to the highest quality standards following strict production guidelines in order to meet the stringent demands of a broad range of medical specialties.
New England Precision Grinding, Inc.
35 Jeffrey Avenue
Holliston, MA 01746
Phone: (508) 429-9999
Fax: (508) 429-6850
Web: www.nepg1.com
E-mail: info@nepg1.com
Contact: Rick Desrosiers
Materials: Wire: 304 Stainless steel, SE nitinol, PTFE coated 304 stainless steel and parylene coated 304 stainless steel.
Services: Centerless grinding, in-feed grinding, step grinding, taper grinding, form grinding, pointing, cutting, grit-blasting, polishing, coining, wire forming, bending, laser marking, assemblies and passivation.
New England Urethane, Inc.
15 Corporate Drive
North Haven, CT 06473
Phone: (203) 239-9629
Fax: (203) 239-1192
Web: www.neuinc.com
E-mail: new.england.urethane@snet.net
Contact: Cynthia Edgar
Materials: Thermoplastics, both rigid and elastomeric.
Services: Custom compounding adding fillers, colors, stabilizers, lubricants, alloys and blends.
Comments: Compound primarily for the medical industry adding radiopacifiers, colors, stabilizers, etc.
Nitinol Devices & Components, Inc.
47600 Westinghouse Drive
Fremont, CA 94539
Phone: (510) 623-6996
Fax: (510) 623-6995
Web: www.nitinol.com
E-mail: sales@nitinol.com
Contact: David Niedermaier
Materials: Superelestic and shape memory nitinol wire, tube, strip, sheet and bar.
Services: Forming, cutting, laser machining, expansion, grinding, surface treatment, electro-polishing.
Comments: Corrosion testing of nitinol components, failure analysis, materials characterization, finite element modelling.
NuSil Technology
1050 Cindy Lane
Carpenteria, CA 93013
Phone: (805) 684-8780
Fax: (805) 566-9905
Web: www.nusil.com
E-mail: silicone@nusil.com
Contact: Stephen Bruner
Materials: Silicones.
Comments: NuSil Technology is a cutting edge manufacturer of silicone for the healthcare industry. NuSil is ISO 9001:2000 certified and has processing and R&D capabilities in North America and Europe.
Polymer Technology Corporation
5120 Parkway Drive
Menomonie, WI 54751
Phone: (715) 235-1464
Fax: (715) 235-1834
Web: www.polymertechnology.com
E-mail: sales@polymertechnology.com
Contact: Steven Johnson
Materials: Medical-grade polyolefins, thermoplastic elastomers. Engineering resins: Ultem, PEEK, polysulfones.
Services: Contract molding, design refinement, assmbly, clean-room molding.
Comments: Our medical device manufacturing services provide production and assembly capabilities and a class 100,000 environment. High-speed robotics and closed-loop processes ensure products are molded under the most controlled environments.
Polyzen, Inc.
1041 Classic Road
Apex, NC 27539
Phone: (919) 319-9599
Fax: (919) 319-8428
Web: www.polyzen.com
E-mail: info@polyzen.com
Contact: Brenda Owen
Materials: Medical grade (including breathable film).
Services: Dip molding (PVC silicone), thin film molding, thermo/vacuum forming, blow molding, catheter/device assembly, radiopaque compounding, lay flat specialty tubing in cleanroom environment.
Comments: FDA and ISO 13485 registered; GMP compliant, contract R&D, consultation and prototype device development.
SaatiTech
247 Route 100
Somers, NY 10589
Phone: (914) 767-0100
Fax: (914) 767-0109
Web: www.saatiamericas.com
E-mail: info.us@saatitech.com
Contact: Kevin Glynn
Materials: SaatiTech provides precision-woven synthetic fabrics for precise blood filtration in arterial, cardiotomy and transfusion filters for wicking and prefiltration in diagnostic test kits, for particle separation in drug-infusion, for flow control media in moisture barriers and for EMI/RFI shielding. Material is available custom fabricated into slit rolls, stamped parts, tubes, pleated elements, bags and various other forms.
Saint-Gobain Performance Plastics
2316 West Wisconsin Street
Portage, WI 53901
Phone: (800) 236-7600
Fax: (608) 742-4731
Web: www.medical.saint-gobain.com
E-mail: sgppl.medmarketing@saint- gobain.com
Comments: Saint-Gobain Performance Plastics has expertise in silicone molding and extrusion technology for medical OEMs. Services include millable and liquid injection molding with automated production cells, peristaltic pump tubing, co-extrusions, tapes, and profiles. The company offers product development assistance, in-house tool design and build, custom silicone formulating and compounding, fabrication and assembly.
Tapemark
1685 Marthaler Lane
West St. Paul, MN 55118
Phone: (800) 535-1998
Fax: (651) 450-8403
Web: www.tapemark.com
E-mail: tmsales@tapemark.com
Contact: Pat Cody
Materials: Flexible roll goods.
Services: Contract manufacturing including coating, printing, laminating, die-cutting, packaging.
Comments: Tapemark is ISO 9001 and 13485 certified and FDA-registered and audited for Device, Drug, Cosmetics and Food. We specialize in single-use pads, soluble film, transdermal patches, hydrogel, custom device components, and drug/ device combinations.
TEEL Plastics
426 Hitchcock Street
Baraboo, WI 53913
Phone: (608) 355-3080
Fax: (608) 355-3088
Web: www.teel.com
E-mail: getaquote@teel.com
Contact: Rick Bonovitz
Materials: The standard frequently extruded resins include: Acryonittrile-Butadiene-Styrene (ABS), Cellulose Acetate Butyrate, Copolyester (PETG), Polyamide (Nylon) 6, Polymide (Nylon) 12, Polycarbonate, Polyethylene (PE), Polypropylene (PP), Rigid PVC, Flex PVC and Styrene. Tubing Types: Swab sticks, Pipettes, Catheter packaging, Tubing for IV sets, Multi-lumen, Flex PVC, Bump tubing and Packaging. Tolerance Ranges: Custom tubing sizes from 0.050” OD to 8.5” OD, cut lengths from .125” and up, cut length tolerances +/- .005” on tubing up to 2.000” OD, wall thicknesses from 0.007” and up, Class 100,000 Clean Room.
Comments: Our healthcare division develops and extrudes cutting edge products that are custom designed, manufactured and sold to leading medical device manufacturers worldwide. Our medical tubing has been used in a variety of lifesaving products including cardiac catheter packaging, IV sets, antiseptic ampoule packaging, laboratory pipettes, swabs and prefilled syringe packaging.
Teknor Apex Company
505 Central Avenue
Pawtucket, RI 02861
Phone: (800) 554-9892; (401) 725-8000
Fax: (401) 729-0166
Web: www.teknorapex.com/current_category.13/vinyl.html
E-mail: vinyl@teknorapex.com
Contact: Michael Doumato
Materials: Apex Flexible PVC compounds, Flexalloy PVC elastomers, Conductive compounds, RoHS-compliant PVC compounds.
TOLAS Health Care Packaging
905 Pennsylvania Blvd.
Feasterville, PA 19053
Phone: (215) 322-7900
Fax: (215) 322-9034
Web: www.tolas.com
E-mail: marketing@tolas.com
Contact: Denise DiLissio
Materials: Tyvek, paper, film, foil, pouches, lidding and rollstock.
Services: Printing, die-cutting and design assistance.
Comments: TOLAS Health Care Packaging is an ISO 9001-2000 certified supplier of sterilizable medical device and pharmaceutical packaging. TOLAS provides Tyvek, paper, film and foil as printed rollstock, pouches and lidding. Materials are suitable for EtO, steam or radiation sterilization and are available in overall or zone coated without proprietary adhesives designed using our SealScience coating technology.
Wacker Chemical Corporation
3301 Sutton Road
Adrian, MI 49221
Phone: (800) 248-0063
Fax: (517) 264-8246
Web: www.wacker.com
E-mail: customercare@wacker.com
Contact: Ed Laperriere
Materials: Elastosil Silicone Rubber.
Westlake Plastics Company
West Lenni Road
Lenni, PA 19052
Phone: (800) 999-1700 (toll free); or (610) 459-1000
Fax: (610) 459-1084
Web: www.westlakeplastics.com
E-mail: michael.kell@westlakeplastics.com
Contact: Michael Kell
Materials: Extruded and compression-molded high performance thermoplastics for the medical device market. Plastics include acetal co-polymer, polyphenylsulfone, polycarbonate, polyetherimide, polypropylene and UHMWPE.
Comments: All stock medical products are typically USP Class VI approved base resins, lot controlled and traceable, as well as stress relieved.
West-Tech Materials
1700 Adams Ave, #211
Costa Mesa, CA 92626
Phone: (714) 641-9269
Fax: (714) 641-9267
Web: www.westechmat.com
E-mail: Rcampo@westechmat.com
Contact: Rick Campo
Materials: Precious metals for implant components & devices, platinum alloys (PtIr, PtW, PtN) in fine wire, ribbon, strip & rod NiTi Tubing.
Services: Precision Micro-Machining (Precious metals, SS, Ti, MP35N) Coil winding—single and multi-filar, complex coils in Platinum alloys, SS, Ti, MP35N, laser processing, welding, cutting and drilling of metals and non-metals. Stent processing, laser cutting, heat setting, EP (ElectroPolishing) and finishing, metal stamping & forming, micro stamping & cold heading Metal Injection Molding (MIM).
Comments: Offer full medical device sub-assembly services that include the integration of machining, coiling, laser processing and clean room assembly. ISO certified manufacturing Class 10,000 clean room assembly.