SPECIAL ADVERTISING SECTION
Contract Services Company Profiles
Adhesive Converter
Acutek International (Brussels) is a custom converter of pressure-sensitive adhesive components. The most commonly used materials are polyethylene/polyurethane foams, nonwovEN and wovEN fabrics, elastics, occlusive and breathable films, thin polyurethane films, hook and loop, solid and laminated foils, antifog films, hydrogels and hydrocolloids, and mineral oil polymers. Applications include pulse oximetry, wound care, incontinence management, transdermal drug delivery, drug infusion therapy, gas monitoring, laparoscopy, muscle/nerve stimulation, diagnostic testing, iontophoresis, and sleep apnea monitoring. In-house capabilities include flexographic printing, precision rotary or flat-bed die-cutting, and multilayer lamination. Acutek also produces a generic, ready-to-market, US FDA 510(k)–approved transparent wound-care dressing, and hydrocolloid dressings. Specialized packaging, such as tamperproof seals, antifog package windows, and custom patterned-adhesive lidding, is available. The ISO 9001/EN 46001–certified and US FDA-registered company has manufacturing facilities in the United States and Europe.
Engineering Services
Total quality management is a founding principle at AP Technologies S.A. (Le Brassus, Switzerland). The company's outsourcing services range from procurement and prototyping to machining, production, assembly, and testing. Complete project management and after-sales service and maintenance are available. The firm has undertakEN the engineering and production of mechanical and electronic assemblies for a number of US and Swiss medical device companies. In some cases, it has also beEN responsible for the distribution and servicing of the products. The firm, which is certified to ISO 9001, develops and markets several products under its own name, including a fine-wire straightening and cutting machine.
Precision-Turned Metal Part Manufacturer
Décolletage AG (Grenchen, Switzerland) manufactures precision-turned metal parts for the medical device and other sectors. The ISO 9002–certified company can produce 1–65-mm-diam parts from a variety of metals and alloys. Machining is performed using CNC or cam-controlled automatic lathes or turret machines. In-house capabilities include grinding, honing, drilling, milling, burnishing, and thread rolling. Complete subassembly services are also offered. The company has implemented a quality management system that covers manufacturing and assembly, as well as technical consultation to customers at the design stage.
One-Stop OEM Supplier
MedSource Technologies Inc. (Minneapolis, MN, USA) is a multifacility supplier of precision components and finished devices to medical equipment OEMs. The integrated design, manufacturing, and assembly network offers one-stop sourcing and cost-effective supply chain management solutions. Services include product development, microprecision machining, wire forming, precision stamping, laser processing, plastics manufacturing, and product assembly. Injection moulding, manufacturing, sterilization, and packaging in a cleanroom environment are also available.
Device Testing Services
A full-service nonclinical testing laboratory, NAMSA (Northwood, OH, USA) specializes in testing medical devices for safety and efficacy. The company designs cost-effective, accurate testing programs and offers guidance in obtaining regulatory approval worldwide to assist companies of all sizes in bringing their products to market. Material characterization, microbial testing, and in vitro and in vivo biocompatibility testing services are provided. Biomatech S.A., an affiliate laboratory in Lyon, France, provides clinical and nonclinical testing of medical devices. The company also participates in establishing testing guidelines for a number of organizations. NAMSA products include standard and custom biological indicators for steam, EtO, dry heat, and radiation sterilization; spore suspensions for qualifying culture media; rapid indicators with 20-second readouts for monitoring sterilization processes; standard and custom chemical process indicators for steam, EtO, and radiation sterilization; and thromboresistant coatings. NAMSA facilities are ISO 9001/EN 45001 certified and FDA and USDA registered.
Tubing and Related Components
UTI (Collegeville, PA, USA) manufactures precision miniature metal tubing and components, Swiss-type and nonconventionally machined products, precision deep-drawn eyelets, and stents. Laser and electrical discharge machining techniques are used to process stainless steel, brass, copper, titanium, tantalum, and other refractory alloys and precious metals. Complete in-house assembly capabilities are available. The ISO 9001/9002–registered company is equipped with an on-site Class 10,000 cleanroom.
Adhesive Components and Assemblies
A leading converter for the medical device industry, Tapemark Medical/Industrial Fabricating Div. (West St. Paul, MN, USA) manufactures custom adhesive components and assemblies for the medical device and diagnostic industries. The company's capabilities include rotary and reciprocating die-cutting, laminating, slitting, level winding, and sterilizable packaging. Cleanrooms with pressure-, particulate-, temperature-, and humidity-monitoring controls are maintained and include adjacent white rooms for packaging services. The company has expertise sourcing pressure-sensitive adhesive films, foils, and single- and double-coated foams, as well as conductive adhesives, hydrogels, and hydrocolloids. Technical development services such as prototyping, short clinical evaluation runs, design of experiment, process validation, and first-article capabilities are available to support customers from the design and regulatory-approval stages through the production process. The ISO 9001/EN 46001–certified company is registered with US FDA and follows GMP requirements.
Nitinol Component Manufacturing
EUROflex Schüssler (Pforzheim, Germany) is a full-service manufacturer of precision-machined nitinol components suited for device applications. The company converts superelastic and shape-memory alloys into components such as stents, filters, coupling devices, and miniaturized instrument parts. Services include product design and development, precision laser cutting, microwelding, electrical discharge machining, forming and shape setting, electropolishing, and gold plating. A range of nitinol tubing, strip, and wire is available for use with the components. Proprietary laser machining and finishing techniques ensure the full use of nitinol's functional properties. Complex shapes and patterns are routinely cut into tubing. Stainless steel, titanium, and tantalum can also be processed. The ISO 9001/EN 46001–certified company meets US FDA requirements.
Full-Service Manufacturing
Harmac Medical Products Inc. (Buffalo, NY, USA) performs assembly, insert and injection moulding, radio-frequency and ultrasonic welding, heat and impulse sealing, and tip forming. The ISO 9001/EN 46001–certified company provides custom tool design and fabrication and in-house quality assurance. Class 10,000 to Class 100 cleanrooms are available. Packaging, labelling, and sterilization services are also offered. Harmac is US FDA registered and follows CGMP guidelines.
Mould Manufacturer
Farlow's Scientific Glassblowing Inc. (Grass Valley, CA, USA) manufactures glass moulds, glass taper tubes, tipping dies, and anatomically correct test and flow models suited for angioplasty balloon and catheter applications. Glass moulds are available in standard configurations within 0.0005 in. ID. Sharp tapers, highly defined transitions, and tight tolerances from 0.0000 to –0.0002 in. can be achieved. The company has developed a range of catheter balloon–forming processes, including a high-pressure unit for nylon balloons. A computerized balloon-blowing machine with touch screEN programming, wireless mouse, and remote viewing will enable service, inspection, and programme interfacing via the Internet.
Nitinol Materials and Components
EUROflex G. Rau GmbH (Pforzheim, Germany) manufactures nitinol materials and custom nitinol components for the medical device and other industries. 
Capabilities include fabricating round and rectangular wires, strips, and tubing; spring winding; shape setting; and surface treatment of superelastic and shape-memory nitinol alloys. Nitinol is a flexible, kink-resistant material suited for use in implantable devices and surgical instruments. The company's partnership with Nitinol Devices and Components Inc. enables EUROflex G. Rau to provide worldwide service, technical support, and superior quality.
Hybrid Power Supplies and Microcircuits
Interpoint (Redmond, WA, USA) designs and manufactures hybrid power supplies and microcircuits for medical and other applications. Standard and customized products are available. The company's microelectronics are suited for use in Class II and Class III devices such as implantable defibrillators, pacemakers, hearing-assistance devices, and surgical instruments. Interpoint offers custom qualification protocols and a computerized component traceability programme that tracks parts and retrieves data for analysis. A strict real-time statistical process control system has beEN implemented throughout the company's ISO 9001–certified facilities.
Precision Tubular Parts
Micro-Tube Fabricators (Middlesex, NJ, USA), a Handy & Harman company, specializes in forming and fabricating small-diameter metal tubing on custom-built production equipment. Miniature tubular parts are produced in stainless steel, titanium, 13-8 nickel and nickel-based alloys, aluminium, and other alloys. 
Applications include minimally invasive surgical instruments used in arthroscopic, electrosurgical, endoscopic, laparoscopic, and orthodontic procedures. The ISO 9002–certified company can cut, flare, reduce, expand, flange, bulge, swage, crimp, close, dimple, lance, notch, slot, bend, coil, pierce, punch, or flattEN small-diameter metal tubing to exacting requirements. Other capabilities include welding, plating, painting, coating, electropolishing, passivation, corsetting, annealing, deburring, honing, drilling, etching, printing, stanching, assembly; and sand, grit, or tumble blasting.
Full-Service Tubing Vendor
Polymerex Medical Corp. (San Diego, CA, USA) is a full-service vendor that offers material selection, formulation, extrusion, design, prototyping, and production services for catheter products. The company manufactures multilumen, heat-shrink, braided, coated, and radiopaque tubing. Off-the-shelf catheter components including shafts are supplied. Catheter OEM and subassembly services can be designed to meet customer requirements. Compliant, semicompliant, and noncompliant balloons are also available. Competitive advantages include short lead times, database management, technical help, and fast prototyping.
Die Cutting and Conversion Services
G & L Precision Die Cutting Inc. (San Jose, CA, USA) specializes in die-cutting, printing, and slitting of films, vinyls, and other nonmetallic components. The company converts PVC, polystyrene, and clear and opaque white polyester laminated on one side with an acrylic pressure-sensitive adhesive. These products are suited for use in lateral-flow backing and dipstick applications. The company's facility contains a range of rotary presses, reciprocating punch presses, a temperature-controlled dry room and a Class 1000 cleanroom. ISO 9002 and US FDA compliance is a priority.
Testing and Validation Services
An independent testing laboratory, Nelson Laboratories Inc. (Salt Lake City, UT, USA) offers routine lot-release testing, sterilization validations, and reuse studies for all processes. Other services include physical and barrier testing, filtration efficiency and validation, a range of haematology and cytoxicity procedures, and microbial identification with the MIDI and Biolog systems. The company's laboratory information management system enables immediate access to study information and test status. Nelson also assists other companies in the design of testing programmes for satisfying regulatory requirements. The company's ISO 9001/EN 45001–certified facility is equipped with a Class 100 cleanroom.
EDM Machining Service
Contract manufacturing services provided by Norman Noble Inc. (Highland Heights, OH, USA) include close-tolerance machining of medical components. The company uses both CNC and manual technology to operate its range of electrical discharge machining (EDM) equipment, which includes 25 CNC 4- and 5-axis high-speed wire-cut machines, and 19 plunge-cut and microhole machines. The company's ISO 9002–certified facility houses a low-particulate cleanroom. Assembly and packaging of machined parts is also conducted in-house, which allows the company to meet first-to-market requirements for its customers. With the recent addition of leading-edge design and manufacturing software, the company can now accommodate large production runs and prototyping.
