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OutsourcingOutlook

Originally Published MPMN May 2005

Outsourcing Outlook

Extrusion


Custom Assembly and Packaging of Disposables Is Available


An FDA-registered contract manufacturer has core competencies in custom assembly and packaging of disposable medical devices, as well as in-house tube extrusion and RF welding. Assembly and packaging services are performed in Class 7 cleanrooms. The company works with its clients to customize process development and validation, specification review, and detailed work instructions. Device integrity testing, packaging development, and 510(k) filing assistance are also available.
Command Medical Products Inc., Ormond Beach, FL www.commandmedical.com


Automated Assembly Systems Can Be Customized

Over the past year, a company has shipped more than a dozen new safety product assembly machines to manufacturers of safety IV catheters, syringes, needles, and scalpels. Components such as springs, protective caps, locking devices, and self-destruct features that are currently being designed into medical devices of the future are all being assembled on the company’s machines. High-speed automation equipment for the assembly of IV products, catheters, blood collection products, syringes, needles, and tubing is offered. Custom, as well as standard, equipment can perform automated assembly and material-handling operations. Equipment design, fabrication, and validation with documentation through installation and service are provided at the customer’s facility. KahleUSA, Summit, NJ www.kahle.com


Merger Creates New Electronics Manufacturing Solutions Provider

An electronics manufacturing solutions (EMS) provider of highly complex and specialized medical devices, implantable technologies, and equipment has been created by the merger of two companies. The new firm also supplies a number of medical customers with electromechanical and board assemblies. It can provide not only highly complex SMT assemblies, but also global turnkey solutions including backplanes, cable assemblies, and fully integrated box build systems. Other services include design, cleanroom manufacturing, direct shipping, and supply chain management. The company has eight locations worldwide—in the United States, United Kingdom, Thailand, Singapore, and China. CTS Electronic Manufacturing Solutions, Glasgow, Scotland www.ctscorp.com


Outsourcer Uses Flexible Manufacturing Methods for Small and Irregular Batches

A medical device subcontract manufacturer offers assembly and packaging from its Class 10,000 cleanroom. Flexible manufacturing methods enable small and irregular batches to be handled, along with high-volume runs. Full sourcing of components is available. Sterilization options include EtO, gamma, and steam. Manual and semiautomatic packaging lines are offered for blister packs, peelable pouches, poly bags, and custom packaging. Soldering, ultrasonic cleaning, electronic assembly, and injection molding services are also provided. Wesley Coe (Cambridge) Ltd., Cambridge, UK www.wesley-coe.com


Fixturing and Automation Services Augment Medical Contract Manufacturing Operations

A company has expanded its capabilities by providing fixtures and automation equipment. Engineering, designing, development, and manufacturing services will be available for special fixtures and tabletop automation equipment. A hands-on approach will speed the process, starting with the actual components, therefore bypassing a lengthy specification and design phase. The company has experience in mechanical, electrical, and pneumatic applications for tabletop assembly, cooling fixtures, nests, inspection devices, end-of-arm tooling, precision drilling, x-y tables, and secondary operations tooling. Project integration and manufacturing, including industrial design, supply chain security and inventory management, validation and quality controls, packaging and labeling, and sterilization responsibility are systematically controlled. Processes are validated under rigorous qualifications, and full documentation is maintained. SMC Ltd., Molding and Manufacturing Div., Somerset, WI www.smcltd.com


Manual, Automatic, or Semiautomatic Assembly Services Are Offered

A full-service company provides assembly services to neurological, OB-GYN, surgical, and orthopedic device manufacturers. Engineering and design services are said to provide clients with product improvements and cost savings, both in materials used and in the assembly process. A machine shop on the premises allows in-house prototyping and fabrication services. Manual, automatic, or semiautomatic production is offered for full or subassemblies. The company has expertise in the use of adhesives, microspot and ultrasonic welding, and the machining and fabrication of metal and plastic parts. HPC MedX, Hanover, PA www.hpcmedx.com


Company Focuses on Assembly with Emphasis on Automation

Providing a full range of contract manufacturing services, a company features assembly capabilities, with specific expertise in automation. Complete or partial assembly of components is offered in facilities compliant with industry standards. Cleanrooms are Class 100,000 certified. Additional services include product design and development, global manufacturing, and distribution. Nypro Medical Products Group, Clinton, MA www.nypro.com


Molding and Assembly Services Include Catheter Production

Silicone injection molding and assembly services are offered in Class 100,000 and Class 10,000 cleanrooms. One of the company’s current assembly projects is a catheter for the treatment of benign prostate hyperplasia. The assembly of the device stretches over a few days. In addition to developing molds and moldings, the company sourced standard components and developed the production process according to ISO and GMP requirements. Medical Rubber, Horby, Sweden www.medicalrubber.com


Assembly Cells Create Mechanical and Electromechanical Housings

A company’s manufacturing and assembly services focus on single-point responsibility for mechanical and electromechanical housings and their components. Assembly cells are housed in a 16,000 sq ft air-conditioned facility organized to undertake simple subassemblies or comprehensive product programs integrating custom production and the procurement of stock materials, if required, for all product components, regardless of the process used to produce them. The company’s engineering and management team can recommend assembly efficiencies that can significantly reduce final unit costs. CWM Contract Manufacturing, Bensenville, ILwww.cwm-contractmfrg.com

Copyright ©2005 Medical Product Manufacturing News

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