Paul Recinos, director of business development, Airex Corp., Somersworth, NH.
As recently as five years ago, contract device design and manufacturing development were usually sequential and clearly segmented processes. Today, product design and manufacturing phases are often concurrent. The customer expects the vendor to participate in the design phase to ensure that the device offers maximum performance at minimum cost. For this approach to be successful, it is essential that the OEM and vendor be as forthright with each other as possible. The confidentiality and intellectual property issues that may arise on either side should be addressed by executing nondisclosure agreements soon after preliminary qualification has occurred. Other key steps OEMs should take include:
- Providing detailed application information to help the vendor interpret specifications and propose design alternatives.
- Delineating mandatory versus desirable features, including product life, operating conditions, and packaging needs.
- Composing a detailed list of deliverables and a timetable, which should include dates for the alpha sample, the prototype, first production article (with validation and verification), and production ramp-up.
- Instituting a formal procedure for changes that must be made after contracts have been signed in response to regulatory requirements.
- Drawing up a budget that includes specific unit cost and compare it with annual and life cycle targets. Make allowances for nonrecurring engineering and tooling costs.
Contract Manufacturer Specializes in Building Radiology and Oncology Systems
Providing design services, brazing, welding, machining, chemical cleaning, and cleanroom assembly to medical OEMs, a full-service contract manufacturer specializes in radiology and oncology systems that incorporate linear accelerators. All contracts cover future redesign, retrofit, refurbishment, and replacement needs. Items that qualify for replacement include electron guns, radio-frequency windows, exit windows, ion pumps, wave guides, and anode assemblies. The company is ISO 9001:2000 certified.
Altair Technologies Inc., Menlo Park, CA
Firm Monitors All Products with 3-D Measuring Machines
Both small batches and large-scale production can be accommodated by a contract manufacturer of micromechanical systems for the medical industry. The company can design a prototype based on the customer’s specifications and then manufacture the product from beginning to end—including packaging. Up-to-date 3-D measuring machines record and monitor the geometry of each product to ensure tight tolerances. Previous projects have served such medical sectors as traumatology, cardiology, and neurology. Class I, II, and III devices can be manufactured.
Cendres+Métaux SA, Biel-Bienne, Switzerland
Contractor’s Capabilities Include Patented Robotic-Winding Technique
An ISO 9001:2000–certified firm’s capabilities include CAD design, prototyping, performance verification, and environmental testing. Automated inspection and assembly equipment, as well as custom tooling, are available. A patented robotic-winding technique ensures precise wire position and tension uniformity over repeated production runs, according to the firm. The company also stocks ready-made electromechanical components than can be incorporated into customer products. Available components include linear and rotary motors, voice-coil actuators, magnetic bearings, and transformers.
Airex Corp., Somersworth, NH
Provider Oversees Full-Service Operation in Chinese Facilities
A U.S.-based contract manufacturer owns and operates multiple facilities in China. The service provider offers end-to-end manufacturing of medical products that can be tailored to the client’s needs and is controlled in-house by the company’s American managers. The contractor controls quality by visiting parts suppliers, inspecting raw materials, employing third-party quality inspectors, and specifying all requirements in writing. In addition to supervising offshore production on behalf of the client, the contractor can set up a factory-within-a-factory system through its Access program, which enables a client to run its own production facility within the contractor’s plant until it is ready to create its own independent manufacturing base in China.
Eastek International, Buffalo Grove, IL
Company Operates Class 100,000 Cleanroom in Mexico
Combining a 1700-sq ft cleanroom with ISO 13485 certification, a contract manufacturer claims to be one of the largest firms with these capabilities in the Tijuana, Mexico, region. The company, which specializes in medical manufacturing, offers full-contract services that include procurement of components, assembly, and packaging. Offices in the United States handle all customs paperwork and shipments to and from the factory.
Coastline International, Tijuana, Mexico