Even if a medical device OEM performs some cleanroom operations in-house, it will nevertheless benefit from partnering with a specialized cleanroom supplier. Matthew B. Boyd, vice president of business development, Boyd Technologies LLC (South Lee, MA), explains why.
MPMN: Why should medical device OEMs partner with contract service providers that offer cleanroom capabilities?
Boyd: Medical device OEMs should seek to partner with contract manufacturers that offer capabilities outside of their core areas of expertise. While some medical device manufacturers maintain noncore cleanroom operations, they can benefit from partnering with providers that specialize in converting capabilities that they do not have. However, OEMs that do perform converting services can enjoy superior economics and greater supply-chain continuity by contracting out their cleanroom needs to specialized providers.
MPMN: What cleanroom infrastructure, systems, expertise, and equipment skills should a medical device OEM expect of a contract manufacturer?
Boyd: First and foremost, medical device OEMs should partner with contractors that maintain ISO Class 7 and Class 8 clean environments that are installed as rooms within a room, in isolated production areas, or beneath an isolation hood. Such clean spaces should adhere to the ISO 14644 standard for classification and testing and the ISO 14698 standard for biocontainment and control. While some OEMs should require their outsourcing partners to maintain clean facilities that adhere to ISO 13485 standards pertaining to medical device products, others should choose contractors with strong CGMP standards in place in combination with ISO 9001. In either case, third-party auditing of cleanroom systems and procedures, performed by independent auditors or customers, is important. OEMs should also endeavor to partner with suppliers that have materials and converting expertise, including the ability to specify and develop materials in partnership with the customer and subcontractors. Similarly, the OEM should choose a partner that can specify and build new equipment or modify existing equipment as a core part of its operations.
MPMN: What trends and developments in cleanroom manufacturing should be foremost in a medical device OEM’s mind when seeking a contracting partner?
Boyd: Supply-chain continuity and traceability are coming under increased scrutiny. Thus, the OEM should ensure that the contract manufacturer can audit not only its suppliers but also its supplier’s suppliers in order to maintain quality standards and create business continuity plans for extraordinary circumstances. The contracting partner must also be able to continually control materials entering the cleanroom for final production under controlled and traceable circumstances. To that end, it should deploy IT-based solutions that allow it to maintain visibility in the global supply chain.
Molding of critical-care devices
Aberdeen Technologies Inc. performs insert molding, micromolding, and liquid-silicone-rubber molding operations in a Class 100,000 GMP-compliant cleanroom. Additional manufacturing capabilities include tube slitting and skiving, bonding, assembly, marking, leak testing, and heat-sealing. The company also provides services to manufacturers with devices under development, offering product and process design, development assistance, and full-scale in-house mold tooling construction. It employs programmable indexed rotary tables that can minimize cycle times and allow for secondary operations to be carried out at the molding machine. The company has produced molded components and subassemblies for such critical-care applications as implantable microdevices, light-refraction oximeters, and biosensors.
Aberdeen Technologies Inc.
CAROL STREAM, IL
Cleanroom thermoformed packaging
Maintaining Class 10,000 and Class 100,000 cleanroom manufacturing space certified to ISO 13485:2003 and ISO 9001:2008 standards, T.O. Plastics manufactures custom thermoformed packaging for medical devices. Specializing in trays made from PETG and polycarbonate, the company has capabilities in thin- and heavy-gauge thermoforming, maintaining a facility that is equipped with a high-speed in-line thermoforming system. It also offers in-house design, rapid prototyping, and tooling services. The vendor provides 100% product inspection, HEPA and ionization-based air cleaning, and burr-free trimming using heated forged dies, line-rule dies, or matched metal dies.
Medical electronic assemblies
Valtronic Technologies, an engineering and contract manufacturing company, concentrates on the manufacture of electronic assemblies for medical devices ranging from cochlear implants to neurostimulators and heart-monitoring equipment. Operating ISO Class 7 and Class 8 cleanrooms, the company can handle small preproduction runs or large-scale full-production volumes. It is FDA inspected, and its quality-management systems are certified to ISO 13485 and ISO 9001 standards. Cleanroom capabilities include gold-ball and aluminum wire bonding; silicon encapsulation; and glued flip-chip assembly using automatic, manual, and pick-and-place machines.
Valtronic Technologies (USA) Inc.
Imaging, orthopedic, and surgical components
Located in a 50,000-sq-ft facility, 3D Medical Manufacturing Inc. provides the medical device industry with complete cleanroom manufacturing services. The contract manufacturer uses its cleanroom to fabricate and assemble components and products such as lens devices for fluoroscopy and endoscopy equipment, orthopedic implant parts and instruments, radiology equipment, and general surgery devices. With more than 1600 sq ft of space designated in its facility for cleanroom and assembly activities, the company specializes in a range of capabilities that include prototyping, packaging, and logistics. The FDA-compliant manufacturing facility is certified to ISO 13485:2003 and ISO 14644-1 standards.
3D Medical Manufacturing Inc.
Riviera Beach, FL
Boyd Technologies LLC, a company specializing in the converting and contract manufacturing of medical disposables, offers expanded capabilities in wound-care device production. Working in a variety of controlled environments ranging from modular cleanrooms to equipment-isolation structures, the company produces components and finished products from technical papers, nonwovens, membranes, films, foils, extruded netting, and nanofiber materials. Formerly a manufacturer of consumer bandages and wound-care products, the company has continually upgraded its validation procedures and GMP levels so that it can meet medical device industry requirements. A new Class 7 cleanroom dedicated to wound-care production will add to its medical device fabrication capabilities.
Boyd Technologies LLC
SOUTH LEE, MA