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Outsourcing Outlook on Cleanroom Manufacturing and Assembly: Q&A

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.

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