Why should medical device OEMs partner with full-contract manufacturers rather than with specialized vendors? Mike Sieron, president and CEO of DG Medical Molding (Centerville, OH), weighs in on this subject.
MPMN: What advantages does a medical device OEM derive from partnering with a full-contract manufacturer?
Sieron: There are many advantages to working with a full-contract manufacturer. First and foremost, the OEM has to qualify only a single partner and does not have to devote additional time and resources to qualifying and managing multiple suppliers--often as many as seven--for a single project. Instead, the contract manufacturer assumes the responsibility of qualifying all necessary suppliers or subcontractors. In addition, the single point of contact that the OEM has with the full-contract manufacturer makes it easy for them to collaborate on projects, obtain status updates, schedule meetings, or perform other joint tasks. And by partnering with a full-contract manufacturer, the OEM is removed from managing conflicts that can arise when dealing with multiple vendors, such as timeline interruptions, material availability, lead times, and logistics. Moreover, by working with a full-contract manufacturer, the OEM can share all aspects of a project with a single vendor, vesting both parties in its success from start to finish.
MPMN: What abilities should a medical device OEM expect of a full-contract manufacturer?
Sieron: Beyond typical manufacturing capabilities such as metal fabrication and plastic molding, for example, an OEM should expect the full-contract manufacturer to have a complete suite of quality certifications, such as ISO 13485, ISO 9001, 21 CFR 820, and GMP. The OEM should also expect the contract manufacturer to maintain an engineering team that can collaborate in such areas as design for manufacturability, prototyping, and program management--not to mention additional operations such as laser marking, assembly, kitting, packaging, and cleanroom capabilities.
MPMN: What trends should an OEM bear in mind when seeking a full-contract partner?
Sieron: The medical device OEM should understand that partnering with a full-contract manufacturer is a strategic relationship and that a good synergy is needed between both parties. The relationship requires open communication and accountability on both sides. From a technological standpoint, regulatory compliance and quality requirements continue to drive higher standards in the medical device industry. Thus, OEMs should partner with contractors that have invested in their facilities and equipment to meet these standards. For example, contract manufacturers that utilize scientific molding technology can ensure the repeatable, validated quality of each molded part they create. Finally, the OEM should pay particular attention to how the contract manufacturer trains its staff to ensure that industry standards are followed without exception.
Medical device assembly services
Operating outsourcing facilities in Tijuana, Mexico, Coastline International focuses on medical device assembly services. Certified to ISO 13485 and ISO 9001 standards, the full-contract manufacturer maintains three Class 100,000 cleanrooms amounting to 9% of its manufacturing area. It provides full-contract services that include procurement of components and assembly of customers' medical device products. The contract manufacturer also produces electronic assemblies, offering through-hole, surface-mount, and RoHS-compliant capabilities.
Molding, assembly, and packaging services
A full-service contract manufacturer produces medical device components from concept to creation. Equipped with an 85,000-sq-ft facility featuring an in-house design department that utilizes 3-D software, Plastics One Inc. maintains a moldmaking shop and plastic injection molding technology. The ISO 9001:2008-certified company's R&D team designs and builds its own customized molding machines and retrofits existing equipment to meet specialized needs. Certified to ISO 7 standards, the contractor's Class 10,000 cleanroom is used to perform medical device molding, assembly, and packaging operations.
Plastics One Inc.
Diagnostic and drug-delivery device manufacturing services
A contract manufacturer of medical diagnostic and drug-delivery devices, Medisize helps select appropriate materials, manufacturing processes, and packaging for OEM customers. Its turnkey competencies extend across several disciplines, such as product design and development, in-house toolmaking, injection molding, insert molding, silicone molding, injection blow molding, film welding, assembly, packaging, and sterilization. All manufacturing is performed in Class 10,000 cleanroom facilities housing 132 injection molding machines and 27 injection blow molding machines.
Medical device molding and assembly services
Vention Medical offers component production and device assembly services to medical device manufacturers. The full-service company's capabilities comprise cleanroom injection molding of components, complete product assembly, and final packaging. They also include such services as tooling design and fabrication, process design and validation, insert molding, micromolding, and two-shot molding. In addition, the ISO 13485:2003-certified contractor performs sterility validation and management, supply-chain management, and manufacturing transfer. The company assembles handheld surgical instruments, catheter-based products, catheter-based diagnostic and delivery systems, drug-delivery systems, and diagnostic devices.
Medical plastics molding
A manufacturer of plastic molded medical device components provides concept review, rapid prototype design, material selection, component assembly and packaging, and sterilization-management services. Supported by process validation and reporting, DG Medical Molding supplies OEMs with thermoplastic and thermoset components. The ISO 13485:2003- and ISO 9001:2008-certified company can perform molding operations in a Class 10,000 cleanroom, and its advanced molding machines are equipped with precision robots and a variety of sensors that can detect production irregularities before the injection molding process is complete. For immediate and future validation purposes, the company's scientific molding system creates a digital record of every component created.
DG Medical Molding