By partnering with a full-contract manufacturer, the medical device OEM can concentrate on such core competencies as product design, marketing, and distribution, according to Ben Bouchard, vice president, international business development, and managing director–China at GW Plastics Inc. (Bethel, VT).
MPMN: Why should a medical device OEM partner with a full-contract manufacturer?
Bouchard: Partnering with a full-contract manufacturer allows medical device OEMs to focus their resources on the parts of their business that make them unique: product design, marketing, and distribution. By utilizing the advanced technologies and capabilities of a manufacturing partner, OEMs can bring products to market in a cost-competitive and timely manner. Furthermore, they have to qualify only a single partner per project, while the partner qualifies any needed subsuppliers. This supply chain strategy improves communication while reducing delays and logistical issues, enabling the OEM to focus on the project itself.
MPMN: What technical expertise should the full-contract manufacturer offer to the medical device OEM?
Bouchard: The full-contract manufacturer should offer the OEM five essential services and skills. First, the partner should be FDA registered so that it is evident to the OEM that the manufacturer has validated processes and adheres to CGMP standards. Second, the manufacturer should employ state-of-the-art manufacturing technologies and capabilities. Third, the partner should embrace and demonstrate design for manufacturing and cost-reduction knowledge so that the product is manufactured in the most efficient and least expensive manner. Fourth, the manufacturer should employ an installation qualification, operation qualification, and performance qualification (IQ/OQ/PQ) process and be able to produce previous-experience documentation to ensure that the process is authorized and certified. Fifth, the manufacturing partner should have an entrenched philosophy of quality.
MPMN: How does contracting with a supplier enable the OEM to keep pace with evolving manufacturing and business trends?
Bouchard: Increasing cost pressures and regulatory oversight continue to be dominant trends in the healthcare and medical device industries. Working with a qualified full-contract manufacturing partner that has direct regulatory experience allows OEMs to access the most current manufacturing practices without assuming the direct burden of inspections, approvals, and investment in ever-changing technologies. The relationship between the OEM and the full-contract manufacturer allows each partner to do what it does best: The OEM can focus on product design, marketing, and distribution, while the supplier can invest in the most advanced manufacturing technologies and implement measures to reduce costs and ensure quality.