By Rod Cain RBC Medical Innovations

So you are thinking about outsourcing the production of your medical device to an FDA registered contract manufacturer?

To help you with this significant business decision we have provided a general list of considerations as a means of assisting your efforts in identifying the appropriate opportunities that may be able to leverage the strengths of outsourcing and ensure you choose the right partner who can support your business objectives.

How Could a Medical Device Contract Manufacturer Contribute?

Regulatory Requirement Guidance – contract manufacturers can offer a diverse portfolio of medical device production and testing experience. They also should have the appropriate certifications and on-going processes to support Device History Record (DHR) Documentation and/or RoHS Compliance for CE mark medical devices.

Quality Management – medical device contract manufacturer partners should be ISO 13485:2012 certified and GMP/21 CFR 820 compliant as well as provide device documentation processes to support traceability within Design History File (DHF), Electronic Medical Device Reporting (eMDR), and Global Unique Device Identification Database (GUIDID) requirements.

Design Engineering & Development – some contract manufacturers exclusively support FDA medical devices and provide full service design engineering, device development, prototyping, and production support that can also maximize Design for Manufacturability (DFM) and speed-to-market efficiencies.

Production Capabilities – contract manufacturers generally have access to global high volume and/or highly specialized supply chains that sometimes are not feasibly accessible for an OEM.  They also have access to the finest and latest state-of-the-art manufacturing and testing equipment technology.

Repair Testing & Servicing – some can perform and handle all warranty and non-warranty service repairs, support return material authorization (RMA), and provide direct customer device return and shipment.

Why Might You Consider Outsourcing to a Contract Manufacturer?

Manufacturing may not be a core competency of your organization.

Your device requires high development and clinical costs, which may limit the resources required to engage in high quality and high productivity manufacturing.

Your organization’s financial objectives result in the consideration of reducing company overhead, including facility costs or a reduction in labor costs.

Internal logistics support may not be “optimized” for procuring and handling materials necessary to ensure the safety and efficacy of your medical devices.

Capital equipment ROI objectives are not being achieve or current manufacturing equipment is outdated for the production of highly complex medical devices.

Risk Mitigation – Managing growth effectively by developing partnerships with supplemental resources to support quality and regulatory compliance, economies of scale, as well as disaster and business recovery planning strategies for your customers and investors is a good business practice.

What to Consider When Partnering with a Contact Manufacturer?

Medical Device Contact Manufacturing Agreement – this document should be utilized to define the foundation of your business partnership objectives. It is important that both parties take ownership within this process to ensure their roles and responsibilities are directly linked to service level requirements and that the teams participate in on-going review meetings to support the joint effort to produce the outcomes.

The following summary list may help you start working through the process of determining how a potential outsourcing partnership with a FDA registered contract manufacturer could contribute to your business objectives.

Potential Obstacles for Successful Contract Manufacturer Partnerships

• Poor “cultural fit” between the OEM and the CM
• Outsourcing of designs not ready for manufacturing, resulting in inefficient production yields
• High levels of debug, repair, support, or poor material quality
• Inaccurate forecasting and lead-time obstacles
• Poor communication, incommensurate goal setting, or infrequent business reviews
• Insufficient investment in people & time to manage outsourcing
• Inadequate “partnering effort” for either party can create manufacturing transfer problems
• Lack of internal buy-in support from OEM’s cross functional organization

Outsourcing the production of a medical device is a complex and difficult process, which requires due-diligence and development support by both partners. The medical device industry offers a diverse and competent network of FDA registered contract manufacturers and the appropriate partner to ensure your products are safe and effective is available within the United States to support your unique potential risk mitigation and growth opportunities.

RBC Medical Innovations is ISO 13485 | ISO 9001 certified, FDA registered and has been supporting the contract design, development, and manufacturing of medical devices since 1994. We focus exclusively on designing and producing Class I, II, and III medical devices for US FDA PMA or 510(k) as well as international CE marking. We have the available resources, capabilities and tools to transform your vision into a commercial device that is delivered to market on target, on time, and on budget today.