Spikes in demand. A sense of urgency to speed new products to customers. A rush to be prepared for regulatory reviews. Pressure to economically scale up production. For those in the medical device industry working to fight COVID-19, these are the new realities. Yet, these challenges also confront many device makers during their normal course of business, albeit without the full dynamics of a pandemic response.

Under any circumstances, a contract manufacturing organization (CMO) can help shoulder the workload of bringing a new device to market. This article reviews key considerations to keep in mind when evaluating a CMO. For experienced medical device original equipment manufacturers (OEM), this information serves as a refresher. For those new to medical devices or embarking on their first CMO search, this is a roundup of qualities to look for and questions to ask of prospective outsource manufacturing partners.

What Do Medical Device CMOs Offer?
Outsourced manufacturing offers a way for device businesses to focus on research and development, marketing, distribution, and other core competencies while leaving the manufacturing to a partner who has already invested in specialized equipment, staff, and quality systems. While the term “outsourcing” can refer to global/offshore production, there are medical CMOs with U.S.-based manufacturing facilities and supply chains. For the purposes of this article, CMO refers to both:

• Contract medical device manufacturers who can perform all aspects of making a device, from process design to packaging
• Medical converters who specialize in formatting components and materials that go into finished devices

Medical device developers and OEMs turn to CMOs for a variety of reasons. Some may have an approved device prototype but lack meaningful manufacturing facilities. They need an experienced partner to help them ramp up to mass production levels. Others require raw materials to be converted into formats they can run efficiently on their own manufacturing lines. Still others may have a short-term need for additional manufacturing capacity, and they are looking for a CMO to duplicate processes they perform in-house. In such cases, the CMO serves as an extension of the OEM’s manufacturing operations, making the exact same products in precisely the same way.

Regulatory and Quality Requirements
In the race to get medical devices to market, CMOs with well-established, certified quality systems and proper accreditation give their customers a head start. At a minimum, look for the following:

• Current Good Manufacturing Practices (CGMP)—Required by the U.S. Food and Drug Administration (FDA) and the Safe Medical Devices Act, these quality best practices have been around since 1978 and were updated in the 1990s. In spring 2018, the FDA announced plans to align CGMP with global medical device quality standards of the International Organization for Standardization (ISO).
• FDA Registration—All businesses involved in production of medical devices intended for use in the United States must register annually with the FDA.
• ISO 13485—This global standard lays out specific requirements for a medical device maker’s quality management system. CMOs who meet the ISO 13485 standard have demonstrated their ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
• ISO 9001—Companies certified under this standard follow globally recognized quality principles to ensure customers receive consistent, good quality products and services.

Bottom line, it’s not good enough for a CMO to claim it has clean facilities and great quality. A CMO must prove such claims with current documentation, certifications, and audit results from recognized regulatory bodies and authorities.

Supply Chain Considerations
“How soon can you make it?” That is often the burning question posed to CMOs. A reputable CMO will provide a realistic lead time based on methodical review of the project and requirements. If a contractor offers up a relatively short lead time right away without asking many questions, this should be a warning sign. It is worth downshifting and determining if the OEM-CMO relationship is feasible. Are the two organizations aligned on capabilities, culture, and goals? If the answer is “yes,” then the CMO can review the project in greater detail and offer a plan for timing and expectations.

The availability and format of raw materials is a major supply chain factor that can greatly affect lead time. Supply chain partners should be included in the early development stages to determine if the specified material is available in the format needed (e.g., slit rolls, cut parts, sheets, molded plastic, laminated, treated with biochemistry formulations). Early supply chain involvement also addresses additional aspects affecting manufacturing: How will materials need to be converted before they can be incorporated into the device? Are raw materials of optimal configuration to allow for the most efficient and cost-effective manufacturing process? If not, can an alternative material be substituted? Is the specified material available in the quantities required for commercial-scale production? These are all issues an experienced medical CMO should be able to help its customers solve.

Following are a few other supply chain questions to keep in mind.

• Will the device require the development of new materials or components? Or can it be made of materials and parts readily available on the market? The former will require additional process design time.
• Does the CMO have a flexible manufacturing system (FMS)? An FMS streamlines design change integration and process adjustment to accommodate growth and evolving market demands.
• What about inventory management systems? In addition to quality systems, a CMO should offer a transparent view into raw material inventories, work in process, and other key performance indicators.

Manufacturing Capabilities
Like the device developers and OEMs they serve, CMOs and converters usually focus on certain types of medical devices and products. For example, some CMOs have years of experience in flexible materials converting or diagnostic test production whereas others specialize in durable medical equipment. While there is no one-size-fits-all checklist, following are some manufacturing capabilities to seek in a CMO.

Process knowledge—A CMO’s greatest strength is its ability to design manufacturing processes for efficient, affordable, safe, and consistent device production in large quantities. There is no substitute for experience in making devices and partnering with customers to devise solutions to their production challenges. Expect a thoroughly documented, stage-gated process with testing at critical project milestones.

Experience with automation—Automation is essential to meet quality and economic targets for modern medical devices. Look for a CMO with high-speed, automated manufacturing lines including vision inspection systems.

New product introduction (NPI) system—With an NPI solution in place, there will always be a clear plan for how the CMO will handle new product launches, including any new processes to be designed and implemented within the CMO’s operations.

Specialists in the field—The best medical CMOs have a strong bench of technical personnel with skills to support customers in their device categories. For example, CMOs engaged in lateral flow immunoassay diagnostic devices have biochemists and materials scientists on their teams, in addition to experts in engineering, safety, and medical device development.

Medical-grade facilities—Closely related to regulatory and quality requirements, medical device CMOs must have facilities equipped with environmental and biosafety controls. If a CMO handles biological substances (e.g., blood, saliva, viruses, etc.), it must have a rated biosafety laboratory. The higher the rating, the greater the risk posed by the substances the CMO is qualified to work with.

Conclusion
CMOs can help device developers and OEMs by providing production capacity and process expertise. CMOs specialize in outsourced manufacturing to produce medical devices efficiently, cost effectively, and at commercial scale. Selecting a CMO is no time for shortcuts. Ultimately, world-class contract manufacturing processes yield the best devices that perform as they should—every time, for every end user.

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Claudio Hanna is business development director for Web Industries Inc.’s medical division (www.webindustries.com). As a CMO, Web has produced more than 100 billion medical and life science diagnostic tests and devices. Hanna has more than 20 years of experience in flexible goods, startup manufacturing, and automation. He can be reached at channa@webindustries.com.

Jennifer Ponti is business development manager for Web Industries’ medical division. Her professional background includes over 15 years of experience with lateral flow devices. She can be reached at jponti@webindustries.com.