Medical contract manufacturing organizations (CMO) have invested in automated equipment and cleanrooms so that they can perform precision formatting and other processes for device OEMs and developers. Image courtesy of Web Industries Inc.
Apple, with its iPhone 11 Pro featuring a one-of-a-kind triple-camera system. Netflix, with its super-personalized recommendations that keep us coming back for more streaming entertainment.
What do these industry disruptors and global game changers have in common? They outsource. Apple has an enduring relationship with contracting giant Foxconn, which specializes in consumer electronics manufacturing. Netflix leaves data center management to Amazon, freeing its team to work on consumer-facing features and Oscar-winning content.
To be the next company to change a generation, medical device developers can also leverage outsourcing.
Why Consider a CMO?
Contract manufacturing organizations (CMO) specializing in the medical device industry provide a path to smooth manufacturing scale-up. It’s no simple task to take a product from prototype to quantities needed for national or global distribution. Building and staffing a factory take time, expertise, and capital investment, and even then, it is often impractical to make all device components in-house.
CMOs usually offer high-speed, automated equipment and specialized knowledge to make some portion of a device, if not most of it. Because CMOs’ costs and capacity are spread across multiple customers and projects, they can offer competitive total value for their contract services. The CMO’s team and production lines often perform the same or similar processes day in and day out, and so they can transition to new jobs efficiently while delivering consistent high quality.
All of this frees the device developer to focus on core competencies, product differentiation, and other value-added activities. Consider the fast-growing microfluidics market, in which firms are racing to develop innovative tests to detect diseases based on miniscule samples of a patient’s blood or bodily fluids. These developers make the greatest gains when they can focus on:
- Research and development.
- Novel product designs.
- User experience.
- Next-generation diagnostics trends.
In turn, a CMO can shoulder responsibility for tasks such as:
- Raw material specification and assessment.
- Manufacturing process confirmation and verification.
- Precision formatting of components.
- Automated device assembly.
When to Engage a CMO?
CMOs specialize in manufacturing process design and optimization. Their ingenuity rests in identifying the most efficient way to produce a device in large volumes, with consistent high quality, at a target cost per unit that meets the OEM’s economic model.
So, the best time to engage with a CMO is after a device design concept has been well vetted and there are early prototypes and initial specifications. At this stage in the product lifecycle, a CMO still has an opportunity to offer suggestions regarding material specifications and other design factors that could pose manufacturing challenges. Then after the design is finalized and frozen, it is ready for the CMO to begin design for manufacturability (DFM), a stage-gated process of technology transfer. During DFM, the CMO examines every aspect of the device and devises the processes to take it to commercial-scale production.
The path described above is only one example of when a CMO can be engaged. CMOs can help at many other junctures in the product lifecycle to help with constraints and urgent deadlines. For instance, a device OEM may find itself facing a tight timeline to finish clinical studies or to launch on schedule. Outsourcing some portion of manufacturing to a CMO can help it cross the finish line in time.
In other cases, a device developer may have the resources in-house to handle some processes but face a high cost of entry to perform others. A CMO may have already invested in the equipment needed to bridge those gaps, and together they can form a cost-effective supply chain for the finished device. This alleviates the need for the device OEM to start from scratch to set up infrastructure internally. For example, a wearable device maker may need help converting large rolls of material into formatted pieces ready for an automated assembly line. A CMO can perform precision formatting of the material, turning it into converted parts that can be fed into the next manufacturing process. This eliminates the need for the OEM to invest in any converting machinery.
What to Look for in a CMO?
Once the decision to seek a CMO has been made, what qualifications should be on the search list? First and foremost, the CMO should have medical industry experience and facilities certified for medical-grade device production. Look for the following at a minimum:
- ISO 13485 certification, which demonstrates that a CMO’s quality management systems meet medical device manufacturing standards.
- Designation as U.S. FDA Registered Medical Device Establishment.
- Compliance with Current Good Manufacturing Practices (CGMP).
- ISO 9001:2008 certification.
- ISO 14001 certification.
Without a strong grasp of medical device complexities, some CMOs will offer a low upfront price but then require a very long timeline to develop a viable manufacturing process. Or there may be baiting and switching. For example, an initial price per unit may be promised, but late in the game, the CMO may need to increase the price.
To avoid this type of scenario, it’s imperative for a CMO to demonstrate trustworthiness. How? The best evidence is clear, open and frequent communication. Expect detailed documentation and complete visibility into every phase of the OEM-CMO relationship. This should include:
- Clarification of intellectual property (IP) ownership.
- Detailed documentation of the project definition, requirements, timing, and deliverables.
- Proposal for design development work needed before the DFM phase, if applicable.
- Prompt communication of problems or issues.
- Regular status updates and debriefings.
- A straightforward path to exit the relationship if desired.
Medical device CMOs also should be able to facilitate introductions to other qualified partners in their supply chain. Such integration opportunities are particularly important for wearables and microfluidics developers, whose emerging markets require multidisciplinary expertise. For instance, one CMO may specialize in converting flexible materials but have established relationships with suppliers skilled in electronics, pharmaceutical formulation, photovoltaics, and software development.
In conclusion, whether the mission is to change the world or expand production of an established product, a good CMO partner can handle the complexities of mass-scale manufacturing. As with any business relationship, trust is key, and there’s no substitute for medical industry experience and certifications. When a CMO can open doors to integration with multidisciplinary partners, that is icing on the cake. In the end, the OEM-CMO relationship should be one that liberates the device developer to excel at its core competency and take its business to the next level.