A medical device CDMO (contract design and manufacturing organization) can bring a range of benefits to your company, whether you are a start-up, academic spin-off, or established medical device brand. Those benefits include expertise benefits, infrastructure benefits, and commercial benefits. How do you choose the right CDMO partner?
The following essential considerations should factor into your decision-making processes.
Factors to Consider in a Medical Device CDMO
Industry Expertise
There are CDMOs and then there are medical device CDMOs. As the medical device industry is unique with the need for an unwavering focus on patient safety, quality, and compliance, direct MedTech industry expertise is essential in a CDMO.
Product Expertise
While medical device experience is essential, it is also beneficial to partner with a CDMO that has expertise in your product area. For example, if your product or product idea is a minimally invasive medical device, the CDMO you work with should ideally have minimally invasive medical device expertise.
Design and Development Experience
The key difference between a CDMO and a more traditional CMO (contract manufacturing organization) is the fact a CDMO will have design expertise and product development experience.
It is also beneficial to choose a CDMO with a broad range of product design and development experience. This includes experience managing complete projects, handling all aspects of the design, as well as experience augmenting existing design teams to develop specialist components that are part of a larger product.
Alignment With Your Requirements
Your medical device company will have limitations, requirements, and ideal ways of working. For example, you could have financial restraints, milestone requirements, or communication preferences. It is important the CDMO you choose aligns with your requirements as much as possible.
Capacity
Capacity is an often-overlooked component of a medical device project, but it is essential. Not only should the CDMO you select have available capacity today but also in the future. For example, you need to have confidence the CDMO has the required capacity to design your product and then manufacture it when you are ready to scale up production. The last thing you want is delays caused by capacity issues right when you are about to commercialize your product.
Facilities and Equipment
The best CDMOs have turnkey manufacturing capabilities with state-of-the-art facilities and a wide range of equipment and resources. This includes cleanroom facilities, advanced manufacturing equipment, the latest technology platforms, and skilled staff, as well as assembly, packaging, and sterilization capabilities.
Investment Strategy
The investment strategy of a CDMO should also factor into your decision-making. Does the CDMO regularly invest in its capabilities – people, technologies, equipment, and facilities? CDMOs that don’t invest quickly get left behind.
Problem-Solving Abilities
Medical device products are becoming increasingly complex through innovative design, miniaturization, complex components, and/or the inclusion of advanced technologies such as sensors. Your medical device CDMO should have extensive problem-solving capabilities and a proven track record to ensure they can deliver on your requirements.
Materials Expertise
The materials used to produce new medical device products are crucial to patient safety, usability, manufacturability, quality consistency, raw material reliability, and, increasingly, sustainability. Therefore, materials expertise is essential.
DFM
DFM stands for design for manufacturing. It is a process that takes place throughout the design stages to ensure the product can be realistically manufactured. DFM objectives include things like reducing the number of components and minimizing the complexity of assembly processes. DFM knowledge and capabilities should be an essential requirement for your medical device CDMO.
Certifications
As a minimum, your medical device CDMO should have an established quality management system (QMS) and ISO 13485 certification. It should also be FDA audited with a valid certification.
Regulatory Knowledge and Support
Compliance with regulations starts at the very beginning of a product development process and is a requirement through the lifecycle of the device. Therefore, regulatory knowledge and support are important considerations when choosing a CDMO.
Your CDMO should have quality and regulatory resources available to give you the support that you need, as well as well-established and robust document control processes.
Supply Chain
Supply chain management is more important than ever given the disruption that many supply chains have faced over the last number of years. The CDMO you choose should have advanced and highly effective supply chain management processes that include strong oversight.
Continuous Improvement
Establishing manufacturing processes to produce your medical device at scale should only be the start of the journey. The best CDMOs adopt a continuous improvement approach to manufacturing, where there is a constant effort to make improvements in key areas.
The same applies to the design of your product – your CDMO should support your efforts for continuous improvement to make the product more effective, for example, or more profitable to produce.
Communication & Transparency
Communication is important in any business relationship, especially one as close and commercially sensitive as the relationship between a medical device company and a CDMO. The communication should be honest and open, and there should be complete transparency.
IP Protection
It is also important your IP is protected at all times, plus you should always retain 100 percent ownership of your IP. Confidentiality is a non-negotiable component.
The Team
Finally, it’s important to get to know the team who will be involved in your project, including the leadership team, design team, quality team, and production team. Do you like and get on with them? Can you work with them? These might sound like low-level considerations, but they are crucially important.
The Arrotek CDMO Approach
At Arrotek, we tick all the boxes outlined in this blog. We know these are the most important considerations for CDMOs as we have extensive experience operating as a CDMO for a broad range of medical device clients. To discuss your requirements and to find out more, please get in touch.
