By Sean Fenske, Editor-in-Chief
 
Contract manufacturing has become such an integral part of the medical device fabrication process that it’s challenging to find OEMs who don’t use outside vendors to assist them. This has often led to a collaborative relationship where greater efficiencies and benefits are realized. However, there are even more advantages that could be enjoyed if this effort began earlier.
 
As a result, more contract manufacturing organizations (CMOs) are incorporating a new letter into their initials. Now, contract development and manufacturing organizations (CDMOs) can get involved with their device company partners during a design phase to create superior savings. This can result in design optimization and seamless transition right into manufacturing.
 
To help clarify how a CDMO differs from a CMO and share insights on the savings that can be realized, Liz Wiederhold, Sr. Program Manager, Product Development, at Paragon Medical, has responded to a number of questions on the topic. In the following Q&A, she tackles what’s driving this change, covers the differences among CDMOs, and offers greater clarification on the benefits.
 
Sean Fenske: What are the major differences between a contract manufacturing organization (CMO) and a contract development and manufacturing organization (CDMO)?
 
Liz Wiederhold: CMOs and CDMOs are primarily differentiated by the scope of services they provide to their customers. As a CDMO, Paragon Medical collaborates with our customers to provide end-to-end solutions including product development, process optimization, and manufacturing.
 
Fenske: Prior to the emergence of CDMOs, where was development taking place?
 
Wiederhold: Traditionally, product development occurred internally at the OEM or medical device company level, with contract manufacturers engaged later in the process to simply execute production based on pre-established designs and specifications.
 
Fenske: Why are more companies seeking to shift to a CDMO? What benefits are realized?
 
Wiederhold: Over the years, there has been a shift for two reasons. First, CMOs have identified design feedback at the time of manufacturing engagement that, if identified sooner in the development state, could have led to reduced cost or improved throughput. These changes earlier in the process could have potentially saved millions of dollars. This has driven earlier engagement with CMOs and an organic creation of CDMOs to support this feedback loop called DFM, or design for manufacturing.
 
Second, organizations need to get creative with their extremely limited R&D dollars and resources. As such, they are reviewing options to see how else CDMOs may be able to support them.
 
OEMs are discovering that partnering with CDMOs offers a cost- and time-efficient way to bring innovative solutions to market without sacrificing quality or creativity. CDMOs already have the infrastructure that brings flexibility and scalability to manufacturing risk sharing. By adding design and development capabilities, we are well-positioned to support the right projects from concept through production.
 
At Paragon Medical, our development team sits a few feet away from the manufacturing floor, allowing them to collaborate in real-time and deliver integrated solutions to our customers. Prints and models can be updated within a day instead of weeks, and parts can be inspected and machining programs adjusted within the hour. We have 3D printers available for quick-turn prototypes in metal and plastic, and a cadaveric lab onsite to quickly assess the usability of an instrument design. Electronic design control systems enable our customers to collaborate with us along the way. We’re not just a CMO with a few development-minded individuals, but a CDMO with the facilities and infrastructure to support each critical step.
 
Fenske: What differentiates one CDMO from another? Do they all take a project from concept to commercialization, through every single step? Do some offer a wider array of services than others? Do they specialize in specific manufacturing capabilities?
 
Wiederhold: When evaluating one CDMO against another, you want to look at their core capabilities from a manufacturing perspective, as well as their development experience and design control capabilities. These are two areas where we are differentiated at Paragon Medical.
 
First, the team itself needs to know what it takes to execute a successful project, be able to work seamlessly alongside manufacturing, and also have a strong foundation of design controls as well as regulatory and audit readiness. At Paragon Medical, our product development leaders have a cumulative 40+ years of experience in large bone orthopedics, including computational biomechanics, 3D-printed implants, surgical process instrumentation, and integrated project management.
 
Second, while most development services groups can conduct testing or create prints and models, not all can provide full regulatory and design control services under a certified QMS. Additionally, our product development leaders frequently support our onsite audits and FDA inspections in both the back and front rooms.
 
Fenske: What advice would you give OEMs who are engaging with a CDMO for design work? What are some best practices for a successful working relationship?
 
Wiederhold: Approach these types of partnerships with collaboration in mind versus the traditional transactional relationship. Avoid the CMO mentality of “please make this part per this print.” The application has multiple forms of scalability, risk sharing, co-development, and flexibility; it’s truly up to the medical device company and CDMO on how they want to approach these types of partnerships.
 
I find a lot of success in talking with our customers about what factors matter most to them, whether it be speed to market, cost of goods, a specific design feature, a test criteria, or even project budget to optimize our design approach. This type of feedback guides how we execute the project on their behalf. Often, we find that by building on a customer’s initial concept or existing data and combining it with our team’s expertise, we can optimize the design and deliver successful outcomes without needing to start from scratch.
 
Fenske: What are some of the benefits of combining design and manufacturing under one roof?
 
Wiederhold: I mentioned a few earlier, but by bringing design and manufacturing under one roof, we can capitalize on significant efficiencies to make the complex simple. We have the right infrastructure here to move quickly, and we’ve intentionally leveraged a robust design control system that can support our customers from a regulatory perspective as well. Additionally, engaging with a CDMO early in the concept phase can significantly reduce time to market. By utilizing the same processes and facilities for both design V&V [verification and validation] and production, it’s often possible to eliminate the need for separate production V&V steps, streamlining the path to product launch.
 
Fenske: How do you see the shift to outsourcing R&D to CDMOs evolving over the next five years?
 
Wiederhold: I see a lot of external partnerships continuing to grow as we all start to find new ways of working together. Innovation never stops; we just have to find a way to keep up and right now, collaboration is key.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
 
Wiederhold: Every company is facing the same challenges these days—working to do more with less—fewer resources, fewer R&D dollars, less capital, and decreased risk tolerance. At Paragon Medical, we are equipped to help our customers maintain momentum across all their projects. Whether it’s supporting critical initiatives or managing essential programs alongside your main priorities, we ensure your pipeline remains robust, allowing your internal teams to stay focused on what matters most.
 
Click here to learn more about Paragon Medical >>>>>