Scaling Orthopedic Programs from Prototype to Production—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief

More medical device manufacturers are seeking assistance from companies that can help during the development phases through to finished manufacturing. They want supply chain partners that can address both ends of the process and ease the transition from one to the other. These companies (contract development and manufacturing organizations, or CDMOs) offer baked-in advantages.

Additionally, while CDMOs can help with the transition from design to manufacturing, offering guidance on Design for Manufacturing and other challenging aspects, they also maintain expertise in good manufacturing practices. For example, some will provide automated solutions to customers to enhance quality and speed time to market. They’ve addressed labor concerns with these technology solutions.

Representatives from Cretex Medical | rms participated in the following interview to further explain the benefits of working with a CDMO. Adam Stromberg, Director of Orthopedic Operations, and Aaron Morrison, Orthopedic Operations Manager, respond to questions regarding the benefits CDMOs offer and how automation can be leveraged to enhance the scale-up process.

Sean Fenske: Orthopedic device companies are seeking contract development and manufacturing organizations (CDMOs) more often. As an established CDMO, what have you heard from customers that’s driving this trend?

Aaron Morrison: Our customers are asking us to do more, and they don’t necessarily have the tools or capacity to build all the manufacturing capabilities in-house to do it themselves. We’re hearing more about the challenges of finding skilled people, getting the right equipment, managing capacity, and keeping up with technological advancements. At the same time, they still need to get products to market faster and keep costs under control.

We also see increased interest in getting manufacturing involved earlier. Customers don’t just want someone to make the part after the design is finished. They want a partner who can help them figure out how to make it better, how to scale it, and how to make it efficiently, all while keeping costs down.

That’s where Cretex Medical | rms can bring what’s needed to the table. We already have the equipment, the people, the engineering support, the quality systems, and the manufacturing experience. Our customers can use those resources without having to build all of that themselves.

Fenske: Why is it so important to be able to keep development (i.e., prototyping) and manufacturing (i.e., production) under the same roof?

Morrison: When the people developing the component and the process work right alongside the production team, it’s easier to identify challenges. The cycle of making iterative changes, receiving feedback and making further changes, is faster when production and design teams are working more closely together.

The people on the shop floor know things that you don’t always see on a drawing or even in the models. They know what machines can do, where a process is going to be difficult, what type of tooling is required, and where you’re going to have problems once you start to scale up and produce thousands of parts. Having development and production together lets us take that knowledge and put it into the process early.

Fenske: How can a company like Cretex help with production scale-up while also addressing labor challenges?

Adam Stromberg: Cretex continuously reinvests in capital equipment and manufacturing technology to increase capacity, productivity, and scalability. We are investing in multi-spindle platforms, automation, and palletized manufacturing systems that allow us to produce more with the available workforce.

Our focus is on maximizing spindle utilization and reducing manual touches. Where possible, we want multiple tools in the cut, longer periods of unattended operation, and complex components completed within a single machine platform. These investments allow us to scale programs while improving consistency and reducing the amount of direct labor required per component.

Fenske: Automation has traditionally been viewed as a sacrifice in quality within medtech manufacturing. What has your experience with automation revealed?

Morrison: Honestly, our experience has shown that automation can actually improve quality. A person can get tired. They can have a bad day. They can get distracted. Two people can look at the same thing and make two different decisions. When you have a properly designed automation process, you will deliver repeatable quality every time.

Keep in mind, you can’t take a bad process, automate it, and expect it to become a good process. You have to understand the process first. Get it stable. Figure out where the variation is coming from. Then automate it.

We’ve also found that automation can give us better process control and better data. We can build checks into the process instead of relying entirely on someone to find a problem at the end. We don’t see automation as giving up quality. We see it as another tool we can use to make quality more consistent.

Fenske: How does a manufacturing partner that uses automated systems affect the costs involved?

Stromberg: Automation requires significant upfront investment, but it can create substantial value over the life of a production program. By increasing machine utilization, reducing manual handling, improving throughput, and creating more repeatable processes, automation can reduce the labor content and overall manufacturing cost per part.

We see benefits increase as production volumes increase. By incorporating Design for Manufacturing principles early on, we can design the process for automation and scale. The process can then absorb growth much more efficiently than a labor-intensive process. For our customers, that can provide greater cost stability, increased capacity, and reduced supply-chain risk as their programs grow.

Fenske: How is automation being used for tasks after manufacturing, such as inspection? Is it being incorporated elsewhere?

Stromberg: Automation extends well beyond the machining process. Cretex uses automation throughout multiple secondary and downstream operations, including inspection, cleaning, anodizing, passivation, tumbling, polishing, sorting, laser marking, and assembly. Investing in technologies such as automated vision systems and X-ray inspection that can evaluate more features efficiently than traditional inspection methods allows us to drive increased output throughout the whole process.

The objective is not simply to automate individual operations, but to reduce manual handling and create a more connected and repeatable manufacturing process from machining through final inspection and finishing. This becomes increasingly important as production volumes grow, and customers expect consistent quality and dependable delivery.

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?

Morrison: One of the most important things I’d tell OEMs is that to benefit from Design for Manufacturing, they should bring in their suppliers before designs are frozen. We can look at the design and say, “Here’s what we’re seeing. Here’s where we think you’re going to have a problem. Here’s a different way we might be able to do this. Here’s where automation might make sense. Here’s what we’re going to do to scale this up.” That’s where you see the real value of Cretex Medical.

At the end of the day, we’re all trying to accomplish the same thing. Make a good part, make it consistently, get it to the customer on time, and do it at a cost that makes sense. From a shop floor perspective, we believe there are a lot of opportunities in orthopedic manufacturing. The technology is advancing, automation is increasing, and we’re learning how to use those tools without losing the manufacturing experience that got us here.

You start with good people. Then you give those people better tools and better processes, and you’ll see what they can really do.

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