Accelerated time to market…supply chain resiliency…relentless focus on innovation and quality. These are of the utmost importance for medical device manufacturers as they commercialize products. Frequently, device companies partner with a contract manufacturer to increase manufacturing capacity and deliver reliable products more cost-effectively. The most sought-after contract manufacturers are the companies that not only work with high-growth customers, but also demonstrate their commitment to quality, growth, cost-containment, and innovation. While easy to say, staying ahead of the curve can be a challenge.

While device companies strive to push boundaries and expand their product portfolios, high tooling costs and long lead times associated with traditional manufacturing make adapting to changing customer demands and product variations difficult. To overcome these challenges, the most innovative contract manufacturers embrace additive manufacturing (AM) alongside traditional manufacturing technologies. Making this shift in their overall approach presents significant opportunities for contract manufacturers to scale their businesses efficiently and effectively.

How AM Tackles Contract Manufacturing Challenges

ARCH Medical Solutions has 23 manufacturing facilities in the United States and nearly 1,000,000 sq. ft. of manufacturing space. It serves as an example of a contract manufacturer centered on growth as numerous headlines document its aggressive M&A strategy. In addition, it provides scale for a breadth of medical device production applications including instruments and implants for orthopedic, spine, trauma, extremity, and dental.

With factories dating back to the 1970s, ARCH began at a time when “AM” was only an abbreviation used after time to indicate the morning. As AM entered the medical device manufacturing workflow, however, ARCH was tangentially connected to the technology, providing post-processing services via its CNC machining and validated special process capabilities. While enjoying success for many decades with its traditional workflow, ARCH realized it needed to challenge its limits. The introduction of this innovation within medical device manufacturing marked a transformative time; the firm needed to push the boundaries of its capabilities for both the company’s current customers as well as to attract new ones. ARCH realized it needed to integrate AM technologies into its workflow.

Following the integration of AM, a contract manufacturer’s customers benefit from design flexibility to produce complex geometries such as the integration of lattice structures in implants to support bone ingrowth and osseointegration. It also allows the organization to meet the rising demand for patient-specific solutions. Additionally, using AM to directly print a medical device eliminates the need for tooling, thus helping to accelerate time to market.

For orthopedic device contract manufacturers, having AM as part of a solution portfolio demonstrates the firm’s ability to support a project, regardless of the scope. Returning to the ARCH example, a manufacturing workflow that includes both subtractive and additive technologies signals to customers the company is not only looking at today’s project but is positioned for those in the future that will likely require advanced technologies to achieve. Following the implementation of AM within a contract manufacturer’s workflow, the organization has access to many more opportunities, even though many of those projects may not require the job to be accomplished completely on an additive platform. A company that focuses on advancements in capabilities is enabling its customers to accelerate their time-to-market and innovation to achieve a competitive advantage.

The Journey to In-House AM

In a highly regulated environment such as medical device manufacturing, contract manufacturers may be concerned about bringing AM in-house due to stringent requirements for the qualification and validation of printers, processes, and devices. It can be a daunting challenge, and some experiences may prove better than others. There are many additive manufacturing solution providers and many options as a result. Beyond selecting the printing technology, there are also a host of additional requirements to consider including navigating regulatory requirements. For this journey, it’s important to select a solution partner instead of simply a technology provider.

Partnering with an AM solutions provider with deep experience and expertise in medical device manufacturing will position a contract manufacturer for the greatest return on its investment. If your partner is also set up to manufacture medical devices, this will put you ahead of the curve. This additional criterion demonstrates the solution provider can “walk the talk,” which can help increase confidence in a successful implementation. With both the contract manufacturer and solution provider having qualified, validated AM solutions to produce devices, the AM solution provider can help the contract manufacturer not only with solution design and validation but also with producing parts until the time when the solution is integrated on-site. This redundancy in validated, qualified production capabilities also mitigates supply chain risk for the medical device company.

Future Expansion Through AM

Working with a reputable contract manufacturer instills trust on the part of the device company. Once the company develops a relationship with a contract manufacturer who is using a specific AM technology to develop its product, that relationship is very likely to be cemented for the long haul. This level of collaboration often allows device companies, as they develop their product roadmaps, to take into account what technology, applications, and support the contract manufacturer addresses today, and determine how that can also help them commercialize future products.

AM continues to revolutionize the landscape for medical device manufacturing, not only for the device company but also for the contract manufacturer. By integrating AM into a historically traditional manufacturing workflow, contract manufacturers have the potential to strengthen and expand relationships with current customers, as well as grow their customer base. It’s a testament to AM’s transformative power to create new business models that empower growth and innovation.

Aaron Schmitz is additive process engineering manager with 3D Systems’ Application Innovation Group, specializing in metal laser powder bed fusion process development as well as validation and qualification. He is a seasoned mechanical engineer with prior experience as both a design engineer and additive manufacturing engineer at GE Aviation and GE Additive. Schmitz received a bachelor’s degree in mechanical engineering from the University of Wisconsin Madison and a master’s degree in mechanical engineering from The Ohio State University.

John Ruggieri is the SVP, business development at ARCH Medical Solutions, where he has spent nearly two decades identifying, securing, and nurturing high-value partnerships with leading medical device manufacturers. Prior to his current role at ARCH, Ruggieri held engineering and operations leadership roles with Seabrook Medical, IMA Nova, Kendro Laboratory Products, and Morgan Engineering. He received an MBA from Worcester Polytechnic Institute, and a bachelor’s degree in mechanical engineering from the University of Massachusetts, Lowell.