A One-Stop-Shop, Turnkey Solution Is Paramount for Success

In today’s ultra-high paced and competitive medical device industry, where speed to market is essential to the OEM’s success and market share, a contract manufacturer’s ability to offer a one-stop shop, turnkey solution of manufacturing capabilities to the customer is paramount for success.
 
A contract manufacturer that offers the complete package within its own umbrella, having manufacturing capabilities from the ground level up—starting at component fabrications through complex sub-assemblies up to top-level finished goods assembly, including packaging, labelling, sterilization, and distribution—offers a significant competitive edge and value proposition to the industry.
 
The contract manufacturer’s offered solution should also encompass the full spectrum of service offerings within the life cycle of medical device procurement—starting from early conceptualization, prototyping, DFM (design for manufacturing), development, design and process validations, and ultimately product launch into full-scale production and distribution—all while utilizing the latest in modern manufacturing technologies and innovations, along with a proven project execution methodology for success. These are some of the most important aspects for business success to the OEM and where the contract manufacturer should have the solution.
 
The result to the OEM customer, healthcare providers, and ultimately the patient is the ability to offer products with competitive innovation, reduced time to validation and product offering to the market, increased quality, more reliable and consistent functionality of the device, overall reduced lead times from both development and manufacturing, and often a cost competitive advantage through the benefits of best-in-class quality manufacturing.
 
Therefore, it is critical and a significant competitive advantage for the contract manufacturer to have the capabilities to procure components within the organization’s own umbrella, controlling component manufacturing, which is critical to device assembly.
 
Additionally, having the technical capabilities to assemble components consistently, reproducibly, and to the highest quality and with a clear understanding of how component and assembly level process design and controls contributes to Critical to Quality (CTQs) and functionality of the device’s intended use.
 
In short, the contract manufacturer must have the ability to not only make components but also assemble those components into finished goods level devices.
 
This gives the contract manufacturer a significant advantage—a comprehensive understanding of the CTQs that are directly impacting the device function—and therefore the ability to control component manufacturing, processes, and assembly, which directly impacts the quality and functionality of the device itself.

Picking the Right Partners

Gaining an understanding of CTQs is established by having the right team, with the right expertise and experience, working closely with the OEM to develop a comprehensive understanding of the functionality and intended use of the device, and translating that need into design for manufacturing and technical process design. Knowing the OEM’s CTQ’s and knowing contract manufacturers’ process capabilities can bring those together for a technical solution—the key to success. This gives the contract manufacturer the ability to control processes and therefore the quality of components that are critical to output (both process input CTQ’s and output to functionality of device CTQ’s).
 
The contract manufacturer’s ability to offer this competitive advantage goes well beyond the controls within its own manufacturing. It also extends to the contract manufacturers supply chain base and approved suppliers. Ultimately, a contract manufacturer’s approved supplier base/logistic network (i.e., raw material suppliers, service providers, other contract manufacturers) is an extension of the contract manufacturer’s capabilities. Choosing the right partners that adhere to the same standards, or better, to your own, is essential.
 
This in turn reduces supplier related requirements such as supplier qualification requirements and audits while increasing quality, reliability, and lead time.  It also offers a significant opportunity for cost savings: reduced logistics and shipping, purchasing resources, purchase orders and minimizes incoming inspections and lot releases of components from external to internal production.
 
Even the most advanced and invested contract manufacturers cannot always have all the capabilities required for every need in the market. OEMs are constantly increasing ingenuity and advancements that require highly advanced solutions. When this is the case, an advanced organization will seek to do the following:
 

• Look to invest in new technologies, create a greater value proposition for the contract manufacturers capabilities within itself. Examples that Micro has invested in beyond our capabilities in medical device metals manufacturing and assembly would include developing capabilities in PEM (Precision Electrochemical Machining), Injection Molding for more turnkey solutions, End of Line Functionality Testing for highly complex and advanced medical devices, such as end-of-arm surgical robotics and other minimally invasive devices.
• Leverage long-term partnerships and supply chain base. An organization’s partnerships should be an extension of their own capabilities; look to qualify suppliers that complement or even exceed your own capabilities.

Conclusion

In today’s ultra-high paced and competitive medical device industry, where speed to market is essential to the OEM’s success and market share, a contract manufacturer’s ability to offer a one-stop-shop, turnkey solution of manufacturing capabilities to the customer OEMs is paramount for success.
 
Therefore, it is critical and a significant competitive advantage for the contract manufacturer to have the capabilities to procure components within the organization’s own umbrella, controlling component manufacturing that is critical to device assembly.
 

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Jason Jacquet is a Technical Sales Engineer at Micro, a full-service cGMP compliant contract medical device manufacturer, FDA and ISO 13485 registered, specialized in precision medical devices.