The Role of Strategic Partnerships in Medical Device Development and Manufacturing

Medical original equipment manufacturers (OEMs) rely on vital partnerships with design and manufacturing partners like Celestica to bring their medical devices to market.

In a recent interview with Medical Design & Outsourcing (MD&O) magazine, Kevin McFarlin, Design Engineering Director at Celestica, outlined three key factors medical device OEMs should consider when choosing a manufacturing partner.

From scaling production to meet global demand, to integrating key design considerations and  incorporating manufacturing insights into product design – Kevin shares how choosing a trusted manufacturing partner with the right capabilities can help medical device OEMs adapt to a changing global landscape and steer confidently into the future.

Read the Q&A below:

MDO: With medical device development times shortening, how can medical OEMs ensure products reach the market quickly and meet increased demand? 

McFarlin: A manufacturing partner with a global presence can help medical device companies launch and manufacture their products quickly and cost efficiently. They need to be able to scale production to make products accessible to a global market.

To do that, products need to be designed with the supply chain in mind. OEMs that leverage manufacturing facilities with a qualified and localized supply chain in the same geography have a more robust distribution channel. They can reduce overhead costs from the raw materials coming into the manufacturing facility and the product distributed to hospitals, doctors and patients. 

MDO: What are the key design considerations medical OEMs should address early in the product design process? 

McFarlin: It's essential for OEMs to start with a clear understanding of both user and business needs while defining use conditions and product requirements in clear, quantifiable terms. Then, teams should design for reliability by anticipating and discovering failure modes through analysis and testing, and eliminate failure modes through design. Additionally, the design process must consider manufacturability, ensuring that the device can be produced efficiently at the necessary scale and cost. 

Lastly, design with the supply chain in mind. Part of this includes conducting a thorough bill of materials analysis to identify and mitigate potential risks. Allowing for the proactive design of alternative components when necessary. These considerations help to ensure functionality and reliability of the medical device and its availability and affordability in the market.

MDO: Why is it crucial to integrate manufacturing and process engineers' insights during the product design phase? 

McFarlin: The manufacturing process should be considered part of product design. Experienced manufacturing engineers can fix assembly problems in the subsystems and components so when they're integrated into a larger system, they won’t contribute to a failure in the field. Following principles of robust design can help teams make more reliable products by eliminating opportunities for manufacturing defects caused by equipment variations and operator dependent processes. This allows the design team to address issues before they invest time, effort, and expense in the design verification of their product. 

Customers partner with Celestica to help turn their innovations into reality. We help them achieve cost and delivery targets, ensure regulatory compliance, and manufacture at the desired scale to meet market and patient demand.

To learn more about the importance of partnerships and early engagement with a strategic partner, read our report on Mitigating Design Risks: Considerations for Medical Device Development and Manufacture.

_{**This Interview was originally published in the May, 2024 issue of Medical Design and Outsourcing, pages 23-24.}