Key considerations for OEMs in medical device design and manufacturing.

Sponsored by Celestica

Recently, the role of medical Original Equipment Manufacturers (OEMs) in global healthcare has become increasingly pivotal. In order to reach customers quickly and cost-effectively, OEMs partner with Electronics Manufacturing Services (EMS) companies like Celestica to help bring their innovative medical devices to global markets. Kevin McFarlin, design engineering director at Celestica, explores how OEMs can leverage partnerships to scale production, integrate design and manufacturing insights, and manage supply chain risks to meet the urgent demands of the global healthcare industry. 

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

McFarlin: OEMs should consider partnering with manufacturers that can scale to high volume. 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 end users. A manufacturing partner with a global presence can help them scale and manufacture those devices at a lower cost. 

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 those 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. This allows 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.

For more information on how OEM’s can benefit from a strategic design and manufacturing partner, read Celestica’s white paper.