By Mike Huiras, Flexan
As medical device OEMs have narrowed their strategic focus to core competencies, innovation, and global market expansion, demand has grown for CMO partners with proven capability to operate in a global regulatory and quality environment. Moreover, OEMs require partners with an operational model adaptable to the modern industry’s technical requirements and unpredictability.
If Flexan is part of early-stage discussion and development, we provide guidance on design for manufacturability. When we qualify transfer of an existing product, we thoroughly examine the transfer (e.g., the product’s design and manufacturability) to confirm we are a proper fit for the project. Once we determine we are aligned with the customer relevant to end goals and timelines, focus shifts to inventory management, supply chain, and regulatory filings. The key aim throughout is to ensure manufacturing is not interrupted, that the customer is not facing a window of time where no partner is supplying product.
Depending on the situation and timeline, it often is prudent to explore, during a transfer, whether opportunities exist to alter product design into something easier or more cost-effective to manufacture. For example, can we develop a manufacturing process that reduces the labor necessary, achieving a better price point for our customers? Manufacturing transfers are inherently costly, so providing optimal return on that investment is critical.
The importance of setting precise expectations, understanding the work streams, and building a mutually agreed upon project plan up front cannot be overstated. Device development and manufacturing transfer always will reveal technical surprises, but surprises as a result of inadequate communication or supply chain disruption can be minimized or eliminated through transparency and effective collaboration.