Effective Communication Drives Successful Manufacturing Transfers And Productive CMO Relationships

The relationship between a medical device OEM and its contract manufacturing organization (CMO) thrives or fails based on communication. Whether remote or face-to-face, these communications must involve the appropriate individuals or teams, be substantiated with relevant data wherever possible, and remain untainted by ambiguity or uncertainty.

This is true whether production of the device transfers directly to the CMO without change or whether design for manufacturability (DFM) is required. Often, DFM is necessary, to some extent, even when the OEM does not believe it will be: for example, alternative raw materials may need sourced to meet greater production numbers, records relevant to the original product design may be missing, or changes may be advisable to make manufacture more cost-effective. Accordingly, a CMO with applicable DFM expertise and the resources to foster effective communication throughout the relationship is an invaluable partner.

While lift-and-shift scenarios — wherein manufacturing is moved from one site to another without product or manufacturing process redesign —are ideal, they also are a rarity.  Consider that many legacy products have been manufactured for years and, during that time, records, drawings, prints, and/or tooling are either incomplete or have not been updated. Although the quality of the product and fit, form and function are meeting the requirements, the existing manufacturing process documentation may not always be recorded in the standard operating procedures (SOPs) or work instructions, or the latest technologies have not been incorporated to facilitate process improvements.