Guidelines For Selecting A Medical Device Contract Manufacturer

By Keith Calvert, Director Development Engineering, Contract Manufacturing West Pharmaceutical Services, Inc.

Twenty years ago, many pharmaceutical and medical device companies viewed device contract manufacturers (DCM) as vendors or suppliers. The relationships were purely transactional. Pharmaceutical and biopharmaceutical companies were somewhat reluctant to outsource higher risk, more complex device assemblies. Today, they are looking for ways to reduce internal resources and expect more ownership of the supply chain, which means contract manufacturers are now providing additional services including drug handling, cold chain storage, sterilization, analytical testing and final packaging.

Collaborating with the right DCM early on, in the process can have many benefits, including risk mitigation, innovative strategies and a faster speed-to-market.

Selecting an experienced device contract manufacturer is an important decision that may impact a drug product’s ultimate success, so a methodical risk-based approach should be taken. Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.