A medical device company taking off on the success of a new product must consider the pros and cons of performing manufacturing in-house versus outsourcing the process to contract manufacturers.  For the OEM there are many marked advantages to partnering with a ‘Full-Contract’ Medical Device Manufacturer.  For starters, the company wouldn’t spend resources on identifying multiple vendors, but instead would work with a single dedicated partner. A Full-Contract Manufacturer will also have established vertically integrated operations and expertise in place, starting with Engineering, Manufacturing, Packaging, and so on.  This one-stop shop model would go a long way in contributing to shorter lead times and improving quality.

Beyond basic manufacturing capabilities an OEM should expect the full-contract manufacturer to possess:

  1. A full suite of Quality certifications such as ISO 13485, GMP and 21 CFR Part 820
  2. A qualified and trusted supplier network
  3. Certified Cleanrooms and Warehouse areas
  4. Additional vertically integrated operations such as Packaging & Kitting and an In-house Engineering team.  Some contract manufacturers such as LSO, take it a step further and provide a full turnkey solution with support activities such as Packaging Validation, Sterilization & Validation and Fulfillment & Distribution Services.
  5. Efficient and detailed processes in-place for failure mapping and correction.

Partnering with a full-contract medical device manufacturer an OEM is relieved of the responsibility of qualifying any further suppliers and will also avoid having to manage and deal with multiple vendors and subsequently any arising conflicts.  These responsibilities are passed on to the Full-Contract Manufacturer.  A good synergy between the OEM and contract manufacturer is essential for a successful relationship. So when choosing a Full-Contract Medical Device Manufacturer, OEM’s should look for Open Communication channels, accountability and traceability of operations.  Finally, from personal experience here at LSO, we know that collaborating with the OEM on a project from start to finish, increases the commitment levels of both parties to see the project to a successful end.