Process Verification and Validation
The technology transfer phase is a time for the CMO to prove precisely how it is going to produce a device. First, there will be feasibility studies to determine whether the CMO’s existing equipment is capable of handling the materials and performing the processes to produce the customer’s product. Then through process characterization and process development, the CMO will determine what methods, machinery, and tools to use to make the device to the customer’s requirements, including initial equipment settings. Then there will be engineering studies to determine exactly how to calibrate equipment to get the desired results.
Scale-up studies and equivalency testing will be necessary to ensure consistent product performance as the CMO ramps up the manufacturing volume. To transition from 50 or 500 units to 50,000 units or eventually 5 million units, the CMO must test devices at frequent milestones along the way to ensure that the device’s physical properties and performance meet design requirements. For example, in scaling up production of an LFI device, the CMO must evaluate whether the test solution still performs as it should when made in incrementally larger batches. The LFI device from a batch of 50,000 devices must perform in precisely the same way as a device from a batch of 50 devices, i.e., negative and positive readings must appear in the same way as they do on the reference device or per the OEM’s specifications.
During OEM-CMO technology transfer, a prototype design does not enter one end of a “black box” and start coming out the other end at great quantities and speeds. Instead, tech transfer should entail a transparent, methodical, stage-gate process, with frequent communication between partners from day one until commercial-scale product delivery.
It is important to remember that tech transfer is not product development. Rather, during this important phase of the product life cycle, the CMO engages in process development to devise a way to make the device owner’s product efficiently and in large volumes. When business partners are aligned on tech transfer’s purpose, priorities and protocols, they can work together to successfully take medical device innovations from the bench to the big time.