Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.
Documentation
At the root of an effective transfer is clear documentation. This must incorporate a robust detailed design process. This commonly includes:
- User requirements.
- Functional requirements.
- Design specifications that can be met by a reproducible process.
- Trace matrix linking requirements to the validation testing.
- Establishing specifications prevents redoing aspects of the validations.
- FMEAs establish how well the output meets the requirements.
- Accurate drawings and bill of material
The FDA requires procedures that describe that the transfer process is correct confirming the design can be incorporated into manufacturing methods and procedures and providing for a production environment that is in compliance.
Manufacturing Instructions and Procedures
Work instructions and SOPs need to be in place based on the validated processes. Robust training of the operators on these procedures is critical and is often overlooked.
Regulatory Requirements
Understanding the correct submission requirements and the time for review is critical. This also needs to include packaging and labeling details.
Sourcing
Identifying the approved suppliers that provide components and raw materials that consistently meet specifications can be a challenge. They must consistently provide timely delivery to order. In some cases, these suppliers may need to provide their certification status and a quality agreement may need to be in place.
Facilities/Equipment
The physical manufacturing environment must be ready to receive the transfer. Equipment must be in place and validated. Spare parts need to be made available. Any environmental requirements such as clean rooms or appropriate temperature or humidity controls must be ready and potential safety issues must be addressed.
Scale-up
In some cases, small batches were used during the early development phases. The required manufacturing batches may be larger. At some point, actual batch sizes need to be produced on the validated equipment. The results of these batches may be part of the submission to the FDA.
Acceptance criteria
The acceptance criteria that was established earlier in the design phase must be achievable on the manufacturing floor. The appropriate test methods and inspections need to be transmitted to the manufacturing floor and the quality organization.
Distribution
Any special criteria such as size, weight or temperature considerations need to be established and in some cases, validated.
Translating all the design documentation and processes is a monumental task. Rework costs in time and money, although not completely unavoidable, can be minimized. In the end, the design transfer process produces a finished product that meets the design requirements in a timely cost effective manner.