The level of specialization and services offered by different companies offering medical device manufacturing will vary based on several factors. For a startup company or an entrepreneur looking for a service for a first-time medical device manufacturing opportunity, getting the right contractor can be the difference between success and failure.
With all contract medical manufacturing, the first inclination of a new company is to look at costs as the single most important option. However, low bids from contractors may be a result of limited services, delayed production dates and perhaps a lack of understanding of the scope and requirements for validity testing and documentation required in medical manufacturing.
Ask About Quality Control
Any company offering contract medical manufacturing needs to have a robust, recognized and highly comprehensive quality control system in place. This includes a careful monitoring and selection of a supplier for parts and materials as well as the services they complete in-house.
Don’t hesitate to ask about the specifics of the quality control system the company uses. Also, verify how the company selects the suppliers of the raw materials or components that may be outsourced.
Full-Service is Superior
Ideally, choosing a company for contract medical manufacturing with limited outsourcing is critical. This allows greater and more complete control over every step in the processing. It also eliminates irregularities that can occur should an outsourced aspect of the manufacturing changes or suddenly beings using different materials, processes or systems.
It will also be critical to find a contract manufacturer with extensive experience not just in the medical device field but in the specifics of the device you are manufacturing. The more complex the device or component is and the more systems involved, the more advanced and experienced the manufacturing company will need to be to ensure that the prototype development and production is handled efficiently and on schedule.
