As a medical device or medical equipment developer, having in-house services for the actual manufacturing of the device or equipment is typically not cost-effective. It is less expensive and more practical to work with a contract medical manufacturing company to provide these specialized prototype and production requirements.
Selecting the correct contract medical manufacturing service is the big issue. For many companies, particularly when this is a first time in working with a medical device manufacturing service, it can seem difficult to know just what to consider.
Actual Experience
One of the key elements to consider is the experience and expertise of the medical manufacturing service you are considering. It is never a good idea to pair two companies in a project without any actual experience in the manufacturing of medical devices and equipment.
This is a very complex area of manufacturing with specific regulations and requirements in all aspects of the design and production components. Traceability of materials, validation of processes and complete documentation will be critical in getting device or equipment approval.
Capacity and Ability
Most contract medical manufacturing companies with experience in the industry offer assistance with prototype development and then transition into small to large volume production.
Some companies only work with prototype development and do no offer production. This will be a critical consideration as it will add to the logistic to consider once the device or equipment is approved and ready for production for sale.
Capacity and ability also include the volume that the company can handle given their existing work and their equipment, machines, and staffing levels. Ideally, the best companies will offer the latest in CNC equipment and precision capabilities to match your current and future needs on this project and additional device development in the future.