Many medical device original equipment manufacturers (OEMs) work with a contract manufacturer on the fabrication and assembly of products for new product designs, especially when the parts need to be precisely machined or cast. In the case of parts made from engineered resins, it is essential that OEMs of medical devices find contract manufacturers (CMs) that do excellent, precise work the first time, every time.
Meeting of the Minds
While a part may be conceived and designed, it is still important for the OEM to choose a CM that has extensive experience manufacturing medical devices and is a good fit culturally. The CM must have the knowledge, equipment and resources to produce medical components with the accuracy and in the numbers that the OEM requires. For the two companies to share a corporate culture and an overall approach to work can also be beneficial in terms of the ensuing business relationship.
The collaborative process is much easier if the manufacture of an existing product is being transferred, all work instructions and current sources should be shared with the new CM. If a new component is being manufactured or a new product being launched, the CM may well be responsible for developing the assembly flow and the work instructions for the build.
Starting from Scratch
In an alternative scenario, if sources for components must be identified and inspected, a different sort activity begins. The entire development, qualification, and supply line management for components must be developed. Ferriot specializes in this type of relationship. This requires an experienced team who are familiar with the medical industries, with the processes and standards particular to medical injection molding, such as cleanliness standards, lot number traceability, medical drying procedures and superior tight tolerance precision molding.
When an OEM is working with a CM, there are a number of steps that can be taken to ensure that a medical device or medical device component is produced precisely and exactly as required on the first run and on every subsequent run. The accuracy of the process begins at the beginning; It starts with a clearly defined product.
The design and specification of any medical-related products must be performed in a very accurate and precise manner. The use of computer aided design (CAD) for medical devices or components is essential in the early stages. The plans created using CAD programs are themselves very detailed and accurate and this can help in the production of accurate components.
Once the flow, work instructions, and components are all in place, operator training and qualification starts. Pilot builds are conducted and comprehensive qualification of the finished product or sub-assembly is the last major effort in preparation for production. This should be carried out by the medical inventor of the product and/or a medical professional with knowledge of medical device production.
As the production phase is entered, having a good plan drives procurement, production and inventory. Having a realistic forecast upon which to build the production plan is very important. When it’s done well, the process will provide great customer satisfaction and great final product.
A Good Contract Manufacturer
There are numerous aspects to manage, when an OEM is participating in a new production program. A good CM will allow the OEM to remain focused on their core competency and intellectual property.
When the CM is truly serving the needs of an OEM, the OEM can spend less capital, hire fewer laborers, spend less time on quality control, worry less about purchasing and know that someone else is ensuring the technical skills of the people involved. The OEM can also control inventories at manageable levels, without being required to focus on details.
Perhaps most important, working with a quality CM offers a single point of contact for everything an OEM might need. There is no more worrying about whether all of the production partners will be able to supply the required components. A good CM takes care of these concerns well in advance.
At Ferriot, we know that manufacturing is complex, but we don’t think it should be more complicated for you than it needs to be. We think of contract manufacturing as a partnership. Like any good partnership, that means we work hard to ensure you get what you need at high quality, on time and on budget.
In Part 1, we discussed mold flow analysis (MFA) and the ways Ferriot uses it to improve the tool design process and, ultimately, the quality of the final custom injection molding we perform for our customers. In this ...