Increasingly, plastics are used in medical devices both as single-use products as well as reusable devices. The use of plastics, even for implantable devices is also on the rise, which means that many more plastic injection molding companies are jumping into this specialized market.
As a pharmaceutical company or an OEM in the medical field, finding the right provider will be important. To help weed out the newer, inexperienced companies in the industry with the established companies with top records for producing quality medical devices, be sure to research the following areas of their production.
What is your experience with similar projects?
When plastic injection molding companies have worked in the medical device manufacturing field for a significant amount of time, they will have a portfolio of past projects. While each is unique, it will provide the OEM with a good understanding of the background experience and expertise of the given company.
Top injection molding services will also be able to provide references, allowing for the OEM to speak directly with past or current customers.
What is your maximum capacity for production and your minimum production requirements?
Not all injection molding services will handle small orders or high-volume production orders. Understanding your anticipated demand for the device as well as how fast production will need to scale up will be important when narrowing down the suitable services.
Is the injection molding company ISO certified and to what certifications?
By using an ISO 13485 certified plastic injection molding service, you are working with a company that has met the most rigorous standards for medical device manufacturing. By choosing from plastic injection molding companies with this certification, and typically also the ISO 9001 certification, there is an assurance of working to industry standards and FDA requirements.
It is also common for medical devices to be molded and assembled in a clean room. Ask about the capabilities and the capacity of this type of production and ensure it matches production requirements.