For companies with an idea for a new or innovative type of medical device, turning to contractors to provide parts and components is a cost and time-saving option. However, there are some important considerations for any company to consider when choosing partners for medical device product development.
As a general rule, it is important to only use companies for medical device product development that are ISO 13485 certified. This means the company has voluntarily gone through the process of developing standards and implementing them across their production facility that meets or exceed the standards of the ISO or the International Organization for Standardization. Most of the companies that have the ISO 13485 certification, which is specifically for the production of medical devices and equipment, will also have ISO 9001 registration, which is quality control across the facility.
In addition, look for companies that will also have the following three elements to the services they offer.
Intellectual Property Protection
In many ways, trusting the idea and the development of a part that could be a groundbreaking change in the care of patients requires complete protection for the Original Equipment Manufacturer. Look for companies that have a written policy on confidentially and intellectual property protection as well as a solid reputation.
Clean Room Molding and Assembly Services
For many types of devices, it will be necessary to use clean rooms for medical device product development. Not all companies that offer injection molding for thermoplastic and thermosetting parts offer this service.
Understanding of Necessary Documentation
In addition to the production facilities as well as the protection of the idea of the product, it is important that the company understand the complexities of medical device development with regards to documentation. This will be essential in the approval of the device and must contain detailed information on the process as well as traceability of materials used.