It is a long process to get any medical device from concept through to cleared and production. This is not only a lengthy process, but there are many pitfalls and errors that can create additional delays, some which can result in the company simply running out of funding and time to get the product to market.
The most common errors that occur in medical device product development can be easily avoided if they are recognized and understood as potential problems.
The single biggest error in medical device product development is to choose services and providers based on price alone. In the medical device manufacturing industry quality control, ISO 13485 certification and experience are going to be a direct factor in how efficient and knowledgeable the provider will be.
By choosing experience over cheap production, it is possible to find ways to streamline the production process or choose lower cost materials that are a better match for the product use.
Failing to Bring in Production Engineers
Using an in-house team to develop the concept is one thing, but turning to experts in medical device product development adds another layer of expertise to the project. It can also assist in preventing months of design efforts in a product that cannot be manufactured to the required standards.
Not Exploring Material Options
With specialized companies that work with plastics and injection molding processes, it is possible to find a better material for the design. New technology in plastics has created options for plastics that self-lubricate to reduce tissue damage, which helps to allow tissue to form with the implant as well as plastics that are resistant to bacterial growth.
Not Understanding Documentation and Validation Needs
Another critical error that many companies make in choosing an injection plastic molding service is to choose a company without an understanding of the documentation needed for validation and documentation.
Issues such as traceability of raw materials, documentation of the manufacturing process and full recording of any changes in any processes need to be maintained by both the company as well as the manufacturing service.