One of the many challenges for startup companies, entrepreneurs, and smaller OEMs in the medical device industry is the cost factor. It can be years to move an idea through the design and approval phase, and this is also a time when there is a large cost burden and no revenue from the product.
For these companies, working with external companies for medical device product development can provide a definite advantage. These outsourced companies can enhance the entire process, and they can be bound to confidentiality about the project, protecting the OEM’s market potential.
Smaller companies and entrepreneurs are not likely to have internal teams of engineers to work on medical device product development. By working with a company that offers both the engineering services as well as the ability to prototype and move into production, the entire process is simplified and streamlined.
With injection molding, which is a standard option for medical parts, working with an injection molding service with extensive experience in producing medical parts and components, is an asset. These companies know the materials, understand the verification processes required, and also know the regulations and design approval requirements.
Material and Production Costs
The best end-to-end services for medical device product development work with the OEM to determine the best materials to use for the part or component. The choice of materials is not only essential for approval, but it can have a significant impact on the life cycle of the part and its durability in the given application. Materials can also be selected to meet FDA and other standards based on the type of medical device.
The material and the production of the injection molds and the parts can also be managed for cost factors. The injection molding company can create production cost options, presenting the OEM with possible solutions to help to keep the cost per component as low as possible while not compromising the safety, quality or adherence to standards.