Medical Device Development Phase II Feasibility

A. Verification of Concept Prototype

Phase two of the medical device contract manufacturing process focuses on the technological product risks and how these risks will be overcome. It may be necessary to test the capability of a medical prototype design concept before further deliberation is given to it. In this situation, a verification of concept prototype is built. After the development of the prototype, a prototype approval meeting is planned. Verification of concept medical prototypes is more often a simply constructed prototype model. This reveals only the features that are in question and proves their capability. The primary objective of a verification of concept prototype model is to help develop a medical device prototype which is going to be ready for medical device contract manufacturing.

Initially, the verification of concept prototypes may be scale models, as in the case of some large products, or models made of other more easily formed materials. Sometimes a verification of concept prototype may include only certain features of our medical prototype design. They may also be created so that we can perform some feasibility testing on our conceptual design, if it is a relatively new and unique idea. Often, with the development of verification of concept medical prototypes, it is not practical to have them created out of the same material that will be used for the final product. For instance, machined steel may be utilized for a verification of concept medical prototype instead of casting. Cast plastic may be utilized as opposed to injection-molded pieces, or other methods that lend themselves to lower-cost verification of concept medical prototyping. The development of prototypes in many industries is even a specialized field for technicians because prototype cost can be significant in the overall research and development process.

B. Alpha Prototype

During the medical device contract manufacturing process, once the verification of concept for medical prototype design is approved, the alpha prototype test plan is to be written. This test proposal is generated prior to the design of the alpha prototype. This written alpha medical prototype test plan document ensures that the required operation of the unit is accounted for and explains in detail the testing requirements that the alpha medical prototype must meet. After authorization of the alpha test plan, the alpha prototype is designed and detailed to meet the design specifications. The overall goal of the alpha medical prototype design is to create a functioning prototype that meets all of the medical device design specifications. Realistically, final production tooling is not accessible at this juncture, so rapid prototyping procedures are usually utilized. ProengineerPortal uses several different prototyping procedures to rapidly produce plastic part designs and injection molding designs without the necessity for costly tooling or industrial design services. Upon successful completion of the alpha medical prototype testing, an evaluation meeting is held to assess the results of the testing and to determine where changes are necessary. These changes will be built-in to the beta medical prototype design, which would be the next step in the product development.