Medical Device Commercialization Overview
Designing and Developing the Product in Detail
How will your product be designed?
Once you’ve established that your basic design is feasible, you can begin to design and develop in detail, the individual components that will be manufactured and assembled to form the product. Up to this point, all efforts have gone to ascertaining that the medical device idea is a sound one: it meets a market need, it will improve patient outcomes and/or lower healthcare costs, the functionality it provides can be reliably packaged into a manufactured product, it can be sold using an economically viable business model, and a pathway has been identified that will allow the product to be approved by regulatory bodies as being safe and effective.
Forma can help transform your medical device design from the rudimentary stage it exists in at this point, to its final form with all components and assemblies designed in detail, documented, and ready for manufacture. It is important to note that once feasibility has been established, all design efforts moving forward must be done under Design Control, as specified in the FDA’s Quality System Regulation. Forma can help you ensure that all design activities are conducted in accordance with the Quality System Regulation and that an adequate design history file is maintained.
Detailed design and development is an iterative process that requires multiple rounds of design and testing. Product requirements specifications must be finalized and translated into “design inputs” which establish the performance benchmarks that must be achieved. Part designs must be conceived, modeled using computer aided design (CAD) software, and tested (either analyzed digitally or tested on prototyped physical parts). Test results form “design outputs”, which must be evaluated to ensure they conform to design inputs.