The most crucial step of Medical Device product development
Proving the feasibility of medical devices is the first important milestone in bringing medical device to market.
Much of the design and development of the device will not take place until feasibility is proven. Read on to understand what feasibility means and what needs to happen before you can prove feasibility. Promotes the feasibility of medical devices
The development of medical devices begins with taking an idea for a new or improved device and turning it into a basic design concept. Once you have a concept, you develop it to a level that allows you to create a working model. You get used to testing that model and finding out if it does what you expect it to do. That model – your Proof of Concept – does not have to prove that you have a path to commercial production. You set it up with a possible pattern.
The purpose of a feasibility prototype is to determine if you can build a vision device using existing components and technologies, or if you need to make some customization and / or innovation. It gives an indication of how big the development effort is and how much resources you need to commit to. Developing a prototype that makes it possible to develop a proof-of-concept model (depending on the complexity of the product, it is sometimes more economical and efficient to abandon proof-of-concept activities in favor of going straight into the possibility). Your concept will inform you of a possible prototype if it is technically possible and can be produced in a financially understandable way.
The feasible design is similar to the work model you have built to prove your concept. While the Proof-of-Concept is a very simple device, designed to prove the principles, a feasible prototype is the Proof-of-Concept model, which reveals what the final commercialized product will look like. In addition to demonstrating the main functionality of the device, the feasibility prototype also includes user interface elements. You can think of it as a product in its first, most rigorous incarnation.
One of the important parts of the project is the feasible phase. In order for FDA to clear the device so that you can market it, the design of the device must be done in the prescribed manner and fully documented. Know that it is design control. The thing about feasibility is that you are free to experiment and try different approaches to achieve your design goals without the burden of documenting each step. Once you have proven the feasibility and turned to actual design and development, you must have a design control system and adhere to its guidelines. This is actually a good thing because as much as possible – the devices are designed in accordance with the principles of sound engineering, and any potential for device failure and harm to users or patients is fully considered.
Design control adds a significant administrative burden and cost, however, you do not need to implement it until you are sure that your device can function to a minimum (commercial feasibility is another question, and the prototype should be developed to prove that the device can be manufactured at a cost that supports the business model).
Proving the feasibility of medical devices dictates the stage for subsequent detailed development. This is the first important milestone in your journey, and it is often crucial to open fund boxes.