Proving medical device feasibility is the first important milestone in bringing a medical device to market.

The bulk of device design and development can’t happen until feasibility has been proven. Read further to understand what feasibility means and what needs to happen before you can prove feasibility.proving medical device feasibility

The Process

Medical device development starts with taking an idea for a new or improved device and turning it into a rudimentary design concept. Once you have a concept, you’ll develop it to the point that allows you to be able to build a working model. You’ll use that model to test and determine if it does what you expect it to do. That model – your proof-of-concept – won’t necessarily prove that you have a path to a commercial product. You’ll establish that with the feasibility prototype.

The purpose of a feasibility prototype is to determine whether you can build the envisioned device using already existing components and technologies, or if you’ll need to do some customization and/or invention. That will give you an indication of how big the development effort is likely to be, and the extent of the resources you’ll need to commit. Developing a feasibility prototype is more rigorous that developing a proof-of-concept model  (depending on product complexity, it is sometimes more economical and efficient to forego proof-of-concept activities in favor of moving directly into feasibility). The feasibility prototype will tell you if your concept is technically feasible, and can be produced in a way that makes sense economically.

The feasibility prototype is similar to the working model you built to prove your concept. But whereas the proof-of-concept was most likely a simple device, designed to prove principles, the feasibility prototype is the proof-of-concept model pushed into a form that manifests what the ultimate commercialized product might become. In addition to exhibiting the device’s major functionality, the feasibility prototype will also include user interface elements. You can think about it as the product in its first, very rough embodiment.

The feasibility phase is among the most important parts of the project. For the device to be cleared by the FDA so that you can market it, the development of the device’s design must be done in a prescribed manner and fully documented. This is know as Design Control. The thing about feasibility is, you are free to experiment and try different approaches to achieve your design goals without having the burden of documenting each step. Once you’ve proven feasibility though, and have moved into actual design and development, you will need to have a design control system in place and adhere to its guidelines. That is actually a good thing because it ensures – to the extent possible – that devices are designed in accordance with sound engineering principals, and that any potential for device failure and resultant harm to users or patients has been thoroughly considered.

Design Control does add a significant administrative burden and cost, however, so you wouldn’t want to have to implement it until you’re sure that your device is functionally viable at minimum (commercial viability is another question, and developing the feasibility prototype should provide evidence that the device can be manufactured at a cost that can support a business model).

Proving medical device feasibility sets the stage for the detailed development that will follow. It’s the first significant milestone in your journey, and is often the key to opening the funding coffers.