6 Steps to move a medical device innovation from prototype to market

Wambui Gachiengo, is an innovation leader in the medical device industry with experience in both North America and East Africa. She shared her insights withe Wilfred Njagi on the process of taking a device from idea to market.

Wilfred: At a very high level what are some of the steps you need to go through from prototyping a medical device innovation to commercialization

Wambui: Always start with the user and keep the end user front and central in the entire process. The first thing to do is to observe and have lots of conversations with people who would be using the device. Once you understand that space then you need to do a lot of homework on the clinical and technology space as well as understanding competitive devices. Once all of that is understood then you can really nail down your requirements and really understand what the device is that you are going to develop. Taking that you then start the development with a very clear understanding of what the user needs. Once you do the development you have to go through the regulatory process and you have to do a lot of testing. That includes user feedback so that you iterate until you get to a device that the market wants and that can be approved from a regulatory stand point and that can also be commercially successful.

In summary :

  1. Start with the User in Mind
  2. Research on the clinical & technology space and understand competitive devices
  3. Nail down the requirements for the development of your device
  4. Start developing with the user needs in mind
  5. Do a lot of testing, incorporate user feedback and iterate until you have a marketable device
  6. Go through the regulatory process

Wilfred: Can you speak to documentation. I know if you are preparing to go through regulatory then all these steps you mentioned need to be documented as you make iterations in your design history.

Wambui: For especially many engineers and some human being in general the documentation is often that thing which is not fun. We want to be developing and building stuff. But if we think of the documentation as part of the development that will enable us to develop a device that is useful, approvable and even commercially successful, the documentation becomes less painful. Documentation would be first of the user requirements. You document those very clearly so that you are very clear about what it is you need to be developing as well as things about the regulatory process. What class of device are you developing? then you have to keep a good record of the flow down of those user requirements to technical requirements then going even further to the testing and the validation of your device. You have to keep a really good and complete design history file and what that means is that any time you make a design change, that has to be documented. When you do your risk analysis and testing, all these have to be very well documented so that you have a good package for your regulatory approval process.

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