When it comes to industries that are really enjoying a period of growth and expansion, the medical device industry is one that sits high atop the list. Technology advances have helped to push this industry to the forefront and have really created a boom that shows no signs of slowing down. The focus moving forward seems to lean toward medical devices that are able to predict patient outcomes and risk by gathering key data. While there have been lots of developments up to this point, there is still a huge amount of progress to be made.
So, what exactly is involved in developing today’s high-tech medical devices? Whether you are a developer yourself who is looking to break into the field or just someone with an interest in where the industry is going, the process can be interesting, to say the least. Let’s take a look at some of the key steps that are required.
Market Research, Risk Analysis, and Funding
The first steps to developing a medical device aren't to jump right in and start with the design; rather, there is a lot of research and legwork. You will need to plan out the development of your design in detail and describe all the steps necessary along the way. There should also be market research done to ensure that your device will be something that is actually needed. It's important to question whether clinical trials will need to be conducted, as this will affect the overall cost. Then there is funding, how much will you need and where do you plan to get it from?
Move Into Prototyping and Trials
At this point, it is time to develop a prototype, which means you will need to use specific software to make it possible. If you are new to things such as PCB design tools, a PCB layout tutorial, such as the one offered through Altium can prove to be useful. Once your prototype is complete, you can move onto the trials.
The trials are a time where it's also important to get feedback from the users. You can take a look at what competitors are doing, how your device differs and, of course, do your market research.
Develop the Final Product
Once you have finished with your trials and the prototype has served its purpose, you are able to make any modifications necessary and set yourself up for the final development stage. It's important to take many things into account at this stage involving the requirements of your customer and risk management. As well, you want to be well aware of all the regulatory requirements.
From here, it's time to think about branding and marketing so you can prepare to launch your device, which is the final stage.
This condensed look at what’s involved in medical device development can help give an overview of the many steps, as well as the incredible amount of planning and research that goes into a single device.
