It is time for you to design a device. You have a great idea. People support you in your idea. You have adequate funding to pursue your plan. It is time to get started.
You plan to create a medical device. Maybe it cleans teeth; maybe it pumps fluids into or out of the body. I don’t know. You haven’t told me yet, but you need to know whether to make a new dedicated device, or turn it into an application for a mobile device. Let’s look at the pros and cons of making dedicated devices and applications.
By making a dedicated device, you have complete control over the product. You decide how it looks, what it does, and when or if it is updated. You can pretty well guarantee that your device will continue to perform in the same way as or better than the day it is purchased. Making a dedicated device also means that you will have to deal with hardware development costs including time, as well as distribution costs that would not have been incurred with just software. Additionally, the burden is on you to ensure that your device passes FDA regulations.
Creating an application is easier up front. You were going to have to develop the software anyway. There is no hardware to be made or worried about or distributed. The lack of hardware is also the downside of this approach. Every time that any device you support gets an OS update, you must be sure that your application not only works, but also that the OS update didn’t open up any security flaws that could affect your device. With medical applications even more than regular ones, if it stops working for even one day, it could cause major problems at hospitals and if it doesn’t work, that may be enough to send users to a “more reliable” device.
Both routes are viable and products have successfully used both in the past. In the case of the applications, updates should come with plenty of warning, and should be testable. Both sides have risks as well. If there are hardware issues or the battery won’t last a whole day, then the manufacturer is the one in charge of fixing it or recalling it.