By: Jonathan Baran
With the recent explosion of mobile technology, applications only possible in our imaginations can now be brought to the devices sitting in our pockets. If executed correctly, these apps have the potential to transform clinical practice.
Before embarking on a potentially expensive development process, however, it is important to ask some important questions. Below is a sampling of those questions.
Ideation and Vetting
What is the problem your app solves? Who has that problem?
It’s common in application vetting to see ideas without a clear focus or intended target customer. When determining the merit of an app idea, it’s important to have a clear idea of the problem and who has that problem. Without these important points, it’s easy to lose focus for the application.
At this early point in development, it’s important to ensure that your potential users do have the problem you’re tackling. To that end, try and talk with as many potential users about the problem you have determined. Conferences such as AMIA and Health 2.0 Conference are great venues, as they are full of potential customers for your app. After talking with users, it’s very common to discover that you do not fully understand the full extent of the problem, which may force you to change direction.
It’s important to ensure that the problem your app is solving is not just unique to you. A common trap people fall into is solving a problem which is actually not a problem or has already been solved more efficiently. This is why it’s important to get adequate feedback from people who have experienced the same problem.
Does your app already exist? Why does it not exist?
Before jumping ahead with a new application, you should first determine if your application already exists, and if not, why. More than likely you’re not the first to think of this app idea. To determine if an application does exist, browsing through applications on the Apple App Store or the Android Market will probably suffice.
If the application does exist, determine what functionality could be added (or removed) from the original application to justify the creation of a new application.
It’s important to know what functionality is needed vs. what functionality is nice to have. Sometimes the best app ideas take other applications and make them simpler and more efficient. Other times, one additional feature makes a good app great.
If the application does not exist, determine why it does not. Has a new technology just been made available that makes a previously impossible application possible? Did someone previously try to make your app (or think about it), but then fail?
It’s important early on to determine which category your app falls into and strategize accordingly. The best way to find out if your app idea was attempted is by asking around. It might be that previously the app lacked a crucial feature or that the developers may have been too ambitious and tried to have their app do everything. It’s sometimes a fine line to walk between an app not doing enough, and an app doing too much.
Will your application be considered a medical device?
From the beginning of your product development cycle it’s important to determine if your application could possibly be classified as a medical device. According to the FDA, a medical device is
… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.
Essentially, what this means is that if your device (ie. cell phone or other mobile device) has an intended use to diagnose, treat, or prevent disease, it could potentially be classified as a medical device.
The phrase “intended use” is where the grey area begins. “Intended use” falls on the party responsible for labeling the device, and is determined by how these potential uses are conveyed in advertising, oral/written statements, marketing, and product labeling.
The topics discussed above are just the starting point for determining FDA-compliance, but it is important to always be cognoscente of these factors early in product development. If you would like more information I would recommend the free ebook on FDA Regulation for Mobile Health. However, it’s important to always consult your legal team before making final decisions.
FDA Clearance required:
- Airstrip OB
- Wavesense Diabetes App
FDA Clearance NOT required:
- HealthFinch UPDRS App
- Epocrates Essentials
Does your app have a potential positive ROI?
For many potential creators, just having an app which solves your problem is more than enough to make you happy. However, if your ultimate goal is to create a successful (and profitable) application, the development costs must be assessed.
Although app development may not take very long, it does come at a price. A good developer can charge between $100-$150 an hour, with the best charging $150+, bringing the price tag of a basic application to around $8,000 to develop. Add in any additional development costs (server backends, websites, etc.) and an app idea could easily reach over $25,000.
With those prices, it’s important to make sure you’ve thought about the above questions to aid in assessing the market and potential regulatory barriers. Often times, a good developer will aid in determining whether or not an application has the potential to make a positive ROI.
These are just some of important questions to ask yourself before you move forward with your medical application. In future articles we will discuss how to design an app that meets the needs of the medical community.
Jonathan Baran is co-founder of HealthFinch, a software development development firm that specializes in mobile medical app development.