Mobile apps have the potential to transform the way we access information about our health. But with users relying on medical apps to provide accurate and reliable information about their health, the stakes for getting an app right are high.
As a leading app development firm, Raizlabs helps clients navigate how to make a medical app by providing expertise and assistance to companies interested in exploring a new area. In this article, we’ll take a closer look at how medical apps differ from other consumer apps.
First, what are medical apps?
According to the Food and Drug Administration (FDA), medical device apps are classified as apps that aid in the diagnosis or treatment of disease.
These apps can help users collect important information about their health, whether it’s managing chronic pain, tracking a sleep disorder, or accessing strategies for managing mental health symptoms.
How do medical apps differ from consumer apps?
Most consumer apps are based on collaboration between a company and an app development partner–but due to their sensitive nature, medical apps also require regulatory oversight from the FDA.
The additional documentation, planning and testing requirements place additional responsibilities on our developers, and can impact the cost to build an app. When investing in a medical app, keep in mind that:
- Timelines may be longer than a non-regulated application. Formal human factors studies may be required to be performed as well, adding to the cost and timeline of the project.
- You’ll work with a larger team of experts. In addition to the app developers who will create the technology behind your app, you’ll work with experts in regulatory affairs, risk management and mitigation. These experts will have their own verification and validation testing processes, and together, everyone will have their own responsibilities in driving and testing the requirements of your medical app.
- Additional documentation will be required. Raizlabs will work with you to determine if your application needs to be submitted for FDA approval, as would be the case with Class 2 medical devices. In the case of a Class 1 Exempt application, we would follow the appropriate guidelines should the FDA require our documentation.
- We’ll adapt to your expertise. For companies already operating in the medical space, they are likely already set up to produce regulated software or hardware within their own Quality Management System, so we often adapt to their own internal process and develop apps for them within their given framework.
Raizlabs can work with a client’s own Quality Management System or within our own framework to ensure the app is designed to the highest possible standards.
Regulations Can Result in a Stronger Product
When designing a medical app, you will have to abide by regulatory rules set by the countries where you plan to distribute your app. Clients should expect a much more rigorous level of documentation throughout the development process, including a strong verification and validation procedure for medical apps.
Although this additional level of scrutiny does add time and complexity to the app development process, these things make your product safer and more likely to succeed.
Raizlabs approaches additional regulatory requirements by working with our clients and the FDA to determine an app’s medical device classification, such as Class 1 Exempt or Class 2, which denotes the risk level of a device to a patient.
Next, we determine the level of controls and documentation that are needed for the software development process for this specific medical application. In all cases of a regulated medical application we take special care to develop the relevant aspects of the Design History File, which helps us demonstrate the app was developed in a safe and effective manner.
Maintaining a Medical App
Mobile app developers find that clients often underestimate the effort needed to maintain an app over time.
For medical apps, you can expect updates much less frequently than a typical consumer application, although updates will likely be required for every major OS release.
Additionally, the FDA maintains Postmarket Requirements, which are the rules that you must adhere to when you have a medical device deployed to the public. This ensures that we’re aware of any issues caused by our medical app or anomalies that were not predicted through our original trials of the app.
Because different operating systems can impact medical apps’ functionality, medical apps must be thoroughly vetted on every operating system and new device on which they have the potential to be deployed. Raizlabs also creates protections to either warn the user or prevent the operation of a medical app on any platforms where it hasn’t been tested.