Developing mobile medical apps is like being in a mixed martial arts ring
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I recently registered to attend a seminar on MMA for work. Then, I happened to mention this plan on social media. Almost immediately, I was inundated by comments and questions from colleagues, friends and family. Why are you going to a mixed martial arts seminar? When did you take up martial arts? One friend questioned, with significant skepticism, my judgment in pursuing a new career in martial arts!
I was, in fact, signing up for a ring-side seat at a seminar regarding the current thinking of the FDA with respect to its intended guidance on mobile medical applications (MMA).
So, as any glib user of acronyms can attest, I found I had some explaining to do. Mixed martial arts (MMA) is a full contact, center-ring battle that can be exciting, challenging and fraught with danger. A number of rules have evolved around it and continue to evolve in order to protect the participants and make the sport safer. Hold on! Designing, developing, testing and delivering FDA-approved mobile medical apps has some surprising similarities to the definition I just provided for mixed martial arts. Let’s explore this a bit further.
What is a mobile medical app?
The Apple App Store currently has about 40,000 apps that are health-related. By the time this blog is published, that number will probably increase by a significant factor. Most of these apps contribute in a benign way to our health and well-being by assisting us with monitoring our diet, tracking our exercise and reminding us to take medications. Other medical apps, however, use data to be predictive. These apps provide guidance on or diagnosis for active disease management or even function as a central command module for controlling connected physical medical devices. So how do I know if my app is considered a “medical” device?
A mobile medical app meets the FDA definition of a regulated medical device when it is intended to be used as an accessory to a regulated medical device or when it is used to transform a mobile platform into a regulated medical device. So what does that mean?
It’s all about the intended use of your mobile app and what risk might be associated with that intended use. It is the intention for medical use and the risk level of something being potentially harmful if it goes wrong that moves the needle into classification as a medical device.
Unregulated mobile apps generally fit into these categories:
Beyond these examples is a whole subset of mobile medical applications that may be subject to FDA enforcement discretion. Low-risk applications such as patient motivators, patient day-timers, some telemedicine applications and interfaces to patient health records are relatively low-risk and may not be subject to enforcement by the FDA. This is not always the case.
Mobile medical apps that clearly introduce the risk of harm or death if they fail or malfunction become classes of intended use that are subject to regulation. These apps require pre-market approval from the FDA before they can be marketed and sold. Generally, apps that perform functions such as active patient monitoring, controlling connected devices and modifying and analyzing data (performing calculations on data in order to be predictive or prescriptive in nature) are considered to be within the scope of the regulated mobile medical app class II or III. You can learn more about FDA classification of devices on the FDA website.
Here’s the catch: even when a mobile medical app falls within the gray area of possible enforcement discretion, the FDA still recommends that these apps be developed within a quality system.
Peruse the FDA website. There are examples of clearly regulated medical mobile applications and clearly non-regulated applications, as well as examples of what may fall into the gray areas in between. When in doubt, contact the FDA and get expert help in determining if your device is subject to regulation.
To be safe, establish and follow good design controls within a quality system. What does that mean? Having a quality system means the organizational structure, responsibilities, procedures, processes and resources for implementing quality management are defined and followed. A simplistic definition of a “design control process” is a controlled means to document and track the history of your requirements, design, development, verification and validation. It also has means for linking information and performing review and approval.
So you want to enter the mobile medical app arena?
Creating FDA-approved mobile medical apps can be a challenging ring to enter for some mobile application developers. Most have not thought about implementing design control measures or about using collaborative development tools to support the development and delivery process. Many are unaware of the regulations and how these may impact them after they deliver an application. So they get caught, unaware, in a choke hold of regulations. They enter the mobile medical app arena unprepared, lacking the needed tools and processes, only to be called out again by the FDA. Many mobile application development teams believe tools and processes slow down the speed of development and innovation and are costly to deploy so they attempt to work without tools or with tools that are not sufficient enough to support a good design control process. But it is much, much more costly and challenging to have the center-ring referee call you down for the count after you have already spent your time and effort designing, developing and marketing your app without any tools or controls in place. The FDA does not look kindly on attempts to reverse-engineer design history!
The best approach is to establish a process up front and implement this process with the correct tools. IBM Rational provides a fully-integrated solution for requirements definition and management, systems and software design, verification and validation, and change control. These tools provide a linking mechanism and a review and change process. This is software engineering 101 best practices for any development process and mobile medical app development should be no different. The way to become an MMA champion—emerging from the ring with a well designed, safe and effective mobile medical application—is to enter the ring equipped with the right tools and processes.
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Ladies and gentlemen, let round one begin!