Mobile Apps & Software Medical Devices

Mobile phone applications allow people to maintain and improve their health by allowing the user to measure: heart rate, blood pressure, blood glucose; count calories; assess exercise regimes and get details about medications.

Mobile applications are mostly simple to use, still, some of them, if they meet certain medical criteria, can be treated as Software Medical Devices. They can also be regarded as Customer Engagement Programs (CEPs) if they are distributed via online distribution platforms (Google or Apple stores for example).

We all know that a Mobile App is a computer program designed to run on mobile devices such as smartphones and tablet computers. This should be distinguished from digital files, like video, PDF document or Excel spreadsheet for example.

When developing mobile apps, it is important to consider the constraints and features of the devices. Mobile devices run on battery and have less powerful processors than personal computers and also have more features such as location detection and cameras. Developers also have to consider a wide array of screen sizes, hardware specifications and configurations because of intense competition in mobile software and changes within each of the platforms.

When a mobile app is developed, it is first tested within the development environment using emulators and later subjected to field testing. Emulators provide an inexpensive way to test applications on mobile phones to which developers may not have physical access. As part of the development process, mobile user interface (UI) design is also an essential in the creation of mobile apps. Mobile UI considers constraints and contexts, screen, input and mobility as outlines for design. Mobile UIs, or front-ends, rely on mobile back-ends to support access to enterprise systems. The mobile back-end facilitates data routing, security, authentication, authorization, working off-line and service orchestration. So, we need to be aware of all the above when developing a mobile app.

Software medical devices have a medical purpose and may help in diagnosing, preventing, monitoring, treating or alleviating disease, injury or handicap. Generally, health care providers, clinical trial investigators, patients and caregivers may use SMDs for activities like calculating doses, medication reminders, tracking symptoms and diagnosis recommendations for individual patients. Like other types of medical devices, SMDs are regulated by boards of health globally.

A variety of Mobile Applications distributed via online distribution platforms and Software Medical Devices open up a vast range of interactions between the pharma industry and various users of medicinal products. This unleashes great opportunities for instant communication and thus better customer’s engagement. Such interactions where there is opportunity for a patient, consumer or healthcare professionals to communicate safety information, such as adverse events, to a pharmaceutical company directly or through a third party vendor are called CEPs. CEPs are a subject for strict FDA, EMA and other authorities regulations and they need to be monitored.

Strategic framework for app investment determination

Investment Consideration

Technical support

• How many updates/versions do you expect to have?
• Does the information within that app change rapidly? Staffing
• How time intensive will the development and ongoing management of the app be? Promotion and PR
• How big is the target customer group? How difficult is it to reach them?
• What is involved in the promotional driver mix?
• What resources are needed to build and maintain traffic to the download page? Platform Decision:
• What is the cost of launching on Android/iOS platforms, or both? Appropriate Functionality:
• Have you included only those functions you know to be beneficial to our customers?

The risk of an app

Adverse Events/CEP

• Does the app design allow for two-way communication and the reporting of adverse events?
• How do you monitor other forums where users can review your app? Review Committees
• What concerns does app functionality pose to internet review committees? (i.e., treatment calculators)
• What is the appropriate language for promoting your app?
• What are the CEP implications based on app functionality? Medical Devices regulation
• Given app functionality, is it likely that your app will be subjected to FDA scrutiny? Pharma mistrust
• Should you use a branded or unbranded approach? What impact does that have on downloads? Malfunction
• Are these significant health risks associated with your app malfunction? Reviewers
• How can we mitigate any negative review/feedback?

Other considerations

• Competitors: is there a marketplace need based on competitor activity?
• Build or buy: Is there a company that already has an audience we want?
• App as a Channel: Can you use the app for targeted ads?
• Data: Who owns the data and what are the implications for your company?
• Pricing: How do pricing scenarios impact ROI and usage?
• Test Control: Can you set up a test/control group to measure performance?
• End-User license agreement: Should language be for underage users and/or parents? Should language reflect information sharing? (e.g., with consortiums)
• Measurement (Mobile App Analytics)