Building Your First SaMD/Clinical Research Application

Design, Cost, Compliance, and Research.

Author Quinn McHenry makes apps with the snazzy crew @smallplanetapps in DUMBO, Brooklyn.

The “app” part of building a clinical research application presents unique challenges. The app takes up something like 5–10% of the overall process (and cost), but it is arguably the most important part, because without it there’s no study. There are a few things to think about before engaging with a partner to help build your app.

Look for Differentiators

You need someone with very strong design chops. With so many factors at play (and stakeholders weighing in), a true design vision can get pushed to the side. The result is an unappealing and/or unusable product with little regard for even the most basic UX principles. Not a lot of shops can make both beautiful apps AND SaMD apps at the same time.

Can your app partner:

• Securely manage protected health information
• Handle quantitative and qualitative market research
• Create user journeys and personas to bring the clinical experience to life
• Exhibit immediate familiarity with compliance requirements
• Implement quality management and risk management systems
• Show a relationship with proven 3rd-party QMS software providers
• Comprehensively document design and code

Be Realistic About Cost

Many large pharmaceutical or healthcare companies don’t have a massive mobile development team in-house, so the cost estimates early on can fluctuate wildly. And, as you can imagine, the costs run higher than a non-regulated app. It doesn’t take long to get deep into six figures. It’s worth bearing in mind that when you work with an app partner, you’re hiring a team with specialized experience, often for an extended period of time. That team often includes:

• iOS and Android developers
• Designers and UX strategists
• A content strategist
• A producer or project manager
• A regulatory compliance manager
• A QA team

Manage the Ecosystem

The FDA approval process is involved. Ditto goes for the app submission process to Apple and Google. It’s rare to find a partner who can manage the timing, expectations, and intricacies of both worlds.

What would you do if your app finally reaches end-users and you need to change something in it stat? In the non-FDA world, you make a quick fix and issue an update, maybe within hours. Working within these regulations takes a different mindset and definitely more than a few hours.

Rethink The Very Nature of Time and Space

Digital agencies are used to working fast and delivering products in relatively short periods of time (MVPs arrive in months, sometimes weeks). The timeline for a clinical trial can seem like it’s from another world, so it’s essential that all the stakeholders get together as early as possible to talk realistically about timelines and deliverables.

The team making the apps also needs to understand the amount of documentation, testing, and approval that’s involved. That’s apparent even in the earliest stages of a project, when a team sets about translating design processes into standard operating procedures (SOPs) that will satisfy regulatory authorities.

A design team should follow best practices and WCAG 2.1 guidelines for accessibility, and your app partner must be able to provide:

• Design concept
• Design system
• Illustrations
• Copy
• A set number of design revisions

Make Testing a Priority

These apps take a long time to build and submit (and resubmit), so you’ll want to make sure that you’ve done your research. Often in product-building, the testing phase can get passed off as an afterthought, a box to get checked. That’s not an option for clinical trial apps.

SaMD apps often require multiple rounds of usability testing. Knowing your market is the key to solving the right problem. If you don’t want to miss your mark, usability testing is essential.