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6 pitfalls to avoid when developing mobile apps for medical devices


In the bustling healthcare landscape, the mHealth market—estimated between $50 billion and $110 billion USD in 2022—is more than just a promising niche. Given the roaring momentum, you’d expect the roadmap for the mHealth App development to be very well defined by now. But the reality is a bit murkier than that. As evidenced in the significant differences in market estimates, defining even what is an mHealth system remains a debate. A bird’s-eye view of the challenges facing the mHealth industry as it moves toward maturity:

Sky-high user expectations: Mainstream consumer apps developed by very large companies with equally large budgets have set the bar extremely high. Companies entering the mHealth space must be deliberate in managing these expectations with all stakeholders, both internal and external.

Consumer app startup culture: Consumer-app style rapid development is enabled by small teams quickly assembled together and leveraging large collections of off-the-shelf software libraries. They operate in a market where failure costs little, you learn from the failure, and iterate. The culture that fits consumer-apps however lacks the processes and systems required to ensure the quality, safety, and security required for mHealth applications.

Regulatory catch-up: Healthcare regulators are grappling to define standards for an industry that’s evolving faster than they can staff and skill up. Regulators understand that mHealth has enormous potential to transform healthcare by reducing cost and bringing care closer to the patient, but they are rushing to prevent the industry from practices that pose risks to the delivery of care.

These three industry-wide challenges translate into common mistakes made by companies as they develop new mHealth solutions. If you’re charting the course for your organization’s mHealth foray, here are a few pitfalls you might want to sidestep:

1. Compliance isn’t a last-minute job: It’s a common misstep to design an mHealth app and then scramble to wrap it in a cloak of compliance. A well-crafted app starts with a foundation of solid design controls and risk management practices from the outset. Retrofitting these crucial aspects as an afterthought can result in software that’s shaky at best, with issues that can’t merely be patched up later.

2. Premature implementation: While the startup world champions the “build fast and iterate” mantra, the mHealth realm demands more caution. Rushing to code can often lead to costly detours and rework. Instead, invest time in proof of concept prototypes that validate your technical approach. Then invest in formative tests with cost-efficient mockups rather than code implementations. These preliminary steps, although seemingly slow, can fast-track the latter stages of development and ensure a smoother rollout.

3. Ambiguous regulatory strategy: Venturing into mHealth without a regulatory compass can lead to directionless development. A well-defined regulatory strategy not only ensures compliance but also streamlines your app’s focus. It delineates the boundaries, ensuring you don’t inadvertently overstep or underdeliver which often leads to failed regulatory submissions.

4. Conflating features: In the bid to offer a comprehensive solution, there’s a temptation to pack an app with myriad features, medical and otherwise. However, blurring these lines can complicate the regulatory process and muddy the app’s core value proposition. Instead, strategically segment medical device functions from non-medical ones, ensuring clarity and minimizing red tape.

5. Settling for mediocre content: User experience is paramount. Lackluster images or poorly crafted content can diminish the perceived value of your app. Remember, in the digital realm, presentation matters immensely. Whether it’s a crisp infographic, a compelling video, or a well-written user guide, quality content can elevate the overall user experience and enhance engagement.

6. Beware of feature overload: While it’s natural to want your app to be a one-stop solution, it’s essential to discern between what’s necessary and what’s superfluous. Prioritize features that align with your app’s core objectives, and resist the allure of adding bells and whistles that don’t directly enhance its value. Overcomplicating the app not only strains development resources but can also confuse and deter users.

Developing a stellar mHealth app isn’t just about coding—it demands a strategic blend of technology, regulatory insight, and market understanding. At Bold Type, we’ve honed our expertise to guide product managers and executives like you through this intricate terrain. Instead of shortcuts, we offer smart cuts. If you’re ready to embark on your mHealth journey with a partner that gets it, let’s connect. Together, we can define the future of mHealth.