Home > Blogs > Healthcare App
In the past years, the digital health industry has been booming, with projection close to $197.88 billion raised in 2025 alone. In an emerging digital health world that is moving from deskilling of healthcare workers toward a primary care that is prevention-oriented and personalized, digital health products can offer promising ways to improve patient outcomes and lower costs. In this industry, there is absolutely no end to the opportunities, from AI-powered diagnostic tools to remote patient monitoring apps.
If you have such an idea, this article will help you bring it to life. This course will tackle everything – from researching the market opportunity to building your minimum viable product (MVP), to preparing for launch. Learn how you can successfully build and launch your own digital health product in 2025.
Step 1: Validate the Market Need Even the most revolutionary product idea will fail without a market. Before you invest time and money into development, you must validate that a target customer base actually wants or needs your proposed solution.
Start by clearly defining your target users and the specific problem you aim to solve for them, ideally with the help of specialized digital health product development consulting to ensure alignment with market needs.
Next, talk to your potential users! This market validation research can involve focus groups, customer interviews, or simple surveys. Here are some important questions to cover:
What challenges do you face regarding this health issue? How are you currently solving this problem? Would you be interested in a digital tool that does [key features of your solution]? Would you pay for something like this? How much? It would be ideal to have at least 30 survey responses or 10 in-depth interviews. If the feedback is overwhelmingly positive, you can be assured that there is a market need. However, if not, you may want to reconsider your assumptions and product concept — you can also read similar case studies on healthcare IT outsourcing to better understand market adaptation.
Pro tip: Create a very simple landing page with the name of the proposed product and ask for the number of people who are willing to sign up early.
Step 2: Define Your Digital Health Product’s Features Now that you’ve confirmed the market need, it’s time to flesh out the details of your digital health product. Outline what features and functionality it will offer to serve that need.
Start by asking yourself these key questions:
What specific health problem will your product solve? Be as detailed as possible. How will it solve this problem better than existing options? What is your competitive advantage? What must-have features will it include to function properly and meet customer needs? What nice-to-have features would enhance the user experience? Document all this in a product requirements document. This will serve as an internal guiding resource as you start building. It can also be shown to developers, designers, and other team members so everyone understands the scope and vision.
The requirements will likely evolve. But resist scope creep by focusing on your MVP first!
Step 3: Understand Industry Regulations Digital health is a very regulated industry. Unlike many tech products, you have to consider laws around privacy, data security, medical claims, and more right from the start.
In the U.S., most digital health products fall under Food & Drug Administration (FDA) policies for medical devices and mobile apps . Depending on your product specifics, compliance might involve:
Registering your company details with the FDA Submitting a 510(k) or De Novo premarket submission Reporting patient safety information from your post-launch surveillance The FDA offers an interactive tool to help determine your regulatory requirements based on how your app functions. Be sure to document their guidance for the development and testing phases.
In addition, you also have to abide by the HIPAA regulations regarding protected health information (PHI). De-identifying patient data, securing records, and restricting access within the establishment are some of these.
Get guidance from a legal expert catering to the digital health industry and follow through with all industry-specific regulations from the beginning. By doing this, it will avoid costly redesigns in the future. Not complying can also jeopardize your entire business and put patient safety at risk.
Step 4: Research Your Competition It’s unlikely your digital health concept is unique. There are over 300,000 health apps in major app stores alone! So your next step is competitive analysis to see what’s already out there.
Thoroughly research digital health products addressing the same health need and target users. Download and test out some of the existing options to better understand their features, functionality, user experience, and pricing.
As you conduct competitive research, answer these types of questions:
How do these competitor products currently solve the problem? Where do they fall short? What features seem most important to target users? How easy are the apps to navigate and use? Take note of any UX/UI pain points. What business models are competitors using (paid vs. free, subscriptions, in-app purchases, etc.)? What are they charging users? How are they marketing the product? Look beyond direct competitors, too. For instance, if you are creating an app for blood sugar tracking, do your research on other complementary products, such as a diabetes management platform.
Instead, learn to make your product different from ones that are already available. It should find ways of improving features, user experience or pricing models to better meet users’ needs.
Step 5: Map Out Your Technology Stack Now it’s time to determine what technology you’ll need to power your digital health solution. This includes:
Core app platform (native vs. hybrid vs. web-based) Front-end app development frameworks Back-end infrastructure like servers and databases Any device hardware needed, like wearables or medical devices Third-party APIs to integrate into your platform Cloud storage provider Analytics software With regards to a technology, you have to choose the one that fits your budget, your development capabilities, targeted device or OS, the user base you expect, regulatory compliance, etc.
You will also have to decide between building everything in-house or outsourcing all or parts of your technology stack. To continue developing an example, you might hire an agency to do the UI/UX design work and keep the app development in-house. Or you might choose to use a health-specific BaaS (Backend as a Service) provider to run your infrastructure.
Pro tip: Architect your software and databases to allow for future scalability as your user base grows.
Step 6: Design an Intuitive User Experience
The user experience (UX) can make or break any digital health product’s success. Having an intuitive and easy-to-navigate app will enable customers to stick around your application as opposed to competing products.
Serve the wireframes as a functional companion to UX designers and usability experts. Simplicity should be a priority, and the interface should be familiar with the design patterns for each device platform.
On the other hand, you would like to personalize the experience as much as possible while keeping health data privacy intact. Find ways to tailor interactions to each user and present useful and relevant information at the perfect time.
Other UX best practices include:
Clean, uncluttered layout focused on the most essential data and features Thoughtful information hierarchy and clear CTAs Minimize required user inputs Help documentation and tooltips for guidance Ensure accessibility for users with disabilities And of course, continuously test and refine the UX with real users through each stage of development. Their feedback is invaluable for optimization.
Step 7: Build an MVP Version 1.0 With your technology stack set and UX wireframes complete, it’s finally time to build your minimum viable product (MVP)—the most basic functional version of your digital health solution.
Stick to your must-have features. Focus entirely on the core functionality you’ve already defined. You’ll have plenty of time to build out additional features once you’ve validated the basics with real users.Don’t over-engineer. One of the most common mistakes is sinking time and money into building the “perfect” app before proving there’s real demand. Solve the primary problem first—everything else can follow.Prepare for multiple test cycles. Expect to run through several rounds of internal testing and debugging before anyone outside the team sees your MVP. Smooth out issues that could derail user experience or product performance.Document everything. Keep clear records of technical specifications, architecture diagrams, QA results, and operational protocols. It’s the kind of groundwork that makes maintenance easier and upgrades more efficient down the road. Step 8: Rigorously Test and Refine Don’t anticipate a flawless digital health product from the start! Instead, plan for multiple testing and refinement cycles to work out kinks both before and after launch.
Begin with internal functional testing. Have your team run through every critical user flow from beginning to end under different scenarios. Identify and fix any bugs, glitches, or performance issues as early as possible.Conduct usability testing with real users. Bring in a small group of your target customers to test the product—ideally using the actual MVP, not just a mockup. Ask them to talk through what they’re doing and where they get stuck. This helps you uncover UX issues your internal team might miss.Run an external pilot program. Invite actual patients or end users to test the product in their daily environment for a set period. Gather honest feedback through structured interviews, surveys, and usage analytics.Track measurable health outcomes. Depending on your product, monitor relevant metrics during the pilot—for instance, improved HbA1c levels for a diabetes app—to validate the real-world impact of your solution.Iterate based on insights. Use everything you’ve learned from testing to refine your product before launch. Make data-informed improvements that enhance both performance and usability. Step 9: Submit for Regulatory Approval While you should design your digital health product to comply with regulations from day one, most solutions require active submission and approval before launch.
Understand the FDA pathways. In the U.S., most digital health products that qualify as medical devices or patient health software require a 510(k) submission to the FDA . Higher-risk products might instead follow the De Novo or Premarket Approval (PMA) route, which typically includes clinical trial data.Prepare a solid premarket submission. Your application must clearly demonstrate that your product is safe and effective for its intended use. This involves thorough documentation, technical validation, and—in some cases—clinical evidence.Plan for a lengthy review process. The FDA approval timeline can vary from 3 to over 7 months. Account for this in your product roadmap and ensure you have sufficient runway to support operations during the waiting period.Anticipate global regulatory requirements. If you intend to launch internationally, research local laws and prepare separate submissions for each region. International approvals can significantly extend your launch timeline. Tip: Joining the FDA’s Digital Health Software Precertification (Pre-Cert Pilot Program) can speed up review for qualifying companies.
Step 10: Finalize Product Branding and Marketing With your digital health solution fully built and approved, finishing touches for launch include branding, messaging, and go-to-market plans.
First up, do your best to finalize the name of your product, logo, colors and everything that is a part of your visual branding assets. Write with the help of graphic designers and copywriters when necessary to present the same, top-class brand across different platforms.
In addition, you’ll also need targeted marketing materials such as one-pagers, explainer videos, website copy, advertisements and sample social media posts. Ensure every asset is mentioned, and with reason, to your buyer personas in terms that are persuasive and driven by benefits.
Finally, detail your complete go-to-market strategy across areas like:
Pricing model and payment plans Sales channels (direct, app stores, enterprise partners, etc.) Customer onboarding and account management PR and community outreach Advertising channels and campaigns Take the time to thoroughly plan effective marketing and sales funnel optimization. This makes all the difference when you launch and start working towards critical mass adoption.
Step 11: Launch and Continuously Iterate! The big launch day has arrived! Congratulations! You have done very well in the product design and development, branding, and distribution of your digital health solution. Pat yourself on the back!
Listen and Refine Based on Feedback The real work has only just started. Launching is just the beginning of a continuous feedback loop—listen to your users, gather their insights, and keep refining your product. Early reviews are golden; treat them as a guide for improvement. Adapt your roadmap to address real-world user behavior and pain points.
Stay Ahead with Innovation The digital health space evolves fast. Regularly explore how emerging technologies like AI, remote sensors, and telehealth integrations could enhance your product. Staying ahead of innovation means you won’t fall behind in relevance or performance.
Validate Through Clinical Outcomes To scale successfully, especially in B2B or enterprise settings, you’ll need proof of impact. Partner with healthcare providers to measure clinical outcomes and gather evidence. Aim to publish results in reputable medical journals—this builds credibility and trust with future customers and investors alike.
Scale With Strong Customer Engagement Don’t just stop at launch—ramp up efforts to acquire and retain users. Keep building your community with personalized support, active social engagement, and ongoing brand campaigns. A loyal user base and positive word of mouth are critical to long-term growth.
Embrace the Journey of Iteration The most successful digital health companies understand that day one is just the beginning. Treat every update as a step forward in improving patient lives and healthcare delivery. Stay agile, stay curious, and stay focused on the mission to create real, lasting change.
Conclusion Thus, following this step-by-step guide will enable you to start with a digital health product concept and develop it into reality. Regulations, technical complexity, budget constraints, and user needs balancing are all to be expected, of course, with some bumps in the road. Yet as you do this, you can be an agile, resourceful creature.
Remember, you’re trying to effect positive change in people’s well-being and the failing healthcare system. Since that driving purpose enables you to acknowledge everything that is hard work, it all makes sense!
And now you have an overview of the process of launching a digital health. Get a strong team and start building something great. Here’s to positively disrupting healthcare with technology and passion.
Frequently Asked Questions How much funding should I expect to need when launching a digital health product? For an MVP, budget between $100,000-$500,000 depending on complexity. This should cover development, regulatory compliance, initial marketing, and 12-18 months of runway. Remember that the FDA approval process alone can take 3-7+ months without revenue, so plan your finances accordingly.
What’s the most common mistake people make when developing digital health products? Skipping proper market validation. Too many founders build solutions before confirming there’s a real problem worth solving. The second biggest mistake is over-engineering the MVP with unnecessary features. Get those 30 survey responses or 10 interviews before investing heavily in development!
How do I balance user experience design with regulatory compliance? Build compliance into your UX from day one rather than retrofitting later. Work with designers who understand healthcare constraints and involve legal experts early. Extensive user testing becomes crucial—observe how real users interact with your compliant design, then iterate within regulatory boundaries.
What’s the best approach to pricing a digital health product? Identify who benefits most and who’s willing to pay. Consumer apps typically use subscriptions ($5-30 monthly), while B2B models often use per-patient or enterprise licensing. Whatever model you choose, demonstrate clear ROI—showing how your $10/month app saves $1,000 in medical costs makes pricing decisions much easier.
How important are clinical outcomes for my digital health product’s success? Absolutely critical for sustainable growth. While early adopters might try your product based on promise alone, enterprise adoption requires demonstrating measurable health impacts. Track relevant metrics during your pilot phase, pursue medical journal publication, and consider formal clinical studies. Strong evidence becomes your most powerful marketing tool.
