For healthcare minimum viable products, the conventional advice of “launching while you’re still embarrassed” is not an option. Although speed to market is crucial in this highly competitive market, the safety, security, and regulatory compliance of the healthcare product are even more so.
So, what is the ideal state of a healthcare MVP, and how can healthcare innovators move fast without cutting clinical or security corners?
Our team has gathered insights from over 300 projects to define the fastest way to launch a healthcare MVP without missing what matters.
What is a healthcare MVP, and why is it different from other minimum viable products?
Overall, an MVP, short for a minimum viable product, is the first version of your product that you need to release to see if your product idea can solve the exact problem the user is facing. At the core of the MVP development stage lies the idea of creating a product version with only the core features that should be enough to make that product functional. After release, developers gather user feedback to make further integrations based on the needs of the target market.
However, a healthcare minimal viable product differs significantly from typical consumer MVPs:
- Your “minimum” must include compliance (HIPAA, FDA, GDPR, etc.).
- Your “viable” must be clinically safe.
- Your “product” must deliver real-world impact, not just engagement metrics.
If we compare traditional MVPs to a minimum viable product in healthcare, the main differences revolve around the following points:
| Aspect | Standard MVP | Healthcare MVP |
|---|---|---|
| Key goal | Validate market fit as quickly as possible | Validate safely and ensure compliance |
| Risk tolerance | Can afford bugs and crashes | Zero tolerance for clinical and security risks |
| Regulatory compliance | Optional (except regulation-heavy industries like fintech) | Mandatory for most healthcare applications |
| Data sensitivity | Moderate | Extreme (PHI, medical records) |
| User testing | Early adopters can tolerate flaws | Clinicians and patients demand product reliability from day one |
| Cost of failure | Lost users, bad reviews | Legal penalties, patient harm |
Prototype vs Proof of Concept vs healthcare MVP development
Contrary to popular belief, a minimum viable product is not always a great starting point, as the path to product-market fit in healthcare is rarely linear. In some cases, healthcare startups need another approach to reach their goals.
- If you’re in the "Can we even build this safely?" phase, then your healthcare project needs a proof of concept or PoC to verify that your high-risk tech idea is feasible in terms of technical implementation. A PoC is usually intended for internal use. Besides technical feasibility validation, startups can leverage a PoC to determine if a project is worth time, money, and resource investment (because no one wants to spend millions on an FDA-rejected idea).
- A prototype is the way to go when the question is: 'Will clinicians and patients use this correctly?'. A prototype is a visual, clickable representation of a product concept that demonstrates the look and interactions of the product. Prototypes provide a tangible way for healthcare companies to test user interaction, spot usability issues, and get early feedback from potential users. Startups can also use prototypes as a way to visually represent the idea and its potential to investors at an early idea stage.
- An MVP is the first true product milestone that answers the “Does this work and comply?” question for healthcare companies. Unlike PoCs and prototypes, MVPs are user-facing and often go through real-world testing in controlled environments. A minimum viable product can generate traction, create measurable patient impact, and start building trust with healthcare professionals and regulators.
Simply put, your starting point depends on where your biggest risk lies:
- If it’s technical, start with a PoC.
- If it’s a usability issue — build a prototype.
- If it’s compliance or functionality in the real market, an MVP is your best bet.
More on the unique challenges of healthcare MVP development
Healthcare MVPs are anything but minimal. Creating one is more about building a Minimum Viable and Validated Product that users can trust, both clinically and ethically. Speed still matters, but to gain traction, innovators must first solve industry-specific development challenges.
Moving fast with a regulatory playbook in tow
When a company is building an application for clinical use, the regulatory bar is high — and rightly so. Since these software products can impact healthcare outcomes, skew clinical decisions, and even lead to health harm, they fall under the FDA, EU MDR, and other global frameworks.
Compliance with healthcare regulations often means that development teams must have structured processes (ISO 13485 Quality Management System), documented evidence of design and risk controls (IEC 62304 Software Lifecycle and ISO 14971 Risk Management), and validated systems in place — even if it’s just an MVP.
Even when a company is building a wellness tool or an application that’s not intended for clinical use, it still needs to bake in basic data privacy and security practices before the MVP launch. Applications that handle health-related data, even outside clinical settings, may still be subject to regulations like HIPAA (in the U.S.) or GDPR (in the EU) based on what, where, and how the data is stored, processed, or transmitted.
👉 In our experience as a healthcare MVP development partner, it’s smarter to bake in compliance readiness from the start, even if you’re developing a product that’s not subject to clearance. Often, products that start as wellness can drift into regulated territory when their features evolve (AI-based diagnosis), USP changes, or the target user audience expands (e.g., clinicians adopting a wellness app for off-label use). Retrofitting compliance equates to rebuilding the product from the ground up.
Grounding an MVP in clinical validation
Unlike MVPs in other industries, healthcare MVPs don’t just test user engagement. Their main focus is on demonstrating their safety and effectiveness in real patient care environments and within clinical workflows. Depending on the product class, this can include expert reviews, usability studies, pilot programs with IRB approval, and more.
Not all healthcare MVPs require full-scale clinical trials, but all must be grounded in credible science (e.g., evidence-based content grounded in CBT principles), as the line between wellness and medicine is thin. So, even if you have a wellness app in development, you need to support your product logic with peer-reviewed research or clinical guidelines, and ideally, collaborate with medical advisors to review your product.
Earning high-stakes user trust from day one
Healthcare software is rolled out to a demanding audience that includes patients, who trust it with their health, and healthcare providers — who stake their reputation on the software and want it to be seamlessly plugged into clinical workflows.
Earning high marks from this audience with a healthcare MVP takes more than a sleek UI or marketing. In this case, the formula for successful adoption includes clinical utility, ease of use, regulatory rigor, and transparent design. Achieving this level of trust during MVP development requires the development team to:
- Co-design with frontline staff to map clinical features to existing clinical pathways
- Base features on medical guidelines or evidence
- Ensure the UX is developed in compliance with best accessibility practices (WCAG, ADA)
- Be transparent about the application’s limitations (e.g., inserting disclaimers such as “this app doesn’t replace professional medical advice), and many other things.
Nailing data security and interoperability
A healthcare MVP won’t even make it to pilot or partnership discussions if it doesn’t have at least a baseline level of data security. That makes encryption, role-based access, audit logs, and other industry-standard data security measures a non-negotiable for a healthcare app from day one.
👉 Even if your healthcare application MVP doesn’t handle PHI (Protected Health Information) yet, it’s recommended you design it as if it will. By segmenting data types early, you will prepare your application for future growth and pivots to clinical cases and avoid expensive redesigns later on.
Besides data security, healthcare development teams also need to factor in interoperability early on if the product needs to be integrated into a larger healthcare technology context. Interoperability requires designing your app to exchange data with EHRs, hospital systems, and wearables.
From a tech standpoint, interoperability is achieved by using data standards such as HL7 or FHIR and standardized vocabularies like SNOMED CT, LOINC, or ICD-10. Although your MVP doesn’t have to support full-scale interoperability out of the gate, its architecture should be designed with interoperability by default.
Healthcare MVP development process, step-by-step
On average, developing an MVP for the healthcare industry can take from 2 to 6 months. The timeline greatly depends on the product complexity, regulatory requirements, and the features included in the MVP. Here’s what the development process looks like once you’ve identified a narrow, high-impact use case and secured a healthcare software development partner.
Product discovery
The development process begins with a thorough product discovery, which enables project stakeholders to gain a nuanced understanding of the product’s goals, users, and compliance landscape. During this phase, the development team maps out the user journey and clinical workflows, creates medically-informed user personas, and validates core assumptions with early prototypes, ideally in real-world environments.
Overall, this stage is dedicated to aligning medical, business, technical, and legal perspectives to lay a solid and comprehensive MVP foundation. If necessary, the development team involves legal and compliance teams to thoroughly examine HIPAA, FDA, and other regulatory guidelines.
Deliverables: Healthcare-grade product specifications, wireframes, a clickable prototype, and a validated product business model.
Development planning
While a high-level set of must-have features is defined during the product discovery phase, the team finalizes and prioritizes them later based on:
- Clinical necessity – What’s needed to ensure patient safety and usability?
- Regulatory risk – Which features could trigger stricter compliance requirements?
- Budget and timeline – How do we balance scope with feasibility?
As for the tech side of things, the development team also decides on a suitable technology stack that would allow them to implement all the features, fast and in a secure way. Interoperability, future compliance, and must-have data security standards are factored into the tech stack selection. Testing strategy planning starts here, too, especially if IRB approval or a pilot is required.
What makes healthcare MVP development projects unique is their focus on documentation. Every decision, from feature prioritization to solution architecture, must be captured in a way that supports traceability and prepares the product for regulatory oversight.
Deliverables: Technology stack definition, team composition and timeline, solution architecture blueprint, initial cost estimate.
MVP development and testing
Although healthcare MVPs are unique in their implementation, the design and development stages use the same agile or iterative development models as other projects, but with a more structured approach and increased documentation rigor. When the implementation begins, the UX/UI design team builds on earlier prototypes to finalize UX, paying attention to accessibility and clinical usability.
On the development side, engineers build the MVP in sprints, according to the pre-defined architecture and documentation trail. Based on the product class, developers may also need to integrate audit logs, encryption protocols, and other safety nets — along with interoperability hooks.
If the team is developing apps designed to gather clinical outcomes or be submitted for regulatory approval (FDA/CE Mark), developers work according to the ISO 13485 and IEC 62304 standards. Aligning the development process with these standards mandates developers to maintain design history files, risk management logs, and traceability matrices.
Throughout development, the team works side by side with QA engineers, end users, and regulatory specialists to test the MVP incrementally and gather early feedback (thus de-risking their project). As for testing activities, the MVP is validated not only for functionality and performance but also for clinical accuracy, user safety, and data integrity.
Deliverables: Final UI/UX design system, functional MVP, source code and technical documentation, testing reports.
MVP validation and release
By the time a healthcare MVP is nearing the end of development, it needs to be validated in the real world, including clinical and regulatory scrutiny. That’s why a medical-grade healthcare MVP isn’t released in the general sense. Instead, it is launched in controlled environments first, which can include:
- Pilot programs with healthcare providers
- IRB-approved studies
- Internal use deployments in partnership with clinical advisors
- Sandbox environments integrated with test instances of EHRs or third-party systems
The data from initial deployments can then be used to back clinical or investor conversations.
If the product is heading for regulatory clearance, the MVP will also serve as the basis for regulatory submissions. That’s why all documentation generated throughout the development must be in an audit-ready form by the time the MVP is feature-complete.
For wellness and unregulated apps, the focus at this stage is on building early traction and collecting feedback from lighthouse adopters. Initial users help validate assumptions about usability, engagement, and outcomes, while their feedback often clues the team in on what features the next iteration or full-scale development should focus on.
Although there are iterations in the life cycle of medical apps, wellness tools, and medical devices, the first round is supposed to do the trick, with the subsequent releases perfecting an already good product.
How much does it cost to build an MVP for healthcare?
The cost of developing an MVP for the healthcare market varies by project based on the app’s complexity, the regulatory path, and the technologies involved. That’s why we always recommend getting a free estimate from a development company to get a realistic sense of the budget early on.
Meanwhile, our team has prepared a sample cost estimate for an MVP using one of our projects, a remote patient monitoring platform, as an example. The estimates are based on the average hourly rate of $50/hour.
| Features | Approximate time, hours | Approximate cost, $ |
|---|---|---|
Mobile (Patient-Focused) | ||
| Project setup | 111 | 5,566 |
| Authentication/Registration | 63 | 3,128 |
| Profile management | 61 | 3,030 |
| Manual data entry | 42 | 2,121 |
| List of clinicians | 18 | 909 |
| Cliicians profile | 15 | 758 |
| Device integration | 64 | 3,182 |
| Patient dashboard | 36 | 1,818 |
| Push notifications | 36 | 1,780 |
| Messaging | 73 | 3,636 |
| Compliance and security | 76 | 3,795 |
| Deployment and integration | 67 | 3,333 |
| Basic analytics | 45 | 2,235 |
Web (Clinician-Focused) | ||
| Project setup | 61 | 3,036 |
| Authentication/Registration | 57 | 2,825 |
| Profile management | 31 | 1,568 |
| Clinician dashboard | 97 | 4,848 |
| List of patients | 18 | 909 |
| Patient profile management | 61 | 3,030 |
| Notifications | 18 | 909 |
| Messaging | 27 | 1,364 |
| Reports | 109 | 5,454 |
| Compliance and security | 63 | 3,163 |
| Deployment and integration | 121 | 6,060 |
General | ||
| Admin panel | 100 | 5,000 |
| Design | 170 | 8,500 |
| Product discovery | 120 | 6,000 |
| Total | 1,759 | 87,950 |
Based on our estimates, developing an MVP for a remote patient monitoring platform will cost you around $87,950. Keep in mind that this estimate includes basic costs related to the development stage.
At Orangesoft, we optimize your MVP development costs by using design systems, UI libraries, reusable components, third-party libraries, and APIs tailored to your project.
What 300+ MVPs have taught us: practical tips for healthcare MVP success
If there’s anything we’ve learned over 14+ years in the market, it's that healthcare software development projects are a complex tale, one that includes a lot of variables. Here are some tips and tricks we’ve curated from building MVPs for digital health and software as medical device products.
Start with the right, very specific problem (and not with the cool tech)
Companies shouldn’t try to flip the script on the entire care in v1. Starting with the smallest possible wedge, like digitizing a manual workflow or addressing a narrow clinical pain point, will help the product achieve initial traction and trust.
For example, Teladoc didn’t start as an all-in virtual care platform. The product started as a lean solution, designed to offer patients 24/7 access to licensed physicians for non-emergency cases. Only after the company corroborated the demand did it expand into chronic condition management, mental health, and complex care coordination.
Invest in documentation like it’s part of the product
While companies that plan to go through a regulatory pathway usually have their documentation in order, those developing initially unregulated solutions tend to skip this step. Later, when they happen to cross the regulated territory as the product evolves, they have to either rebuild the app or backfill documentation retroactively — both of which are costly and time-consuming.
That’s why it’s always a good idea to prepare for future product versions, even if the initial version is not regulated. Documentation might seem excessive at first, but it’ll save a company lots of money and trouble while also allowing it to progress into more high-stakes areas.
Use regulatory constraints as design tools
Most healthcare innovators think that it’s either compliance or user-centered healthcare UX. And most of the time, compliance requirements take hold, which leads to a fully compliant but painfully clunky interface. But that doesn’t have to be a trade-off if the design team uses regulatory compliance as creative guardrails.
For example, UI/UX designers can integrate mandatory clinical logs by transforming them into clinician-friendly dashboards.
Know your SaMD class early
If your healthcare solution is intended for one or more medical purposes that perform those purposes without being part of a hardware medical device, it’s likely to be classified as a Software as a Medical Device. Once your solution is tagged as such, it falls under specific regulatory scrutiny depending on its intended use, risk profile, and jurisdiction.
Establishing a clear understanding of where the product stands on the regulatory spectrum will help companies identify the right regulatory pathway and inform everything from risk management strategies to software architecture and testing protocols.
Don’t just claim “Our AI is 99% accurate”, prove it
In healthcare, a company can’t just go around throwing claims that their algorithms are the best. Regulators like the FDA (and clinicians, for that matter) expect solid, real-world evidence that your tool lives up to the promise. That means a company must publish validation results, disclose test datasets, and be transparent about how the tool fares across populations and edge cases.
Every claim of accuracy must be broken down to tell exactly what you’re measuring, what threshold you’re using to define a positive case, and how it holds up outside of your test lab.
A healthcare MVP is never minimum
In healthcare innovation, speed matters, but speed-building essential features at the cost of security, compliance, and user trust can only get you so far. A healthcare MVP isn’t about building the smallest product. It’s about building the safest version of your vision that still cuts it in terms of real-world impact.
If you start with a regulatory-first mindset, parallelize clinical validation, and build modularly for future scaling, you can enter the market faster — without cutting corners that come back to haunt you.