A guide to software as a medical device (SaMD) development

Successful software as a medical device (SaMD) development takes more than strong engineering. As digital health matures and competition intensifies, teams that focus solely on features will fall behind. The winners will be those who combine product strategy, compliance, usability and adaptability to create products that endure.

The opportunity for medical device software is massive — the market is projected to reach over $700million in the U.S. alone by 2033 — but success is contingent on more than building an app. It demands a holistic development strategy that integrates regulation, scalable architecture, data, go-to-market strategy and business goals.

A step-by-by-step guide to SaMD development

Here we'll outline the proven frameworks and innovation insights to help you develop SaMD that gains approval and thrives in an ever-evolving healthcare ecosystem.

1. Product strategy

Good SaMD development starts with a clear product vision grounded in clinical reality and market demand. Strong teams align the problem, the evidence and the value proposition before a single feature is designed.

This means defining the smallest meaningful clinical claim, understanding where your product sits in the competitive and evidence landscape and building a roadmap that can evolve without increasing risk or derailing regulatory plans.

In a regulated environment, an “MVP” must already be safe, effective and audit-ready, so early choices about scope, claims and intended use become the backbone of the entire development lifecycle.

The clearer the product strategy, the smoother the path through classification, design and eventual commercial success.

2. Commercial strategy

Even the most advanced medical device software can struggle without a clear path to market and a viable business model. Healthcare adoption hinges on trust, evidence and aligning with existing incentives, therefore commercial planning must begin early.

A strong strategy identifies the primary buyer whether that’s providers, pharma, payers or consumers, and shapes the product’s positioning, workflow fit and evidence requirements accordingly.

Clinical validation becomes a core part of the commercial story, helping organizations justify adoption and integrate the solution into care delivery. Partnerships with insurers, device manufacturers or EHR platforms can accelerate entry, while reimbursement pathways determine whether the product can scale sustainably.

Choosing the right monetization model (subscription, usage-based, enterprise licensing or reimbursement-driven) ensures the SaMD delivers measurable value while supporting the ongoing lifecycle, compliance needs and continuous improvement required in regulated healthcare.

3. Regulatory strategy

Regulatory strategy is a detailed plan outlining how a company will navigate the legal and regulatory requirements needed to market its products, while adhering to compliance with all relevant regulations and standards.

The Intended Use, Risk Classification and the Regulatory Pathway for the SaMD determine not only evidence requirements and development strategy but also cost and speed to market.

At Star, we assess our clients' business goals and budget to select the primary markets for SaMD launch. We help define the intended purpose of the medical device and risk classification, and make necessary input to product requirements to clearly set the medical device boundaries

Antonina Burlachenko

Head of Quality and Regulatory Consulting at Star

For example, when Heart for Health, a Dutch SaMD developer, needed to meet EU MDR compliance, they partnered with Star. Together we defined the regulatory strategy for the EU market and developed MDR-compliant documentation that met immediate compliance without disruption, and set up long-term growth with a scalable QMS. Which leads on to the next step.

4. Establish a Strong QMS Foundation

Compliance starts with a functional quality management system (QMS). Frameworks like ISO 13485, IEC 62304 and ISO 14971 ensure product safety, risk management and lifecycle traceability.

A strong QMS that actually works does more than help pass audits, it establishes a culture of quality and accountability across the entire organization. By embedding structured processes, teams can reduce rework, accelerate approvals and build confidence with regulators and investors alike.

We provide ready-to-use ISO 13485, ISO 14971, and IEC 62304 know-how sets that help kick-start QMS setup and implementation, shortening the path to compliance and reducing risks for new SaMD initiatives

Antonina Burlachenko

Head of Quality and Regulatory Consulting at Star

5. User-centered design

User experience in healthcare goes far beyond aesthetics, it’s central to safety, trust, and adoption:

• Patients: Simplicity, accessibility and trust in data use. This means designing onboarding flows that reduce friction and provide accessibility for people with diverse needs, and building transparency around privacy and consent. In patient-facing apps, UX design must minimize the chance of errors, encourage adherence to treatment plans and accommodate diverse populations with different levels of health literacy and accessibility needs
• Clinicians: For clinician-facing tools, the priority is seamless integration into existing workflows, so that the software supports decision-making without adding friction or cognitive overload. Clinicians expect technology to fit naturally into their routines and present insights that accelerate, rather than slow down their decisions

The best practices for medical device software design go beyond generic UI advice. SaMD development benefits from interaction models that feel natural in clinical or patient contexts, and from data visualization techniques that turn complex datasets into clear, actionable insights. 

Human factors like engineering and usability testing are essential disciplines, as they ensure designs aren’t just compliant but genuinely usable and supportive in the fast-paced, high-stakes settings where they’ll be relied on every day.

6. Data strategy

A strong data strategy is the true fuel of SaMD development and the wider digital health revolution. It’s not just about storing information but about creating a reliable pipeline that ensures data is captured with clinical accuracy, securely stored with regulatory-grade protections and transmitted without loss or corruption.

Beyond infrastructure, teams must think about how healthcare organizations will derive actionable value from this data, whether through decision support, predictive analytics or integration into broader health IT systems.

Data is also the foundation for training and validating AI models. Effective data lifecycle management ensures that high-quality, representative datasets are collected, processed and made available when needed. Even if your initial product doesn’t leverage AI, a forward-looking approach means preparing for models that may evolve over time, starting with structured logic or decision trees but requiring reliable data pipelines to mature into more advanced intelligence.

7. Future-ready architecture

Scalability and interoperability hinge on architecture decisions. Building the right technical foundation early isn’t just an IT consideration but a long-term business strategy. Choices made here influence regulatory compliance, speed of iteration, cybersecurity posture and ultimately the product’s longevity in the market:

• Cloud vs. edge vs. hybrid: Balance latency, performance and data control. Cloud offers scalability and global reach, while edge computing provides low-latency processing critical for connected devices and wearables. But the best solutions often use a hybrid approach
• Interoperability, APIs and standards: Leverage FHIR, HL7, and IoMT interoperability for seamless data exchange across health systems. This reduces integration costs and improves adoption by fitting into existing clinical workflows
• Modular systems: Enable faster iteration and regulatory submissions. A modular architecture allows you to upgrade or replace components without revalidating the entire system, accelerating innovation while staying compliant
• Buy vs build decisions: Assess which components should be developed in-house for control and differentiation, and which can be leveraged from proven platforms to save time and cost

Interoperability is more than a feature on a product; it’s a service that extends beyond the initial sale and requires ongoing monitoring and maintenance

Yanick Gaudet

Interoperability Solution Architect at Star

8. Cybersecurity

Healthcare is among the most targeted industries for cyberattacks. Breaches not only damage trust but can have direct patient safety implications. Architecture must embed encryption, identity management and real-time threat detection to meet HIPAA, GDPR, ISO 27001 and evolving global security standards.

By making cybersecurity a first-class design principle, teams involved in SaMD development protect both patient data and clinical outcomes while strengthening regulatory confidence.

As we often tell clients, cybersecurity for conventional software differs from cybersecurity for AI systems. You must implement AI-specific guardrails and risk management practices to secure algorithms, data pipelines, and model updates effectively

Maksym Tsivyna

Information Security Manager at Star

9. Verification, validation and clinical evaluation

Validation is the stage where ideas meet the reality of clinical use. It goes beyond unit tests and prototypes and demonstrates that the medical device software works safely and effectively in real-world conditions. This includes verification testing against documented requirements, simulated and live validation within actual clinical workflows and clinical evaluation studies tailored to the product’s risk class.

Increasingly, this stage also draws on the broader evidence ecosystem — the data, systems and operational processes that function like a logistics chain for capturing, transporting and integrating real-world evidence from clinical settings back into product assessment.

The goal is to prove that the software functions, but also to demonstrate — through real-world data streams and HEOR (Health Economics and Outcomes Research) analyses — that it consistently supports patient safety, clinician trust, and meaningful clinical and economic outcomes under real-world pressures. And all of this must be documented in a way that’s always audit-ready, not hastily assembled at the end of development.

Formal clinical trials represent the most rigorous layer of validation. They build on verification, clinical evaluation and the upstream evidence ecosystem, and are required for higher-risk or innovative SaMD development prior to regulatory submission.

These trials generate controlled evidence of safety, efficacy and performance, while HEOR and real-world evidence complement them by demonstrating value, cost-effectiveness and impact in routine practice. This gives regulators, payers and healthcare stakeholders the confidence to approve, reimburse and adopt the product at scale.

Clinical trial expectations and data requirements vary significantly by jurisdiction. Planning for these data requirements early at the stage of regulatory strategy prevents costly delays. Failing to align evidence with regulatory expectations can result in non‑conformities and regulators may ultimately withhold market authorization

Antonina Burlachenko

Head of Quality and Regulatory Consulting at Star

10. Market clearance

Once SaMD development and validation are complete, teams must prepare submissions for FDA, EU MDR or other regulators. This process requires assembling technical documentation, clinical evidence, risk management files and cybersecurity documentation aligned to regional requirements. 

As part of the broader regulatory strategy, market clearance pathways vary by jurisdiction. For example, FDA 510(k), De Novo, or PMA routes in the US and CE marking under MDR in the EU. Selecting the correct route and ensuring that submission packages are complete is critical to avoid non‑conformities and regulatory delays.

Securing clearance is a major milestone, as it opens access to reimbursement, enterprise adoption and clinical use.

11. Post-market evolution

Achieving clearance is only the midpoint. Launch is just the beginning, as SaMD success depends on lifecycle management and continuous evolution. Once a product reaches the market, the real test begins: proving that it can remain safe, effective and reliable over time.

Companies need to put in place robust systems to capture feedback, monitor risks and adapt as both medical practice and technology change. SaMD development is subject to continuous oversight and must evolve with both regulatory requirements and user needs:

• Post-market surveillance and monitoring: Track product performance, safety signals and real-world outcomes
• AI/ML updates aligned with evolving regulation: Track adaptive system behavior and prevent performance drift to remain compliant
• Continuous usability improvements should reflect clinical feedback and evolving patient needs so that the product remains intuitive and trusted 
• Service reliability and business continuity planning in line with ISO 27001/22301 are essential to guarantee that systems remain available and resilient in the high‑stakes environment of healthcare

Finally, every new feature or major update must be carefully assessed to determine whether it changes the product’s intended purpose, risk profile, or performance claims. Some enhancements may require re-validation or even trigger a new market clearance submission.

Building a structured process for ongoing regulatory assessment helps avoid surprises and ensures the product can evolve without jeopardizing compliance or patient safety.