Healthcare Software Product Development

This step lays the clinical, technical, and regulatory foundation for your future healthcare software product. At this stage, it's important to:

• Define the product vision by answering the following questions: what problem the software solves, how clinicians, administrative staff, or patients interact with the software, and what task it is designed for.
• Determine the product's regulatory classification and pathway. Does your solution qualify as SaMD? What regulatory requirements apply? What class of device is it and does it require 510 (k) submission or PMA (premarket approval)? Misjudging your software's medical classification at this step can mean losing months and tens of thousands in rework.
• Map your solution against real-world care workflows. ScienceSoft's consultants analyze how your product will fit into existing systems (e.g., EHR, RIS, LIMS), user roles (e.g., nurses, lab techs, radiologists), and physical environments (e.g., bedside, home, operating room).
• Gather user input to frame usability risks. Business analysts study and interview real users, such as clinicians, administrative staff, or patients, to understand their workflows, needs, and limitations. They define how users will actually use the software and what could go wrong from a usability or safety perspective. This step informs a high-level functional scope and risk assumptions.
• Draft a lightweight functional and regulatory roadmap focusing on what's essential for early success. Instead of exhaustive specifications, the goal here is a prioritized core feature list aligned with your minimum viable compliance obligations, business outcomes, and funding stage.
• Create a decision-grade business case that will show what the product will cost, how it will create value, and why it is worth investing in it based on real-world examples (e.g., what a remote patient monitoring app typically costs and earns), regulatory requirements, and impact on healthcare delivery (e.g., hospital readmission reduction, nurse time saved).
• Identify critical risks early, including technical design issues (e.g., PHI processing, international data transfer), clinical reliability, and validation strategy. This avoids rework and audit issues later.

Once your product's clinical goals and compliance scope are defined, solution architects translate them into a lean, resilient system architecture. The main goal is to ensure that the architecture meets regulatory and data privacy requirements (e.g., HIPAA, GDPR, MDR), scales safely as you onboard users, and supports interoperability with third-party systems (e.g., EHRs, RIS, pharmacy platforms).

Architects begin by identifying critical technical priorities, such as real-time performance (e.g., for vitals tracking or alarms), auditability (e.g., traceability of clinical decisions), and integration protocols (e.g., HL7 or FHIR for hospital systems).

Then, they select an architecture style, such as microservices or modular. For example, SaMD solutions with frequent algorithm updates might benefit from containerized microservices with separated risk-class modules.

Next, the solution is broken down into functional modules (e.g., patient onboarding, clinical data ingestion, treatment logic). Each module is mapped to a cloud infrastructure (e.g., AWS or Azure). Dataflows are defined, including inbound (e.g., from wearable devices), outbound (e.g., report exports to EHR), and internal (between modules).

Architects also define the tech stack and data exchange formats, taking into account licensing and maintenance risks (especially for open-source libraries), API standardization and support for medical vocabularies (e.g., SNOMED CT, LOINC), expected validation and qualification requirements for regulatory submissions.

In healthcare, the user interface isn't just about convenience. It directly affects patient safety and clinical efficiency. At this stage, UI and UX designers focus on reducing cognitive load, minimizing input errors, and guiding users through critical workflows. The design approach depends on who will use the software - clinicians, patients, or both.

For clinician-facing interfaces (e.g., decision support, telehealth control panels, diagnostic input screens), UI and UX teams make the solution:

• Easy to use under pressure via implementing large buttons, logical tab order, and simple navigation.
• Safe by design through pre-filled fields, default options, and validation rules that align with clinical logic.
• Support multitasking with keyboard shortcuts, undo or redo features, and also by making critical information (e.g., vital signs) always visible.

For patient-facing solutions, designers address:

• Digital literacy gaps by using clear language, simple visuals, and step-by-step onboarding.
• Accessibility through compliance with Web Content Accessibility Guidelines (WCAG) 2.2. and ISO 9241 principles, screen reader and keyboard navigation support. For solutions intended for use in the US, the requirements of the Americans with Disabilities Act (ADA) are also considered.
• Emotional usability via stress-aware interactions, error messages that offer clear next steps.

The overall UI and UX design process includes:

• Creating wireframes or clickable prototypes based on the MVP feature set.
• Running usability tests with real users or using feedback from domain experts or compliance consultants when real users are unavailable.

• Following IEC 62366 usability standards, when the solution is likely to qualify as medical device software or SaMD.

For healthcare software, development must do more than deliver features; it must ensure trust, traceability, and regulatory compliance. We recommend the Agile approach with short sprints, but with a critical overlay: development should always be guided by compliance, patient safety, and clinical logic.

At this stage, startups should:

• Break the product into clinically meaningful increments, not just "login" or "chat module," but "vitals capture flow" or "treatment plan adjustment logic."
• Validate logic early with medical experts. For example, in a remote patient monitoring app, ensure alerts and thresholds reflect clinical norms to avoid false negatives or alarm fatigue.
• Include compliance checks in each sprint, e.g., log data flows for HIPAA impact review or document logic behind alerts or treatment decisions for SaMD traceability.

Functional and performance testing ensures software works well on different devices and under different usage loads, which is especially critical for real-time or cloud-connected tools.

Usability testing helps prevent workflow or decision errors, which is particularly important if clinicians will use the software under pressure.

Security testing should be started from sprint one, especially for apps processing PHI or interfacing with hospital systems. Test for issues like weak access controls or insecure code.

If your software connects to a physical device (e.g., a wearable, or alert system), simulate real-world use scenarios. For example, test connectivity drop-offs in home care environments or battery faults in eldercare devices.

Pre-launch activities depend heavily on your product's regulatory classification and deployment environment.

If your software qualifies as a medical device, pre-launch activities may include weeks or even months. Here's what we recommend:

Finalize your technical documentation, including:

• Software architecture diagrams (how your app is built).
• Data flow diagrams (how the data moves through your app).
• Validation reports (proof that your app operates safely and correctly).
• Usability test results (showing it's safe to use according to IEC 62366).

Initiate your premarket submission:

• FDA 510(k) process for the US.
• MDR/IVDR Notified Body review for the EU.

You cannot launch your product widely until you get regulatory approval. Only a very limited pilot use is allowed under a formal clinical investigation protocol or usability testing not involving diagnostic or treatment use.

If your software does not qualify as a medical device (e.g., appointment scheduling), the process is faster, but still requires structured preparation to protect users and data. Here's what you should do:

• Launch a limited-access pilot to internal staff, test clinics, or early adopters.
• Use pilot feedback to refine task flows, onboarding, and language clarity.

• Prepare basic documentation, such as user manuals for clinicians or patients, and support content (chat, FAQs, in-app tutorials).

After the initial release, focus on continuous product evolution. Gather feedback from real users, such as clinicians, administrative staff, or patients, and adjust the system accordingly to enhance care workflows, patient safety, and engagement. If your solution qualifies as medical device software, monitor for post-market safety signals, manage documentation for audits, and implement updates in line with regulatory changes (e.g., FDA guidance updates or MDR amendments). Track your system’s performance, uptime, and data integrity, especially for apps handling PHI. Enhance your app with strategic new features that will increase its immediate value, such as FHIR-based integrations with EHR systems, predictive analytics modules, AI-powered virtual assistants, in-app communication capabilities, multi-language support, and more.