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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program

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Effective Requirements Engineering in Early-Stage Digital Health Startups.

Marius Gerdes¹, Sascha Noel Weimar¹, Florian Mazura¹

¹Karlsruhe Institute of Technology, Karlsruhe, Germany.

Studies in Health Technology and Informatics

|May 17, 2025

Summary

This summary is machine-generated.

This case study presents a four-phase requirements engineering process for digital health startups. Resource-constrained startups can implement this process to ensure regulatory compliance for software as a medical device.

Keywords:

Requirements engineering digital health startups medical device medical software product development regulatory compliance

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Area of Science:

Digital health
Software as a Medical Device (SaMD)
Regulatory compliance

Background:

Early-stage digital health startups face challenges in developing software as a medical device (SaMD).
Integrating requirements engineering with product development is crucial for regulatory approval.
Resource constraints in startups can hinder robust process implementation.

Purpose of the Study:

To examine the implementation of a requirements engineering process in early-stage digital health startups.
To demonstrate a practical, four-phase process for SaMD development.
To show that effective requirements engineering is feasible for resource-constrained startups.

Main Methods:

Case study methodology.
Development of a four-phase requirements engineering process.
Integration of requirements gathering into the product development lifecycle.

Main Results:

The proposed four-phase process was successfully implemented in early-stage digital health startups.
The process effectively integrated requirements engineering with product development.
Startups were able to establish processes supporting future regulatory compliance.

Conclusions:

Resource-constrained digital health startups can implement effective requirements engineering processes.
The demonstrated process supports regulatory compliance for software as a medical device.
This approach can serve as a model for other digital health startups seeking regulatory approval.