Turning proprietary AI diagnostic model into compliant, market-ready digital solution
● Context
A leading Software-as-a-Medical-Device (SaMD) company partnered with Star to bring its AI diagnostic model to market through a compliant, mobile-first cloud platform.
Designed for secure data sharing between patients and clinicians and for AI-driven assessment, the solution showcases how proprietary models can be scaled responsibly in regulated healthcare environments. The objective was to increase diagnostic capacity through an innovative, AI-powered clinical approach. Their challenge was turning a validated, proprietary algorithm into a scalable, regulatory‑compliant product ecosystem that could safely capture and process sensitive, image‑based data from patients and securely share it with healthcare providers (HCPs), while seamlessly integrating into existing clinical workflows.
● Impact
- Delivered a Class III / Class C compliant software ecosystem (mobile, web, cloud) that successfully passed regulatory validation in multiple markets.
- Enabled real-time AI-assisted decision-making by clinicians through an intuitive interface and seamless workflow integration.
- Established a scalable cloud infrastructure on AWS supporting secure data exchange and model updates.
- Reduced diagnosis turnaround time and improved accessibility to specialist-grade insights.
● Journey
We became the client’s strategic, long-term design and development partner taking responsibility for three key components of the solutions:
- Mobile application for standardized data and skin surface image capture, optimized for diagnostic accuracy and patient experience.
- iOS app integrating specialized hardware (e.g., imaging add-on).
- Built for secure, reliable image acquisition and transmission.
- Web portal for professionals, providing an intuitive, workflow-aligned interface to access AI results and manage cases.
- Designed with a human-centered approach to align with clinical routines.
- Implemented with robust authentication, traceability and role-based access.
- Cloud backend integrating the AI engine via AWS for scalable inference and compliant data handling.
- Designed under IEC 62304 and ISO 13485 frameworks.
Given the client’s multi-market regulatory complexity, our Regulatory Consulting team worked hand-in-hand with software engineers and the client’s internal team to ensure data privacy, solution security and medical device requirements were embedded into both the architecture and workflows, including integrations with national health systems and third-party platforms.
In addition to delivering technical outcomes, our team produced the required compliance documentation for a Class III medical device to enable market entry.
● What's next?
Following a successful multi-year collaboration, the solution has been fully integrated into the company’s product ecosystem and extended to third-party technology partners through new API layers. Today, the company stands as a proof point of how proprietary AI can be scaled responsibly, using compliant, user-centered design to deliver faster diagnostic and create tangible patient impact in regulated environments.
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