The startup needed to develop a fully compliant standalone SaMD platform that could integrate seamlessly into existing radiology workflows. However, building a system that aligned with FDA regulatory requirements while maintaining high diagnostic performance posed a significant challenge.

The absence of a unified platform made it difficult to combine DICOM image viewing, AI model inference, and clinician workflows into a single interface. Ensuring interoperability with existing PACS systems and healthcare IT environments added further complexity.

Additionally, the solution required robust cybersecurity controls, clinical validation, and proper labeling documentation to meet FDA 510(k) submission standards. The lack of in-house expertise in regulatory pathways and validation processes slowed down the product’s go-to-market timeline.

The startup needed a partner who could deliver an end-to-end SaMD platform—covering development, integration, validation, and compliance—while ensuring scalability and clinical reliability.