Situation

A startup developed an intracranial pressure sensor but encountered fundamental problems after bringing it to market. The new automated redesign didn't work, and funding was limited to three months. A successful 510(k) submission was critical to selling the company.

Task

Shoreview Technologies was initially hired to provide a due diligence assessment in preparation for the company's sale. We discovered that the software was far from ready. After presenting a completion plan to Venture Capital investors, we were tasked with managing and completing the software development.

Action

• Established software development leadership and addressed major productivity issues.
• Implemented agile methods to provide transparency and confidence in development progress.
• Managed FDA-compliant firmware development activities and artifacts under IEC 62304 and IEC 14971.
• Designed and verified algorithms for filtering measurements, sensing catheter connection, detecting faults, and executing a calibrated priming cycle.

Result

The 510(k) submission was completed just as funding ran out, enabling the successful sale of the company. The project achieved regulatory compliance and market readiness under extremely tight constraints.