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

• 📌 Took over software development, identifying and addressing productivity issues (e.g., only an hour of work being checked in per week).
• 📌 Implemented agile methodologies to provide transparency and confidence in development progress, presenting updates to board members to secure continued funding.
• 📌 Wrote all software and managed all FDA-compliant firmware development activities and artifacts following IEC62304 and IEC14971 standards.
• 📌 Designed, implemented, and verified novel 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.