Situation

Our client, a large medical device company, faced an FDA warning due to a software bug in a fielded product. Their development process lacked maturity, making it critical to address the issue efficiently without heavy investment in reverse engineering.

Task

We were hired to assess their software development process, identify how the issue occurred, and recommend practical changes to align their practices with industry standards.

Action

• Conducted interviews with R&D leadership and teams over several days.
• Reviewed development artifacts and identified seven key areas of concern.
• Balanced cost, risk, and effectiveness to propose practical changes.
• Presented a clear plan to senior leadership that fit their operational and financial constraints.

Result

The client was impressed with the speed and clarity of our recommendations. They initiated a year-long engagement for us to lead their teams in re-architecting one of their product development programs and establishing a sustainable path forward.