Our client is an MIT-associated technology start-up software-only medical data company that delivers AI toolkits, to provide real time actionable insights to providers. They are headquartered in Boston MA and work with over 40 medical centers and hospitals to develop physician centric models of care.
The start-up’s team was faced with a challenge of balancing the tempo and needs of an early lifecycle start-up and the regulatory compliance & documentation burdens that come with developing an FDA regulated software as a medical device (SAMD).
Further, how can they do this while staying true to the agile principles that drive the startup community and at price point that is achievable for a startup?
By developing a customized ELC, then deploying it into the startup’s projecting tracking & knowledge/feature management suite, we were able to simplify daily development activities through the consistent delivery of high-quality user stories, which were then packaged into feature bundles designed to be FDA compliant.
This further underscored the success of adopting a structured ELC with strategic sourcing model.
The fact that the initial user stories’ content would be provided to the FDA had the additional net benefit of increasing story quality, which lead to a 12% increase in work units completed due to decreased development follow-up time. What additional repackaging was necessary to support the transformation of user story into compliant documentation was handled offshore, with all changes retaining full Product Owner supervision & signoff, ensuring full compliance. In addition, by bringing on development resources that could contribute in parallel, development was greatly accelerated, such that Q3 features on the product roadmap were developed as-of Q1.
- 12% Increased Completed Work Units
- Increased Story Quality
- Accelerated Development by a factor of 33%