From Prototype to FDA Clearance
By Quantiva Team
How Quantiva Transformed Penn Medicine Research into an FDA-Cleared Platform
In oncology, speed and accuracy matter enormously. Before radiation therapy can begin, clinicians must identify and outline organs on medical images — a process called contouring — to protect healthy tissue. This labor-intensive task typically consumes many hours per patient.
Penn Medicine researchers created an AI model capable of automating this organ identification, completing in minutes what previously took hours manually. The accuracy matched human work, and the improved speed enabled mid-treatment plan adjustments. Though promising, the research needed commercialization infrastructure to reach clinical settings.
QRS, a Penn Medicine startup, partnered with Quantiva to transform the prototype into a fully compliant, secure, and scalable Software as a Medical Device.
Regulatory Foundation
Quantiva established a complete quality management system and formal algorithm change protocol, allowing continuous AI improvement within FDA compliance frameworks.
Infrastructure
The team designed secure cloud architecture supporting production, testing, and demonstration environments with automated scaling and strict data governance.
Results
- FDA 510(k) clearance achieved
- Operating costs reduced by two-thirds
- Contouring time reduced from hours to minutes
- Consistent clinical accuracy maintained
The initiative demonstrates how lab research can be transformed into clinically available technology that directly impacts patient care.