How Quantiva Transformed Penn Medicine Research into an FDA-Cleared Platform

In cancer care, timing and precision are critical. Before a patient can begin radiation therapy, clinicians must map out where the radiation should go and what areas need to be protected. This process, known as contouring, involves identifying and outlining organs on medical images so that healthy tissue is not harmed during treatment. It often takes a dosimetrist many hours to complete this step for a single patient.

The challenge is not just the required investment in time. If a patient’s anatomy changes during the course of therapy, updating the treatment plan can be difficult and further delay treatment. As a result, many patients continue with a plan that no longer fits them as well as it should.

At Penn Medicine, a team of researchers developed an artificial intelligence model that could contour organs automatically in just minutes. Accuracy remained on par with manual work, and the speed meant that clinicians could now update plans mid-treatment. The innovation had clear clinical value, but it needed more than promising results to make real-world impact.

To bring this technology into the clinic, Penn Medicine established QRS, a startup focused on commercializing the AI platform and delivering it to hospitals and care providers. The goal was ambitious: transform a research prototype into a fully compliant, secure, and scalable Software as a Medical Device ("SaMD").

QRS partnered with Quantiva to help make that happen. (Note: Despite the coincidence of similar names, Quantaras and Quantiva are otherwise independent entities)

Building for Trust and Compliance

Our first priority was ensuring that QRS could meet the standards required for FDA clearance. Together, we established a complete quality management system tailored to the needs of a cloud-based medical platform. Every part of the development and release process became traceable, auditable, and reliable.

We also worked with the team to create a formal algorithm change protocol. This allowed QRS to continue improving their AI models while staying compliant with FDA rules, removing a common barrier to innovation in regulated environments.

Cloud Infrastructure Built to Scale

Quantiva then designed a secure, cloud-native system to run the QRS platform. It supports production, testing, and demonstration environments while maintaining strict data controls and access policies. The infrastructure is fully automated and scalable, adapting to different client needs without extra complexity or cost.

By optimizing for both compliance and efficiency, we helped QRS reduce operating costs by over sixty percent. The platform is now built to grow, without compromising on performance or security.

Real Results for Clinicians and Patients

With a robust system in place, QRS successfully achieved FDA 510(k) clearance. Their AI-powered contouring solution now helps clinicians deliver more adaptive, personalized treatment by significantly reducing the time it takes to prepare therapy plans.

• FDA 510(k) clearance achieved
• Scalable and secure cloud infrastructure deployed
• Operating costs reduced by two-thirds
• Contouring time cut from hours to minutes, with consistent clinical accuracy

What started in the lab as a research prototype is now available to improve outcomes in clinical practice. We are proud to have supported this journey.

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At Quantiva, we help bring critical technologies to life. Whether your team is working on AI in healthcare, building a regulated platform, or scaling for impact, we are here to help you go further and faster with confidence.

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