Key Innovation
By taking a simulation-driven approach to x-ray source and robotic integration, we accelerated a novel intraoperative radiation therapy system from concept to FDA clearance.
Robotic Radiation Therapy
Client
Empyrean Medical Systems
Practice Areas
Core Disciplines
Overview
Empyrean Medical Systems worked with Triple Ring to design and develop a compact, robotically guided intra-operative radiation therapy device. The system was engineered to deliver targeted radiation therapy within surgical environments while maintaining a strong focus on usability and patient-centered design.
The resulting platform combined robotic guidance, precision radiation delivery, and mobile system architecture to support flexible clinical workflows and improve intra-operative treatment capabilities.
Challenge
Empyrean required development of a compact, mobile radiation therapy system capable of delivering low-energy radiation with precise beam directionality during surgical procedures. The system needed to maintain high performance standards while remaining easy to operate within the constraints of clinical environments.
In addition to performance requirements, the platform required integration of multiple complex subsystems, including custom x-ray sources, beam steering electronics, and robotic positioning components. The development effort also required preparation of a complete design package supporting regulatory submission.
Robotic Radiation Therapy
Overview
Empyrean Medical Systems worked with Triple Ring to design and develop a compact, robotically guided intra-operative radiation therapy device. The system was engineered to deliver targeted radiation therapy within surgical environments while maintaining a strong focus on usability and patient-centered design.
The resulting platform combined robotic guidance, precision radiation delivery, and mobile system architecture to support flexible clinical workflows and improve intra-operative treatment capabilities.
Challenge
Empyrean required development of a compact, mobile radiation therapy system capable of delivering low-energy radiation with precise beam directionality during surgical procedures. The system needed to maintain high performance standards while remaining easy to operate within the constraints of clinical environments.
In addition to performance requirements, the platform required integration of multiple complex subsystems, including custom x-ray sources, beam steering electronics, and robotic positioning components. The development effort also required preparation of a complete design package supporting regulatory submission.
Client
Empyrean Medical Systems
Practice Areas
Core Disciplines
Solution
Triple Ring collaborated with Empyrean throughout the full product development lifecycle, from concept generation through system integration and clinical validation. The engineering effort focused on delivering precise radiation delivery capabilities while maintaining usability and manufacturability.
Development priorities included:
- Designing custom x-ray source technologies supporting 3D beam directionality
- Applying Monte Carlo simulations to validate radiation delivery performance
- Integrating robotic motion systems supporting accurate positioning
- Preparing documentation supporting FDA regulatory submission
Outcome
Triple Ring delivered a fully integrated radiation therapy system that was verified, clinically validated, and submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The resulting platform supported regulatory approval and demonstrated reliable clinical performance.
Following regulatory submission, the system design was successfully transferred to manufacturing and launched into the market. The completed platform enabled advancement of intra-operative radiation therapy capabilities and supported commercialization of the robotic radiation delivery system.
Triple Ring Talent
The Story Behind the Innovation
At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined radiation physics, custom x-ray source development, robotic systems integration, and regulatory engineering expertise to deliver a fully verified, FDA-submitted intra-operative radiation therapy platform from concept through market launch.
Chris and Barry collaborated with many talented colleagues across Triple Ring and Empyrean Medical Systems on this project.
Chris Mitchell, PhD
Bio and Electrical Engineering & Program Management
Dr. Chris Mitchell brings deep experience leading multidisciplinary teams developing complex imaging and medical device systems. His work focuses on guiding technical programs from concept through implementation, helping translate advanced technologies into reliable, real-world solutions.
Barry Wood
Biomedical & Mechanical Engineering
Barry Wood develops mechanical and biomedical systems with a focus on design and performance analysis. His work supports the creation of robust solutions for complex applications, contributing to dependable system function from concept through implementation.
