Radiadyne’s Radiation Dose Monitoring
Real-Time Dosimetry for Personalized Cancer Care
Problem
Radiadyne, after years of research with MD Anderson, needed a cutting-edge fiber optic dosimeter that measured radiation doses in real time, without correction factors. They also wanted a reusable system to reduce treatment costs across multiple cancer therapies. Protecting organs near the site of radiation treatment for cancer was a pivotal goal of the system. Radiadyne selected HaA to bring this technology to market.
Solution
HaA PD designed and engineered the OARtrac system which included a sensor cable, processing device, and balloon catheters. The team overcame challenging requirements needed for success such as advanced calibration, radiation shielding, reusability, and identification. The team created unique solutions to address these needs involving precise fixturing, multi-layer material construction and RFID identification tags.
Outcome
This first-of-its-kind platform enabled truly adaptive radiotherapy, earning a 2018 MedTech Engineering Breakthrough Award (#1 out of 3000 applicants globally). The final system was accurate and easy to use, and garnered positive feedback from everyone who used it. The potential of the OARtrac system made Radiadyne suitable for acquisition and the company was acquired by Angiodynamics in 2018.
Services Provided to Develop Radiadyne’s Radiation Dose Monitoring
Research
As part of our market research, our team collaborated to document challenges experienced by end users and understand the requirements for a successful system.
Analyzed failure modes in current procedures and ensured that we captured critical needs.
Traveled to MD Anderson to study their radiation labs, understand workflow and interviewed physicians and techs in a facility that performs 1200 procedures a day.
Usability
Reviewed procedural videos and documentation to evaluate product usage.
Identified unmet needs in the market to ensure the product met the needs required for success.
Workflow Optimization
Mapped the full surgical procedure to pinpoint failure points.
Streamlined workflow to reduce complexity and enhance efficiency.
Program Management
Based on experience and simple math, we were capable of estimating part cost at the onset of the project allowing for proper budgetary planning.
Developed a detailed summary of the project, including milestones, product cost targets, pre-engineering tooling costs, and estimated testing costs.
Engaged with partner vendors early to ensure realistic, real-world cost projections.
We acquired an installation company and trained them on what was needed to install the systems into the vaults. We finalized the protocol for installation with MD Andersson and this defined the installations of these systems through the entire US, culminating in a multi million dollar deal.
Project Management
Managed the project timeline from start to finish, assigning roles and responsibilities of both internal and external resources.
Regulatory Compliance
Operated within the company’s Quality Management System (QMS).
Supported and provided regulatory documentation and work instruction development as part of our regulatory compliance services.
Industrial Design
Within our Industrial Design services, we sketched initial concepts and built CAD models.
Down-selected designs based on human factors, environmental needs, and product workflow.
Developed graphics, color material finish and branding.
Final designs balanced form, fit, and function.
Engineering
Selected a mechanism that maintained a compact form factor while ensuring full functionality.
CAD Development
Developed detailed 3D CAD models based on final product specifications.
Prototyping
Built fully functional, highly complex prototype that was light tight, which meant that all vents and channels had to be sealed. These units were used for calibration and testing, and to fuel investor confidence.
Manufacturing Support
Identified appropriate tooling and injection molding manufacturers for scalable production.