Brief description of the organization
Waterloo Regional Health Network (WRHN) supports the health and well-being of the communities of Waterloo Wellington and beyond. WRHN is home to 19 areas of care, including seven regional programs that serve patients across the province, in places like Brant, Bruce, Grey, Haldimand, Huron, Norfolk, Oxford, and Perth counties. With three hospital sites, five community sites, and more than 10 partner sites, WRHN is here for patients and families close to home. Our regional programs help care for more than 10 per cent of Ontario's population.
In 2024/2025, WRHN served more than 224,000 patients, providing nearly 741,000 visits. The care we provide supports children and adults of all ages and from many backgrounds through every stage of life. WRHN is committed to working with community members, partners, and local organizations to build a health network, shape services, and deliver care that meets the needs of the diverse and rapidly growing population we serve, now and in the future.
Problem area
Intracardiac echocardiography (ICE) has become the dominant imaging modality for catheter ablation procedures in modern electrophysiology, particularly in zero‑fluoroscopy workflows where ICE replaces traditional X‑ray imaging for catheter visualization and procedural guidance. ICE catheters (such as the Biosense Webster SoundStar and Siemens AcuNav) require operators to maintain a continuous pinch grip on a rigid handle while making fine articulation adjustments throughout procedures that routinely last two to four hours. This sustained static load produces measurable hand and forearm fatigue, contributes to musculoskeletal injury patterns documented in interventional cardiology literature, and degrades imaging stability during the most critical phases of ablation.
A hands‑free, articulated external holder with an ergonomic clutch mechanism would address three concurrent problems: operator musculoskeletal strain, image instability during prolonged holds, and the inability to maintain ICE position while the operator performs other procedural tasks. Existing solutions in adjacent domains (TEE probe holders, surgical retractor arms, articulating monitor mounts) demonstrate the mechanical principles, but none are purpose‑built for the unique constraints of ICE catheter stabilization in the EP lab environment, including sterile field compatibility, rapid clutch release for emergent repositioning, and integration with standard fluoroscopy table rails.
There is significant potential for joint research publications (biomechanical validation, ergonomic outcomes, procedural efficiency), grant funding through medtech innovation pathways, and eventual commercialization given the absence of a dedicated commercial product in this space.
Main objectives
Precision. Enable stable, reproducible ICE imaging without manual holding, supporting the high‑precision requirements of zero‑fluoroscopy ablation workflows. The holder must maintain catheter tip position within a clinically acceptable tolerance (target: less than 2 mm drift over 30 minutes of static hold) and permit fine articulation adjustments without disturbing the established imaging plane.
Ergonomics. Reduce operator musculoskeletal load during prolonged procedures by eliminating sustained pinch‑grip force on the catheter handle. The clutch mechanism must allow single‑handed operation, rapid release in under one second for emergent repositioning, and intuitive use without disrupting procedural flow.
Safety and compatibility. Decrease cumulative radiation exposure for the operator by enabling greater distance from the table during imaging. The device must be compatible with standard EP lab fluoroscopy tables (Maquet, Skytron, or equivalent rail systems), tolerate the sterile field environment, and pose no risk of unintended catheter advancement or retraction during use.
Translational potential. Position the resulting prototype for downstream regulatory submission (Health Canada Class I or II, FDA 510(k) pathway), peer‑reviewed publication of the biomechanical validation work, and engagement with industry partners for commercialization.
Scope of work
- Concept review and requirements definition — Review existing concept sketches and prior art, including TEE probe holders, articulating arms, and surgical retractor systems. Conduct structured stakeholder interviews with EP physicians, EP nurses, and industry representatives to define functional and ergonomic requirements. Produce a formal requirements specification document and preliminary design concepts.
- Detailed design and CAD development — Develop detailed mechanical design in CAD with attention to articulation joints, clutch mechanism, table‑rail interface, and sterility considerations. Perform preliminary biomechanical analysis (force budget, holding torque, articulation kinematics). Identify materials and manufacturing approach. Critical Design Review with sponsor at term end.
- Prototype fabrication — Fabricate the first functional prototype using shop fabrication, 3D printing, or hybrid approaches. Bench‑test on simulated catheter loads. Iterate on clutch mechanism and articulation joints based on observed performance. Conduct ergonomic assessment (RULA or REBA) with simulated procedural use.
- Validation and final deliverables — Refine prototype based on subject matter expert feedback from the EP team at WRHN. Conduct structured bench validation against the requirements specification. Produce final design documentation suitable for downstream regulatory and commercial development. Final symposium presentation.
Deliverables
Functional bench prototype with accompanying design documentation package, including a requirements specification, CAD files, bill of materials, validation test report, and recommendations for downstream development pathway.
Team meeting frequency
Standard capstone milestone schedule with weekly or biweekly team‑led meetings as the team prefers. Sponsor available on flexible cadence based on project phase, with denser availability during requirements definition (Term 1) and validation (Term 4)
Skills and training required
Mechanical design and CAD proficiency (SolidWorks, Fusion 360, or equivalent), medical device design fundamentals, familiarity with design controls and ISO 13485 principles, ergonomic and biomechanical assessment methods (RULA, REBA, force measurement), prototype fabrication including 3D printing and basic machining, materials selection for medical devices, and an interest in human factors and human‑computer interaction. Prior coursework or projects in medical device design or assistive technology is an asset but not required.
Resources required
Sponsor will provide existing concept sketches and prior art review, access to the WRHN electrophysiology lab for in‑situ observation of ICE workflow (subject to scheduling and infection control protocols), structured time with the EP physician team for requirements gathering and design feedback, access to representative ICE catheters and table‑rail hardware for fit testing and bench setup, and clinical mentorship throughout the project. Sponsor will facilitate introductions to industry contacts and Communitech and Velocity ecosystem connections where relevant for commercialization discussions.
NDA or a commercialization agreement for this project?
Yes