Our Electrophysiology Device Capabilities
We partner with startups and established OEMs to convert early clinical concepts into scalable, manufacturable EP devices.
Concept Development & Feasibility
We evaluate your performance requirements and design an initial catheter architecture. By analyzing mechanical trade-offs and identifying potential risks early, we help prove core technical assumptions before committing major capital.
EP Catheter & System Architecture
Our team designs multi-lumen shafts, handle mechanisms, and integrated delivery systems. We balance wall thickness, lumen layout, and outer profile dimensions to ensure your device meets strict anatomical constraints without compromising functionality.
Steerable Catheter & Handle Mechanism Development
Precise distal control requires reliable mechanical engineering. We design custom handle assemblies, pull-wire mechanisms, and articulation joints that give physicians predictable 1:1 torque response, tactile feedback, and smooth steering.
Material Selection & Component Integration
Cardiac catheter development requires careful material choices. We select and integrate biocompatible polymers, nitinol structures, braided reinforcement layers, and specialized coatings to achieve the right blend of flexibility, pushability, and kink resistance.
Catheter Shaft, Distal-Tip, & Electrode Considerations
We engineer custom shaft profiles with variable stiffness zones along the catheter length. Our team manages distal-tip assembly, electrode placement, and internal wiring layouts to ensure structural stability and mechanical integrity during positioning.
Prototype Development & Iterative Engineering
Using our on-site prototyping equipment—including catheter braiders, precision lathes, laser welders, 3d printers, and laminators—we build functional prototypes quickly. This allows us to rapidly test, iterate, and refine designs on the bench.
Bench Testing, Verification & Validation (V&V) Support
We establish and execute custom bench testing protocols to measure trackability, pushability, curve retention, actuation force, and joint strength. All testing is conducted under ISO 13485 design controls to support regulatory readiness.
Controlled Builds & Low-Volume Manufacturing
We build pilot lots and early clinical units inside our flexible ISO Class 7 and Class 8 cleanroom, providing full material traceability, validated assembly steps, and inspection-ready devices.
Contact Rev.1 Engineering for Electrophysiology Device Development Services
Minimally Invasive Development Services
Developing electrophysiology (EP) devices requires precise mechanical engineering, reliable shaft construction, and controlled steering. Whether you are building high-density mapping catheters, cardiac ablation platforms, or steerable sheath systems, navigating the complex chambers of the heart leaves no room for mechanical error or inconsistent assembly.
At Rev.1 Engineering, we support medical device companies throughout the entire EP development cycle. From initial concept feasibility and rapid prototyping to verification testing and manufacturing transfer, our team provides the hands-on engineering chops and cleanroom infrastructure needed to bring complex cardiac devices to market.
Types of Electrophysiology Devices We Support
Our engineering team has extensive experience developing specialized instruments, sheaths, and catheters across cardiac rhythm management applications.
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Electrophysiology Mapping Catheters: High-density and multi-electrode catheter structures designed for precise placement against cardiac tissue.
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Cardiac Ablation Catheters: Catheter assemblies engineered to support thermal, RF, or cryoablation delivery pathways.
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Steerable Sheath Systems: Deflectable access sheaths designed for smooth navigation and stable positioning in cardiac chambers.
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Diagnostic EP Catheters: Multi-lumen diagnostic catheters built for consistent mechanical performance and placement.
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Multi-Electrode Catheter Platforms: Complex array structures and basket geometries engineered to collapse for sheath delivery and expand reliably upon deployment.
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Cardiac Access & Navigation Systems: Custom dilators, introducers, and steerable access tools built for delicate cardiac pathways.
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Guidewire-Compatible Catheter Systems: Interventional catheters designed for seamless tracking over standard clinical guidewires.
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Custom EP Device Platforms: Unique, new-to-market cardiac delivery platforms built to address unconventional clinical access challenges.
Working with Rev.1 Engineering
Engineering Challenges We Solve
Translating an electrophysiology concept into a production-ready device involves solving complex physical and manufacturing puzzles. We help development teams address common technical hurdles, including:
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Precise Steering & Navigation: Designing deflection mechanisms that maintain accurate curve geometry and positioning in tight anatomical spaces.
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Torque, Pushability, & Flexibility: Tuning braid pitch, coil density, and polymer durometers to deliver smooth pushability and 1:1 rotational control.
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Component Density & Profile Limits: Fitting pull-wires, internal lumens, and wiring arrays into small-diameter shafts without compromising wall strength.
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Mechanical Integrity & Joint Bonding: Establishing reliable, repeatable bonding techniques for distal tips, marker bands, and multi-durometer shaft transitions.
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Design for Manufacturability (DFM): Streamlining assembly steps, designing custom production fixtures, and reducing manual variation from day one.
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Risk Reduction in Early Phases: Catching mechanical failure modes early in R&D to avoid costly redesigns during formal verification testing.
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Quality System & Regulatory Alignment: Maintaining complete Design History Files (DHF) and Device Master Records (DMR) to support FDA and international regulatory filings.
Why Work with REV.1 Engineering?
Medical device companies choose Rev.1 because we combine deep catheter engineering experience with flexible, hands-on execution.
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Minimally Invasive Catheter Expertise: Decades of collective experience designing complex steerable catheters, delivery sheaths, and interventional systems.
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Full Lifecycle Support: We support your project from early napkin sketches through functional prototyping, pilot builds, and commercial manufacturing transfer.
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On-Site Cleanroom Facilities: Our 2,000 sq. ft. ISO Class 7 & 8 cleanroom space allows us to assemble traceable, high-quality units under strict quality protocols.
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Manufacturability Focus: We design with production in mind, ensuring your device can be assembled consistently and cost-effectively at scale.
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Collaborative Approach: We work directly with your internal team, offering clear communication and fast adjustments as project requirements evolve.
Our Device Development Process
We follow a structured, phased approach to manage risk, maintain design controls, and keep your timeline moving 2x faster.
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Discovery & Clinical Requirements
We define user needs, target anatomy, performance metrics, and preliminary regulatory pathways. -
Concept & Feasibility
We generate initial designs, evaluate trade-offs, perform analytical modeling, and test early proof-of-concept models. -
Prototype Development & Controlled Builds
We iterate rapidly in our prototyping lab, refining functional designs and building pilot lots in our ISO cleanroom. -
Verification, Validation & Design Refinement
We subject the design to rigorous bench testing, simulated use testing, and formal design verification. -
Manufacturing Planning & Production Transfer
We finalize DFM documentation, build assembly fixtures, train line operators, and transfer the validated process to your chosen commercial manufacturing facility or proceed with low-volume manufacturing in-house to support your needs.