AngioDynamics’ Solero MTA System

Optimizing Design for Next-Generation Tissue Ablation

Problem

The AngioDynamics Solero is a microwave-powered ablation catheter, with a heated ceramic tip, saline-cooled steel shaft, and compact plastic handle for guidance. When we began the project, the device was already in production, but our goals were to improve the manufacturing process and refine the next-generation design.

At the time, production involved multiple complex steps including gluing, inserting, compressing, coating, welding, and soldering, creating a labor-intensive process that occasionally resulted in inconsistent device performance.

Solution

Challenges in the existing manufacturing process prompted the need to improve the catheter assembly and reduce the risk of tip assembly failures.

We began by evaluating the catheter from the distal tip through to the handle, reviewing the overall design, testing materials, and working directly with manufacturing partners to understand process limitations. From this work, we developed a practical methodology that improved the overall manufacturing process and increased the robustness of the assembly. As part of the design updates, we replaced the ultrasonic-welded housing with a snap-fit assembly and introduced a self-cooling tip mode to ensure the tip did not overheat. Together, these changes simplified production and improved overall device reliability.

Outcome

We improved product performance including the tip design, sharpness of the tip, (which facilitated penetration through flesh) and created a dip coating that helped facilitate insertion and removal. Our work reduced overall cost, increased overall product performance and increased user experience.

This technology gave AngioDynamics a competitive, revenue-growth product in image-guided soft-tissue ablation. This device is a faster, single-applicator microwave ablation system with regulatory clearance that expanded AngioDynamics’ oncology/interventional portfolio, supported sales/cross-sell opportunities, and helped differentiate the company versus radiofrequency and older microwave offerings.

Services Provided to Develop AngioDynamics’ Solero MTA System

Research

  • HaA conducted an alignment exercise that uncovered many questions related to the product, procedure, and the sources of information within the company. This helped to focus the team on what answers were needed and where those answers would be obtained. 

  • Analyzed failure modes in current procedures and ensured that we captured critical needs.

Usability

  • Reviewed procedural videos and documentation to evaluate product usage and understand current challenges

  • Identified unmet needs in the market to ensure the product met the needs required for success.

  • Multiple usability feedback sessions were conducted with a range of physicians. HaA was able to create a unique test system that allowed the device to be used realistically without needing fluoroscopy or animal or human specimens. 

UI / UX Design

  • Established UI/UX requirements early in the program to ensure usability, safety, and ergonomic performance were foundational to the design.

  • Re-designed the handle geometry around human factors considerations, including grip variation, hand sizes, tactile feedback, and procedural control.

  • Evaluated materials, including  surface textures, and grip features to balance stiffness, comfort, and durability.

  • Implemented design changes driven by clinician interaction and workflow to improve ease of use and procedural confidence.

  • Extended UI considerations to the RF generator, incorporating GUI updates to align system feedback with clinical expectations.

Workflow Optimization

  • Mapped the full surgical procedure to pinpoint failure points.

  • Streamlined workflow to reduce complexity and enhance efficiency.

Program / Project 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.

Regulatory Compliance

  • Qualified in, trained on and operated within the company’s Quality Management System (QMS).

  • Supported and provided regulatory documentation and created work instructions for manufacturing.

Industrial Design

  • 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

  • The HaA engineering team designed multiple iterations of the device and worked closely with high capability contract manufacturers to make sure the device could be made repeatedly and within specifications. 

  • Led mechanical and electrical engineering efforts to support a full product redesign informed by manufacturing, UI/UX, and safety requirements.

  • Evaluated and selected advanced materials and coatings to meet performance, durability, and biocompatibility requirements.

  • Introduced new fabrication processes, including precision grinding of a single-crystal sapphire distal tip.

  • Designed and integrated a new RF antenna architecture to generate a controlled and effective RF field.

  • Balanced stiffness with flexibility requirements across the shaft and handle assemblies.

CAD Development

  • Developed detailed 3D CAD models based on final product specifications.

Prototyping

  • As part of our prototyping services, we built fully functional units for animal trials and testing.

  • Prototyped parts using various methods including 3-D printing, laser cutting, and CNC machining. The team worked closely with the final component suppliers to make sure prototype designs were easily transferable to manufacturing. 

  • Conducted theoretical thermal and system-level analyses to predict performance and safety margins.

  • Built multiple prototype iterations to validate analytical models under real-world operating conditions.

  • Executed iterative test-and-refine cycles until performance targets and safety requirements were met.

  • Verified subsystem and full-system performance prior to design freeze.

Human Factors Testing  

  • The HaA team performed testing at the state of the art AngioDynamics lab located in Central Massachusetts. 

  • Prioritized patient and user safety as the primary driver of the full system redesign.

  • Performed exposure and risk assessments related to mechanical design, material selection, coatings, and electrical performance.

  • Integrated system safeguards to prevent overheating in the tip.

  • Selected and validated thermocouple to ensure accurate temperature monitoring and closed-loop control.

  • Completed risk analysis informed by prior product performance, field feedback, and updated user scenarios.

Manufacturing 

  • Conducted a comprehensive review of all manufacturing and assembly processes for the complete probe system, including cabling, connectors, RF plug, distal tip, and integration with the RF generator.

  • Evaluated each component (19 individual components) for potential redesign based on manufacturability, safety and reliability.

  • Assessed and optimized fabrication processes, including soldering, adhesive bonding, and ultrasonic welding.

  • Identified manufacturing-driven design improvements to reduce complexity and improve consistency.

  • Defined revised manufacturing processes, assembly flows, and quality checkpoints and developed more than 30 detailed work instructions covering all components, subassemblies, and final assembly steps.Documented all verification and validation testing results in preparation for manufacturing transfer.

  • Updated the bill of materials to reflect new components, materials, and suppliers.

  • Created sourcing strategy and identified qualified manufacturers for externally supplied components, including the thermocouple, wire, and RF antenna, while keeping everything else with in-house manufacturing 

  • Traveled to their in-house manufacturer, located north of Albany NY, to ensure everything was properly transferred.