Optimal Design: User Centric Surgical Tool Development
Role: Product Design Lead
Project Overview:
As the Product Design Lead, I took charge of a collaborative effort to redesign catheters and slitting tools used by Electrophysiologists (EPs) during pacemaker implantations. The goal was to address existing design flaws, particularly in left ventricle lead placement, and enhance overall functionality.
Project Goals:
Develop an enhanced catheter and slitting tool for Pacemaker and Implantable Cardioverter-Defibrillator lead installation. To achieve this we needed to:
Develop new catheter and slitting tool designs.
Evaluate EPs' preferences and identify factors influencing their preferences for the surgical tools.
Assess the degree of improvement over existing designs.
Uncover potential problem areas in the new designs for further refinement.
Prototype slitting tool created on SLA 3D Printer.
Development Approach:
I led a team of experts through an extensive development process:
Brainstorming: Collaborating with mechanical engineers and medical experts to generate a wide range of ideas which were subsequently refined into actionable concepts.
Prototype Testing: EPs in multiple hospitals across New Jersey and Minneapolis - St. Paul examined and provided feedback on catheter prototypes.
Simulated Procedures: Utilizing a silicon heart model, EPs tested prototype catheters to simulate cannulation of the coronary sinus for left ventricle lead placement.
Slitting Tool Evaluation: EPs evaluated prototype slitting tools and performed catheter removal procedures with them.
Human Factors evaluation of catheter and slitting tool.
Results and Impact:
As the Product Design Lead, I closely observed EPs during evaluations, leading to design enhancements that eliminated user errors and improved usability. Notably, these improvements resulted in a utility patent.
Patent: Slittable delivery device assembly for the delivery of a cardiac surgical device
The research provided crucial customer insights and a profound understanding of human factors, guiding actionable design recommendations. My role ensured that the final product met EPs' needs, enhancing medical procedures' safety and efficiency.