Expertise
01 MedTech / ISO 13485
02 EMI Shielding Design IEC 60601
03 Mechanical Design
04 Complex Mechanisms
Intravascular Imaging Medical Device
Led the redesign of the Patient Interface Module (PIM) for a MedTech Startup, Conavi Medical. The system is used to rotate and axially position the Catheter within human blood vessels. The system was redesigned from the ground up for manufacturability (DFM), ease of assembly (DFA), serviceability (DFS), and reliability, taking it through the entire product development lifecycle while meeting strict medical device standards (ISO 13485). Custom jigs and tooling were designed to build and test the system reliably, including authoring of assembly work instructions, training in-house assemblers, and creating technical drawing packages for production transfer and manufacturing.
*Done during previous employment at Conavi Medical*
What:
The Patient Interface Module (PIM) is used to rotate and axially position the Catheter within human blood vessels. The PIM was redesigned from the ground up for manufacturability (DFM), ease of assembly (DFA), serviceability (DFS), and reliability.
How:
Simplified complex mechanisms, optimized subassemblies for efficiency, and collaborated with electrical engineers for seamless integration. I developed EMI shielding, validated the design through iterative testing, and created production tooling and documentation to support assembly and regulatory compliance.
Outcome:
Production time for the PIM reduced from 1/month to 1/week. The PIM has been deployed at 7 hospital sites across North America, gaining important clinical evidence.
