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Redesigned intravascular imaging medical device optimized for DFM, DFA, and DFS using advanced mechanical engineering services.

Patient Interface Module

Medical Device End-to-End Mechanical Engineering Solutions

I led the redesign of an existing medical device system while working as Lead Mechanical Engineer for a MedTech Startup Conavi Medical. The system, the Patient Interface Module (PIM), 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.

 

Now it's being used in 7 hospital sites in the US and Canada (New York Presbyterian, Montefiore, Emory Healthcare, Mount Sinai, Cleaveland Clinic, Sunnybrook, Virtua Health).

 

The PIM is used for intravascular imaging using ultrasound and optical coherence tomography (OCT) technology and disposable catheters, where the PIM is used to control the catheter inside the vessels.

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Our Expertise

01. Mechanical Engineering & Hardware Design

02. System Integration & Electronics Design

03. Medical Device Product Testing

04. Production Transfer & Assembly Tooling

Mechanical Engineering & Hardware Design

I dove straight into learning about the existing issues from the previous PIM to redesign it for enhanced manufacturability, increased production efficiency, and streamlined servicing.

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This involved simplifying overly complex parts and mechanisms, significantly improving the ease of manufacturing and assembly. Achieving this required a deep understanding of system functionality, which we successfully leveraged.

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Additionally, I developed new subassemblies optimized for assembly line efficiency. These subassemblies were designed to be built, tested, and prepared by trained assemblers, ensuring that complex builds did not slow down subsequent stages. The modular design also prioritized serviceability, allowing field technicians to easily swap components in and out, minimizing downtime during maintenance or repairs.

Printer Parts
Durable Delrin plastic shaft with precision O-ring grooves, custom CNC-machined and designed using mechanical engineering services.

Full System Integration &
Electronics Design 

3D printed PCB prototype with connectors, designed for sizing tests through electronics systems integration and mechanical engineering solutions.

I collaborated closely with electrical engineers to design and integrate the main controller board, optimizing its overall size and layout. As the mechanical lead, I maintained continuous communication with the electrical team, ensuring seamless alignment between mechanical and electrical requirements. This involved providing critical mechanical data, such as board dimensions, connector placements, and keep-out zones.

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I designed shielding to address EMI considerations, ensuring compliance with IEC 60601 standards for medical devices. These shields effectively reduced electromagnetic interference, enhancing the reliability and safety of the system.

Medical Device Product Testing

I designed and developed breadboards to test multiple iterations throughout the redesign process, from early concept development to pilot builds. This involved creating breadboards compatible with existing system components to evaluate initial redesign concepts effectively. With each iteration, I refined the breadboard design to closely mimic the final product, addressing and resolving any issues along the way. Ultimately, these iterative improvements culminated in a robust pilot build, ensuring the system's reliability and performance. 

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All testing was conducted according to medical device standards, with documenting formal testing procedures to ensure compliance with requirements. Detailed test results were captured in formal design test reports, providing a comprehensive record of performance validation and ensuring the system's reliability and regulatory compliance.

Comprehensive product testing services for multiple assemblies to ensure reliability and functionality.
Specialized product testing services tailored for medical devices to validate performance and safety.
Test result images from medical device testing services.

Production Transfer & Assembly Tooling

I designed custom tooling for part alignment during assembly to support complex automated mechanisms within the PIM. I also authored work instructions, providing clear guidance to manufacturing teams during production builds.

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I helped transfer designs to production by creating 2D technical drawings including GD&T and had in-depth knowledge of critical assembly features to apply appropriate tolerances. Additionally, I developed detailed assembly drawings with exploded views, ballooned items, and bills of materials (BOMs) usable for all production teams.

Performing product testing on a test bench with force testing machine.
Professional 2D assembly technical drawing services created by an experienced mechanical engineer.

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