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Biomedical Design

Biomedical Devices for Animals:

My major work was on implantable blood flow measurement probes for animals - in particular a  Miniature Blood Flow Probe for Mice.  This device - developed under NIH/NHLBI SBIR funding - was a miniaturized ultrasonic transit-time blood flow probe for use in mouse physiological studies. 

The device was developed in consultation with Drs. Tom Smith and Mike Callahan at the Wake Forest School of Medicine, who also developed the surgical protocols for device implantation on the mouse kidney artery. 

My contribution was the probe mechanical and ultrasonic design, as well as developing a unique photopolymer process for producing the probe bodies at the Cornell National Nanoscale Facility, as well as the device ultrasonic design.  I also shepherded the project from R&D to manufacturing, and developed all assembly procedures, fixtures, and mold and wrote the assembly documentation and quality control documentation compliant with ISO 9001 standards. 

This project was extremely successful - it has been in commercial production since 2002, and in testimony to Congress the NIH cited this project as an SBIR/STTR success story.

Biomedical Devices for Humans:

A Flow Monitor for Pediatric Hydrocephalic Shunts – I wrote successful Phase-I and Phase-II SBIR proposals to fund an implantable, human-use device for measuring fluid flow in pediatric hydrocephalic shunts. Recruited a leading pediatric neurosurgeon to collaborate on the project, then managed all interactions with clinical collaborator, Institutional Review Boards, design consultants, and a collaborating shunt company, and arranged for clinical research approval at the Children’s Hospital of Wisconsin.  Performed risk analysis on prototype devices and arranged for necessary electrical, plastics biocompatibility, materials traceability, and MRI testing. Wrote initial  invention descriptions for US Patent Application #20090143673 Transit Time Ultrasonic Flow Measurement  & helped patent counsel prepare the patent application & identify new claims.

Clamp-On Cardiac Output Sensors - took an existing R&D design for a clamp-on ultrasonic tubing flow sensor & moved it into manufacturing. Prepared Pro/Engineer component and assembly drawings of all mechanical components and redesigned the device labels in Corel Draw. Worked with manufacturing to prepare assembly instructions, flow calibration procedures, and probe accuracy studies for the FDA 510(k) submission and a CE audit. Researched & specified new electrical cable designs that could withstand both Ethylene-Oxide and STERRAD sterilization.

Pressure Sensor R&D:

Teamed with Cornell on a successful $255,000 New York State STAR grant application that funded Cornell research on a new microminiature pressure measurement technology. Interfaced with the Cornell researcher on technology issues and assisted Transonic's legal counsel with provisional patent reviews and intellectual property licensing meetings and negotiations. Developed a pro-forma invention financial analysis to assist in the negotiations.

New Pressure Sensor Technologies - Performed literature search & market studies on miniaturized pressure catheter technologies suitable for human Fractional Flow Reserve measurements and animals research measurements. Supported the Transonic VP of Marketing during conference calls with interventional cardiologists.

Links to Useful Biomedical and FDA Information:

Regulatory Testing:

  • MRI Testing for implantable medical devices

Regulatory Oversight:

Commercialization: