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Biomedical Design

Your innovative biomedical device will require costly Research & Development and field testing before the world can use it.

I have the hands-one experience to help you navigate the funding, design, and testing challenges that you will face.

Specifically, I have wide experience in biomedical engineering and the associated design and regulatory issues associated with designing and microfabricating implantable and on-implantable devices for animals and humans.

As a result of this experience, I can develop grant proposals, concept videos, and prototypes for your new biomedical device.

Your concept prototoypes would be designed with mechanical and microfabrication 2D and 3D CAD programs (Autodesk, Pro-Engineer, Alibre, Rhino, L-Edit, Mentor Graphics), and then fabricated through local machine shops, 3D printing vendors, and the facilities of the Cornell National Nanoscale Facility.

The following sections show how I can help make your biomedical product R&D a success.

Biomedical Devices for Humans:

My most recent project involved microfabricating flexible, biocompatible polyimide & SU-8 circuits at the Cornell National Nanoscale Facility. These flexible circuits were part of the Boston Retinal Implant Project - a research project seeking to develop a next-generation implantable retinal prosthesis - a system that restores site to people blinded by advanced macular degeneration. microfabricated_circuits

(Pictures from IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 56, NO. 10, OCTOBER 2009
Development and Implantation of a Minimally
Invasive Wireless Subretinal Neurostimulator
, Shire et al...)

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A Flow Monitor for Pediatric Hydrocephalic Shunts

I wrote Phase-I and Phase-II SBIR proposals to fund an implantable, human-use device for ultrasonically measuring fluid flow in pediatric hydrocephalic shunts. I recruited a leading pediatric neurosurgeon to collaborate on the project, then managed all interactions with clinical and animal research collaborators, Institutional Review Boards, design consultants, and a collaborating shunt company, and arranged for clinical research approval at the Children’s Hospital of Wisconsin. 

For the design, I performed risk analysis on a prototype devices and arranged for the necessary electrical, plastics biocompatibility, materials traceability, and MRI testing. Also wrote the initial  invention description for US Patent Application #20090143673 Transit Time Ultrasonic Flow Measurement  & helped patent counsel prepare the patent application & draft new claims. The image above a concept 3D rendering inspired by the patent diagrams.

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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 CorelDraw. 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.

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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. 

Pictures from CNF 2006-2007 Research Accomplishments

My contribution was the probe mechanical and ultrasonic design, as well as developing a unique SU-8 photopolymer process for producing the probe bodies at the Cornell National Nanoscale Facility, as well as the device ultrasonic design. (See pictures above). 

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.

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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.

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Links to Useful Biomedical and FDA Information:

Regulatory Testing:

Regulatory Oversight:

Commercialization:

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