Expert Details

Expert in Medical Devices

Expert ID: 733320 Wisconsin, USA

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Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards.

Overview of Skills:
Software
 Thermo-electrical simulations of RF surgical electrodes with Comsol: Definition of geometry and algorithms.
 Code writing in C, C++, C# and Matlab (including statistics toolbox and signal processing).
 Experience in embedded systems, electronics, neural networks and signal processing.
 Experience with database (dotProject) both as user and as programmer.
 Experience with PID controller and control system modeling.

Grant Proposals
Experience in preparing grant proposals (NIH, SBIR)

Laboratory
 Extensive experience in designing medical devices including catheters, ECG, pulse oximeters and endoscopes.
 Extensive experience in the installation of new equipment.
 Extensive experience in maintenance of electronic parts.
 Extensive experience in scheduling the usage of the equipment.
 Experience with in vivo and in vitro experiments.
 Experience with clinical testing.'

Hardware Design—Extensive experience in:
 Analog and digital electronics and microcontrollers.
 Biomedical instrumentation.
 Implementing new hardware and software.
 Prototyping, jigs and assembly.
 Selection of components and vendors and quotations.

Business
 Strategic planning
 Business planning
 Supply chain
 Successfully obtained FDA approval for medical device

Expert is knowledgeable of temperature sensors and has designed electronic instrumentation to measure thermal properties of materials. He worked on the endoscopic industry improving devices and working close to the supply chain.

Premarket notification to the equivalent Brazilian agency, the Agência Nacional de Vigilância Sanitária (ANVISA).
Conduct testing of company medical equipment according to standards and directives from the International Electro-technical Commission (IEC), U.S. Food and Drug Administration (FDA) and/or the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) and approve medical devices accordingly.

Education

Year Degree Subject Institution
Year: 2003 Degree: Ph.D. Subject: Electrical Engineering/Biomedical Engineering Institution: The University of Texas at Austin
Year: 2000 Degree: M.S. Subject: Electrical Engineering Institution: University of Brasilia
Year: 1998 Degree: B.S. Subject: Electrical and Electronic Engineering Institution: Federal University of Paraiba
Year: 2017 Degree: MBA Subject: Stategy Institution: University of Wisconsin Madison

Work History

Years Employer Title Department Responsibilities
Years: 2016 to Present Employer: Undisclosed Title: Associate Professor Department: Electrical Engineering and Computer Science Responsibilities: He teaches medical instrumentation and medical device design.

 Plan curriculum in Biomedical Engineering.
 Develop laboratory material and facilities in Biomedical Instrumentation and Control Systems.
 Develop new courses in Control Systems.
 Develop courses in embedded systems.
 Overseas Biomedical Design courses.
 Apply for federal and state grants.
Years: 2015 to 2016 Employer: Astus Medical Manufacturing Title: Chief of Research Officer Department: Research and Development Responsibilities: Implemented all manufacturing practices and Oversee Research and Development (R&D), Grant Writing, providing technical assistance for new bmedical devices, logistics coordination and giving presentations to outside organizations.
Oversee Premarket Notification Applications (510k) to the U.S. Food and Drug Administration (FDA) and premarket notification to the equivalent Brazilian agency, the Agência Nacional de Vigilância Sanitária (ANVISA).

Develop and produce new biomedical components and products by studying customer requirements; research manufacturing and assembly methods and materials; design appropriate electronic testing methods to verify the capabilities of company-produced systems and components; develop and implement test methods to ensure product quality control.
Conduct testing of company medical equipment according to standards and directives from the International Electro-technical Commission (IEC), U.S. Food and Drug Administration (FDA) and/or the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) and approve medical devices accordingly.
Oversee compliance with federally-established Good Manufacturing Practices (GMPs) at the Madison, Wisconsin manufacturing facility and ensure compliance with company codes and adherence to established company-wide goals.
Oversee all staff recruiting, training and performance management including performance evaluations;
Apply for grants and negotiate research funding and develop / monitor the local office budget and equipment resources accordingly.
Years: 1996 to 2015 Employer: Universidade de Brasilia Title: Professor Department: Electrical Engineering Department Responsibilities: He taught medical instrumentation, electronic circuits and medical device design. He developed research on medical device and performed testing on medical devices according to ANVISA/Inmetro/IEC standards. He was a principal investigator on several multi-million research projects funded both by the government and by the industry.
Years: 2018 to Present Employer: Undisclosed Title: Chief Research Officer Department: Responsibilities:  Design medical devices for CO2 management.
 Draft patent application.
 Develop prototypes and commercial units.
 Develop marketing strategies.
 Give presentation for prospective investors.
 Define strategies for FDA De Novo and PMA processes.
 Design Manufacturing plant.
Years: 2016 to 2017 Employer: Self Employed Title: Principal Research and Development Engineer Department: Responsibilities:  Design medical devices for improving the treatment of sleeping apnea.
 Draft patent application.
 Develop prototypes and commercial units.
 Develop marketing strategies.
 Give presentation for prospective investors.
 Mentor junior engineers.
 Define strategies for FDA De Novo and PMA processes.
 Design business model.
Years: 2006 to 2015 Employer: University Title: Professor Department: Responsibilities:  Lead a group of 5 scientists.
 Develop projects for medical device industry and for the Brazilian Government.
 Work as consultant for the Brazilian National Health Surveillance Agency (“Agência Nacional de Vigilância Sanitária,” o “ANVISA” in Brazil – equivalent to Food and Drug Administration [FDA]) regarding medical devices.
 Work as consultant for the Brazilian Ministry of Health on medical device innovation systems.
 Provide analysis for start-up companies at the Universidade de Brasilia.
 Obtain grants for facility construction at the University Technological Park.
 Manage the medical device testing center following IEC standards utilized by Brazilian industry.
 Lecture to both undergrad and graduate students on topics including: Biomedical Instrumentation; Biomechanics of Human Movement; Electronics; Electrical Circuits; and Logical Circuits.
 Found the Graduate Program in Electronic and Automation Systems Engineering (“Programa de Pós-Graduação em Engenharia de Sistemas Eletrônicos e de Automação,” o “PGEA”).
 Coordinate operations and implement strategic programming for the PGEA, including collaboration with the coordinator for the Department of Electrical Engineering, the President of the Universidade de Brasilia, and the President of the program “Coordination for the Improvement of Higher Education Personnel”
Years: 2013 to 2016 Employer: Various Title: Research Scholar Department: Responsibilities: • J-1 Program Sponsor: University of Wisconsin-Madison.
• Permanent Employer: Universidade de Brasilia, Brasilia, Brazil.
• Position Code: 213 (University Teaching Staff, Including Researchers).
• Research Project: Currently developing a study that will improve radiofrequency ablation.

Government Experience

Years Agency Role Description
Years: 1996 to 2015 Agency: Brazil/University of Brasilia Role: Professor and Researcher Description: He taught medical instrumentation, electronic circuits and medical device design. He developed research on medical device and performed testing on medical devices according to ANVISA/Inmetro/IEC standards.

International Experience

Years Country / Region Summary
Years: 1974 to 2013 Country / Region: Brazil Summary: Native Brazilian

Career Accomplishments

Awards / Recognition
Scholarship for high productivity in applied research for the industry, CNPq, Brazil
Scholarship for high productivity in applied research, CNPq, Brazil
Scholarship for high productivity in applied research, CNPq, Brazil
Publications and Patents Summary
He published over 10 research papers on liver and cardiac ablation techniques. He also presented several works on medical devices on scientific conferences. He as a provisional patent on a sleep apnea device.

Additional Experience

Expert Witness Experience
Consulting: Projects Developed
2009 to 2015
• Wrote research proposal for submission to Brazil and obtained federal grant.
• Negotiated the contract with Brazil.
• Designed and implanted an official laboratory of testing medical devices according to International EMC and Product Safety Standards including electromagnetic compatibility.
• Installed an electromagnetic anechoic chamber for testing medical devices.
• Developing a number of the technologies for the medical device sector.
• Managed all aspects of the project.

2012 to June 2015
• Train personnel for evaluation of premarket notification for medical devices in Brazil.
• Evaluate premarket notification for medical devices.
• Wrote research proposal for submission and obtained federal grant.
• Specified and purchased electronic parts and equipment.
• Negotiated the contract with the agency.
• Modeled radiofrequency liver ablation procedure close to large vessels using finite element modeling.
• Managed all aspects of the project.

2003–2009
• Wrote the proposal for submission and obtained federal grant.
• Managed all aspects of the project.
• Negotiated the contract with the agency.
• Specified and purchased electronic parts and equipment.
• Developed an instrument for the in vitro measurement of thermal relaxation time of tissue using the hyperbolic wave equation for heat transfer.
• Modeled a system for controlling a HIFU device using FPGA architecture.
• Modeled liver RF ablation using non-Fourier equation.
• Built an esophageal catheter acquisition system for monitoring atrial thermal ablation.
• Developed an instrument for in vitro measurement of the convective heat transfer into the hepatic artery and portal vein.
Training / Seminars
Master of Business administration. To be completed n May/2017.
Other Relevant Experience
Industry-funded Project Participation:

2017: Develop complex finite element models (thermal, electrical, mechanical and chemical).

2012 to 2017: Wrote research proposal, Manage group of three scientists, Designed a voice recognition system for laparoscopy system; the system will be launched on the market, Design parts of the endoscope camera, Design parts of the xenon light source.

2012 to October 2015: Lead a group of 3 scientists, Launched equipment for the tracking and calibration in the Brazilian territory, Serve as the sole coordinator of the Russian station in Brazil, Managed all aspects of the project.

2012 to January 2014
• Wrote research proposal and submitted grant proposal and obtained federal grant from Brazil.
• Managed group of four scientists.
• Developed CAD design for liver ablation electrodes.
• Simulated radiofrequency (RF) liver ablation using Finite Element Modeling.
• Built liver ablation electrodes prototype.
• Developed software to predict the size of the lesion during radiofrequency (RF) liver ablation.

2011
• Developed software for communication management between the company and the vehicle tracker.
• Managed all aspects of the project.

2011
• Managed software development.
• Researched and developed software architectures for IP telephony configuration.

2011
• Built a laboratory set-up in order to measure software and hardware parameters and investigate failures in a new check scanner.
• Tested check scanners in order to evaluate their performance under stress: the tested scanner is a successful product that has been commercialized by the company since 2011.
• Managed all aspects of the project.

2011
• Developed a PC-based software module for gestures on the trackpad and mouse.
• Managed all aspects of the project.

2009–2011
• Wrote research proposal and submitted grant proposal and obtained federal grant from Brazil.
• Specified and purchased electronic parts and equipment;
• Developed a real time system of alertness of truck drivers;
• Managed all aspects of the project.

2010–2011
• Wrote research proposal and submitted grant proposal and obtained federal grant from Brazil.
• Equipment produced is a real-time system, which controls the speed and gas consumption of trucks (this equipment has been commercialized in the Brazilian market since 2011).

2009
• Specified and purchased electronic parts and equipment.
• Developed Smartphone software for video conferencing through a 3G network.
• Managed all aspects of the project.

2007–2009
• Managed a group of three scientists;
• Developed an embedded platform based on FPGA technology in order to accelerate the development of medical devices. The equipment has been commercialized by the company since 2009.

2004-2005
• Design a catheter-based instrument to measure the convective heat transfer in the portal vein.

Language Skills

Language Proficiency
Portuguese First language
English Proficient. Lived in the USA for over 8 years

Fields of Expertise

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