GSE Biomedical, design, development and testing of medical devices
Prof. Ramsés Galaz, PhD
PhD Biomedical Engineering, McGill University, Montreal, Canada.
Master of Mechanical Engineering, McGill University, Montreal, Canada. B. Eng. Mechanical Engineering & Management, Tecnológico de Monterrey.
Dr. Galaz has more than 15 years of experience in the fields of mechanical design, biomedical engineering, and manufacturing engineering. He has submitted more than 15 international patent submissions of medical devices in different areas of medicine, particularly in the Orthopedics and Cardiovascular fields. He has lectured in more than 40 international conferences and has successfully won 9 grant applications. He has been a part-time professor for 8 years teaching Biomechanics and Cardiovascular Engineering at Monterrey Tech University. He has been involved in the development of several medical devices from conceptual design all the way to finished product. Dr. Galaz is also a shareholder of ZIPTEK LLC and COO of ZIPTEK Mexico SA de CV, a company that develops bioabsorbable knotless tissue repair devices.
Ramsés Galaz Mendez , PhD – Curriculum Vitae
Date of birth: November 26, 1976
Current work e-mail: ramses.galaz@gse-biomedical.com
WORK EXPERIENCE
CEO / Owner. GSE Biomedical (GALAZ SCIENCE AND ENGINEERING SA DE CV). A company with the purpose of designing, manufacturing and distributing class I, II and III medical devices to the Latin American market. September 2004 – present.
COO / Co-founder / shareholder. ZIPTEK LLC (Sarasota, FL) and ZIPTEK MEXICO SA DE CV. An orthopaedic medical device company focusing on designing, producing and worldwide distribution of proprietary technology for knotless and bioabsorbable tissue repair systems in orthopaedic surgery. www.ziptekglobal.com. March 2012 – present.
Director of Research, Office of Technology Transfer, Graduate Studies, and Continuing Education. Instituto Tecnológico y de Estudios Superiores de Monterrey. Sonora Norte Campus. November 2011 – December 2014. I coordinated all research and tech transfer activities in the campus (areas include solar biomedical engineering, renewable energy, automation, mechanical design, mining applications) as well as the pursuit of funding through grants and consulting project with local and national industries.
Professor, Instituto Tecnológico y de Estudios Superiores de Monterrey. Monterrey Campus (Department of Biomedical Engineering – Faculty of Medicine), Mexico City Campus (Department of Biomedical Engineering), Laguna Campus (Biotechnology Department) and Sonora Norte Campus (Department of Mechatronics Engineering). August 2008 – present. Courses taught at the institution:
- Cardiovascular Engineering (videoconference to Monterrey Campus)
- Biomechanics (videoconference to Monterrey and Mexico City Campus)
- Advanced Biomechanics (videoconference to Monterrey Campus)
- Medical Technologies (videoconference to Laguna Campus)
- Mechatronics Engineering Project
- Applied Mechanics
- Computational Finite Element Analysis
- Manufacturing Technologies
Biomedical Engineering Researcher, Cardiovascular Engineering Laboratory, McGill University and Montreal Heart Institute, September 2002 – March 2008, Montreal, Canada.
Manufacturing Engineer and Production Supervisor, Cooper Industries, Bussmann Division, August 1999 – August 2000, Chicago, Illinois. Supervised 60 team workers and floor supervisor to produce electric line items worth $23M USD in annual sales. Performed Lean Manufacturing, Kaizen, ERP Systems projects within the plant. Outsourced an entire production line to a plant in Cd. Juarez, México.
Manufacturing Engineering Consultant, Center for Integrated Manufacturing Systems, ITESM, September 1996 – May 1999. Monterrey, México.
EDUCATION
Doctor of Philosophy – Biomedical Engineering. McGill University, Montréal, Québec, Canada. Research field in computational modeling of atherosclerotic plaque rupture. Thesis “A computational analysis to assess the coronary atherosclerotic plaque vulnerability to rupture due to hemodynamic effects”. May 2009.
Master of Engineering – Mechanical Engineering. McGill University, Montréal, Québec, Canada. Thesis: “Structural optimization of a coronary stent interacting with a hyperelastic arterial wall”. June 2004.
Bachelor of Science in Mechanical Engineering and Management. Instituto Tecnológico y de Estudios Superiores de Monterrey. México. May 1999.
Minor in Artificial Intelligent Systems. Center for Artificial Intelligence. Instituto Tecnológico y de Estudios Superiores de Monterrey. México. May 1999.
Certified Manufacturing Technologist. Society of Manufacturing Engineers. Dearborn, Michigan. September 1998.
Certified Solidworks Associate (CSWA) – Mechanical Design, Dassault Systemes Corporation, Certificate C-EM4FHHGYWW, March 2015
CONFERENCES
Galaz R., Mongrain R., Ranga A., El-Khoury N., Tardif J.C., Structural analysis of a coronary stent interacting with an hyperelastic arterial wall, Endocoronary Biomechanics and Restenosis Symposium, Paris, France, 2003.
Galaz R., Mongrain R., Ranga A., Brunette J., Bertrand O.F., Tardif J.C., FEA Structural Analysis of a Coronary Stent Interacting with an Hyperelastic Wall, Proceedings of the 1 International New Cardiovascular Congress, Québec City, Sept 10-11, Abstract P-11, p 68, 2004.
Galaz R., Mongrain R., Ranga A., Brunette J., Bertrand O.F., Tardif J.-C., FEA Structural Analysis of a Coronary Stent Interacting with a Hyperelastic Arterial Wall, Les Dix-septièmes Entretiens du Centre Jacques Cartier, Nano-biointerfaces pour les dispositifs intelligents,Oct 7-8, Montréal, 2004.
Galaz R., Pazos V., Mongrain, R., Leask R., Tardif, J.C., A numerical model of the rupture mechanics of the fibrous cap in atherosclerotic plaques, PACAM IX – Ninth Pan American Congress of Applied Mechanics, Mérida, Yucatán, México, January 2-6, 2006.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Modelling of Hemodynamic Stress Effects on Rupture Mechanics and Fibrous Cap Collagen Architecture of Atherosclerotic Plaques, Book of the Proceedings of The IASTED Conference on Modelling and Simulation, Montreal, 2006 Editor(s): R. Wamkeue 630 pages, ISBN: 0-88986-592-2.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Modelling the stress condition dependant anisotropy and rupture mechanics of atherosclerotic plaques, Proceedings of the 2006 ASME Summer Bioengineering Conference, Amelia Island, Florida, 2006.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Fluid-structure interaction computational modeling of realistically reconstructed atherosclerotic plaques to assess their vulnerability to rupture based on collagen fiber architecture # 6721, Proceedings of the 5th World Congress of Biomechanics, Munich, Germany, 2006.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.-C., Fluid-structure interaction computational modelling of realistically reconstructed atherosclerotic plaques to assess their vulnerability to rupture based on collagen fibre architecture, Journal of Biomechanics Vol. 39, 2006 Supplement 1 [abstract].
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Transient Fluid Structure Interaction Computational Analyses to Assess Patient Specific Atherosclerotic Plaque Vulnerability, CompMed SSH Symposium on Computer Simulation in Medicine 2007, Montreal, Quebec, Canada, 2007.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Computational sensitivity analyses to assess atherosclerotic plaque vulnerability, 21st Canadian Congress on Applied Mechanics, Toronto, Ontario, Canada, 2007.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.C., Computational analysis to assess atherosclerotic plaque vulnerability due to hemodynamic effects, Proceedings of the 2007 ASME Summer Bioengineering Conference, Keystone, Colorado, 2007.
Galaz R., Mongrain R., Leask R., Tardif J.C., Patient-specific coronary plaque vulnerability analyses based on 3D computer models of the mechanical interaction between hemodynamics and plaque constituents., Accepted abstract at the Canadian Cardiovascular Congress 2007, Quebec City, Canada, 2007.
Galaz R., Mongrain R., Leask R., Tardif J.C., Computational fluid-structure interaction studies to assess the mechanical fatigue vulnerability of patient specific coronary plaques, Congres de la Recherche en Biomécanique Endocoronaire EBR2008, Marseille, France, April 2008.
Galaz R., Olivas L., Mongrain R., Stent design optimization to minimize longitudinal deformation, Congrés de la Recherche en Biomécanique Endocardiovasculaire EBR 2012, Marseille, France, May 2012.
Mongrain R., Galaz R., Ranga A., El-Khouri N., Bertrand O.F., Tardif J.C., Structural Analysis of a Coronary Stent Interacting with the Vascular Wall during Angioplasty. Archives of Physiology and Biochemistry, 111, Supp. p. 8, 2003.
Mongrain R., Galaz R., Bertrand O., Deep wall injury due to atherosclerotic plaque reconfiguration during angioplasty and in-stent restenosis, 5th World Congress of Biomechanics, Munich, Germany, 2006.
Mongrain R., Galaz R., Bulman-Fleming N., Ruzzeh B., Bertrand O.F., Tardif J.-C., Multidisciplinary Design Optimization of Stents, Proceedings of the ASME Summer Bioengineering Conference ISBN 0-9742492-1-1, Vail, Colorado, June 22 – 26, 2005.
Mongrain R., Galaz R., Ranga A., El-Khoury N., Bertrand O.F., Tardif J.C., Structural analysis of a coronary stent interacting with the vascular wall during angioplasty, XXVIII Congres de la Societé de Biomecanique, Poitiers, France, 2003.
Pazos V., Mongrain R., Galaz R., Leask R. Tardif J.C., Development of an atherosclerotic phantom with a lipid inclusion, Proceedings of the 5th World Congress of Biomechanics, Munich, Germany. 2006.
Mongrain R., Faik I., Ruzzeh B., Galaz R., Bertrand O., Optimization of drug-eluting stents using numerical simulations, Congres de la Recherche en Biomécanique Endocoronaire EBR2008, Marseille, France, April 2008.
JOURNAL PUBLICATIONS
Brunette J., Mongrain R., Laurier J., Galaz R., Tardif J.C., 3D flow study in a mildly stenotic coronary artery phantom using a whole volume PIV method, Journal of Medical Engineering & Physics, 30(9):1193-1200, 2008.
Ranga A., Mongrain R., Galaz R., Biadillah Y., Cartier R., Large displacement 3D structural analysis of an aortic valve model with nonlinear material properties. Journal of Medical Engineering & Technology, 28(3):95-103, 2004.
Galaz, R. , Pagiatakis, C. , Gaillard, E. and Mongrain, R. (2013) A parameterized analysis of the mechanical stress for coronary plaque fibrous caps. Journal of Biomedical Science and Engineering, 6, 38-46. doi: 10.4236/jbise.2013.612A006.
Pagiatakis C, Galaz R, Tardif JC, Mongrain R. A comparison between the principal stress direction and collagen fiber orientation in coronary atherosclerotic plaque fibrous caps. Medical & Biological Engineering & Computing.June 2015, Volume 53, Issue 6, pp 545-555
BOOK CHAPTERS
Mongrain R., Leask R., Galaz R., Ranga A., Brunette J., J.C. Tardif, O.F. Bertrand, Image Based Biomechanics of Coronary Plaque, Plaque Imaging: Clinical analysis and its applications using MR, CT, Ultrasound and Microscopic., eds J. Suri, C. Yuan, D. Wilson, S. Laxminarayan, IOS Press, Amsterdam, 2005.
Galaz R., Mongrain R., Pazos V., Leask R., Tardif J.-C., Fluid-structure interaction computational modelling of realistically reconstructed atherosclerotic plaques to assess their vulnerability to rupture based on collagen fibre architecture. Publisher: MEDIMOND, Bologna, Italy. (Book contribution of the Proceedings of the 5th World Congress of Biomechanics)
AWARDS
“Academic excellence teaching award”, issued by Instituto Tecnológico y de Estudios Superiores de Monterrey, May 2010
“Academic excellence teaching award”, issued by Instituto Tecnológico y de Estudios Superiores de Monterrey, May 2012
“Distinguished profesor award of Biomedical Engineering class of 2015”, issued by Instituto Tecnológgico y de Estudios Superiores de Monterrey, Dec 2015
GRANTS
Fondo Mixto CONACYT – Sonora State Government. Issued for TAUVEX S.A. de C.V. Grant proposal title “Propuesta para el equipamiento de un laboratorio de diseño de nuevos productos en una empresa manufacturera de dispositivos medicos clase I y II”, SON-2007-CO2-79571. January 2008.
CONACYT INNOVAPYME 2010, Innovation stimulus program. Issued for TAUVEX S.A. de C.V. Grant proposal title “Optimización topológica de tornillos ortopédicos para mejorar su biocompatibilidad”. June 2010.
CONACYT INNOVAPYME 2011, Innovation stimulus program. Issued for TAUVEX S.A. de C.V. Grant proposal title “Desarrollo de nuevos dispositivos médicos expandibles utilizados en varios procedimientos en anestesiología regional y obstétrica, cardiología, radiología y medicina del dolor”. June 2011.
CONACYT PROINNOVA 2011, Innovation stimulus program. Issued for TAUVEX S.A. de C.V. Grant proposal title “Diseño y desarrollo de un nuevo método e instrumentos de cirugía mínimamente invasiva para reconstrucción y reparación de tejidos”. December 2011.
Fondo Mixto CONACYT – Sonora State Government. Issued for TAUVEX S.A. de C.V. Grant proposal title “Desarrollo de prototipos y pruebas clínicas de un nuevo dispositivo para la automuestreo de células epiteliales del cérvix para la detección del cáncer cervico-uterino y VPH”. December 2011.
CONACYT PROINNOVA 2014, Innovation stimulus program. Issued for GALAZ SCIENCE AND ENGINEERING S.A. de C.V. Grant proposal title “Diseño y desarrollo de un sujetador de tubo endotraqueal pediátrico para aplicaciones de terapia intensiva”. March 2014.
CONACYT PROINNOVA 2014, Innovation stimulus program. Issued for GALAZ SCIENCE AND ENGINEERING S.A. de C.V. Grant proposal title “Diseño de un implante coronario bifurcado para la prevención del infarto agudo al miocardio”. March 2014.
CONACYT PROINNOVA 2016, Innovation stimulus program. Issued for GALAZ SCIENCE AND ENGINEERING S.A. de C.V. Grant proposal title “Diseño, Optimización y Desarrollo de un Implante Endovascular Coronario para la Prevención del Infarto Agudo al Miocardio”. March 2016.
CONACYT INNOVAPYME 2016, Innovation stimulus program. Issued for ZIPTEK MEXICO S.A. de C.V. Grant proposal title “Diseño y Desarrollo de un Nuevo Método y Dispositivos para Cirugía Ortopédica con Polímeros Bioabsorbibles”. March 2016.
PATENT APPLICATIONS
Dispositivo intravaginal de diseño anatómico y colapsable para el automuestreo de células epiteliales del cérvix. Submitted to the Instituto Mexicano de la Propiedad Industrial. August 2009. Registro MX/2009/057823, Expediente de Patente MX/a/2009/009553
ANATOMICALLY DESIGNED AND COLLAPSIBLE INTRAVAGINAL DEVICE FOR SELF-SAMPLING AND CONTAINMENT OF CERVICAL EPITHELIAL CELLS. Application # PCT/IB2010/002057. World Intellectual Property Organization (WIPO). August 20, 2010.
ANATOMICALLY DESIGNED AND COLLAPSIBLE INTRAVAGINAL DEVICE FOR SELF-SAMPLING AND CONTAINMENT OF CERVICAL EPITHELIAL CELLS. Application # US2012/0157878 A1. United States Patent Office. June 21, 2012.
SURGICAL SUTURE SYSTEM, TISSUE RESTRAINT/SUTURE CAPTURE AND TISSUE ANCHOR. WO2014055767A1 PCT/US2013/063277, European Patent Office EP2903546A1
SURGICAL SUTURE SYSTEM, TISSUE RESTRAINT/SUTURE CAPTURE AND TISSUE ANCHOR. UNITED STATES PATENT AND TRADEMARK OFFICE Patent No. 9,307,979 B1. Issue date: Apr. 12, 2016
SISTEMAS DE SUTURA QUIRÚRGICA, RESTRICCIÓN DE TEJIDO/CAPTURA DE SUTURA Y ANCLAJE DE TEJIDO. Instituto Mexicano de la Propiedad Industrial MX/a/2015/004243, PCT/US2013/063277
Anatomically designed and collapsible intravaginal device for self-sampling and containment of cervical epithelial cells. US20120157878A1. United States Patent Office. June 21 2010
DISPOSITIVO DE ACCESO INTRAVENOSO EXPANDIBLE. Instituto Mexicano de la Propiedad Industrial MX/a/2012/001390
Endoprótesis vascular para trAtar lesions bifurcadas en arterias coronarias. Instituto Mexicano de la Propiedad Industrial MX/2015/003501
Tornillo transpedicular para la alineación de la columna. Instituto Mexicano de la Propiedad Industrial MX/2015/003517
Sujetador de tubo endotraqueal para pacientes pediátricos Instituto Mexicano de la Propiedad Industrial MX/2015/003489, PCT Application PCT/MX/2015/000012
Dispositivo para autotoma de muestras de células epiteliales para la detección de cáncer cervicouterino. Instituto Mexicano de la Propiedad Industrial MX/2015/003513, PCT Application PCT/MX/2015/000013
INVITED LECTURES
Biomecánica, Congreso Internacional de Ingeniería Mecánica, ITESM, Monterrey, México. October 2003.
Onceavo Día del Ingeniero Mecánico, Biomecánica, ITESM, Monterrey, México. April 2004.
Optimización del diseño de prótesis endovasculares, III Congreso Internacional de Ingeniería Biomédica, ITESM, Monterrey, Mexico. April 2007.
Interacción Fluido Estructura y Biomecánica de Tejidos, III Congreso Internacional de Ingeniería Biomédica, ITESM, Monterrey, Mexico, April 2007.
Diseño de implantes cardiovasculares, VI Simposium de Ingeniería Biomédica, ITESM, Monterrey, Mexico, March 2010.
Aplicación de análisis de elemento finito al diseño de dispositivos médicos. VII Congreso Internacional de Ingeniería Biomédica, ITESM, Monterrey, Mexico, March 2011.
“Marco regulatorio del mercado de dispositivos médicos COFEPRIS / FDA”. Expo-Manufactura 2012, Cintermex, Monterrey, N.L. Mexico, March 2012
Guest speaker at convocation ceremony for graduating class of December 2011. ITESM Campus Sonora Norte. Hermosillo, Sonora, Mexico, December 2011.
“Impactos de la vinculación empresa-academia en el marco del programa de estímulos a la innovación”. Consejo Estatal de Ciencia y Tecnología, Hermosillo, Sonora, October 2012.
Diseño de implantes ortopédicos, IX Simposium de Ingeniería Biomédica, ITESM, Monterrey, Mexico, April 2013
La ingeniería mecánica en el diseño de dispositivos médicos, XXVI Congreso de Ingeniería Mecánica, ITESM, Monterrey, Mexico, November 2013
Quality systems for medical device manufacturing. 2nd International Conference on Design and Processes for Medical Devices, Monterrey, Mexico March 2014
Desarrollo de un implante endovascular coronario. Caso de éxito con el Instituto Nacional de Cardiología. Investigación Innovadora: Del Laboratorio al Mercado. National Institute of Genomic Medicine. Mexico City, September, 2016.
AFFILIATIONS
President of the Mexican Chapter of the Society of Manufacturing Engineers (SME) 1998 – 1999.
Member of the American Society of Mechanical Engineers since 1996.
Member of the 2011 editorial board of the newspaper “EL IMPARCIAL”.
Member of the Technical Evaluating Committee of CONACYT – FOMIX – Sonora State Government July 2011 – present.
Member of the Accredited Evaluators Registry of Conacyt (Registro Conacyt de Evaluadores Acreditados – RCEA). September 2012- present. RCEA-07-24782-2012
Reviewer at the Journal of Medical Devices (Published by the American Society of Mechanical Engineers – ASME). ISSN 1932-6181