Dr. Kevin Soucy
Kevin Soucy is a Principal Consultant with CardioMed Device Consultants, bringing extensive expertise in medical device development and regulatory strategy. Prior to joining CardioMed, Dr. Soucy was a Senior Lead Reviewer with biomedical engineering expertise at the U.S. Food and Drug Administration (FDA) for 7 years.
Dr. Soucy joined FDA, Office of Cardiovascular Devices, Heart Valve Device Team in 2018. His primary role was premarket medical device review, including pre-clinical testing and clinical study design, to support the advancement of projects toward market approval. His areas of expertise includes pre-clinical verification and validation testing, simulated use testing, particulate and coating integrity test criteria, and risk-mitigation approaches for transcatheter heart valve replacement systems and novel heart valve repair devices. During his time at the FDA, Dr. Soucy contributed to over 500 regulatory submissions, including Pre-submissions, Breakthrough requests, IDEs, 510(k)s, PMAs, and post-market compliance and surveillance reviews. He reviewed adverse event MDRs for several Class II and Class III device product codes. In addition, he actively participated in AAMI, ISO, and other recognized consensus standards activities, representing the FDA’s perspective, including a task group to develop recommendations for cardiovascular transcatheter delivery systems.
Dr. Soucy earned his B.S. in mechanical engineering from the University of New Hampshire in 2003. He then completed both a Master’s and Ph.D. degrees in biomedical engineering at Johns Hopkins University in 2010, with a research focus on vascular function in response to aging and ionizing radiation.
Dr. Soucy then joined the Cardiovascular Innovation Institute of the University of Louisville where he developed mechanical circulatory support devices. As faculty in both the Departments of Cardiovascular & Thoracic Surgery and Bioengineering, his research focused on the feasibility and efficacy of left ventricular assist devices in delivering pulsatile flow as well as mechanical-biological synergistic therapies for heart failure patients. Through this experience, Dr. Soucy gained hands-on experience with computational modeling, benchtop simulated use testing, hemodynamic data acquisition and analysis, large-animal GLP studies, and NIH SBIR grant writing. Dr. Soucy maintains an adjunct faculty position in the University of Louisville Bioengineering Department.
Chiara Lorenzetto
works with CardioMed Device Consultants as an affiliate consultant and brings almost 20-year experience in new medical device and pharmaceutical product development.
Chiara has scientific-technical background in biotechnology and holds the qualification to the profession of Biologist from the University of Pavia (Italy). She is a specialized Project Manager and worked for many years in the medical device industry leading several cross-functional teams focused on the development of new and innovative products from idea generation to product launch on the market. She was also in charge of leading a laboratory devoted to the development and implementation of biological/biochemical assays (both in vitro and in vivo) for drug discovery and pharmaceutical compounds’ activity testing.
Since founding Niu Consulting in 2018, she has worked with a wide range of companies world-wide as well recognized consultant specializing in biological safety assessment of medical devices. She provides her expertise to medical device manufacturers and supports them with the biological safety assessment of their products, according to ISO 10993 standard series and US-FDA Guidance Use of International Standard ISO 10993-1. She interacts with European Notified Bodies and FDA to address topics related to biological safety evaluation plans, biological testing, material chemical characterization and toxicological risk assessment. She also supports companies in the interaction with testing laboratories, in the definition of most appropriate testing plans as well as in the management and optimization of project timelines to facilitate companies in the achievement of their product development objectives.
Lynn Bailey
Lynn is a consultant at CardioMed Device Consultants. She is a well-recognized consultant in the area of preclinical cardiovascular and vascular device studies.
Lynn holds a degree in Wild Animal Training and Management from Moorpark College and is certified as a Laboratory Animal Technologist by the American Association for Laboratory Animal Science. She started her research career at Walter Reed Army Medical Center in Washington, DC in 1987 performing lab functions relating to animal studies for all departments within the medical center, including pediatrics, nephrology, ophthalmology, and cardiology. In 1997 she took a position running the preclinical cath lab at the Cardiovascular Research Foundation (CRF) where she played a pivotal role in running animal trials related to drug coated stents, intravascular imaging studies, NOGA mapping and intracardiac therapies. She was recruited to Stanford University in 1999 to become the Managing Director of the Interventional Cardiology Research Lab at Stanford University. This lab was prolific in partnering with industry to develop new catheter based technologies for cardiovascular disease, including atherectomy and mitral valve repair amongst others. In 2006 she joined the Center for Biomedical Sciences and Emerging Technologies (CBSET) as the Director of Interventional Services. This lab is a not-for-profit contract research organization that specializes in preclinical GLP studies. As a research interventionalist, Lynn has performed thousands of highly technical, interventional catheter-based procedures and is experienced creating diseased models of myocardial infarction, thrombectomy, elastase-induced aneurysms, and in stent restenosis. As a Study Director, she has directed hundreds of regulatory studies to determine safety of coronary and peripheral artery stents, drug coated balloons, OCT, IVUS, and NIRs technologies, atherectomy, and thrombectomy devices. She has a broad knowledge of lab operations (in-life and pathology), regulatory requirements for animal research, animal models for cardiovascular and vascular device testing, and protocol development / report writing. Lynn is practiced at working with a team of lab operations staff, veterinarians, pathologists, medical writers, and quality assurance auditors to produce high quality results and reports. She has authored or coauthored numerous abstracts and peer reviewed articles for medical journals and professional meetings.
Dr. Ajit P. Yoganathan
Dr. Ajit P. Yoganathan is a Principal Consultant at CardioMed Device Consultants. He is also an Emeritus Regents’ Professor and the Wallace H. Coulter Distinguished Faculty Chair in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and Emory University, and a member of the National Academy of Engineering. He received a Bachelor of Science and a Doctor of Philosophy in Chemical Engineering in 1973 from University College, University of London and in 1978 from the California Institute of Technology, respectively. He joined the faculty at Georgia Tech in 1979, and over the years has made significant professional contributions at both the national and international levels. He played a key role in the creation of the master’s and Ph.D. degrees in bioengineering and the joint Ph.D. in Biomedical Engineering with the Emory University School of Medicine, and was also the Founder and Director of the Center for Innovative Cardiovascular Technologies
Dr. Yoganathan’s 45+ year research career has been pioneering and translational in nature by applying basic engineering science to develop meaningful human health outcomes, specifically in the realm of cardiovascular engineering and biology. In his effort to take an interdisciplinary and translational approach to his research, Dr. Yoganathan has established collaborations with clinicians, scientists, and industry professionals world-wide. His work utilizes experimental and computational biomechanical techniques to study native and artificial heart valves, structure function of the left and right sides of the heart, congenital heart diseases, and to develop minimally invasive cardiovascular interventions. He also uses non-invansive techniques such as laser Doppler velocimetry, digital particle image velocimetry, and Doppler ultrasound and magnetic resonance imaging to study and quantify blood flow physiology in the cardiovascular system, both on the bench and in vivo. His research success has led to more than 450 peer reviewed journal articles in leading biomedical journals and more than 40 book chapters. He has also been an invited speaker to over 300 conferences/lectures around the world and has mentored more than 50 doctoral students, 35 masters’ students, and 30 post-doctoral trainees.
Dr. Yoganathan’s career has been distinguished by a number of high honors. In 1985, Dr. Yoganathan was awarded an Alexander von Humboldt Fellowship from West Germany to spend 9 months at the Helmholtz Institute for Biomedical Engineering, Technical University of Aachen. He received the Edwin Walker Prize from the Institute of Mechanical Engineers, UK in 1988. In 1992, he was elected a founding fellow of the American Institute of Medical and Biological Engineering. The same year, he also spent six months at the University of Aarhus, Denmark as a Visiting Professor of the Danish Research Academy. He received the H.R. Lissner Award, for his contributions to the field of bioengineering in 1997 from the American Society of Mechanical Engineers. In 2005, he was awarded the Theo Pilkington Award, for his contributions to Biomedical Engineering education by the American Society of Engineering Education. That same year he was also appointed Chair of the Cardiovascular Sub-Committee (SC2), International Standards Organization Technical Committee (TC 150) on Implants for Surgery. In 2010 he was appointed the Founding Editor in Chief of Cardiovascular Engineering and Technology – the newest journal of the Biomedical Engineering Society. (CVET was accepted to PubMed in 2015, and in 2016 it was selected for coverage in Thomson Reuter’s citation indexing services and received an Impact Factor of 1.451 in 2018.) In 2012, the Biomedical Engineering Society bestowed Dr. Yoganathan the Pritzker Lecturer Award, one of the highest honors given to a BMES Member. In 2012, the Children’s Hospital of Philadelphia (CHOP) conferred him the Ann Newman Lecturer Award, the only engineer to have been awarded this honor. In 2015, in recognition of his significant contributions to the field of engineering, he was elected to the prestigious National Academy of Engineering in Washington, D.C. For his leadership and work on International and U.S. standards on cardiovascular medical devices, he was presented with the 2015 Standards Developer Award from the Association for the Advancement of Medical Instrumentation. In February of 2017, Tamils’ Information awarded him their Lifetime Achievement Award, presented to him by the mayor of Toronto at City Hall in Toronto, Canada. In 2020, he received the Professional Impact Award for Education from the American Institute for Medical and Biological Engineering (AIMBE), and was also inducted as the Inaugural Honorary Fellow of the American Association of Thoracic Surgery (AATS).
Additionally, Dr. Yoganathan has been active in inventing and developing a variety of medical devices and currently has 19 issued U.S. patents, with another 7 patent applications under review. In October 2009 he licensed one of his patents on heart valve repair, of which he is co-inventor, to a major cardiovascular medical device company (Edwards Lifesciences). The device is currently in animal studies. In November of 2009 he co-founded APICA Cardiovascular using other co-invented intellectual property. APICA is located in Galway, Ireland, with an engineering research office in Atlanta, GA. The company raised USD $5.5 million in venture capital funds. The company’s first product, a “bloodless” ventricular access and closure device, received CE mark approval in Fall 2013. APICA was acquired in July 2014 by Thoratec (the largest left ventricular assist device manufacturer) for USD $75 million. Another one of his inventions, a children’s continuous renal replacement therapy device, is currently under further development and initial animal studies, funded by a NIH challenge grant and a FDA pediatric device center grant have started.
The impact of his contributions to clinicians is profound, especially in the area of congenital heart diseases. The surgical planning tool he envisioned together with Prof. Jarek Rossignac, called SURGEM, is one such practical application of fluid mechanics in treating kids born with half a heart (single ventricle). This anomaly occurs in 2 in 1000 of every child born in the USA and 4 in 1000 in China. As part of this pioneering and translational work, he – together with Dr. Kanter, Chief of Pediatric Cardiac Surgery at Emory and The Children’s Hospital of Atlanta (CHOA) – developed the Y-graft surgical operation in 2011, based on his Optiflo patent. The Y-graft operation was listed as one of the top innovations in 2013 by CHOA and has since been used in about 50 plus children in Atlanta, the Children’s Hospital of Philadelphia and Stanford University Children’s Hospital.
Dr. Yoganathan also regularly works with medical device regulatory organizations. Since 1979, he has worked with the FDA and in 2004 he was appointed Chair of the International Standards Organization committee for implantable cardiovascular devices. This later appointment was a major achievement/honor, which recognizes research contributions and leadership in the field of cardiovascular medical devices at an international level. This leadership appointment has major implications with respect to international standards work as well as the US national standards and further interactions with the Food and Drug Administration (FDA) and the European Union (EU) community. During decades of research on heart valves, he has also worked with every manufacturer that has a replacement valve on the American market, including St. Jude Medical, Edwards Lifesciences, Medtronic, Carbomedics, Sorin Biomedical, and Boston Scientific, as well as with a number of smaller (including start-up) biomedical companies. Additionally, he consults with the major CV imaging companies, such as Philips, GE and Siemens.
Since 1975, all prosthetic heart valves implanted in the U.S. – more than two dozen valve designs – have been studied and evaluated in Dr. Yoganathan’s lab.
Meagan Fagan, M.S.
Ms. Fagan joined CardioMed in January 2019 as a Regulatory Consultant. Prior to consulting, she served as the Director of Technology for an innovative medical device company that specialized in the use of supercritical fluid technology to enhance drug delivery from drug-eluting implants (Class III medical devices). Her various roles within the organization allowed her a “hands on” approach from product/process feasibility, preclinical through FIH clinical trials to obtaining CE Mark and finally IDE approval. Ms. Fagan has over 12 years of experience in research/product development, design control and risk management along with preclinical device strategy and testing for combination medical device products, specifically drug-eluting stents. She has prepared pre-IDE and IDE submission materials and responses to interactive feedback with FDA; and drafted successful technical files that led to CE Mark approval.
Ms. Fagan earned her Master of Science degree in Chemistry from the University of North Carolina Charlotte and her Bachelor of Science degree in Chemistry with a minor in Biology from Mount Mary College. She is a member of the Regulatory Affairs Professional Society (RAPS).
CEO – Jasmine D. Patel, PhD
Jasmine Patel is the Managing Director at CardioMed Device Consultants. Dr. Patel has broad experience in medical device product development, particularly design controls, risk management, feasibility and verification/validation testing, and biomaterials biocompatibility. She specializes in the preclinical development and benchtop evaluation of endovascular devices, including stents, heart valves, drug/device combination products, vascular patches and grafts as well as catheters, syringes and needles.
Dr. Patel has extensive experience in preclinical testing in accordance with ASTM and ISO standards, and developing customized test protocols for new implant technologies. This encompasses biomaterial characterization to final device performance, and evaluation of the device/tissue interface using experimental, cadaveric, and computational analysis. She also has expertise in mechanical behavior of polymeric biomaterials and soft tissue (i.e. heart valves), particulate and coatings characterization, retrieval analysis, and MRI testing of passive and active medical devices. Dr. Patel has also provided regulatory consulting for preclinical device evaluation in support of a client’s submission or responding to questions from the FDA or other regulatory bodies.
Prior to joining CardioMed, Dr. Patel was a medical device consultant at Exponent, a science and engineering consulting firm. Before that, she was the Senior Scientist at Icon Interventional Systems, a cardiovascular device startup. Dr. Patel has also served as an advisor to a London-based healthcare consulting firm and has conducted technical and marketing assessments for firms on potential investment opportunities in the cardiovascular medical device sector. She also conducted research at Harvard Medical School, the Cleveland Clinic and Case Western Reserve University in the areas of heart valve tissue mechanics, polymeric biomaterials, and control of infection associated with implantable medical devices. She was an adjunct professor at Drexel University in the School of Biomedical Engineering, Science and Health Systems. Dr. Patel received her Master’s and Doctoral degrees from Case Western Reserve in Biomedical Engineering and her Bachelor’s degree in Biomedical Engineering from Boston University.
Roseita Esfand, PhD
Dr. Esfand works with CardioMed Device Consultants as an affiliated consultant. She has more than 20 years of experience in the delivery of pharmaceuticals from medical devices, and formulation of injectable, oral, and transdermal oncology drugs.
Throughout her career, Dr. Esfand has played a key role in the research, development, regulatory and commercialization of medical devices and pharmacological products. She has led multi-disciplinary teams of scientists and engineers tasked with providing technical and regulatory support to manufacturing, development, quality control, and quality assurance.
Dr. Esfand has extensive experience in the regulatory process of novel product development, manufacturing transfer, and scale-up from the laboratory bench to commercial scale production with expertise in combination products, using dendrimer and polymer technologies as delivery systems for oncology, anti-microbial, and anti-inflammatory drugs. She has successfully worked with international clients to gain EU and US regulatory approvals.
Dr. Esfand has served as scientific, regulatory, and manufacturing consultant to multiple start-up biotechnology companies and held scientific leadership positions at SmithKline Beecham (UK), Dendritech and Dendrimer Nanotechnology (US), Strapharma and PanBio (Australia), as well as IBI (Canada).
Rick Galgon, MD, MS
Dr. Galgon is a Principal Consultant at CardioMed Device Consultants. He provides clinical, engineering, and regulatory strategy consulting services for the medical device and related industries, specializing in the development and manufacture of interventional cardiology and general hospital devices.
Prior to joining CardioMed, Dr. Galgon worked for six years as a scientific reviewer for the U.S. Food and Drug Administration (FDA) in the Office of Device Evaluation (ODE), Interventional Cardiology Devices Branch and General Hospital Devices Branch. As a member of the Interventional Cardiology Devices Branch, he served as primary reviewer for balloon angioplasty catheters, intravascular brachytherapy devices, atherectomy catheters, embolectomy catheters, diagnostic and therapeutic intravascular ultrasound catheters, intravascular filters, and intravascular distal emboli protection devices. As a member in the General Hospital Devices Branch, he served as primary reviewer for external mechanical and electromechanical infusion pumps, implantable infusion pumps, intravascular administration sets, intravascular catheters, implantable intravascular ports, drug injection devices, hospital beds, hospital bed mattresses, and patient lifts/transfer devices. In addition, he played a central role as a division-level focal point for electromagnetic compatibility (EMC), software development, and magnetic resonance (MR) compatibility issues for medical devices. He served as a Center liaison to voluntary standards development organizations for infusion pumps and hospital beds, and represented the Agency at scientific symposia and intra-governmental meetings. For his efforts, he received both individual and group recognition awards from the Agency.
Dr. Galgon holds a considerable, in-depth understanding and experience in the fields of medicine, biomedical engineering, medical devices, medical device regulations, and regulatory submission requirements. He has extensive experience with overseeing clinical trials, searching and reviewing clinical literature, interpreting and evaluating scientific data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices. He earned is medical degree from Albany Medical College, master’s degree in engineering and applied physics in biomedicine from Johns Hopkins University, and bachelor’s degree in biomedical engineering from The Catholic University of America. He is a board certified anesthesiologist and faculty member in the Department of Anesthesiology at the University of Wisconsin in Madison, WI. He has published articles pertinent to the practice of anesthesiology and critical care medicine.
CONTACT DR. GALGON
Office: (410) 674-2060
Fax: (410) 674-2133
Email: rgalgon@cardiomedllc.com
Elisa Harvey, DVM, PhD
Dr. Harvey is a Principal Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
Prior to joining CardioMed, Dr. Harvey worked for more than ten years in FDA’s Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health. She began as a reviewer in the Obstetrics and Gynecology Devices Branch. Later she became Chief of the Peripheral Vascular Devices Branch with the Division of Cardiovascular Devices. In this position she oversaw the review and approval of a wide variety of devices including peripheral and carotid stents, vena cava filters, stent-grafts for the treatment of thoracic and abdominal aortic aneurysms, and numerous other catheter-based technologies. Her most recent position at FDA was overseeing the Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) Programs in ODE. Here she directed regulatory policy for IDEs and HDEs, and managed ODE’s growing pre-IDE program, which has become an invaluable part of the device development plan.
Dr. Harvey’s diverse background includes basic and clinical research, and clinical veterinary experience. She has extensive experience in review and approval of preclinical animal protocols, feasibility and pivotal clinical study protocols, and optimizing pre-IDE packages in order to maximize the effectiveness of meeting with the Agency in the pre-IDE phase.
Prior to her work at FDA, Dr. Harvey practiced veterinary medicine full time for several years. She earned her Bachelor’s degree in biology at Mary Washington College, her Master’s and Ph.D. degrees in zoology and reproductive physiology respectively at the University of Connecticut, and her veterinary medical degree from Tufts University.
Selected Publications
Mona Advani, MS, MBA
Ms. Advani is a recognized consultant in the medical device industry with 20 years of professional experience in domestic and international regulatory affairs. She has worked with small and large medical device companies to develop regulatory and clinical strategies, focusing on the appropriate development of corporate and product development strategy together with regulatory and clinical affairs. Ms. Advani has successfully obtained marketing clearance for a variety of medical devices, both in the United States and internationally, including the European Union (EU), Japan and Canada. She works diligently to prepare and represent clients in regulatory meetings with FDA and other Regulatory Agencies, including FDA panel meetings and FDA presubmission interactions. She has prepared numerous 510(k) and IDE Applications. She has also assisted in responses to FDA compliance actions and 483 letters.
Ms. Advani has worked in the medical device industry holding the titles of Senior Director of Regulatory Affairs and Clinical Research, Manager of Business Development, Manager of U.S. Regulatory Affairs, Manager of International Regulatory Affairs, and Regulatory Affairs Coordinator. In addition, she is fluent in written and spoken Japanese.
Ms. Advani earned her MBA degree from San Francisco State University, her MS degree in Immunology and Infectious Disease from the University of London, and her BS degree in Biology from Brown University. She has organized international regulatory affairs workshops; presented at the RAPS Annual Regulatory Affairs Professionals Society Meeting; and published articles in the Regulatory Affairs Focus magazine.