Chris Owens has over 25 years of medical device experience holding senior-level executive positions in both commercial and technical areas. He is currently the President & CEO of Gynesonics Inc. Gynesonics is a privately held medical device company, dedicated to advancing women’s health by developing transcervical, uterus-preserving, incision-free minimally invasive technologies for diagnostic and therapeutic applications. In addition, Mr. Owens also serves as an Independent Board of Director for the company PQ Bypass, a peripheral vascular graft and stent company, and Amphora Medical, a company developing a novel treatment for over active bladder. Mr. Owens previously served on the board of RF Surgical, with products for the detection of retained surgical sponges, acquired by Medtronic in 2015. Prior to joining Gynesonics, Chris was the President & CEO of IDEV Technologies from 2008-2013. IDEV was a privately held medical device company focused on the peripheral vascular market, which was acquired by Abbott in 2013. From 2005-2008, he served as Vice President of Worldwide Marketing for MicroVention, a startup medical device company in the neurovascular space that was purchased by Terumo Corporation. From 2003-2005, he was the Vice President of Global Research and Development for the Surgical Division of Bausch & Lomb. Mr. Owens earned a bachelor’s degree and a master’s degree in Plastics Engineering from the University of Massachusetts, Lowell, and an MBA from the University of Phoenix.
Jordan has more than 24 years of manufacturing and operations experience in the regulated environment of both the DOD and medical industry with more than 20 years exclusively working with Medical Systems and Devices including many successful product launches, fundraisings, and mergers. Expertise includes all aspects of corporate definition, Strategic Planning and leadership as it applies to medical capital equipment as well as disposable medical devices design, development, manufacturing and deployment. Jordan is a multiple patent holder on many medical device technologies. Previous positions include: President and COO of Polymorfix, General Manager of ev3 Sunnyvale, VP of Operations of Appriva Medical, Senior Director of Operations at LocalMed, Inc., Surgical Manufacturing Engineering Manager at Coherent Medical, Inc., and Member of Technical Staff (Physics) at Hughes Aircraft Company.
Jordan is a graduate of the University of California at Davis with a B.S. in Applied Physics.
Jiayu has over 20 years of design and product development experience in medical device industry. Before joining Gynesonics, he was a chief engineer at GE Ultrasound where he led global research teams on technology innovation, studying new clinical solutions and creating of new device platforms. Prior to GE Healthcare, Jiayu was the VP of Engineering at U-Systems, where he led the team that invented the system for automated breast cancer screening and delivered clinical results. The system received FDA PMA approval in 2012 and later acquired by GE Healthcare. Before that, he was served as senior engineering managers at ONI acquired by Ciena and Diasonics Ultrasound acquired by GE.
Jiayu received his M.S. degree in Mechanical Engineering from Tsinghua University, Beijing China and Ph.D. in Electrical Engineering from Pennsylvania State University.
Dennis has worked in various Johnson & Johnson capacities for a total of 20 years as Director of Clinical Research at the Pharmaceutical Research Institute; Director of Medical Affairs for Ethicon Inc; and World-Wide Vice President of Clinical, Regulatory and Medical Affairs for Cordis Corporation. During his 11 years with Cordis, Dennis served as a Board Member and had responsibility for the clinical development of cardiology, neurovascular and endovascular devices.
While at Johnson & Johnson, Dennis received the Johnson Medal, the highest scientific recognition awarded by Johnson and Johnson in recognition for the clinical development of a topical growth factor for the treatment of chronic wounds. Dennis also served as the Director of Clinical Research in the gastrointestinal therapeutic group at Glaxo for one year.
For the past five years, Dennis has been serving as a clinical/regulatory consultant to a variety of device and combination product companies in the US and Europe. Before joining the medical device industry, he practiced family medicine in the Philadelphia area. His medical degree is from the Penn State Hershey Medical Center.
Taraneh has over 15 years of research and clinical experience in the medical device industry. Prior to joining Gynesonics, she was the Program Director, Clinical Affairs at St. Jude Medical where she led preclinical research, clinical feasibility IDEs, pivotal IDEs, and post-market studies of a range of innovative technology solutions. Responsible for Cardiac Resynchronization Therapy clinical programs globally, she developed strategic clinical plans and interacted with FDA, TUV and other regulatory agencies to achieve regulatory and market access objectives with clinical trials. Taraneh has collaborated with physician experts worldwide to design and conduct clinical studies that address unmet clinical needs, resulting in several dozen published scientific journal articles and accepted conference abstracts. She has successfully led clinical premarket applications through the preparation, submission, and FDA review and approval. She also holds 93 issued patents and 62 pending patent applications with the USPTO in the field of medical device therapy solutions.
Taraneh graduated magna cum laude from the California Polytechnic State University (Cal Poly), San Luis Obispo, with a B.S. degree in computer engineering. She also received a M.S. with distinction in Electronic Engineering from Cal Poly, and a M.S. and Ph.D. in Biomedical Engineering from the University of Southern California.
Diane has served in senior management of medical device regulatory affairs for more than 17 years. Previously, she was the Vice President of Regulatory Affairs with Alara, Inc. in Fremont, CA. Before joining Gynesonics, her experience covered FDA collaboration, pre-market submissions, clinical studies, compliance planning, and European regulatory requirements in the fields of digital imaging, bone densitometry, and light-based cosmetic therapy. She also has more than twenty years of experience in the development and management of quality systems in FDA regulated industries.
Diane is Regulatory Affairs Certified by the Regulatory Affairs Professional Society. She received her B.S. in Chemical Engineering with distinction from the University of Rochester.
Rich has 25 years of medical device experience, in which the last 12 years have included executive commercial roles and general management responsibility. Prior to joining Gynesonics, in 2013 he served as a global commercial operations strategic consultant at IDEV Technologies, a private company focused on the peripheral vascular market, which was acquired by Abbott Vascular in 2013. During 2011-2012 he was General Manager of Orthopedic & Woundcare division of Synovis Life Technologies. The company, which developed chemically crosslinked tissue products used in a range of surgical applications, was acquired by Baxter International in 2012. From 2001 through the beginning of 2011 he served in positions of increasing commercial responsibility, and as a corporate officer and President at Cardiogenesis Corporation. The company was acquired by Cryolife Corporation in 2011.
Rich earned a B.A. (Finance) from the University of Notre Dame and a M.S. in Systems Management from the University of Southern California.
Before joining Gynesonics, Mike spent 14 years in the field of Ultrasound at Acuson/Siemens. There he held a variety of positions, including individual contributor, functional and project manager. He contributed to all of Acuson’s platforms from the 128 to the Sequoia platform. After Acuson, he joined Optiscan as Director of Software and Electronics. Opticsan was a startup which was developing a non-invasive blood glucose monitor for home use by diabetics. Mike was promoted to VP of Engineering while at Optiscan. He was instrumental in defining and realizing several generations of the spectrometer prototypes made by Optiscan. Mike has several patents in glucose measurement.
Mike earned his B.S. in Electrical Engineering from Massachusetts Institute of Technology.
James has more than 26 years of experience in the medical device industry focused on manufacturing and engineering management. Most recently, from September 2013 to March 2016, he served as Vice President of Manufacturing and Engineering at Tridien Medical, a manufacturer of patient positioning devices and support surfaces to assist caregivers in preventing and treating pressure ulcers. James’ responsibilities at Tridien included managing three domestic manufacturing facilities with more than 300 employees. Prior to that he performed senior manufacturing/operations leadership roles with Class III implantable heart valves/transcatheter delivery systems (Medtronic), Class II therapeutic laser systems (BIOLASE), Class II/III cardiology and electrophysiology products (J&J/Biosense Webster). He began his career with Baxter/Edwards Life Sciences as a manufacturing/packaging engineer.
James has a B.S. in Engineering Technology from West Coast University and a MBA in Technology Management from the University of Phoenix. He completed six sigma training and implementation with Johnson & Johnson and served for four years in the U.S. Air Force as a Metrologist.
Dr. Toub received A.B. and M.D. degrees from the University of Chicago, and earned an M.B.A. with a concentration in management information systems from Drexel University. David is a Fellow of the American College of Obstetricians and Gynecologists and a Diplomate of the American Board of Obstetrics and Gynecology. After postgraduate medical training in obstetrics and gynecology at Brigham and Women’s Hospital, Massachusetts General Hospital and Albert Einstein Medical Center, David completed a fellowship in pelvic surgery (advanced laparoscopy, hysteroscopy and gynoncology) at Graduate Hospital under Harry Reich, Francis Hutchins, Jr. and Michael Campion. He also served as an attending physician at Pennsylvania Hospital, where he held faculty appointments at both Thomas Jefferson University and the University of Pennsylvania. David currently holds an adjunct faculty position at Albert Einstein Medical Center in Philadelphia.
A laparoscopic surgeon with a special interest in providing alternatives to hysterectomy, Dr. Toub has been a faculty member at several conferences organized by the American Association of Gynecologic Laparoscopists (AAGL). He has also presented at annual meetings of the AAGL and the European Society for Gynaecological Endoscopy and was a Keynote Speaker at a course on hysteroscopy at the Royal College of Obstetricians and Gynaecologists. David serves as an expert reviewer for the journal Obstetrics and Gynecology and is a current reviewer and a former member of the Editorial Advisory Board of The Journal of Minimally Invasive Gynecology. Prior to joining Gynesonics, David served as Chief Medical Officer at MedCases and VP, Medical Director at SciFluent, where he combined his clinical and information technology backgrounds to develop innovative continuing medical education programs for the web.