Robert A. Poggie, PhD
President, BioVera, Inc.
Bob has over 20 years of professional experience in the medical device industry. He has been involved in research, clinical study, regulatory approval, and market development activities in large and start-up companies. He is a proficient author of journal publications and is a scientific presenter at medical society meetings.
Before forming BioVera, Bob served as the Director of Global Brand Management for Zimmer Trabecular Metal Technology, Inc. The orthopaedic implant products he was responsible for saw rapid growth. He facilitated the products’ technical market positioning and served as the brand management liaison to Zimmer headquarters. Bob coordinated the publication of several clinical studies of orthopedic implants, surgical protocols, and product literature. He wrote the FDA and international submissions that resulted in numerous regulatory clearances for spinal, hip, knee, and shoulder products. He also created the education and training materials for prospective surgeon users and the company’s sales associates.
Prior to Zimmer, Bob was Director of Applied Research for Implex Corp. Implex brought a novel biomaterial into reality through coordinated testing, animal studies, and human clinical studies. Bob managed the research, the lab and university testing, and the worldwide regulatory clearances of all the orthopedic products. He initiated and managed several FDA regulated investigational studies, which included the recruitment of surgeon investigators, clinical site data compilation, and publication results.
Prior to his tenure at Implex, Bob was a senior research engineer for Smith & Nephew. He was responsible for metallurgical and tribological research, and contributed to the development of biomaterials such as oxidized zirconium bearing surfaces for hip and knee components.
Bob has published numerous peer reviewed papers and presented globally as invited faculty at over 100 medical conferences and education courses. He is a member of several professional engineering and medical societies. Bob holds a BE in Mechanical Engineering and MS and PhD degrees in Materials Science & Engineering, all from Vanderbilt University.
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Debbie Iampietro, BS, BA
Debbie Iampietro is the president of QRC Consulting Associates, a firm specializing in addressing the quality system and regulatory affairs needs of companies in the medical device industry. She has over 30 years of experience in the areas of Quality Assurance, Quality Control, and Regulatory Affairs. She has significant experience with the implementation and maintenance of quality systems in accordance with US FDA and ISO regulations, as well as extensive background in regulatory submissions (510K, IDE, PMA) in both the domestic and international arenas. Additional experience includes auditing, design controls and product testing protocol development, biocompatibility assessments, process and packaging validations, clean room and sterilization validations and assistance with software QA and validations.
Prior to founding QRC Consulting Associates, Ms. Iampietro held various positions and worked on a wide variety of medical devices and regulatory submissions at St. Jude Medical (Cardiac Assist Division), Vision Sciences, Boston Scientific Corporation, Haemonetics and USCI (Division of C. R. Bard). She served as Director of Quality Assurance and Regulatory Compliance at Boston Scientific Corporation, Director of Quality Assurance and Regulatory Affairs at St. Jude Medical – Cardiac Assist Division, and was Director of Regulatory and Clinical at Assurance Medical.
Ms. Iampietro began her career with a Bachelor of Science degree in chemistry and subsequently earned an MBA. She has designed and implemented training courses for Quality Systems and Quality Auditing. She was previously an instructor at Regis College in the Master of Science - Health Product Regulation Program. She has been a guest speaker for the FDA Regulations course within the Biomedical Engineering Program at Worcester Polytechnical Institute. She has co-authored an article published in MDDI entitled “Medical Device Reporting: A Global Perspective for the 21st Century”, and authored an article published in MDDI in August 2007 entitled “Control of Outsourced Processes”.
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Rita M Wadleigh, CQA
Rita Wadleigh is the President of Device Compliance Consulting (DCC), LLC. She has over 25 years experience with medical device development, manufacture, and compliance and has held positions of increasing responsibility with medical device manufacturers such as CR Bard, SleepNet, Matrix Technologies, Luxtec, and Integra LifeSciences. DCC is a consulting firm specializing in the quality management systems and regulatory needs of medical device manufacturers. Rita’s wide exposure to resources supporting the medical device industry, her varied experience within the medical device manufacturing field, and her practical approach to quality system development make her an asset when evaluating and developing any quality management system.
Rita continues to be active in the American Society of Quality as a Certified Quality Auditor (CQA), as Co-Chair of Programs for the Biomedical Division and is a Past-Chair of the New England Biomedical Discussion Group (NEDG).
Rita has her Bachelor of Science Degree in Mechanical and Industrial Engineering from Clarkson University.
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Milo Kral, PhD
Milo Kral received his BE in Mechanical Engineering from Vanderbilt University in Nashville TN (1984) and then worked at the Rochester Products Division of General Motors in Rochester NY for the following 6 years. He then returned to Vanderbilt for his MS and PhD. in Materials Science and Engineering and subsequently worked for two years in the Physical Metallurgy Division at the US Naval Research Laboratory in Washington DC. Thereafter, he was appointed to the faculty of engineering University of Canterbury, Christchurch New Zealand, where has spent the past 10 years and currently holds the rank of Reader (Associate Professor), director of the Electron Microscopy Center and Head of Mechanical Engineering.
His primary research interests are in the area of structure-property-processing relationships in structural metals with an emphasis on failure analysis and characterization techniques, particularly analytical transmission and scanning electron microscopy. Dr. Kral has over 50 refereed journal publications, conference articles and book chapters, including a Chapter in the Volume 9 of the Metals Handbook. He has successfully mentored six PhD and five ME students and has managed research grants of over $2M from both federal sources and private companies. He is an active member of TMS and has organized several symposia at TMS Annual meetings.
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Sam Nasser, MD, PhD
Dr. Nasser is a fellowship-trained, board-certified orthopaedic surgeon specializing in the branch of orthopaedic surgery known as adult reconstruction. His expertise includes complex joint replacement procedures of the hip and knee, operations to revise failed joint replacements, and the treatment of musculoskeletal infections. He has done extensive research in these areas, as well as investigations involving the response of the body to the metals, plastics, and ceramics used in orthopaedic surgery. He has lectured around the world, and has published over forty scholarly articles and ten book chapters. His work has been recognized with numerous academic and professional honors including the prestigious Sir John Charnley Award from the Hip Society (U.S.).
Following his undergraduate education at Michigan State University, Dr. Nasser attended Wayne State University for his medical and graduate training, graduating with honors in biomedical research in 1982. He completed his surgical internship and orthopaedic surgery residency at the Wayne State University Affiliated Hospitals in 1987. This was followed by a National Institutes of Health Surgeon-Scientist Fellowship in adult reconstructive surgery, and a second fellowship year in adult reconstructive orthopaedic surgery at the U.C.L.A. School of Medicine. Prior to his return to Detroit in 1993, Dr. Nasser was Assistant Professor of Orthopaedic Surgery at the Emory University School of Medicine in Atlanta, GA.
In 2005, Dr. Nasser was promoted to Professor of Orthopaedic Surgery at the Wayne State University School of Medicine, where he teaches students in all four years of their medical education. He also holds the position of Associate Professor of Biomedical Engineering in the Wayne State University College of Engineering, where he lectures on topics ranging from biomaterials and biocompatibility to metallurgy to muscle physiology.
Dr. Nasser joined the Beaumont Hospital System in 2005, and was appointed as the Director of the Adult Reconstruction Service at Beaumont Grosse Pointe in 2008.
Among his professional affiliations are memberships in the American Academy of Orthopaedic Surgeons, the Orthopaedic Research Society, the Society for Biomaterials, the Musculoskeletal Infection Society, and the prestigious American Orthopaedic Association. He served on the A.A.O.S. Committee on Biological Implants for six years, and was the physician representative to the Food and Drug Administration Good Practice Committee on Orthopaedic Devices from 1999 to 2005. He serves on the editorial boards for several orthopaedic journals, and recently completed his tenure on the board of directors of the International Society for Technology in Arthroplasty where he served from 2002 to 2008.
Dr. Nasser has been listed by the Best Doctors in America annually since 2002, and one of America's Top Physicians by the Consumers Research Council of America since 2004.
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