Gold University of Minnesota M. Skip to main content. University of Minnesota.
Driven to Discover.
DMD

Advancing US Early Feasibility Studies for Innovative Medical Technology

Wednesday, April 13, 3:45-5:15
Ski-U-Mah, McNamara Alumni Center

Organizer: Stephanie Christopher, Program Manager, Medical Device Innovation Consortium (MDIC)
Moderator: Bill Murray, President and CEO, Medical Device Innovation Consortium (MDIC)

"CDRH Efforts to Enhance the Early Feasibility Study Program"
Carla Wiese, Policy Analyst for the Early Feasibility Program, U.S. Food and Drug Administration

"EFS Strategy and Perspective"
Angela Mallery, Regulatory Manager, North American Science Associates, Inc. (NAMSA)

"MONA LSA Thoracic Branch Early Feasibility Pilot IDE"
Vicki Pearson, Vice President, Regulatory Affairs, Medtronic Aortic and Peripheral Vascular (APV)

"MDIC Blueprint for Early Feasibility Study Success"
Karim Benali, Vice President and Chief Medical Officer, Abiomed


Session Abstract:

In 2013, CDRH released final guidance titled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies to encourage sponsors to conduct early feasibility studies in the U.S. Developing clear guidelines for the earliest phases of testing medical devices will help encourage medical device innovation in the U.S. This session will discuss the CDRH guidance, the Medical Device Innovation Consortium Blueprint for Early Feasibility Study Success and experiences from sponsors who have submitted Early Feasibility Studies to CDRH.


Session Organizer Bios:

Stephanie Christopher, Program Manager, Medical Device Innovation Consortium (MDIC)
Stephanie Christopher, Program Manager at Medical Device Innovation Consortium (MDIC), manages MDIC’s Patient Centered Benefit-Risk and Clinical Trial Innovation and Reform projects. Stephanie has focused her career on highlighting the patient voice in clinical practice and decision-making, with special skills in health communication, public health project management and communication education.

Bill Murray, President and CEO, Medical Device Innovation Consortium (MDIC)
Bill joined MDIC in August of 2013 as the first President and CEO. He has over 25 years of senior leadership experience spanning the range of privately financed start-up to billion dollar plus global businesses. Bill’s small company experience spans 5 years as CEO and executive consultant, including 3 years as CEO of ReShape Medical. His large company experience includes leadership as the Molecular Biology Division President of Applied Biosystems, and at Medtronic where he spent nearly 20 years in various senior leadership positions, including President of the Pacemaker Business. Bill has also served as interim President and CEO of MTS Systems (MTSC) a public $500M industrial technology company. Bill currently serves on the Boards of MDIC, ILT, Sonex Health and Meso-FLow and previously served on the Boards of MTS Systems, LifeSync Holdings, and ReShape Medical. Bill has also served on various industry association and community leadership boards. He earned a Bachelor of Science Degree in Electrical Engineering from The University of Florida.


Speaker Bios:

Carla Wiese, Policy Analyst for the Early Feasibility Program, U.S. Food and Drug Administration
Carla Wiese has been at the Food and Drug Administration (FDA) for four years working as a consultant, lead reviewer and most recently as the Policy Analyst for the Early Feasibility Program. Prior to working at the FDA, she worked in the medical device industry for 12 years as a research and development engineer working in both a large company and a small startup. While in industry she managed an early feasibility study in Santiago, Chile. Carla earned a Bachelor of Science Degree in Mechanical Engineering from The Ohio State University.

Angela Mallery, Regulatory Manager, NAMSA
Angela has been in the medical device regulatory profession for over 25 years, covering a wide range of products and submissions. She has been developed and implemented world-wide regulatory strategies, ranging from large to small start-up companies. Product areas include Cardiology, Peripheral, Neuro, and Orthopedic devices.

Vicki Pearson, Vice President, Regulatory Affairs, Medtronic Aortic and Peripheral Vascular (APV)
Vicki and her staff have global regulatory responsibility for all pre- and post-market activities for the three Medtronic Aortic and Peripheral Vascular (APV) franchises, including Aortic, endoVenous and Peripheral therapies. She has over 30 years’ experience in the regulated industry, including Class III medical devices, pharmaceuticals and combination products. Vicki joined Medtronic’s Cardiac Rhythm Disease Management team in 1995, transferring to Medtronic Neuromodulation in 1999, and Medtronic Endovascular Therapies/APV in 2007. Prior to Medtronic, she worked at Upsher-Smith Pharmaceuticals in Minneapolis, Minnesota. Academia predated her regulatory career; she was a clinical research coordinator for clinical pharmaceutical studies at the University of Minnesota Medical School. She also taught clinical biochemistry at the University of Nebraska Medical Center, Omaha, Nebraska, and Metropolitan Medical Center in Minneapolis, Minnesota. Vicki earned her bachelor’s degree in Medical Technology from Minnesota State University, and is a graduate of the Minnesota Management Institute at the University of Minnesota, Carlson School of Management.

BenaliKarim Benali, Vice President and Chief Medical Officer, Abiomed
Dr. Karim Benali joined Abiomed in 2004 as Vice President of Product Development responsible for planning and directing the full range of Abiomed’s product development policies, objectives and initiatives. In 2006, Dr. Benali was appointed as Abiomed’s Chief Medical Officer. Dr. Benali is responsible of leading the clinical strategy and initiatives to advance the field of acute heart failure for patients that are supported with Abiomed’s products through evidence based medicine, the design and execution of large and complex trials and registries. Dr Benali came to Abiomed with twelve years of international experience in medicine, clinical research, bioengineering and biostatistics, with a strong focus on cardiology.

Prior to Abiomed, Dr. Benali worked for GE HealthCare, where he led the introduction of two of the company’s top products in cardiology. As the Global Clinical Research Leader for the GE cardiovascular business, he led the clinical introduction of the world’s first digital flat panel imaging system that has become a standard in the CathLab. After that, as Global Manager, he pioneered the first cardiac procedures on the newly introduced hybrid imaging platform and positioned GE as market leader in Cardiac PET/CT. Prior to GE, Dr. Benali worked in the academic field at several renowned European medical and research institutions including the Assistance Publique – Hopitaux de Paris, the Cyceron research center and the Inserm Institute. He was part of the French multidisciplinary team that contributed actively to the bourgeoning field of the human brain mapping project using multimodality imaging techniques. In the 90s, he was a key member of the small team that pioneered one of the first real-time neuronavigation procedures in brain surgery using real-time quantitative spatial fusion of 3D MR/CT/PET images with patient's brain. In parallel, Dr. Benali directed the clinical research program at the High Institute of Technology and Management in Paris, France where he taught biostatistics and Six Sigma methodology.

Dr. Benali earned an MD degree from Institut National de l’Enseignement Superieur des Sciences Medicales in Algiers, an MS in Bio-imaging and Bio-engineering from the University of Val de Marne — Paris XII, and a Pierre & Marie-Curie University Diploma in Biostatistics and Clinical Research from University Paris VI.


Presentation Abstracts:

"CDRH Efforts to Enhance the Early Feasibility Study Program"
Since the release of the Early Feasibility Study Guidance document in 2013, CDRH has had the opportunity to identify some challenges seen with these submissions. Some examples include issues with submission quality, appropriateness of FDA recommendations for early stage devices, timely feedback from FDA and CMS reimbursement. These will be outlined in this presentation along with CDRH's plan for addressing the challenges and enhancing the experience of EFS submitters.

"EFS Strategy and Perspective"
In 2013, CDRH released final guidance titled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies to encourage sponsors to conduct early feasibility studies in the US. Developing clear guidelines for the earliest phases of testing medical devices will help encourage medical device innovation in the US. This session will discuss the CDRH guidance, the Medical Device Innovation Consortium Blueprint for Early Feasibility Study Success and experiences from sponsors who have submitted Early Feasibility Studies to CDRH.

"MDIC Blueprint for Early Feasibility Study Success"
One of CDRH’s strategic priorities is to facilitate U.S. patient access to safe and effective new technologies of significant health importance first-in-the-world. To support this priority, in October 2013, CDRH released final guidance titled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, to encourage sponsors to advance U.S. innovation by conducting their early feasibility studies the U.S. Developing an efficient, transparent and predictable device development ecosystem, including clear guidelines for the earliest phases of testing medical devices, will help encourage medical device innovation in the U.S. The Medical Device Innovation Consortium (MDIC), a Minnesota-based public-private partnership to advance the regulatory science of medical devices, initiated an Early Feasibility project to facilitate the interpretation and use of this new CDRH guidance. To facilitate use of the CDRH guidance, MDIC developed “Blueprint for Early Feasibility Success,” a best practices roadmap for navigating the challenges and maximizing opportunities for successful US early feasibility studies. This presentation will highlight the Blueprint, which will be released in draft form in April, and includes considerations on study design, IRB and human subjects, regulatory issues and site selection.


Related Sessions:


Register Now


Stay connected with the DMD Conference through LinkedIn Twitter Facebook Icon G+ YouTube