Judges

  • A leader in the area of Medical Device Development and Exploratory Research, Dave Knapp has been working to treat unmet needs in coronary, cardiovascular and pulmonary medicine for 20 years. Dave’s current focus as Vice President of Corporate Research at Boston Scientific is on developing new solutions and fostering growth in White Space areas. Coordinating open collaborative efforts has been a key focus area, including developing relationships with external institutions and connecting across disciplines and functions to drive meaningful innovation. Dave has a Bachelor of Science in Chemical Engineering from the University of Michigan, Ann Arbor and a Ph.D. in Chemical Engineering and Materials Science from the University of Minnesota. His undergraduate research focused in the area of cell separation and biochemical engineering at the University of Michigan and MIT, followed by a focus on Tissue Engineering at the University of Minnesota, contributing to deeper understanding of wound healing and developing bio artificial tissues such as liver, artery and heart valve leaflets. Following his tenure as a research scientist and operations engineer at Amoco Oil Company, Dave joined the Corporate Research team at Boston Scientific to help lead a development effort in Drug Eluting Stents. Since then, Dave has held a number of roles within Boston Scientific, spanning from exploratory to commercialization phases of the development cycle for various medical technologies in the cardiovascular space. His current role in Corporate Research focuses on innovation and driving new growth in white space areas and expansion into new geographies. Dave has presented at several conferences including meetings for the American Institute of Chemical Engineers (AIChE), Institute for Electrical and Electronics Engineers (IEEE), and Society for Biomaterials. He is an author on a number of publications in the areas of biopolymer rheology, in vitro assays for cell migration and traction, and modeling mechanism of release from controlled release formulations.
  • Randall L. Schiestl, PMP, is the Vice President, R&D, Global Technology at Boston Scientific Corporation where he leads a team of talented R&D engineers, scientists and technicians chartered to develop and sustain a broad family of minimally invasive medical devices. Specific responsibilities include: technology management; product design; computational analysis, packaging, labeling and sterilization engineering; university relationships, new product development facilities and labs; knowledge management; and sustaining engineering. He has global responsibility for building technical community, emerging market sourcing and managing R&D information systems across BSC. His engineering teams are located across multiple facilities both US and OUS. Mr. Schiestl (Randy) has a BSME degree from the University of Minnesota, college of Science & Engineering, high distinction He also holds MBA and Executive MBA degrees from the University of Minnesota, Carlson School of Management. Randy has completed the Medical Technology Management mini-MBA at St Thomas University and is certified as a Project Management Professional. Work history includes Honeywell, Alliant Techsystems, and Boston Scientific with functional responsibilities in project and program management, product and process development, strategic planning, mergers and acquisitions, manufacturing management, supply chain, quality, information systems, test facilities, and operations. Randy serves on multiple local and national industry advisory boards and consortiums including the Medical Devices Industry Consortium, the Medical Industry Leadership Institute, Heart Advisory Committee, AHA Twin Cities Board, Life Science Alley, FIRST Robotics and UMN Biomedical, Medical Device Center, Nanotechnology IABs. He received the 2011 UMAA Alumni Service Award from the University of Minnesota, College of Science & Engineering and the Design of Medical Devices Conference Award in 2012.
  • Mark Boden, PhD, is a Senior Research Fellow at Boston Scientific where he is in charge of identifying, creating, and developing medical devices to improve patient care. He has technical expertise in biomaterials, infection control and prevention, device design, university and hospital collaboration, exploratory research, and identification and development of strategic growth areas. Dr. Boden is on the Advisory Boards at the National Academy of Sciences, Biomedical Engineering Materials and Applications; Massachusetts Medical Device and Development Incubator; NHLBI; Syracuse University Biomaterials Institute; UMass Lowell; and the University of Vermont.
  • Barbara Huibregtse has 25 years of experience in translational research in multiple disciplines, translating bench and in vivo data to prepare for First in Man and pivotal trials in cardiac, vascular, neurovascular, neuromodulation, orthopedics, urology and endoscopy disciplines. She is Vice-President of Pre-clinical Sciences, which includes supervision of two laboratories, the Research and Training Center and a Tissue and Cell Engineering Laboratory at Boston Scientific Corporation. Prior to Boston Scientific, she was a Senior Scientist at Genzyme Corporation, working on Autologous Chondrocyte Transplantation, as well as small molecules, alternate cell therapies and other treatments for orthopedic and dermatologic disease. Barb received her B.S. in Animal Science from Pennsylvania State University, and DVM from University of Minnesota College of Veterinary Medicine, followed by an internship at the University of Illinois and a post-doctoral fellowship at Case Western Reserve University in mesenchymal stem cell biology with applications in orthopedic disease. Barb has presented at several international and national conferences on translational and device research, and cell therapy topics, and has several publications in different fields.
    ESD Professor of Engineering Systems at MIT Sloan School of Business
    • Professor of Engineering Systems at MIT Sloan School of Business
    Professor Stuart Madnick has been a faculty member at M.I.T. since 1972. He has served as the head of MIT's Information Technologies Group for more than twenty years. During that time the group has been consistently rated #1 in the nation among business school information technology programs (U.S. News & World Reports, BusinessWeek, and ComputerWorld). Dr. Madnick is a prolific writer and is the author or co-author of over 380 books, articles, or technical reports including the classic textbook, Operating Systems (McGraw-Hill), and the book, The Dynamics of Software Development (Prentice-Hall). He has also contributed chapters to other books, such as Information Technology in Action (Prentice-Hall). His current research interests include connectivity among disparate distributed information systems, database technology, software project management, and the strategic use of information technology. He is presently co-Director of the PROductivity From Information Technology (PROFIT) Initiative and co-Heads the Total Data Quality Management (TDQM) research program. He has been active in industry, making significant contributions as a key designer and developer of projects such as IBM's VM/370 operating system and Lockheed's DIALOG information retrieval system. He has served as a consultant to many major corporations, such as IBM, AT&T, and Citicorp. He has also been the founder or co-founder of several high-tech firms, including Intercomp (acquired by Logicon), Mitrol (acquired by General Electric's Information Systems Company), Cambridge Institute for Information Systems (subsequently re-named Cambridge Technology Group), iAggregate (acquired by ArsDigita which was subsequently acquired by Red Hat), and currently operates a hotel in the 14th century Langley Castle in England. Dr. Madnick has degrees in Electrical Engineering (B.S. and M.S.), Management (M.S.), and Computer Science (Ph.D.) from MIT.
  • Dr. Sharma is a cardiac Electrophysiologist with 25 years of experience in academic (Canada) and private practice medicine (California). For the last 7 years he has been at Boston Scientific Corporation RM, St. Paul, and is currently Vice President of Medical Safety. In this role Dr. Sharma works with the Quality and Regulatory groups to monitor fielded products; manages an external Boston Scientific Physician Board; reviews Clinical trials protocols, and deals with clinical issues; works with R&D to address known and potential product issues (e.g. Implantable Loop recorder); co-inventor on several patents; supports sales at physician meetings globally; on the teams for the Atritech ($200 million) and Cameron Medical ($3 billion) acquisitions; and assists in animal lab product assessment. He has published over 150 medical articles and lectured internationally. In medical practice Dr. Sharma frequently was an external consultant, advisor, and investigator to biomedical companies.
    Principal Research Scientist at Sloan School of Management - Massachusetts Institute of Technology
    • Principal Research Scientist at MIT
    Michael Siegel is a Principal Research Scientist at the MIT Sloan School of Management. He is Co-Director of the PROductivity from Information Technology (PROFIT) Project. Dr. Siegel’s research interests include the use of dynamic modeling and data mining for management and process improvement in healthcare organizations, narratives networks, cyber security and vulnerabilities, information technology for financial risk management and global financial systems, applications of computation social science to analyzing state stability and cyber security, digital business and financial services, financial account aggregation, heterogeneous database systems, managing data semantics, query optimization, intelligent database systems, and learning in database systems. His work in benchmarking commercial Value-at-Risk software systems has been very well received by academics, practitioners and regulators. Dr. Siegel has been active in research to improve patient safety and improve efficiency in a wide range of healthcare organizations and processes.
    Associate Director, Global Digital Customer Engagement at Biogen
    • Associate Director, Global Digital Customer Engagement at Biogen
    Shwen brings over a decade of experience in digital strategy, social media and pharmaceutical marketing/communications, both on the client-side and at leading agencies, and across consumer and professional verticals. Shwen is a well regarded pioneer in Digital Health and Social Pharma, who was recently recognized as a “Top 40 Healthcare Transformer” by MM&M (2015). He has played chairing roles at Digital Pharma East since 2009 (including Social Innovation Day in 2014) and ALI’s “Social Media and Multi-Channel Marketing for Pharma” since 2013. He also sits on a a number of advisory boards, including: Google (Healthcare), South by Southwest (SXSW), Digital Health Coalition and Medical, Marketing and Media, among others.
  • Sri has over 25 years of experience with 15+ years experience in systems architecture and design, software design and development. Sri has managed the development of over 18 full SDLC products. He has managed a department with a $4M budget and a team of 20+ direct and indirect reports in a class III medical device environment, enabling rapid development in an FDA regulated environment. Sri is also process expert and was responsible for re-writing the entire software development process to provide guidance on proper design controls to satisfy industry best practices, FDA guidelines and IEC62304:2006 and other regulatory bodies. Sri has extensive experience as a chief software architect of implantable medical devices that have generated more than $2 Billion in the last 10 years. He accomplished this by building highly talented software, firmware and test development teams (including 2 managers) and has mentored and motivated a small team to achieve superior performance. Sri has interfaced with Medical Advisory Boards (industry leading physicians) to discuss future product portfolio and new applications and to gather the voice of the customer. He has been to numerous site/Operating room visits to observe first hand use of the products. Sri has worked with industrial design houses to develop the user interfaces.
    Director, health@ei2 at GA Tech Enterprise Innovation Institute
    • Senior Strategic Advisor for HIT and Interoperability at Georgia Tech Enterprise Innovation Institute
    Steve is an experienced healthcare management and information systems consultant with 40 years of experience serving healthcare providers, payers and suppliers of services and products. For providers, Steve’s experience includes clinical, patient management and financial information systems strategic planning, evaluation, selection and implementation assistance. For payers and suppliers, he has used his extensive understanding of the provider segment to assist clients with formulating product strategy and improve product and services delivery. Steve was with Andersen Consulting (Accenture) for 25 years. He was in their healthcare practice as a partner for 15 years, including management responsibilities for health information technology strategy and systems integration. Following Accenture, he was President of Superior Consultant’s e-health Division. Following Superior, Steve was Director of BearingPoint’s Clinical Transformation practice. Most recently, Steve was a VP for Health Services for North Highland Company. Steve’s client experience covers a wide range of technology enabled performance improvement engagements for health care delivery organizations. Clients include community hospitals, academic medical centers, home health care and small and large ambulatory clinics. His clients have also included commercial payers, including health maintenance organizations, and for-profit physician management companies. He has worked with a number of established and start-up healthcare suppliers and vendors to improve delivery of products and services or introduce new products and services to providers. In July 2010, Steve was named the director of health@ei2 and is now Senior Strategic Advisor for HIT and Interoperability, including the Interoperability and Integration Innovation Lab (I3L).
  • I am interested in utilizing my clinical and technical expertise, as well as industry experience, to explore novel ways of harnessing innovations in cardiac device therapies. Specifically, my interest focuses on sudden death, cardiac arrhythmia, and stroke prevention. I am passionate about medical device safety and, and am interested in the challenges posed by the growing interface between sophisticated devices and the desire for simple, cost-effective diagnostic and treatment modalities. Experience includes: - CRM Medical Device Industry: Providing medical input into trial safety surveillance and design; post-market risk management and surveillance; regulatory body interfacing; process improvement; integration and diligence activities. - Cardiac sub-specialty clinical work involving cardiac electrical disturbances, and management of all aspects of prevention and treatment of sudden cardiac death, including implanting and managing defibrillators, pacemakers, CRT devices and performing radiofrequency ablations. - Training and teaching of medical and pharmacy students and specialty resident level physicians in all three of my board-certified specialties (internal medicine, cardiology, electrophysiology/EP). - Publication of original research; invited reviews in collaboration with international authorities in the field of EP; and book chapters in collaboration with scientific leaders in the fields of cardiology and EP. I have an international, multilingual background and insight into medical systems in both developed and developing countries. I have lived and practiced in Seattle, St. Louis, Johannesburg, and Nottingham. I presently reside in Boston. Specialties: - Medical device development and surveillance - Adult cardiology - Adult clinical cardiac electrophysiology - Adult internal medicine
    MIT Hacking Medicine
    • Graduate Research Assistant at Koch Institute for Integrative Cancer Research at MIT
    Christopher Lee is currently a PhD Candidate in the joint Harvard-MIT Division of Health Sciences and Technology working in the Koch Institute for Integrative Cancer Research developing new drug delivery techniques and therapeutics for urological diseases under Professor Michael J. Cima. Additionally, Chris is also the co-founder Recon Therapeutics, a medical device start-up focused on providing an improved platform to help patients mix, dose, and inject therapeutics that are delivered in a powered form. Among his various other awards, Chris is a 2015 Forbes 30 Under 30 Honoree for Healthcare, a World Economic Forum Global Shaper, and an Inc.com top 50 young entrepreneur under 25. Chris received his bachelors from the University of Connecticut, and masters from Johns Hopkins University.    Chris is also a Co-Director of MIT Hacking Medicine, an organization that is focused on energizing and connecting the best minds across the health ecosystem to solve meaningful healthcare challenges. To date, MIT Hacking Medicine has helped inspire the inception of nearly 20 active companies that have subsequently raised over $90M in financing. Chris has personally helped organize and lead over 20 MIT Hacking Medicine hackathons across several US States and international locations. 
  • In 1982 I was diagnosed with a rare arrhythmia and that was the beginning of my journey with heart issues. I was one of the first AV ablations at University of California San Francisco in 1983 and have been 100% pacemaker dependent for over 30 years. As a lifelong heart patient, I did not want to become a victim of heart disease. Instead I wanted to pursue my desire to become an athlete and competitive cyclist. After having open chest surgery in 2010, doing any kind of physical activity was a frightening idea. However, with the help of wearable devices and applications, I had the data I needed to get from the hospital bed to back on the bike and across the finish line of my first bike race. Since then I have competed in cycling events both domestically and internationally. I founded Tour de Heart to share how using Technology + Medicine + Activity can be a path for Heart Patients to get their active lives back. The goal of Tour de Heart is to empower patients to become accountable and knowledgeable for their health care by having the information that they need.
    Vice President Strategic Marketing at Arsenal Medical
    • Vice President Strategic Marketing at Arsenal Medical
    Toby Freyman is VP of Strategic Marketing at Arsenal Medical. Prior to joining Arsenal Medical, Dr. Freyman was an Associate Principal with Charles River Associates (CRA) where he was involved in the launch of new bio-pharmaceutical products. Before CRA, Dr. Freyman was a Principal Engineer with Boston Scientific Corporation’s Corporate Research and Advanced Technology Development group. In this capacity, he focused on the identification and development of combination products to treat cardiovascular diseases. While at Boston Scientific, Dr. Freyman managed a group of senior-level scientists and established partnerships with leading academic and corporate collaborators. Dr. Freyman has 12 scientific publications and presentations, 23 patents and 13 patent applications. He holds a Ph.D. in Materials Engineering from MIT, where he received a National Institutes of Health Graduate Fellowship through a joint program with Harvard and MIT.
  • Scott performs buy-side and sell-side transaction advisory services and market assessment at RNA Capital Advisors. He specializes in the assessment of healthcare and lifescience companies, products, technologies, and opportunities via the dual lenses of financial and market analysis in the settings of sell-side fundraising, buy-side diligence and investment analysis, and internal strategic positioning and decision-making. Scott holds a PhD from the Harvard-MIT Division of Health Sciences and Technology, following a BA in Physics from Cornell University.
    • Commercialization
    • Regulatory Strategy
    • Project Management
    • Business Development
    • Boston Scientific
    • Endoscopy
    • Market research
    • Clinical Needs Validation
    • Quality System
    • Regulatory Submissions
    • FDA
    • Medical Devices
    • Product development
    • Quality
    • Validation
    • Voice of the Customer
    • Clinical Need
    • Primary and Secondary Market Research
    • Market Sizing
    Global Product Manager, Boston Scientific Endoscopy
    Seasoned medical device professional with over 10 years of experience. She is currently a global product manager, responsible for upstream and downstream marketing activities for one of the fastest growing franchises. She has been involved in the technical development and commercialization of several Endoscopy devices. She holds three patents in methods of pancreaticobiliary access. She recently completed her MBA at MIT Sloan School of Management. While at Sloan, she worked on several startups and participated in the MIT 100K pitch competition. Most recently, she was a business consultant to one of the MIT Media Lab Camera Culture Lab project. She led the competitive assessment, value proposition validation and target customer identification through primary and secondary market research for their pilot product. She also designed the first human use trial for the device. Lastly, Vanessa worked at Sanofi, where she was the business development intern responsible for a detailing agreement announced in Aug 2015.
  • Tim Harrah is a Research Fellow and Technology Assessment Manager in the Urology and Pelvic Health Division of Boston Scientific. Since 2015 he has led the Division’s Advanced Technology group. This group’s responsibilities cross all division franchises in exploratory R&D, technology assessment and front end innovation management. The group currently has active programs aimed at finding and solving clinical unmet needs across kidney stone management, prostate disease, bladder dysfunction and erectile restoration through the development of capital, single use and implantable products. Tim has been with Boston Scientific since 2008 and holds a PhD in Biomedical Engineering from Tufts University and BS degrees in Biomedical Engineering and Chemical Engineering from Johns Hopkins.
    • Interventional Cardiology
    • Vice President, Clinical Interventional Cardiology at Boston Scientific
    Dr. Allocco joined the Boston Scientific clinical team in July of 2006 and is currently Vice President of Clinical for the Interventional Cardiology division. His team is responsible for all Boston Scientific clinical trials in interventional cardiology. Dom received his BA in Economics from Harvard College and then received his MD from Stanford University. He also holds a MS in Engineering from Stanford University as well as a MS in Biomedical Informatics from the Massachusetts Institute of Technology. Dom completed residency training in Internal Medicine and fellowship training in Cardiology at Beth Israel Deaconess Medical Center in Boston. He is based in Minnesota.
    • Cardiovascular Disease
    • Internal Medicine
    Associate Professor of Medicine at UMass Medical School
    • Associate Professor of Medicine at Umass medical school
    David D. McManus, MD, is a clinical cardiac electrophysiologist at the University of Massachusetts Medical School (UMMS) and cardiovascular outcomes researcher at the Meyers Primary Care Institute (MPCI). His goal is to improve our understanding of the epidemiology of atrial fibrillation (AF) in order to prevent AF and better treat patients with this increasingly prevalent arrhythmia. He is currently using the rich databases of the Cardiovascular Research Network (CVRN) to describe the contemporary epidemiology of patients with AF and heart failure (HF). He has published in the areas of AF and HF epidemiology, cardiac remodeling, and completed a cardiovascular epidemiology fellowship at the Framingham Heart Study (FHS).
  • My primary research area is software engineering. I am specializing in meta-composite systems development in the area of biomedical informatics. I define meta-composite systems as a system of systems – a system whose goal is to integrate and personalize existing data, tools, and methods to a user’s specific needs. I address both technological and social aspects of meta-composite systems development. I research technologies like SOA, web services, business processes, social networking, and mobile technologies. In my PhD dissertation, I developed a meta-composite framework for developing systems with process-personalized and customized support for human interactions. Currently, I am working with researchers in the areas of health services, translational, and biomedical research to develop the following systems: Social networking, Collaborative, Health games, Research integration and automation, Mobile-decision support, and Electronic medical, health and personal record integration.
  • Jeffrey Stahmann is an engineer with over 25 years of experience in the medical device field at Boston Scientific. During his medical device career he has worked as a development engineer and a research scientist. Jeff has led the development of numerous implantable devices including cardiac pacemakers, defibrillators, cardiac resynchronizers, and implantable pressure sensors. He also has experience in the design of neural stimulators and implantable loop recorders and has contributed to the conception, research and development of sensors and diagnostic algorithms for various conditions including cardiac arrhythmias, heart failure and sleep apnea. Jeff is currently leading the identification, funding and development of exploratory growth areas for the Rhythm Management Division of Boston Scientific. He is a prolific inventor and has over 300 issued US patents.
  • Julie Thompson is an R&D Director at Boston Scientific Corporation where she leads a team of scientists and engineers focused on developing sensor and diagnostic capabilities for improved cardiac patient management. Her responsibilities include providing strategic direction, building partnerships, and supporting development and implementation of diagnostic capabilities across a range of BSC products. Julie has been with Boston Scientific for 15 years, holding scientist and management positions in cardiac research, with a focus over the last decade on overseeing the development of novel heart failure diagnostic capabilities. Julie has a PhD degree in electrical engineering signal processing from the University of Michigan.
    • Interventional Cardiology
    • Senior Medical Director, Interventional Cardiology Division at Boston Scientific
    Dr. Christen joined the Boston Scientific medical team in August of 2009 and is currently Senior Medical Director in the Interventional Cardiology division. His team is responsible for providing medical oversight of several cardiovascular trials and post-market safety surveillance activities. Dr. Christen received his M.D. and Ph.D. degree from the University of Geneva Medical School, Switzerland and passed the United States Medical Licensing Examination in 1996. He is Swiss Board Certified Cardiologist. He also performed a Post-doctoral Research Fellowship in Cardiovascular Medicine at Brigham and Women’s Hospital and Harvard Medical School from 2006 to 2009.
  • John Kummailil, PhD, has 16 years experience finding technical solutions to business problems in medical devices. He has experience managing complex operations, research and development programs, product development, technology development, and outsourcing. Dr. Kummailil specializes in management and strategy and execution of complex projects that involve technical, logistical and business process challenges in the medical device space.
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