"Becoming a Medical Technology Innovator"
Mississippi Room, Coffman Memorial Union

Conference Welcome and Plenary Session
Moderators: Arthur Erdman, Conference Chair and William Durfee, Conference Co-Chair

Keynote Address:

"How Big Data and Cognitive Computing will Transform Healthcare"
Martin S. Kohn, MS, MD, FACEP, FACPE, Chief Medical Scientist, Care Delivery Systems, IBM Research

Sponsor Exhibit Showcase (Meridian Foyer, The Commons Hotel)

Keynote Luncheon
Memorial Hall, McNamara Alumni Center
Moderator: Paul Iaizzo, Conference Co-Chair, Departments of Surgery, Integrative Biology and Physiology, Carlson School of Management, University of Minnesota

Sponsored by: Medtronic, Inc.

Keynote Addresses:

"Medical Technology Innovation in Israel, the Start-up Nation"
Chaim Lotan, Heart Institute, Hadassah-Hebrew University Medical Center and President, Israel Heart Society

Sponsor Exhibit Showcase (Meridian Foyer, The Commons Hotel)

Wednesday, April 9, 2014 - Technical Sessions

8:00-10:00

Sponsor Exhibit Showcase (Meridian Foyer, The Commons Hotel)

10:30-12:00

12:15-1:45

DMD Award Keynote Luncheon
Memorial Hall, McNamara Alumni Center
Moderator: Arthur Erdman, Conference Chair

Sponsored by: Boston Scientific Corporation

Emerging Medical Innovation Valuation Competition Awards
Presented by Stephen T. Parente, Director, Medical Industry Leadership Institute, University of Minnesota

Keynote Address:

"Towards the Essence in Medical Device Design"
Just Herder, Delft University of Technology
Recipient of the 2014 Design of Medical Devices Conference Award

2:00-3:30

Sponsor Exhibit Showcase (Meridian Foyer, The Commons Hotel)

Scientific Poster Session & Tour of the TCF Bank Stadium
DQ Room, TCF Bank Stadium (Premium Entrance under Benton County on the SW side of the stadium - There will be a Shuttle Service Available)

Thursday, April 10, 2014

7:00

Registration and Continental Breakfast

8:00-9:30

"Regulatory Science" Symposium

Welcome and Introduction:
Tina Morrison, PhD, Advisor of Computational Modeling, Office of Device Evaluation, CDRH/FDA and Dawn Bardot, PhD, Senior Program Manager, Medical Device Innovation Consortium (MDIC)

Keynote Addresses:

“What Does Regulatory Science Mean to Device Submission that Include Computational Modeling and Simulation”
Tina Morrison, PhD, Advisor of Computational Modeling, Office of Device Evaluation, CDRH/FDA

“How Can Regulatory Science Help Medtech Innovators”
Bill Murray, President and CEO, Medical Device Innovation Consortium (MDIC)

“Modeling and Simulation: Using Regulatory Science to Inform Reimbursement”
Tamara Syrek Jensen, Deputy Director, Coverage and Analysis Group (CAG), Centers for Medicare & Medicaid Services (CMS)

9:30-10:00

Sponsor Exhibit Showcase (Meridian Foyer, The Commons Hotel)

"Regulatory Science" Symposium

Technical Session

Welcome and Introduction:
Tina Morrison, PhD, Advisor of Computational Modeling, Office of Device Evaluation, CDRH/FDA and Dawn Bardot, PhD, Senior Program Manager, Medical Device Innovation Consortium (MDIC)

Keynote Addresses:

“Regulatory Science Methods: The Medical Device Development Tool”
Kathryn M. O'Callaghan, Senior Science Health Advisor, Office of the Center Director, CDRH/FDA

“Verification, Validation, and the Social Negotiation of Trust in Technology”
Laura A. McNamara, PhD, Principal Member Technical Staff, ISR Systems Engineering and Decision Support Organization, Sandia National Laboratories

12:00-1:45

Keynote Luncheon and Awards
Memorial Hall, McNamara Alumni Center
Moderator: Will Durfee, Conference Co-Chair and Dawn Bardot, Senior Program Manager, Medical Device Innovation Consortium (MDIC)

Sponsored by: Burroughs Wellcome Fund

Three-in-Five Awards Presentation
by Jesús Cabrera, 2nd Year Innovation Fellow, Medical Devices Center, University of Minnesota and Just Herder, Delft University of Technology

Keynote Address:

“Device Innovation and Regulatory Science”
Ellen R. Strahlman, MD, MHSc, Senior Vice President, Research & Development, Chief Medical Officer, BD
Honorary Recipient of the Woman in Med Tech Award presented by Dana Boyle, VP of Community Engagement LifeScience Alley

2:00-3:00

Tours

Sign-up for tours at The Commons Hotel Registration Desk.

Departure will be from the Memorial Hall, McNamara Alumni Center. You will be escorted to the facility.

Click on each tour facility name below for more information:

Center for Research in Education and Simulation Technologies (CREST)
CREST is the associated research branch of SimPORTAL (Simulation PeriOperative Resource for Training and Learning), the simulation center for the University of Minnesota Medical School. The mission of CREST is to be a world leader in the research and development of novel curricula and simulation models to drive the future of healthcare professional education.

At the heart of our simulation work is an innovative method for building accurate, 3D reconstructions of human anatomy. Using real patient MR and CT data as reference models, and cadaveric photography for accurate texturing, our lab can construct any organ system, catered specifically to any patient, condition, or surgical procedure. Our method allows us to build organ systems in a variety of resolutions, ranging from low end meshes ideal for volumetric simulation, to high end meshes used for photo realistic animation and illustration. We also have an artificial tissue lab with analogue models benchmarked against our human tissue database. CREST is also the host and for live 3D visualization, recording, and streaming between the FV operating rooms, the Medical School and the Medical Devices Center. 

Experimental Surgical Services (ESS)
At Experimental Surgical Services, we are experts in designing and conducting the appropriate research to determine the safety and efficiency of medical devices. We have more than 25 years experience in pre-clinical assessment for the medical industry. In fact, we are the industry leader in researching and testing cardiac devices and surgical techniques. We complete more than 500 open heart procedures a year and more than 1,500 procedures annually. ESS is directed by Richard W. Bianco who has 25+ years of experience in the pre-clinical assessment of virtually every animal model. The ESS staff, of in-house surgeons, work with device companies to develop and validate research methods, provide consultation as necessary and offer interpretative and technical support. 

Interactive Visualization Lab (IV Lab)
IV Lab research involves data visualization, computer graphics, and human-computer interaction. Current projects include visualization of time-varying (motion) data, large-scale data visualization, perceptually optimized visualization, 3D user interfaces, haptics, and pen and multi-touch input techniques. Our work is supported by the National Science Foundation, National Academies Keck Futures Initiative, grants from industry, and the University of Minnesota.

The research group includes about 10 undergraduate and graduate students. The IV lab in Keller Hall is equipped with high-end graphics workstations that drive a series of innovative visual displays and interactive devices. Major equipment includes a Multi-Surface, Multi-Touch Virtual Reality Environment and a 3D Haptic (Force-Feedback) Display. We also work regularly with the visualization facilities at the Minnesota Supercomputing Institute.

Medical Devices Center (MDC)
The Medical Devices Center at the University of Minnesota is a unique interdisciplinary program that resides within the Institute for Engineering in Medicine. The MDC aims to strengthen interdisciplinary research among faculty in the health sciences and engineering in areas specifically related to medical devices. The center trains the next generation of medical device inventors (including the Innovation Fellows Program) and fosters new relationships with the medical device industry and government agencies to improve health care worldwide. The tour will highlight the 8,000 square foot. facility that is configured to promote interdisciplinary medical device development including needs assessment, creative brainstorming, prototyping and testing. Additional tour times are to be announced 

Minnesota Nano Center (MNC)
The Minnesota Nano Center is a state-of-the-art facility for interdisciplinary research in nanoscience and applied nanotechnology. The Center offers a comprehensive set of tools in two clean rooms for fabricating new micro- and nanoscale devices, such as integrated circuits, advanced sensors, and microfluidic systems. The Nano Center is also equipped to support nanotechnology research that spans many science and engineering fields, in areas as diverse as cell biology, high performance materials, and biomedical device engineering. This interdisciplinary work takes place in two new specialized labs to support interdisciplinary research in bio-nanotechnology and nano/micrometer-scale materials. Tour attendees will see the Nano Center’s new Class 100 clean room and its fabrication tools, as well as our new applications labs devoted bio-nanotechnology and nanomaterials.

The Visible Heart Laboratory (VH Lab)
World-renowned researcher Paul Iaizzo, PhD, has been at the University of Minnesota since 1990, performing research and teaching graduate and undergraduate courses. In 1997, Dr. Iaizzo and his coworkers created the Visible Heart® laboratory in collaboration with Medtronic, Inc. Today, this lab is a premiere place to perform translational systems physiology research that ranges from cellular and tissue studies to organ and whole body investigations. The VH Lab also has a unique human heart library. The Visible Heart® lab embodies a creative atmosphere which is energized by some of the best and brightest students at the University. Our lab staff has more than 100 years of collective research experience and functions as a highly efficient and productive team. 

MINNESOTA NEUROMODULATION SYMPOSIUM

2:00pm - 8:00pm, April 10, 2014
8:00am - 2:00pm, April 11, 2014
The Commons Hotel, Minneapolis, MN

Welcome to the Neuromodulation Symposium organized by the Institute for Engineering in Medicine. Neuromodulation is a rapidly-growing field, encompassing a wide spectrum of implantable and non-invasive technology-based approaches for the treatment of neurological and psychiatric disorders. Advancing the field of neuromodulation represents challenges to developing engineering methodologies, understanding mechanisms of neuromodulation at cellular and systems levels, clinical application to treat patients, as well as regulatory process. This symposium is aimed at bringing together basic scientists, engineers, clinicians, industrial practitioners and entrepreneurs to discuss challenges and opportunities in neuromodulation. The symposium will consist of plenary presentations by leaders in academia, industry and government, and poster presentations to exchange ideas in this exciting field. The Symposium will be held immediately following the Design of Medical Devices Conference. We look forward to seeing you in Minneapolis on April 10-11, 2014.