Show Preview: Design of Medical Devices Conference 2023

University of Minnesota, Minneapolis, MN

The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering. Engineering to fight cancer, neurological disorders, failing organs, and many other ailments. As part of Innovation Week, the Design of Medical Devices Conference highlights advances and new directions in medical engineering, from basic research to advanced medical technology.

CONFERENCE SCHEDULE (all times CDT)
Monday, April 17 Individual Workshops 8:00 AM–5:00 PM

Becoming a Medical Technology Innovator

This fast-paced workshop takes you through the process of early-stage innovation for medical devices. Through lectures from experts, hands-on design activities, and networking you will learn the steps needed to develop a new medical device including understanding and refining needs, creating and testing prototypes, regulatory and reimbursement, and what investors and company managers look for when you pitch your idea.

Regulatory 101: Medical Devices

This workshop will include an introduction to U.S. regulations and working with the FDA, conducting clinical studies, design of quality systems, submission pathways, as well as advertising and promotion requirements, and working with FDA. All sessions will be conducted by some of the most respected experts in the field. This workshop imparts critical knowledge for anyone who is new to the medical device industry or hoping to join it. And if you’ve been in the industry, it’s always a great idea to refresh your knowledge.

ASME V&V 40 Workshop

Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices was published in 2018 to support the credible use of modeling and simulation within the medical device industry. This standard was developed through close collaboration between medical device developers, regulatory agencies, and other device industry stakeholders, and provides modelers in the medical device industry with a framework for establishing model credibility requirements. This introductory course will provide an overview of the standard and highlight its key tenets through a few medical device examples and active discussions.

CONFERENCE SCHEDULE (all times CDT)

CONFERENCE SCHEDULE (all times CDT) KEYNOTES

Tuesday, April 18, 8 AM

Plenary Keynote

In this role, he leads the global Ethicon franchise and serves as a member of the Johnson & Johnson Medtech Global Leadership Team. Makatsaria has more than 25 years of medtech leadership experience with Johnson & Johnson. He began his career with Johnson & Johnson in 1996 as a sales representative in Russia and has since gone on to lead Johnson & Johnson Medical Devices businesses across Europe, Middle East, Africa, and Asia Pacific. Prior to his current role, he also served as chairman of Johnson & Johnson China responsible for the enterprise.

As an active thought leader in the medtech industry, Makatsaria is committed to the advancement of healthcare for patients. While in Asia, he served as the chairman of the Asia Pacific MedTech Association and as a member of the Business Advisory Board of the Singapore Management University. Currently, he is actively engaged with AdvaMed, leading industry-wide efforts advocating for greater access and equity across global healthcare systems. Vladimir holds a bachelor’s degree in Physiology and master’s degrees in Healthcare Administration and Business Administration from the University of Minnesota.

Tuesday, April 18, 12 PM

Keynote Luncheon: Innovation Drivers in Cardiac Rhythm Devices

Whitman, PhD, is a research director in Cardiac Implantables Research & Technology. Whitman has more than 25 years of experience in the medical device industry and leads a team focused on novel cardiac therapies and implant procedures for pacemakers and defibrillators. Her research interests include hemodynamics of arrhythmias, minimally invasive cardiac procedures, and design and delivery of pediatric devices.

As a prolific innovator, she holds 28 patents. Whitman is a Medtronic Bakken and Technical Fellow and a University of Minnesota Institute for Engineering in Medicine (IEM) fellow. She serves on the Purdue School of Biomedical Engineering Advisory Board. She holds a bachelor’s degree in mechanical engineering from the University of Wyoming. Whitman was a National Science Foundation Research Fellow during her graduate studies with an MS in food engineering and PhD in biological engineering from Purdue University.

Wednesday, April 19, 8 AM

Plenary Keynote

White Delaney serves as professor and dean, School of is the Knowledge Generation Lead for the National Center for Interprofessional Practice and Education. She served as associate director of the Clinical Translational Science Institute — Biomedical Informatics and acting director of the Institute for Health Informatics (IHI) in the Academic Health Center from 2010 to 2015. She serves as an adjunct professor in the Faculty of Medicine and Faculty of Nursing at the University of Iceland, where she received the Doctor Scientiae Curationis Honoris Causa (Honorary Doctor of Philosophy in Nursing) in 2011.

Delaney is an elected Fellow in the American Academy of Nursing, America College of Medical Informatics, and National Academies of Practice. She is the first Fellow in the College of Medical Informatics to serve as a dean of nursing. Delaney was an inaugural appointee to the USA Health Information Technology Policy Committee, Office of the National Coordinator, and Office of the Secretary for the U.S. Department of Health and Human Services (HHS).

Wednesday, April 19, 10:30 AM

Cardiovascular Keynote: Pacemakers and Implantable Cardioverter Defibrillators in Pediatrics — The Next Generation

Berul, MD, is earned both his bachelor’s degree in biology and master’s degree in pharmacology from Bucknell University in 1984 and received his MD from University of Maryland in 1988. Dr. Berul completed pediatrics residency at Yale, followed by fellowship in pediatric cardiology and electrophysiology at Children’s Hospital of Philadelphia. He was the director of the Pacemaker and Defibrillator Program at Boston Children’s Hospital, Harvard Medical School until moving to lead the Children’s National Cardiology program in 2009. Dr. Berul is a tenured professor of pediatrics and bioengineering at George Washington University School of Medicine, and holds the endowed chair Van Metre Companies Professorship in Cardiology.

Dr. Berul is actively involved in key organizations such as the Heart Rhythm Society, the American Heart Association, American College of Cardiology, and Pediatric and Congenital EP Society (PACES), of which he was past president. He is currently an associate editor for Heart Rhythm Journal. Dr. Berul has mentored dozens of trainees and advocates for young investigators and clinician-scientists. Over the past 3 decades, his research focus and passion is to develop novel minimally invasive approaches to the heart and improving methods for pediatric pacing and defibrillation. Dr. Berul has more than 300 publications and is an invited speaker nationally and internationally in the area of pediatric cardiac electrophysiology and miniaturized device development.

Wednesday, April 19, 12 PM

IEM Distinguished Keynote Luncheon: Re-Thinking STEM Outreach & Engagement: Building Capacity through Building Community

Every child, regardless of their zip code, race, or gender should have access to high-quality STEM engagement and education. STEM NOLA, the flagship affiliate of STEM GLOBAL Action, has developed a community engagement model that directly addresses the historical challenges and barriers to STEM access for underserved and low resourced communities. The model offers processes featuring intentionality and consistency, all while leveraging innovative approaches to entice community and family involvement.

Through research and years of practice, STEM NOLA understands that early and ongoing exposure and experience of youth to STEM concepts in a rigorous, culturally relevant environment is absolutely critical to unlocking the doors of economic opportunity that STEM careers uniquely provide. Our model features paid programmatic staff, college and professional volunteers, hands-on learning opportunities, and a culture of excellence which translates into a high-quality mechanism of tackling real-world challenges and fostering self-agency of participants. This methodology supports long-term engagement and ongoing mentoring for regular program participants.

In this session, attendees will be provided an in-depth overview of STEM NOLA’s core programming and model, particularly its approach to captivating the hearts and minds of diverse youth, families, and communities.

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