2025 PDIC Breakthrough & Networking

Gwen Fischer, MD
Associate Chair of Research, Associate Professor, Department of Pediatrics

Dr. Fischer is an Associate Director of the Earl E. Bakken Medical Devices Center, Associate Chair of Research, Associate Professor, Department of Pediatrics, Faculty Member, Division of Pediatric Critical Care Medicine, Pediatric ECMO Co-Director, UofMN Medical School. Dr. Fischer is a Pediatric Critical Care Physician with a passion for development and testing of innovative medical products and pharmaceuticals. Her expertise is in critical care from preemies to adults, and devices for adults and pediatric patients with an emphasis in congenital heart disease, ECMO, and cardiopulmonary devices. Dr. Fischer founded and directs an industry-academic consortium to accelerate pediatric medical devices (www.thepdic.org). Dr. Fischer has significant experience in developing medical devices and has successfully worked with numerous medical device companies in product development, including clinical studies, and commercialization. Dr. Fischer has con
sulted with the FDA Pediatric Advisory Committee and reviewed post-market SAE for drugs and devices. Dr. Fischer is a sought-after speaker with a portfolio of publications on medical device, critical care, ECMO, drugs and innovation. Dr. Fischer has received numerous awards including ‘Minnesota’s Top Doctor.”

Balakrishna Haridas, PhD
Professor of Practice, Biomedical Engineering
Cain Faculty Fellow
Director, Research - Translational & Industrial Research, Biomedical Engineering
Deputy Executive Director, Principal Investigator and Co-Founder, FDA Southwest Pediatric Devices Innovation Consortium
Affiliated Faculty, Professor, Mechanical Engineering
Texas A&M University College of Engineering

Sophie-Charlotte Hofferberth, MBBS
Co-Founder, President
Autus Valve Technologies, Inc.

Sophie-Charlotte Hofferberth, MD is the Co-founder and President of Autus Valve Technologies, Inc. As a post-doctoral research fellow in the Department of Cardiac Surgery at Boston Children’s Hospital, Dr Hofferberth led the conception, design and development of the Autus Valve - a novel synthetic size-adjustable surgical pulmonary valve replacement device specifically designed for pediatric patients. The Autus Valve is currently under clinical investigation in a U.S-based Pivotal IDE Study.

Megan Mueller
Senior Clinical Research Manager
Medtronic

Parker Tyler, MBA
Director Clinical Development
Edwards Lifesciences

Abstract: Traditional medical device innovation relies heavily on physical testing methods such as bench testing, animal studies, and clinical trials. This dependency introduces significant challenges and uncertainties, particularly in understanding the impact of variations in patient populations, clinical use, and manufacturing processes. These challenges are especially pronounced in pediatric innovation, where variability and sensitivity are heightened, often leading to unexpected outcomes that hinder product commercialization.

The new paradigm in medical device innovation leverages virtual patient populations, device digital twins, and clinical decision-making models to simulate variations comprehensively. This approach enhances learning, reduces risks, lowers costs, and accelerates time-to-market. In the pediatric domain, this transformation is poised to overcome the unique barriers to innovation, facilitating faster and more reliable development of medical devices for children.

Bio: Parker has over 11 years of experience at Edwards Lifesciences working in various functions including manufacturing, new product development, and reliability engineering. She has helped develop, commercialize, and scale multiple structural heart products. Through this experience she has developed a unique perspective on the challenges that products encounter due to user, patient, and manufacturing variation increasing post commercial launch. Throughout her different roles she has maintained a passion for and focus on better understanding and improving system and device performance to be robust to variation, to limit the surprises in the field. In her current role as Director of Clinical Development, she is creating new frameworks and technology to improve our ability to understand system performance and has recently been very active in the virtual patient and in silico clinical trial community. She believes that virtual patient and in silico modeling will transform how medical devices are developed, commercialized, and scaled. These technologies will be integral for ensuring reliable and high performing medical devices in diverse and highly variable patient populations.

Parker has a B.S. in Biomedical Engineering as well as an MBA from the University of Utah. She is passionate about driving transformation change in health equity through advanced technology and strategic partnerships. 

Christine Luk, MS
Associate Regulatory Affairs Manager
Proxima Clinical Research, Inc.

I am a Regulatory Affairs Manager at Proxima Clinical Research leading a powerhouse team of associates and specialists to research, strategize, and compose documentation to clients and FDA. I also serve as the Portfolio Manager of the Southwest-Midwest National Pediatric Medical Device Innovation Consortium (SWPDC), assisting over 300 pediatric device companies. I have a masters in Biomedical Engineering from Rice University, where I am also an advisory board member for Rice 360 Institute for Global Health. As an engineer, entrepreneur, and regulatory affairs expert, I am passionate about providing innovators guidance and resources to successfully navigate the pathway to market.

Frank Jaskulke
Vice President Sales & Business Development
Avio Medtech Consulting

Frank Jaskulke is committed to making the job of medical innovators easier. He spent 20 years at the Medical Alley Association building community assets to help startups access capital, customers, and talent. Now, he is at Avio Medtech, partnering with entrepreneurs to help their ventures take flight.

Gene Paranuk
Managing Director
In2being

John Behr
Executive Director
Educational Technology Innovations (ETI)
University of Minnesota