PDIC Breakthrough & Networking

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PDIC Breakthrough

Workshop Chair: Gwen Fischer, University of Minnesota

Medical device development for children lags significantly behind the adult market. This innovation gap results in families and health care providers improvising or making due with inadequate products. Please join us at the Pediatric Breakthrough Event-where we focus on getting medical technologies to pediatric patient access. This event also gives a chance for providers and inventors to connect with industry members, engineers, and others involved in medical technology development for kids.

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1:00-1:45pm Check-in & Networking

1:45-2:00pm Introduction to the Pediatric Breakthrough by Gwen Fischer

Gwen Fischer - 2023 Session Organizer - Peds & Digital Tools

Gwen Fischer
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.”

2:00-2:30pm Keynote: Chester Koh, MD

Chester Koh, Texas Children’s Hospital - PDIC Breakthrough Speaker DMD2024

Professor of Urology, Pediatrics, and OB/GYN
Baylor College of Medicine
Texas Children’s Hospital

2:30-2:50pm Keynote: Balakrishna Haridas, PhD

Balakrishna Haridas - 2023 Speaker

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

2:50-3:10pm Keynote: Rachel Brucker, Medtronic

Rachel Brucker - PDIC Speaker

Rachel Brucker, JD, MBA
Sr Program Manager,  R&D,
Special Requests Program, Medtronic

Rachel manages the Special Requests Programs for the Cardiac Rhythm Management and Neuromodulation businesses at Medtronic. Special Requests programs are primarily focused on developing or modifying devices to support unmet, unique patient needs. In her role in R&D, Rachel oversees the entire lifecycle of a portfolio of devices, from concept to post-market surveillance and obsolescence.  

Although unique patient needs may arise across a broad range of ages, support of unique pediatric patients is a major area of focus for these programs. Rachel has been leading efforts within Medtronic to seek market approval for certain pediatric products that were developed under her programs and provides counsel to other businesses within Medtronic that are seeking to develop pediatric and small patient population devices. Rachel is a member of the AdvaMed Pediatric Working Group and the Southwest-Midwest National Pediatric Device Innovation Consortium.

Rachel has 13 years of experience in the medical device industry in the Regulatory and R&D functions and holds a JD and an MBA from the University of Minnesota. Rachel is driven to make a meaningful difference in the lives of patients with unique needs, especially pediatric patients.

3:10-3:30pm Keynote: Stacy Kromenhoek Boston Scientific

Stacy Kromenhoek - PDIC Speaker

Stacy Kromenhoek
Boston Scientific

Stacy Kromenhoek, MBA has serves as the Global R&D Operational Excellence Director for Boston Scientific. Boston Scientific is a top-tier medical device company and multinational manufacturer treating conditions in the cardiovascular space, peripheral interventions and oncology, neuromodulation, endoscopy and urology. She began her career in medical devices with Abbott Laboratories and transitioning to Bard Access Systems and later Wright Medical; with focus areas in oncology, cardiovascular and orthopedics. She joined Boston Scientific in 2009 as a technical SME, growing into Project Management and Corporate Innovation. In 2017, Stacy joined Optum/UHG Corporate Strategy to explore the broader patient continuum in healthcare delivery. As the world experienced the pandemic in 2020, she pivoted her role to build an Emergency Preparedness & Response business unit. At the intersection of federal and state business and Public Health, she created programs that provided millions of COVID tests and vaccinations, the first test to-treat program in the nation and emergency border health operations. She returned to Boston Scientific and her ‘medical device roots’ in late 2022. She holds an undergraduate degree in Microbiology from the University of Kansas and received a MBA from Westminster College. She is an active advocate in STEAM programs at Boston Scientific and at The Bakken Museum where serves on the Board of Directors (and at the schools her twins attend!).

3:30-4:45pm Industry Panel

  • Pat Dillon, MNSBIR, Inc.
  • Frank Jaskulke, Medical Alley
  • Emma Moran, Cobicure
  • Jann Eichlersmith, Venn Foundation

panelists added as they are confirmed

Pat Dillon - DMD Session Organizer, Speaker and Keynote

Pat Dillon, CDR, USN (Ret), MBA
President and Founder, MNSBIR, Inc.

Pat Dillon, MBA has worked with hundreds of small businesses to secure millions of dollars during her 30 years of experience in the federal Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Programs. In current role as founder and President of MNSBIR, Inc., she leads the strategic vision of the private, non-profit to facilitate commercialization of deep tech ideas, concepts, and projects by leveraging federal research and development investments. Pat collaborates closely with the University of Minnesota, Technology Commercialization Office and the Venture Center, and serves as the Chair of the College of Science and Engineering, Technological Leadership Institute’s Advisory Board, and she worked with the Mayo Clinic, Office of Entrepreneurship leading to the first-ever graduate course called Accelerating SBIR/STTR Funding for Healthcare Innovations. Pat was awarded the prestigious Small Business Administration Tibbetts Award for excellence in the SBIR/STTR Programs. Pat has been a commercialization plan reviewer for the National Science Foundation, the Department of Energy, and the United States Department of Agriculture. Pat is a 2001 recipient of the City Business’ 25 Most Innovative Woman Award (now the Minneapolis/St. Paul Business Journal). Pat is a retired United States Navy Commander combat veteran with 40 years of service with one tour in Kabul, Afghanistan in 2011-2012. Pat earned an MBA and BS from Winona State University, Winona, MN.

Frank Jaskulke - DMD Conference Speaker

Frank Jaskulke
Medical Alley

Frank Jaskulke is the VP of Innovation at Medical Alley where he leads startup and international work.

Emma Moran, Cobicure - DMD Speaker

Emma Moran

Emma is the strategic lead at CobiCure, a pediatric healthcare non-profit focused on advancing the development of pediatric medical devices.  CobiCure partners with key medical technology innovators and leaders across the field to advance device solutions for children, particularly those with congenital diseases.  Emma is a biomedical engineer with experience in the medical device industry, having various roles at Cook Medical including research, strategic assessment, and corporate development. Throughout her career, Emma has been passionate about addressing the inequities in pediatric device development and identifying new technologies, approaches, and business models for advancing pediatric care.

4:45-5:00pm Closing Remarks

5:00-6:30pm Networking Reception

Light Appetizers and Cash Bar in Heritage Gallery, McNamara Alumni Center

PDIC Breakthrough Hosts