Wednesday, November 29, 12:00-1:00 PM
Meeting Room C
Organizer: Gwen Fischer, Critical Care Physician, University of Minnesota Masonic Children's Hospital
This session will focus on the challenges of pediatric medical device innovation and potential solutions to these challenges. Speakers will discuss design,testing, clinical trials, regulation, manufacturing, and other topics related to the developmental life cycle of a pediatric medical device. They will also discuss resources and programs available to pediatric medical device inventors.
"Pediatric Medical Device Development in the U.S."
While there are several challenges facing pediatric medical device developers in the U.S., in recent years successful innovation in this area has increased. This talk will discuss possible roadmaps for getting a pediatric medical device to market in the U.S.
Gwen Fischer, Critical Care Physician, University of Minnesota Masonic Children's Hospital
Gwenyth Fischer is a pediatric Critical Care Physician at the University of Minnesota Masonic Children's Hospital Pediatric Intensive Care Unit and Cardiovascular Intensive Care Unit. She is also an alumnus of the Medical Device Innovation Fellows Program at the University of Minnesota.
Dr. Fischer founded and currently directs the Pediatric Device Innovation Consortium (PDIC), and is always focused on getting pediatric technologies to market. She has been a co-inventor of several adult and pediatric medical devices and currently acts as the clinical advisor for the Medical Device Center fellows program.
"Pediatric Medical Devices in the European Union (EU): From clinical needs to innovation and development."
Children are entitled to a safe medical care, which should reflect the current state of science and technology. The design and development of medical devices and surgical tools for the pediatric field is still a challenge. Due to regulations, higher development costs and the small market share of pediatric medical devices, development in this field is more complicated and burdensome.
We are reporting about the current situation of pediatric medical devices in the EU, with particular focus on clinical needs, regulatory framework and healthcare economics. A comparison with pediatric medicines in Europe as well as with pediatric medical devices in the U. S. is carried out.
We are providing an overview about the development of medical devices for this special population in Europe. Ongoing R&D projects, network activities (e. g. PedMedDev @ Germany, www.pedmeddev.org) and funding opportunities, which are aiming to promote and improve development and innovation of medical products for children and adolescents in the EU, are discussed.
Ludger Tüshaus, Pediatric Surgeon, Department of Pediatric Surgery, University of Lübeck, Germany
Dr. Ludger Tüshaus is working as an attending at the Department of Pediatric Surgery, University of Lübeck, Germany. He is board certified in Pediatric Surgery as well as in Pediatrics. His clinical emphasis is pediatric trauma (e. g. fractures in children) and newborn surgery.
The focus of his scientific work, besides pediatric medical devices, is the development of intelligent osteosynthesis and orthoses for children. In 2015 he founded the AG "Pediatric medical devices and surgical instruments".
Dr. Tüshaus is involved in numerous academic teaching, training and consulting activities concerning biomedical engineering, development of medical devices and regulatory affairs as a specialist for pediatric medical devices.