Media Library

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Evaluation of the Paediatric Regulation: how the current framework can be improved

Increasing safety in children using the example of drug therapy

Proving the effectiveness of pediatric medical devices
This talk first examines where effectiveness data are required for new pediatric medical devices. After CE marking, most medical devices are reimbursable in German healthcare without any need for effectiveness data. In the second part, the challenges of performing clinical studies on (pediatric) medical devices are discussed. The typical problems, e.g. impossibility of blinding, presence of learning curves, and incremental device modifications, can all be solved. Therefore, randomized controlled trials on new pediatric medical devices should be considered the standard option, unless the expected treatment effects are large and thus clearly detectable in observational studies.

Closing Discussion Session 1

New frontiers in regulatory affairs using the example of closed loop systems in pediatric diabetology

How to get from clinical data to clinical evaluation for pediatric medical devices
Among many other things the Medical Device Regulation (MDR; (EU)2017/745) requires a clinical evaluation as part of the conformity assessment for every medical device. This clinical evaluation provides evidence of the safety, performance and benefit of a medical device based on clinical data. For pediatric medical devices gathering sufficient clinical data is a formidable task, because compared to adult populations, pediatric patient populations are much smaller, more often affected by rare diseases, represent vulnerable populations, and many relevant medical devices are not approved for pediatric use. Unfortunately, the MDR does not adequately consider the specific challenges of pediatric patient population with respect to the requirements for clinical data.

Concepts to overcome hurdles of innovation and development of pediatric medical devices

Closing Discussion Session 2

The power of computational modeling for clinical trials and regulatory processes
Computational modeling and simulation (CMßamp;S) has the potential to revolutionize medical device development by accelerating innovation and providing comprehensive long-term safety evidence. ßnbsp;The vision is that CMßamp;S results will join bench, animal, and human testing as an essential element of device approvals. ßnbsp;However, the credibility of a computational model must be established before using CMßamp;S results for decision-making. ßnbsp;ASME, US FDA, and others are developing standards and guidance focused on CMßamp;S credibility and reporting to support regulatory evaluation. ßnbsp;This presentation will provide an overview of the regulatory opportunities and discuss current challenges.

Using real-world evidence (RWE) to enhance regulatory and clinical trials

Wrap up and Closing

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Child centered VR

Checklist for the process and demand-oriented implementation of a virtual reality concept in a children's hospital

Hygiene protocol for clinical VR applications in times of COVID-19

VR for the MRI
We present the concept, design, and evaluation of a playful mobile virtual reality (VR) app for children to reduce anxiety and stress during MRI examinations. The "Pengunaut Trainer" aims to help children familiarize themselves with the medical environment so they can be examined without fear, rendering sedation unnecessary. The patients learn about the procedure and train to remain motionless during a virtual MRI scan. We conducted a one-year clinical trial to evaluate the game design and efficacy of our intervention. The participants reported improved feelings towards the upcoming MRI examination and experienced less anxiety and more positive feelings during the scan. Our results and the positive feedback from parents, medical professionals, and media experts support the validity of our approach.

VR and procedural pain
Procedural pain is a cause of significant pain and anxiety in children. In a Danish survey more than half of children in pain during their hospital stay mentioned procedural pain as a significant source. Distraction is a powerful measure in modifying the pain experience. In this contribution to the webinar Virtual Reality VR is presented as a novel measure in distraction and an innovative way of improving the experience for the child especially during painful procedures.

VR interventions in pediatric mental health
Although virtual reality (VR) application have received considerable attention in adult patients, their usage in treating children and adolescents with mental health issues is lagging behind. Hence, this presentation set out to introduce several VR interventions which are currently being developed or have recently been evaluated specifically for children and adolescents. In particular, virtual reality exposure therapy (VRET) tools for the treatment of specific phobias, eating disorders and autism spectrum disorders, as well as VR-based biofeedback applications and serious games for patients with ADHD are introduced. Finally, specific challenges of using VR in children and adolescents are discussed.

VR for team training and surgical training

Computer Vision and Graphics for Mixed Reality in the Operating Room
Computer vision and graphics methods are building the foundation for successful development of Mixed Reality applications. Virtual Reality is a great tool to plan or train a surgical procedure, while Augmented Reality (AR) has the potential to assist intraoperatively. Providing a precise overlay of virtual objects in the actual real environment is a particular challenge of AR applications which requires advanced methods for registration and tracking. In this talk, I will discuss research results of Virtual and Augmented Reality in the surgical context. These are exemplified within the domain of head (ENT, craniofacial, reconstructive) and abdominal surgery.

VR training and simulation for pediatric trauma
Focused on solutions for the burden of diseases in low- and middle-income countries (LMICs), the objective of this presentation is to explore how technology can play a role in pediatric trauma education and consequently, how it can improve quality of healthcare. After screening more than 10,000 articles for two scoping reviews - Pediatric Trauma Education in LMICs and Technologies for Pediatric Trauma Education, the authors conclude that there is still a lack of pediatric trauma education initiatives in LMCIs, and that virtual reality has advantages to address this problem compared to other technologies.

Welcome to the first virtual children's teaching hospital
Welcome to the first virtual children's teaching hospital. This virtual reality project is developed for Medecins Sans Frontieres (MSF) and intended to be used during the pediatric emergency triage and treatment courses MSF provides in the field. The goal of the program is to immerse students in a safe, virtual environment to practice the skills they've just learned. The VR goggles do not need any internet connection, and can therefore be used in the remote locations MSF works in.

Ethics for research and use of VR in children

VR for pain and anxiety in pediatric patients: The child psychologist's view

Pioneering the field of medical VR

Wrap up and Closing