CSI FRANKFURT 2022

PEDIATRIC Device development

Wednesday, june 22, 2022

The interventional medical device field is the fastest growing field in medicine and patients have gravitated towards less invasive procedures and preventative care. The morning program will be focused on regulatory updates and streamlined, global approaches designed to expedite these initiatives in a practical and cost-efficient way.

In the pediatric world, many clinical needs remain overlooked. The afternoon sessions will focus on emerging initiatives to address these unmet clinical challenges. Special emphasis will be given to practical solutions, from engineering to funding. It will include the regulatory landscape, as well as new avenues from special foundations, charities and organizations. 

WHY ATTEND?

In this fast-paced arena, it is key to:

  • stay abreast of critical MDR, FDA and CFDA regulatory changes and opportunities
  • address critical unmet clinical needs in the pediatric/congenital world
  • share solutions from foundations, VCs and corporations

PRELIMINARY PROGRAM - PEDIATRIC DEVICE DEVELOPMENT

DEVELOPED BY: HOWARD LEVIN, HOLLY WITHIN & SIR SHAKEEL QURESHI

THE PROBLEM
Challenges of unmet pediatric clinical needs and lack of financial support
Challenges from a corporate perspective - Case examples

Pediatric entrepreneurs and case examples

  • Transmural shunt-new technology
  • Pulmonary artery augmentation using a patch
  • Leveraging sleep to deliver cardioprotective treatments in Cystic Fibrosis 
  • Bioresorbable stents for CHD: The greatest unmet need in pediatric interventional cardiology
  • Technical/clinical solutions to prevent and treat migraines in children
The Process -- Need for global strategies to address pediatric technologies
Brexit and MDR—Real world experience of impact on pediatric treatment at NIS

Living with the MDR: Dos and don’ts—pathways for harmonizing pediatric applications

FDA USA regulatory opportunities—Compassionate use and special pathways

EU regulatory pathways Competent Authority/Notified Body - vulnerable populations, compassionate use 

China regulatory opportunities

Panel discussion: How to harmonize, where to go, universal pathways for pediatric needs
The Solution – Funding future directions - CALL TO ACTION

Coridea/Deerfield Catalyst Initiative, COBECURE

Vesalius Biocapital III

Targeted funds and grants - Philanthropic charities and other avenues

Call to action:

  • Key takeaways and next steps
  • Announcement of forum for innovators and financiers to come together

Panel discussion: Solutions, breakthroughs, innovative ideas, next steps

 

BROWSE THE FULL CSI 2022 PROGRAM

This session is part of CSI Frankfurt 2022, the leading conference on congenital, structural and valvar heart disease interventions, which will take place June 22-25, 2022 in Frankfurt, Germany. Drop in for the day, or join us for the full 4-day program providing a comprehensive overview of the field presented by experts and key opinion leaders from all over the world.