Annual Conference

ASAIO Pediatric Medical Device Day 2017

ASAIO hosted the 6th Annual Pediatric Medical Device Day
at the 63rd Annual Conference in Chicago June 21 – 24, 2017
Wednesday June 21, 2017

ASAIO Pediatric Day Special Session
“Getting A Pediatric Device To Market”

Pediatric Consortia Presentations:

“Berlin Heals C-MIC:A Disruptive Approach for the Treatment of Heart Failure with a Novel Microcurrent Application”
Johannes Mueller, MD and Peter Goettel, MD

“Corinnova’s Novel Device for MCS”
  Keith Svagerko, BS, MHA, MBA

Pediatric Day Topics:

Bringing Products To Market
Orphan Products Funding for Clinical Trials
Orphan Products PI Perspective
Demystifying The FDA Process
Where The CDRH Is Going

Updates From The Field
PediMacs
Early Report From PumpKIN
Quality Improvement Science of VADs

Getting An Idea Off The Ground
Pediatric Device Consortia

New Ideas In Anticoagulation
DTis
Is TEG No Longer Needed?
Surface Passivation
Bioinspired Surface Coating for Mechanical Circulatory Support
Acute Stroke Management

ASAIO Pediatric Day Special Session
Getting A Pediatric Idea Off The Ground

ASAIO hosted the second “Pediatric Device Consortia Consulting Forum” at the 63rd ASAIO Annual Conference in Chicago June 21 – 24, 2017.  This session is designed to allow selected entrepreneurs to present novel ideas on how to get a pediatric device into the market place before a panel of members from the FDA’s Pediatric Device Consortia (PDC).  FDA funds the PDC to provide expert support services to innovators of pediatric devices.  These services include business and regulatory consulting, as well as device testing capabilities.  Some specific areas of expertise provided by the Consortia include intellectual property advice; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design.

All Proposals were reviewed by a diverse committee comprised of a pediatric cardiothoracic surgeon, pediatric cardiologist, regulatory expert, pediatric biomedical engineer/perfusionist, and a business expert.