New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by regulatory agencies responsible for safety and efficacy. As far as those regulatory bodies are concerned, the path to clinical trials in humans is the same whether it’s research or commercial driven. Failing to walk that regulated path – one with deep roots in the U.S. Code of Federal Regulations and substantial data and documentation requirements – can have very real consequences.
GCMI Director of Product Development Mike Fisher, joined Scott Hollister, Georgia Tech Coulter Department of Biomedical Engineering Professor and Patsy and Alan Dorris Chair in Pediatric Technology, and Meredith Capasse, Human Protections Program and Research Regulatory Affairs for Children’s Healthcare of Atlanta to walk as through the required steps and, more importantly, why they’re required for academic researchers and innovators with novel medtech ideas or technologies.
- What does the IRB want to know and why when you’ve reached the end of discovery and want to push a project forward?
- What is a design history file and why does it matter?
- What delights an internal review board and how should researchers best approach them?
- How did Dr. Hollister set himself up for successfully delivering the first 3D printed tracheal implant in a pediatric patient in Georgia?
“Talk to your IRB as early as possible. They’re here to be your partners.” – Meredith Capasse
“Be willing to pivot to meet the needs of a regulatory body. Their job is hard and they’re trying to make you successful.” – Mike Fisher
“We think about mitigating risk [when it comes to patient devices]. Engage with the FDA early and often. We sometimes have our differences, but both of our goals are to keep people safe and to make the most effective device possible. If you’re thinking about going down this road, think about the final use in patients and start to investigate the steps you’ll have to go through to get your device to that final goal.” – Scott Hollister
It’s all right here in a 60 minute deep dive. For faculty researchers and those that support them, we’re confident it’s worth your time.
An affiliate of the Georgia Institute of Technology, the Global Center for Medical Innovation (GCMI) helps verify, validate and accelerate commercialization of new medical technologies that save lives and improve patient care. From our Northyards and 14th Street facilities in midtown Atlanta, we help find the finish line for medtech innovations at any point on the pathway from bench to bedside. Principal investigators, faculty and student projects served include:
- Dr. Andres Garcia
- Dr. Scott Hollister
- Dr. Omer Inan
- Coulter Foundation
- Over 20 additional GT faculty members
Who do we help?
We help individual clinician innovators, start up companies, engineers and scientists with university supported technologies, large and small medical technology customers including industry partners and health systems. Our milestone driven process helps ensure our customers’ ideas achieve a capital efficient path to market from IP, market assessment, design, prototyping, testing and training.