New medical technologies for pediatric care face difficult hurdles to commercialization, especially industry investment, due to relatively small market size and the quickly shifting nature of pediatric anatomy. In many cases, compassionate or “expanded use” regulatory pathways are needed to make new technologies available for clinical use in pediatric patients.
In December, GCMI Research Engineer Sarah Jo Tucker spoke with Georgia Tech Pediatric Technologies about the expanded access pathway with the FDA. It can be a key component for academic and industry professionals looking to translate research into clinical use, providing valuable insights into pathways for treating serious or life-threatening conditions when no alternative therapies are available.
As we have for more than a decade, GCMI helps innovators, start up companies, engineers and scientists with university supported technologies, and medical technology customers of all sizes including industry partners and health systems. We are well versed in the requirements for pediatric technologies and have the capability to serve as “manufacturer of record” inclusive of small volumes of devices intended for highly specific, compassionate or expanded use cases.
At the end of the day, GCMI is fully committed to our customers’ success and welcomes you to contact us at any point in a technology’s pathway from the ‘back of the napkin’ to the bench, manufacturing, bedside and beyond. It’s never too early to get in touch. You can reach us via the form below.