Innovation in pediatric technologies that address unmet clinical needs lags behind innovation for adult populations in large part due to its relatively small market size and ROI (return on investment) prospects for industry, continuously changing anatomies of children, and limited populations for testing and clinical trials.


Activity sequence and process matters a great deal when it comes to de-risking new medical technologies and ultimately achieving regulatory approval for clinical use.


GCMI follows a proven, phase-gated medical technology design and development process that allows for a disciplined medical device design and product development approach for unmet clinical needs across the spectrum including pediatrics.


Amy Leiter, Executive Director of Strategy, GCMI, Saylan Lukas, Director of Design & Engineering, GCMI joined Leanne West, Chief Engineer, Pediatric Technology, Georgia Tech for a Pediatric Tech Talk Webinar on Wednesday, June 21, 2023.


What do researchers, investigators or clinicians with ideas for solutions to unmet clinical needs need to know about risk, regulatory, efficiency and efficacy in medtech design and development activities for new pediatric technologies? What are the biggest hurdles that plague medtech innovators, including pediatrics, the most?


“If innovators take off too far and too fast into product development before answering questions on regulatory pathways, IP and freedom to operate, market size and clinical need, there is a high risk of wasting scarce resources, including funding. Slow down early to go fast later. This is why our Phase Zero program exists.” – Saylan Lukas


“When working with pediatric providers, especially children’s hospitals, bring in their procurement and value analysis teams early in the process. How does the team order the device or technology? Is it covered by insurance? Who will carry responsibility for manufacturing? Is the outcome superior to the current device being used in the clinical setting? How do you clean and store it? 


“Those answers and inputs make a stronger story in clinical uptake and commercialization. In short, it’s never too early to have those conversations with hospital or provider administrators and value analysis teams.” – Amy Leiter


We invite you to check out the 30 minute recording and learn more from the team via the Georgia Tech Pediatric Technologies news and blog