By Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Health System
Are you interested in advancing device clinical trials in general, but also learning about potential innovative pathways for pediatrics? If yes, then make plans to attend The MedTech Conference one day early to participate in the 7th Annual Pediatric Device Innovation Symposium, Sunday, Sept. 22. In addition to the much anticipated $150K “Make Your Medical Device Pitch for Kids!” competition that focuses on neonatal and NICU devices, we’re assembling a lineup of industry-leading keynote speakers and panelists who will address the program theme “Pediatric Device Clinical Trials: Forging a Better Path.”
It’s widely known that pediatric medical device development profoundly lags behind device development for adults. At the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System, we’re focused on finding solutions that will bring medical device innovations to market faster to benefit children. We recognize that one of the major barriers to accomplishing this is the challenges inherent in the pediatric device clinical trial process, which is why we’ve chosen this as the symposium focal point for 2019. To boost innovation in pediatric device field, there needs to be more cost-effective and novel clinical trial study designs and regulatory pathways to assess safety and efficacy of devices in small populations. On September 22nd, we’ll discuss ways to optimize and improve current approaches.
In contrast with drug trials, device trials are generally less understood in academic medical centers at clinical sites. Adding to this complexity is the nature of the pediatric population. Designing devices for children requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level. Unlike the process for drug trials, the safety and efficacy testing of medical devices for first-in-human use is not conducted in a Phase I through Phase IV clinical trials approach. Device testing is stratified based on the class of device and level of risk. Minimal risk devices do not require clinical trials, whereas drug studies always require clinical trials conducted in phases. Devices have no Phase I equivalent to drugs. It would be unethical and unnecessary, for example, to implant a pacemaker or a coronary stent into a healthy subject under the auspices of a Phase I trial. Sadly, safety review boards (IRBs) and certain stakeholders are not always trained to appreciate these nuances. We want to bring awareness for more efficient and innovative ways to validate pediatric medical devices and bring these products to market safely and in an accelerated fashion.
Join us at this action-oriented symposium to dig deeper into innovative concepts and fresh ideas to close the device gap in pediatric health care. Hear from the spectrum of stakeholder voices including biohealth innovators, clinicians, device sponsors, institutional review board members and children’s hospital executives. These voices provide a much-needed 360 degree-view of the critical issues that impede pediatric device clinical trials and explore practical solutions to stimulate innovation and commercialization.
Register today and stay tuned to http://pediatric-device-symposium.org/ for keynote speaker announcements, panel themes and updates about the $150K NICU pitch competition. We look forward to seeing you in Boston in September!