A medical devices company needed a way to measure drug injector depth in pediatric populations in order to conduct a clinical trial in very young patients. Their drug needs to be delivered at just the right level: too shallow results in delivery into the subcutaneous layer, rendering the drug ineffective, and delivery too deep is unsafe, as the needle would hit bone. The band of muscle into which the drug must be injected is much thinner in infants than it is in adults, therefore needle depth has to be more precise. These pre-filled syringes are used by non-specialists in emergency situations, so must be robust and deliver drugs accurately.
Although the drug itself is approved, expanding the indication to infants requires a clinical trial in this particular population. Evaluation of drug delivery is essential to the clinical trial, which our clients will use to address requests from the FDA to move forward with regulatory approval for the use of these devices in patients weighing less than 15kg.
Our medical imaging consultant Colin Miller (link) has substantial experience in the pharmaceutical industry, so was well placed to take on this challenge. He became remotely embedded in our client’s team, whose task was to precisely evaluate where these injectors deliver drugs. They found that currently available imaging protocols were not sufficiently precise to measure needle depth, so new strategies and methods to acquire images were needed. Our consultant provided managerial support as well as technical expertise and strategic guidance. Together, he and our client’s team developed a novel, ultrasound-based acquisition protocol that the client will use in their upcoming clinical trial. Our consultant continues to act as the clinical lead on this project, managing the imaging core lab and vendor selection and providing ongoing managerial support and leadership throughout the trial.