Pediatric medical injection kit validation
We executed every stage of the project from protocol writing to recruitment of a hard-to-recruit population (clinical trial pediatric nurses) to writing the validation report.
The validation study included HCP training, done by our on-staff RN to demonstrate techniques, a 24-hour decay, and a 60-min validation session, during which participants had to prepare and administer two doses of the kit.
The current medication requires patients to receive multiple injections in the knee for a full dose.
The manufacturer had three goals for this project: to better understand and improve the current routine of doctors that administer this drug, to gather feedback on using the drug for osteoarthritis of the ankle, and to receive feedback on a prototype syringe design.
We observed current practices by visiting orthopedic surgeons’ offices and gathered feedback on their current routines, thoughts on injecting into ankles, and possible dosage reductions. HCPs were asked to perform a simulated injection and provide feedback for future development.
The sessions concluded with the HCPs administering a simulated injection with a prototype syringe into a model of a knee and providing high-level directional feedback for future development.
We provided HCP feedback on the possibility of dosage reduction, shared design recommendations on improving stability of the prototype syringe, and offered positive feedback on the possibility of utilizing current drugs for new applications.