Case studies

Injection devices

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Pediatric medical injection kit validation

A pharmaceutical company required a validation study to determine if the preparation and administration of an injection kit requiring the reconstitution of a pediatric medication was safe and effective.

Challenge

Our client asked us to determine if nurses could prepare an injection device and reconstitute the drug for a clinical trial.

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.

Approach

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.

Outcome

We evaluated and updated their Risk Assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.

Next-gen osteoarthritis

A pharmaceutical manufacturer was exploring next generation improvements for currently available medication to treat osteoarthritis in the knee.

Challenge

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.

Approach

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.

Outcome

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.

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