Informing Pediatric Drug Delivery Device Development
A pharmaceutical team needed reliable caregiver evidence to guide development of a pediatric drug-delivery device while difficult recruitment threatened the original study plan.
As senior team lead and trusted client advisor, I guided the engagement through a shift to in-home evaluation while preserving research rigor, budget, regulatory usefulness, and client confidence.
The findings informed ongoing device refinement and were documented to support future FDA submission needs, allowing the engagement to emerge from a difficult situation with stronger contextual insight.
Keywords: Research Strategy · Drug Delivery · Usability & Human Factors · Client Leadership · Regulatory Strategy · Pediatric Care
Project Info
Client: A Major Pharmaceutical Manufacturer
Time: 2024, 6 Months
Role: Team Lead, Client Advisor, Research Strategist
Project Overview
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We began by working with the core client team to clarify the decisions the work needed to support and align around the usability questions and knowledge gaps most relevant to the device in development.
The evaluation compared two percutaneous syringe devices and explored caregiver perceptions of confidence, control, comfort, ease of use, and the overall administration experience.
My role was to ensure the approach remained focused on the product decisions and future evidence needs behind those questions.
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The original plan called for thirty in-facility assessments across three markets, but difficulty reaching pediatric caregivers threatened the study plan.
I worked across the client team, project team, and recruiting partner to reset expectations and develop an alternative approach, ultimately moving the work into participants’ homes while preserving objectives and budget.
Because I had an established relationship with the account, we were able to treat the change as a thoughtful adaptation rather than a failure of execution.
I also managed the IRB process and ensured the revised approach remained appropriate for the study objectives and documentation requirements.
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The project team evaluated simulated use of both devices, capturing use errors and near misses alongside comparative assessments of confidence, control, comfort, and ease of use.
I provided senior oversight throughout the work, helping the team interpret emerging patterns and ensuring the analysis remained connected to the client’s development questions.
The resulting evidence combined task performance, root-cause assessment, and qualitative understanding of why caregivers responded differently to the two device experiences.
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We translated the findings into a clear view of use-related risks, caregiver preferences, and design considerations relevant to the device in development.
I worked with the team to distill the most consequential implications for business leaders while ensuring the evidence was documented and packaged in a way that could support future FDA submission needs.
The engagement ultimately gave the client greater confidence in both the direction of ongoing device refinement and the regulatory usefulness of the evidence.
Key Takeaways
Reducing the Emotional Burden of Administration
Many caregivers preferred the device with a hidden needle because they believed it could create a less traumatic administration experience for their child.
The preference extended beyond traditional usability measures and reflected concerns about fear, comfort, and a child’s willingness to undergo treatment.
This gave the client an important experiential consideration to carry into continued device development.
Understanding Caregiver Tradeoffs Around Dosing
The development team also needed to understand how frequently caregivers would be willing to administer treatment.
Although participants generally preferred more widely spaced doses, caregivers expressed a strong willingness to follow recommended schedules when they believed doing so was necessary for their child.
This helped distinguish stated convenience preferences from the tradeoffs caregivers were prepared to make in a pediatric treatment context.
Challenges
Protecting Confidence Through a Difficult Pivot
Recruitment challenges put the original plan at risk and created understandable concern for both the client and delivery team.
My long-standing relationship with the account allowed me to reset expectations, maintain focus on the decisions that mattered, and guide the team toward an alternative without undermining confidence in the engagement.
That trust created the space needed to adapt successfully.
Turning Constraint into Better Context
Moving the work into caregivers’ homes initially appeared to be a compromise, but it ultimately brought the device into a more natural environment.
The team adapted the evaluation setup to maintain consistency while gaining additional context around how caregivers thought about administration in everyday life.
The engagement therefore emerged from a difficult situation not merely completed, but with stronger contextual understanding and a satisfied client relationship.