When Science Outpaces Infrastructure: People, Process, and Technology Challenges for Precision Dosing in Children

The implementation of novel precision medicine tools in pediatric medicine requires buy-in from multiple interest groups and a shift from traditional medical paradigms. In an effort to implement a precision drug-dosing project for an anti-coagulant drug in the neonatal intensive care unit (NICU) at a large children's hospital, a multi-specialty team made up of clinicians, scientists, private industry, and technology specialists formed and worked collaboratively over multiple years. Despite best efforts, the project's success was hindered by multiple foreseen and unforeseen barriers. Through the telling of a specific case example, these barriers and the key considerations for mitigating them are discussed to give future teams better knowledge and preparation abilities. The themes discussed are encompassed by "people," "process," and "technology." The integration of precision dosing tools into hospital systems (such as electronic health records [EHR]) demands careful coordination across clinicians, pharmacists, nurses, and hospital information technology (IT) teams. Informaticians play a key role in safely embedding innovations into clinical practice. Ethics boards face challenges evaluating novel technologies like AI/ML. Comprehensive representation on ethics boards is essential for effective oversight of new digital tools. Technical integration of third-party applications into EHRs is complex, especially across international borders. Differences in measurement units, coding systems, and test environments can cause deployment issues. Privacy assessments, secure data access protocols, and data residency and compliance are critical. Finally, sustaining precision medicine innovations requires institutional investment beyond initial research funding. Success hinges on attention to people, process, and technology.