Findings
Successful PT implementation requires iterative planning across six stages to adapt to changing study goals and patient needs.
Early engagement with patients, caregivers, sites, and regulatory bodies is critical to align PT goals with stakeholder priorities.
Identifying technical, operational, and compliance risks early on is essential for smooth implementation and scalability.
Rapid, small-scale tests of technologies can help address unknowns, refine user experience, and mitigate technical risks before full-scale pilots.
Scaling PT across geographies and populations requires addressing regional variations in infrastructure, regulations, and cultural acceptance.

Recommendations
Start with a clear, organization-wide PT strategy to align with clinical trial goals and define success metrics.
Involve patients, sites, and regulatory authorities early to gather insights and ensure alignment with their needs and priorities.
Test technologies in controlled environments to validate functionality, usability, and integration before pilot studies.
Use technology pilots to collect data on feasibility, usability, and implementation challenges to inform broader rollouts.
Leverage learnings from pilots to develop a scalable strategy that addresses technical, regulatory, and cultural barriers.

Regulatory Considerations
Determine whether the technology is classified as a medical device and ensure compliance with relevant regulations (e.g., FDA, EMA, MDR).
Address data protection regulations, such as GDPR, by implementing robust privacy measures and secure data storage practices.
Account for region-specific regulatory requirements and infrastructure challenges during scaling.
Proactively consult regulatory agencies during pilots to align on technology use, endpoints, and data validity.