Findings
Vendor selection should assess 13 categories, including General organizational operation and products, Quality Management Principles, Practices of product or service design, Device supply and provisioning, Account provisioning, Study specific materials, Live trial support, Trial closeout activities, Data handling/processing and data flow (GDPs), Device and Data (sensors + raw data) algorithm accessibility, Interoperability/Integration, Validation/Clinical Relevance/standard of documentation, and Cybersecurity. Key aspects to consider include having Validation and verification of the device and algorithm in place, ability to support multiple countries, an established quality management system. Vendors must assure maintained data integrity and quality, and provide evidence of Good Clinical Practice (GCP) compliance. Robust practices in Good manufacturing practice, Good product development practices (for hardware and software, including software lifecycle documentation), and Good scientific practices are required.

Recommendations
Sponsors should engage with vendors early in study design to tailor the technology capabilities and data requirements to patient needs and preferences. Vendors are typically responsible for device verification and analytical validation, but collaboration with sponsors and other stakeholders on clinical validation is beneficial to establish validation thresholds, specific needs of target clinical populations, and acceptability and usability of the technology. Sponsors should enable a feedback loop from patients back to vendors to improve technology for specific target populations. Sponsors or researchers should prioritize access to high-fidelity and sensor-level data to enable novel research and assessment of additional health aspects. Specific inquiries for vendors should cover: measurements offered (Accelerometry output for scratch detection, sleep measurement, environmental factors, and vitals), device material and safety testing (irritation/sensitization), usability/patient burden (e.g., disturbance during sleep), and applicability to Pediatrics, different ethnic groups, and different skin colors.

Regulatory Considerations
For software development, vendors should document and monitor the software lifecycle for quality, and demonstrate that algorithms have been tested with appropriate datasets. Assurances of GCP compliance are necessary. Vendors should demonstrate that their manufacturing practices ensure devices from different batches provide the same result measurements. Collaboration on clinical validation with sponsors and other stakeholders is a key component to generate the necessary evidence for the Validation/Clinical Relevance/standard of documentation requirement for regulatory purposes.