Under grant from the Bill & Melinda Gates Foundation, The Arcady Group developed a detailed target product profile (“TPP”) for highly accurate, affordable, re-usable, configurable, scalable, TB-appropriate digital medication monitors that provide timely reminders and deliver patient-specific information regarding medication adherence (hereafter, “TB Reminder-Monitors”). This target product profile was subsequently converted into a detailed RFP and accompanying specifications for the development and manufacture of the foregoing TB Reminder-Monitor. Following development thereof, The Arcady Group developed and documented procedures for quality assurance and for comprehensive field-testing of these TB Reminder-Monitors with TB patients and TB providers.
In fulfillment of The Arcady Group’s global access obligations in connection with grants received from the Bill & Melinda Gates Foundation, set forth herein are three sections, or documents, that contain this TPP and these testing protocols. Also set forth herein is information with respect to Wisepill Technologies’ evriMED® TB Reminder-Monitor, selected by The Arcady Group for use in Bill & Melinda Gates Foundation-funded trials and demonstrations in China, India, and Africa:
Section 1: A Target Product Profile of an Electronic Dose Monitor
Section 2: QA Requirements & Testing Protocol
Section 3: Field Test/Pilot Study Protocol
Section 4: evriMED®: An Available, Scalable Solution