Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment

Technological innovations, market need, and evolving regulatory requirements has led to a rapid growth in Point of Care (POC) testing and devices. POC testing involves medical diagnostic tests performed outside a laboratory environment, and increasingly in the home setting. Home-use devices aid in the early detection of potential health conditions in the absence of symptoms, facilitate early and more optimal treatment interventions and reduce burden on healthcare systems. The evolution of home-use devices and changing regulatory landscape and evidence requirements presents challenges for clinical researchers that require innovative and robust operational and technical solutions.

Pharmaceutical, biotechnology, medical device, and diagnostics companies - areas within companies: data analysis, health economics, outcomes research, medical affairs, clinical research, clinical trials, innovation, technology, project management, real-world evidence

Speakers

Andy Bevan
MRes CBiol CSci MRSB, Executive Director, Peri- and Post-approval Studies
PPD

Ken Butz
MS, Director, Regulatory Affairs, Medical Devices and Diagnostics
PPD

Tom Healy
Senior Director, Data Architecture, Digital and Decentralized Solutions
PPD

Margaret Moos
MS, Business Optimization Lead, Executive Director, Project Delivery
PPD

Christine Varner
Director, Non-Interventional Studies
PPD