Director Program Project Management - Global R&D - Therapy Program Home
Fresenius Medical Care
Pre-Conference Workshop Day
Sunday, May 2nd, 2021
Remote patient monitoring (RPM) systems use digital technologies to monitor patients outside of conventional clinical settings, such as in the home, and electronically transmits that information securely to their health care providers.
Smart, connected medical products offer exponentially expanding opportunities for new medical services, far greater reliability, much higher product utilization and capabilities that cut across and transcend traditional boundaries of a single medical product.
When it comes to remote patient monitoring, capabilities are evolving and expanding, but there are challenges to widespread adoption. The interconnectivity of various different medical and non-medical devices found a system which poses completely new challenges for manufacturers and operators.
This workshop is aimed to understand the different components of which a typical RPM system is composed of.
In interactive group sessions the participants will be challenged to run risk assessments and to find the right mitigations for various different challenges in a RPM environment.
· Framing a regulatory strategy in the context of a RPM system
· Understanding risk components, risk statements, risk severity and derived security design controls
· Understanding aspects of Post Market Surveillance tasks for a RPM system
· Exploring design patterns for smart concepts to operate RPM systems
· Understanding value drivers for commercialization and scale considering the different user groups of a RPM system
Main Conference Day One
Wednesday, June 2nd, 2021
1:35 PM Optimising Remote Patient Care
• Explore modular software architectures in Remote Patient Care environments
• Factor MDR and GDPR compliance processes in Remote Patient Care environments
• Discuss cybersecurity risk management in Remote Patient Care environments, including post market surveillance
• Evaluate the benefits and risks to patients and care-givers considering Human Factors in Remote Patient Care environments