The connected device market is an emergent field in medicine that has been steadily rising over the past decade. These connected technologies have delivered improvements in treatment outcomes and the patient experience across many market segments including cardiovascular, diabetes, single-use endoscopes, neurology, and orthopedics. The terminal sterilization of connected devices can present several unique challenges in comparison with standard non-connected devices. Their complex nature and combination of materials and electronic components can lead to malfunctioning devices.
To help address these challenges, manufacturers of the connected devices must consider terminal sterilization during the initial design phase and develop a partnership with a sterilization provider to select the most suitable sterilization modality. This can be achieved with collaboration between experts in engineering, materials science, biocompatibility, microbiology, and regulatory affairs.
During this webinar, the following topics will be covered:
- Terminology and examples of combination and/or connected devices.
- Discuss the challenges inherent to terminal sterilization of combination and/or connected devices.
- Sterilization modalities options, and capabilities for sterilization of a combination / connected devices.
- The importance of pre-and post-sterilization testing.
- The need to anticipate regulatory requirements and work closely with the appropriate agencies to ensure compliance with safety and efficacy standards.