The Connected Device Journey
Navigating Design Challenges, Sterilization Solutions, Lab Testing & Regulatory Compliance for Market Success
Watch On-Demand
Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device.
SYMPOSIUM PROGRAM
- Day 1
- Day 2
- Day 3
So you think you’ve got a connected medical device?
Development of a Connected Device
Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and some testing is not enough. You should not go to a test facility and ask them what testing should be done. You should have planned, documented, and developed the device knowing what testing would be required. All medical devices need to have a complete, current, and accurate design and development file, connected devices especially so. With multiple subsystems, components, software and interconnectivity to consider, following the design control methodology will help the development team stay organized and on track. We are here to help
Packaging and Sterilization Modality Selection for Connected Devices
As medical devices become increasingly complex and connected, selecting the right sterilization modality is more critical than ever. This session will explore key considerations for choosing the most suitable sterilization technologies for connected devices, balancing efficacy and material compatibility. We will also address packaging design considerations, transportation challenges, and shelf-life validation to ensure product integrity from sterilization to end use.
Split into 3 subsets: Sterilization, Battery, Packaging
Design Development Pitfalls in Connected Devices
Connected devices often feature complex system architectures with multiple components and subsystems, frequently developed by different teams. This session will highlight common pitfalls encountered during the development of connected devices—issues that, if identified too late, can lead to significant timeline delays and resource overruns. Drawing from their extensive experience, the speakers will share key warning signs and practical strategies to mitigate risks, helping you navigate development challenges more effectively.
Biocompatibility Evaluation, including a discussion on E&L for Medical Devices
Biocompatibility is a broad analysis of the overall safety of the device to the patient due to materials and manufacturing processes. An overview of important considerations and regulatory expectations will be provided in this presentation. The assessment of extractables and leachables, which relates to chemical characterization of devices, is an important step in the Biocompatibility Evaluation. This presentation will also give an introduction into the definitions and concepts of extractable and leachable testing. More specifically, a high-level perspective will be given on the regulatory landscape, along with which guidelines should be considered for connected device. A specific case study will give practical example of the different steps involved in these analytical studies.
The assessment of extractables and leachables, which relates to chemical characterization of devices, is an important step in the qualification process to ensure patient safety. This presentation will give an introduction into the definitions and concepts of extractable and leachable testing. More specifically, a high-level perspective will be given on the regulatory landscape, along with which guidelines should be considered for connected device. A specific case study will give practical example of the different steps involved in these analytical studies
510(k) Marketing Submissions and Predetermined Change Control Plans
This presentation will explore the intersection of Artificial Intelligence (AI) in medical devices and the FDA’s 510(k) premarket notification process. It will highlight and address the challenges posed by the dynamic nature of AI when compared to traditional regulatory frameworks, particularly regarding device modifications and updates. The presentation will also discuss the use and application of Predetermined Change Control Plans (PCCPs) within device submissions. The presentation will highlight how well-defined PCCPs can streamline the regulatory pathway for AI medical devices by proactively outlining anticipated changes and ensuring patient safety and regulatory oversight. Key considerations for developing robust PCCPs will also be discussed, providing practical insights for manufacturers.
Does your Quality Management System have the right capabilities to ensure that your XBU Connect Device will be safe and effective?
Placing a connected device in the marketplace presents new risks for your quality management system (QMS). The QMS processes impacted include but not limited to: Regulatory, Clinical, Design Control, Risk Management, Validations (design, process and software), Post Market Surveillance. This presentation will look at the present cGMP and EUMDR regulations and their impact on connected devices.
Sterilization Process Design for Connected Devices
Developing a robust sterilization process is critical to ensuring product safety and compliance. This session will provide key insights into designing and validating gas and radiation sterilization processes. Attendees will gain a high-level understanding of process development, validation, routine monitoring, and maintaining long-term process effectiveness.
Regulatory Requirements & Software Development for Medical Device Cybersecurity
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (FDA’s CDRH) and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have established stringent regulatory requirements to ensure the cybersecurity of medical devices. The FDA’s CDRH mandates evidence of a comprehensive vulnerability monitoring and management program, a total product lifecycle approach to device security, and the provision of a machine-readable Software Bill of Materials (SBOM). Additionally, the FDA retains the authority to impose further requirements as deemed necessary by the Secretary of Health and Human Services (HHS) through regulation. Detailed guidance on these requirements is outlined in the 2023 Final Premarket Guidance, the 2024 Draft Select Updates for the Premarket Guidance, and the 2016 Postmarket Guidance.
Medical Device Data Integrity and Accessibility Concerns
This presentation will explore the critical challenges of data integrity and accessibility within the context of AI-powered, FDA-regulated medical devices. It will delve into the importance of robust and reliable data for the development, validation, and ongoing performance of these technologies while ensuring compliance with HIPPA and the General Data Protection Regulations (GDPR) in the EU. The session will highlight key concerns related to data quality, bias, security, and provenance (under data integrity), as well as the difficulties in accessing diverse datasets, navigating privacy regulations, and facilitating data sharing (under data accessibility). The presentation will emphasize the potential impact of these issues on patient safety and regulatory compliance.
Common Submission Pitfalls and Best Practices
This presentation will explore the critical challenges of data integrity and accessibility within the context of AI-powered, FDA-regulated medical devices. It will delve into the importance of robust and reliable data for the development, validation, and ongoing performance of these technologies while ensuring compliance with HIPPA and the General Data Protection Regulations (GDPR) in the EU. The session will highlight key concerns related to data quality, bias, security, and provenance (under data integrity), as well as the difficulties in accessing diverse datasets, navigating privacy regulations, and facilitating data sharing (under data accessibility). The presentation will emphasize the potential impact of these issues on patient safety and regulatory compliance.
Supplier Quality Management Risks
Ensuring a successful product launch of a connected device requires that your supply chain be capable and available thru the different design and development stages. However, supplier quality management issues continue to be a top observation by regulators and notified bodies. This presentation will look at the risks associated with the supplier quality management system
Crisis Management and Recalls in Connected Devices
When a recall occurs the Regulatory Agencies such as the FDA require communication that is timely about corrective actions being taken by companies that FDA may consider have high-risk products. These actions can include removing products from the market, correct the products or even update instructions for use. We will discuss recall scenarios and risk management strategies that can be employed with a focus on lot release, sterility and safety. Additionally, the key areas Device Inspections will focus on for products that have been recalled. In addition, how can companies prepare for inspections by having robust recall procedures in place as well as preparing key high risk areas for compliance.
Decontamination Methods for Reusable Connected Devices
Some connected devices can be used by a single patient or by multiple patients. As such, these devices are considered reusable medical devices and it is important to ensure that they are decontaminated (clean and disinfected) between uses. Reprocessing validation testing is needed to ensure that the decontamination procedures are effective. Additionally, it can be difficult to know how to decontaminate these devices as they can be used in healthcare facilities or at-home. This presentation will review the required testing to validate the decontamination procedures and review common decontamination procedures for connected devices.