Post Market Surveillance Resource Management

Background

ECI was enlisted to guide a medical device company through remediation planning and execution resulting from FDA 483 observations and a warning letter, due to deficiencies in their post-market surveillance activities. In parallel with the remediation activities, the organization was also under acquisition by a competitor within the life sciences sector. ECI was engaged to ensure regulatory compliance, manage multiple workstream remediation activities, and facilitate a smooth transition amid the acquisition.

Approach and Solution

To tackle this multifaceted challenge, ECI formulated a comprehensive approach drawing on its team of subject matter experts (SMEs) and consultants experienced in FDA regulations. The strategy encompassed several key steps:

1. Warning Letter Response Strategy: ECl's expert SMEs conducted in-depth reviews of the post-market surveillance workstream to identify deficiencies to formulate appropriate and exhaustive action plans to ensure regulatory compliance.
2. FDA Communications and Audits: ECI supported communications with the FDA, including responsive actions and provided on-site FDA audits pertaining to the warning letter. This ensured effective interaction with regulatory authorities throughout the remediation process.
3. Acquisition Support: Simultaneously, ECI facilitated the acquisition process, ensuring a seamless transition by aligning the client's daily complaint processing and medical device reporting with updated procedures. The ECI team even provided training to the client's management and staff to ensure everyone was aligned with the new procedural requirements.

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Comprehensive Action

ECI proposed a comprehensive remediation plan that addressed the identified issues. The plan included recommendations for procedures and reporting tools to align with regulatory requirements and facilitate effective complaint handling. ECI established interim controls for monitoring and managing complaints, ensuring that the client's operations remained compliant with both US and OUS regulatory standards during the remediation process. Multiple protocols were initiated to tackle the FDA observations, encompassing reviews, assessments, updates, and potential submissions to regulatory authorities. ECI strategically deployed resources to manage the remediation process effectively and efficiently:

• Project Management Support: ECI provided project management support for all remediation activities, ensuring coordination, efficient execution, and timely progress tracking.
• Post Market Quality Management Alignment: ECI aligned the client's post-market quality management systems with regulatory requirements, ensuring compliance and improved efficiency.
• Remediation Resources: ECI allocated and managed 80 experienced consultants to address the FDA observations and enact the necessary changes in the client's systems.
• Daily Complaint Monitoring Support: To ensure seamless complaint processing, ECI allocated and managed an additional 45 experienced consultants, in addition to managing the client team, to provide ongoing support for daily complaint monitoring, including processing, coding, assessment, and reporting of new complaints in both US and overseas markets.
• Duration and Activities: The engagement spanned 24 months, from June 2021 to July 2023, during which ECl's team of experts undertook a range of tasks and activities.
• Verification and Closure: The team ensured correct complaint coding and closed all open and aging complaint files, streamlining the complaint handling process.

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Results

The collaborative effort yielded the significant results for the client:

• The client's post-market surveillance processes were effectively brought into compliance, thanks to ECl's meticulous planning and execution.
• The utilization of complaint processing procedures and templates developed during the project led to leaner and more compliant operations for the client.

In conclusion, this case study showcases how strategic resource management, combined with regulatory expertise, can lead to successful remediation efforts and improved compliance within a complex and critical industry within a defined time-period. ECl's unique approach and efficient deployment of resources enabled the client to overcome challenges, rectify deficiencies, and transition smoothly through a transformative acquisition.