Transforming Complaint Management for Enhanced Medical Device Performance

Background

Our client is a Europe-based MedTech manufacturer specializing in products for Anesthesia, Critical Care, Disinfection, Sterilization, and Cardiovascular procedures. Operating in over 40 countries and having a presence in more than 130 countries, the client provides hospitals and life science institutions with innovative products and solutions to enhance clinical outcomes.

The customer faced significant challenges in managing a high volume of complaints. This included issues with backlog management, complaint registration, reportability assessment, IMDRF coding, customer follow-ups, investigation, and complaint closure. The complexity and volume of these tasks necessitated a streamlined and efficient solution to ensure compliance and customer satisfaction.

Challenge

The client faced a significant backlog of complaints across multiple processes that needed urgent attention. A primary challenge was segregating complaints into reportable and non-reportable categories and assigning the correct codes. This process was critical to ensuring compliance and accurate reporting.

Additionally, the client aimed to improve current operations by consolidating and centralizing complaint handling across various units and divisions. This objective was essential to streamline workflows, enhance efficiency, and ensure consistent complaint resolution across the organization.

Impact

• The backlog of complaints was reduced by 70%, leading to improved turnaround times and faster resolution of issues.
• The development of lean processes streamlined complaint management, making the system more efficient and effective.
• The new processes enhanced overall productivity by 40% and led to substantial cost savings, especially in the deployment of new medical devices.
• The Communication and Operating Model facilitated strategic alignment and efficiency across subsequent program phases, greatly enhancing operational effectiveness.