Case Study
Transforming Complaint Management for Enhanced Medical Device Performance
![1-Jul-01-2024-10-28-47-5028-AM 1-Jul-01-2024-10-28-47-5028-AM](https://asset.tataelxsi.com/hubfs/1-Jul-01-2024-10-28-47-5028-AM.jpg)
Complaints Managed
Backlog complaints readdressed and updated
Ageing of Complaints
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.
Solution
Tata Elxsi identified key automation opportunities to address the backlog of over 3,000 reopened complaint files and improve business outcomes. We reassessed and updated the backlog, implementing an automation solution for coding complaints. Additionally, the complaint investigation process was optimized by establishing a communication & operating model, ensuring alignment between complaint processors and investigators.
Tata Elxsi also consolidated and streamlined the complaint investigation and management processes across various units and divisions. This included optimizing processes, limiting interfaces, and leveraging advanced tools to enhance efficiency and consistency.
![3-Jul-03-2024-09-40-45-1724-AM](https://25392521.fs1.hubspotusercontent-eu1.net/hub/25392521/hubfs/3-Jul-03-2024-09-40-45-1724-AM.png?width=1147&height=650&name=3-Jul-03-2024-09-40-45-1724-AM.png)
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.
Services rendered
Tata Elxsi
- Complaint Intake & Evaluation
- Customer Follow-Ups
- Investigation Management
- Trend Research
- DHR & Risk Management
- Complaint Closure
- Data Analytics & Performance Documentation
- Document Control
- SOP Evaluation & Harmonization
- Training Compliance & Documentation
Deciphering the PFAS Regulations for Medical Device Manufacturers
The medical device industry is on the cusp of significant change as new regulations on PFAS (Per- and Polyfluoroalkyl Substances) come into effect. PFAS, known for their unique properties and widespread use in medical devices, are now under increased regulatory scrutiny due to their potential health and environmental risks.
Transforming MedTech Operations and Device Quality through Design History File Compliance
With a global presence in over 25 countries and sales in over 100 countries, our client is a medical technology leader with a comprehensive portfolio designed to maximise mobility and improve health.
EU MDR Remediation and Global Submission Support for Non-EU Countries
Our client is a US-headquartered global leader in medical technology, services, and solutions with a presence in over 150 countries and more than 350 locations. They specialize in various therapy areas such as Cardiovascular, Cardiac Rhythm, Digestive & Gastrointestinal, and Diabetes, to name a few.