Post-market surveillance, complaint handling, regulatory reporting support, and medical information services

Type of products covered: medical devices, therapeutic drugs, drug device combination products, SaMD.

Processes owned: Multilingual complaint intake and registration, coding, regulatory reporting, investigation coding, and closure of reportable and non-reportable complaints, across US, EMEA, LATAM, APAC and Canada.

Medical information: Medical and technical inquiries in multiple languages via voice and non-voice channels.

Client Background

The customer is a world leader in specialty oncology injectable, integrated infusion therapy, generic injectable pharmaceuticals, generic acute-care, and medication management solutions.

This US-based Company has global operations that develop, manufacture, and sell medical technologies used in vascular therapy, oncology, and critical care applications. Products are designed to prevent bloodstream infections and in protecting health care workers from exposure to infectious diseases or hazardous drugs. In addition, the company's IV medication compounding and delivery products are designed to improve medication, dosing accuracy, and clinical workflows.

Challenge

It was observed that the First Pass Yield score was significantly lower against the 98% target, indicating a decrease in intake efficiency and loss of productivity due to multiple iterations and lack of training and synergy between business units. This could also lead to late registration, red metrics, regulatory reporting, and quality management system.
Lack of procedural standardization.

Solution

Implemented the following initiatives:

Strategic planning to facilitate vitality and refresher trainings for quality issues.
Improved service levels in various functions: Opportunity areas were identified to improve cycle time on specific device types, improved submission timeliness for regulatory reports, timely movement of records, accuracy and quality of work for complaint intake, and triaging.
Improved processes: because the organization was divided into different business units, there were nuances in a number of aspects whether in process, training, certification, and even reporting methodologies.
Process transformation and standardization: close collaboration with customers on procedural updates and documentation. Bringing in the best practices and amplification in synergy with Wipro's in-house solutions and quality excellence initiatives.

Business Impact

Green metric for Critical Accuracy Score due to process standardization.
Improved complaint intake and registration efficiency.
Reduced late registrations — cost/penalty avoidance.
Increased customer satisfaction with improved response time.

Tangible Benefit:

Savings of approx. $70,000 within 6 months of the engagement, despite the COVID-19 pandemic.

Intangible Benefits:

Improved productivity.
Improved end user satisfaction.

“This is a story of consistent growth, improved quality outcomes, consistent performance, flexible team, proven scalability, and a highly responsive team.”

Service Offerings

Service Offerings

Client Themes

Client Themes

Post-market surveillance, complaint handling, regulatory reporting support, and medical information services across US, EMEA, LATAM, APAC, and Canada, for a US-based medical device manufacturer.

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