End-to-end multilingual complaint handling and regulatory reporting for a large Class III medical device manufacturer, for its global supply.

The engagement to support post-market surveillance activities led to a 40% reduction in complaint handling operations cost.

Processes owned: performing multilingual intake/data entry, triage, complaints investigation, regulatory assessment/decision (US/OUS), regulatory reporting, direct submission (US/OUS), good faith efforts, and complaints closure.

Client Background

The customer is a worldwide developer, manufacturer, and marketer of medical devices, whose products are used in a range of interventional medical specialties. For more than 30 years, they have advanced the practice of less invasive medicine, by providing a broad and deep portfolio of innovative products, technologies, and services across a wide range of medical specialties. The Company's products help physicians and other medical professionals improve their patients' quality of life, by providing alternatives to surgery.

Challenge

The client's challenges and key objectives for the outsourcing are focused on four key elements:

Cost reduction and flexibility to scale: with the increasing demand for support required to run their post-market activities, there was also a drive to provide a solution that is cost-efficient for the organization, and the ability to expand the portfolio with minimal impact to cost and resource requirements.
Improve 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.
Improve processes: since 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.
Increase productivity and ensure productivity gains: there were a number of opportunities available to standardize and optimize work and processes, that would lead to the optimum utilization of the resources.

Solution

Deployed a team of consultants to redesign processes for harmonization across divisions.
“Risk mitigated” transition approach based on product division, product complexity, and risk.
Intensive training programs and training content developed.
Right-shoring to ensure skilled resources are deployed.
100% audits during ramp-up and stabilization phase for quality assurance.
Six sigma project to improve complaint accuracy and reduce rework by cutting down on critical errors.
Six sigma project to improve reportability and complaint documentation accuracy.
Creation of a center of excellence for the complaint processing team, consolidating both intake and complaint management into multiple locations within Asia, Europe, and US.
Optimized complaint handling costs by 40%.
Productivity improvement of 18% delivered in three years.
Business value meter (BVM) at $540,000 in 3 years to create a total value of $1,120,000 in FY 2020-21.
Operating at 100% achievement of the corporate work in progress goals.
Operating at 99.9% compliance levels across all service level agreements (SLAs).
Operating at 100% timeliness on complaint intake, triaging, and translation activities.

“Quality of Service” is the foundational element of our solution.

“An engagement built on collaboration, competence, efficiency, trust, transparency, and timeliness. A partnership that will continue to raise the standards on culture, agility, performance, and compliance; with an aim to continue to transform customer experience and further improve patient care.”

Service Offerings

Service Offerings

Client Themes

Client Themes

End-to-end multilingual complaint handling and regulatory reporting for a large Class III medical device manufacturer, for its global supply.

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