Optimizing Complaint Handling To Scale Global Quality Operations

Quality experts from Cardinal Health and PwC discussed industry trends and strategies for effective complaint handling solutions

As medical devices and diagnostics grow more complex and customer expectations rise, accurate and efficient complaint handling is becoming increasingly vital for scaling compliant operations.

A comprehensive transformation approach integrates people, processes, and technology. While it might appear faster to simply solve for one of those elements, a more sustainable solution is to approach transformation in pragmatic, digestible programs. This can, however, present a prioritization dilemma. Where does one start?

Consider drivers for transformation

Companies must consider the compelling drivers for transformation and identify what internal and external factors place stress on the effectiveness of current processes to support future needs.

For example, companies that are investing heavily in growth through acquisition and portfolio diversification find that legacy processes and systems lack the flexibility to scale across portfolios.  In 2023, 127 medtech M&A deals were announced, totaling over $47.7 billion and the first half of 2024 has seen 114 acquisitions totaling $40.3 billion.¹  Conversely, companies that have recently divested find a new opportunity to scale down or right-size their processes and systems to better fit new operating models.

Companies that may have paper-based or custom on-premise processes and systems are reaching a pivotal point where the maintenance of complex, legacy systems is cumbersome and increases the risk of non-compliance.

Additionally, rapidly evolving regulatory requirements remain a critical external influence.  Traditional complaint handling processes are not optimized to handle increasing, unstructured sources of customer feedback (like social media).

Salil Thakar, who co-leads PwC’s Quality Management Consulting team, said, “Users, patients, and healthcare providers have access to a wealth of information about products and alternatives, which raises the bar for how companies address and process complaints. Quality management platforms, analytics capabilities, AI, and other automation advances present an opportunity to challenge the paradigm for how complaints are managed traditionally.”

His comments resonated with the areas that our attendees described as top of mind, with most attendees interested in discussing how to scale complaint handling across varying portfolios globally, or how best to get a transformation program mobilized.

Establish a strong foundation of streamlined processes

Transforming complaint management requires a focus on process before technology as companies must determine how to contend with global variations or requirements across diverse portfolios. It is crucial to balance flexibility with consistency while recognizing that compliance needs to serve as a baseline requirement, not the ultimate goal.  An organization must therefore set a bar above and beyond the bare minimum for compliance.

Pat Tucker, a quality and regulatory leader at Cardinal Health shared from experience, “We saw the need for a universal system that could streamline processes and eliminate paper-based workflows. The best strategy for Cardinal Health was bringing together all business segments to develop a system that addressed their unique needs while fostering efficiency and collaboration.”

As companies optimize complaint handling processes, it is equally critical to streamline beyond the core complaint handling process. Robust complaint handling relies on robust intake information. Equally, robust and timely action depends on the ability of the complaint handling process to identify critical indicators and escalate them appropriately. Each company may have different bottlenecks; some elements of these cross-functional processes may require more attention than others.

Thakar shared, “Understanding the cross-functional nature of complaint management—linking with commercial, customer service, supply chain, and manufacturing—is key to effective transformation.”

Using technology to streamline complaint management

Technology can serve as a powerful enabler in the complaint management process by streamlining workflows and enhancing decision-making capabilities.

Thakar shared how technology enables companies to link risk files with complaint handling processes by using a single source of truth for decision-making, overcoming historical challenges of data disconnection and complex coding systems.

“Technology today can anchor decision-making on a single source of truth, addressing challenges like connecting risk files with complaint handling. For example, by integrating robust risk files and automation, companies can map complaints to risk codes and improve decision-making, even transforming unstructured data into actionable insights for more effective investigations.”

Tucker emphasized the same points by sharing how Cardinal Health is already experiencing the benefits of its digital transformation for complaints.

“At Cardinal, moving to a unified quality management system is just the beginning. Centralizing our software into one system improves data entry and timeliness in complaint management, allowing us to streamline processes from intake to investigation. Additionally, using technology to enhance data capture and reduce non-value-added tasks helps ensure a robust and comprehensive complaint file.”

Turning Complaints into Opportunities for Improvement

Companies must proactively address the challenge of evolving their processes to drive success with advanced solutions while preserving control and compliance. Thakar shared the tactics medtech companies should adopt to ensure this is not a barrier to transformation.

“One, align on what the complaints transformation is intended to achieve, whether it’s efficiency, consistency, or risk reduction. Two, understand and map your data sources to ensure a single source of truth and effective data flow through the future process. Three, focus on executing and adapting the complaints process to fit your enterprise model, upskill teams, and ensure accurate data intake.”

Once these foundational elements are addressed, focusing on integrating automation and intelligent decision-making can help unlock the full potential of your complaints management system.

References

^{1. JP Morgan, US Licensing and Venture Report, 2024↩}

Next: Learn how Philips and Lilly are embracing quality transformation to keep pace with changes and meet new challenges.