Medical Device Quality Series: Gathering Insights from Complaints Data – A CQ Guide

Introduction

A medical device company specializing in neurostimulation technology for a non-opioid approach to pain management realized that their CRM, inventory management, and Quality Management were disconnected from each other.

This lack of data visibility and seamless flow of information across business systems reduced both productivity and operational efficiency. The company’s business leaders were unable to leverage critical data (at the right time) which undermined their growth strategies.

Additionally, the inefficiency spilled over to complaint processing as well, and though sales volume was growing, the company was falling behind on resolving complaints.

This was because the complaints were tracked manually, which made it challenging to keep up with every detail. Each complaint submitted was touched by several stakeholders across quality and compliance, engineering, sales, and R&D teams — which prompted the need for a more collaborative and connected solution.

The lack of an integrated complaint management system also made it difficult to initiate a CAPA or a root cause analysis (RCA) process. In cases where the root cause of the complaint was due to a supplier quality issue, the process of handling the complaint became more complex. While the company prided itself on delivering high levels of patient satisfaction, it was critical to upgrade and automate complaint handling.

Streamlining the complaint management process became extremely important to fix issues on time, proactively mitigate risks, increase brand reputation and drive growth.

Inefficient complaint management is a problem faced by most medical device companies. The only way to do this right is to automate the entire quality management workflow where processes, people, and systems are truly connected. The complaint management module has to be integrated with the rest of the business processes.

In this post, we look at how medical companies are embracing automation, digital transformation, and next-generation technologies to build a world-class complaint handling workflow. More specifically, leaders in the medical device industry are deriving intelligence from complaint data to proactively mitigate risks, spot opportunities and improve their overall product.

Risk-aware Complaints Handling

Business leaders in the medical device industry often point out that every complaint is different. One needs a system that does automatic triaging of complaints based on risk level and urgency.

Additionally, end-to-end management of complaints driven by a seamless flow of information across the enterprise is a “must-have”. ComplianceQuest’s Complaint Management System automatically queues all complaints that require further triaging to be reviewed by the relevant complaint coordinator.

By taking advantage of data and Artificial Intelligence framework of Einstein Predictive Analytics, complaint handling teams can automatically triage complaints based on risk level and urgency. Following the triage, a complaint is routed for further investigation and evaluated for the need to report to a regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the complaint’s severity and priority.

Manual and legacy systems that operate in silos are extremely inefficient and ineffective when it comes to managing complaints. One needs a next-generation solution that is truly integrated with the end-to-end product lifecycle. Right from intake of complaints to regulatory submissions to complaint resolution, one needs to take advantage of automation.

An effective solution is one that will drive continuous improvement of the entire workflow, ensure all regulatory requirements are taken into account, and proactively work to minimize risk.

12-steps for Better Complaints Handling

Businesses can manage their complaints workflow from intake to remediation and continuous improvement using ComplianceQuest’s Complaints Management solution:

• The medical device company receives customer complaints and feedback from various touch points such as website, mobile app or phone call, which is recorded and routed for further triaging using ComplianceQuest’s In-take feature.
• Complaints are automatically queued and the relevant complaint coordinator/manager notified for further action using Triaging and Initiation.
• Medical device quality leaders can identify reportable adverse events as well as the type of report leveraging the embedded Regulatory Submissions and Decision Tree functionality.
• Manage regulatory assessments and timelines for regulatory submissions using the Regulatory Assessments and Submissions feature.
• Gain a better understanding of performance and stability of components and access valuable inputs for root cause analysis in Product History Review.
• Medical device quality leaders, complaint handlers from multiple sites and subject matter experts from the supply chain can collaborate for Investigation and Root Cause Analysis.
• Systematically evaluate complaints against CAPA requirements and access CAPA results such as investigations, CAPA actions, effectiveness plans and verifications with CAPA Evaluations.
• Collaborate using an online portal, a central repository for information, chatter for in-house social networking, and a transaction-based communication approach using the Communication and Collaboration feature.
• Seamlessly integrate with the CRM to provide end-to-end visibility and timely response to customer complaints using CRM Integration.
• Access customer complaints on the go and initiate appropriate responses without delays with this Mobile-Ready solution.
• Like and follow relevant records in the system and be notified via email, dashboard, and mobile to stay abreast of developments as the solution is enabled for Social Like and Follow.
• Utilize pre-developed best-practice-based reports or customize reports and dashboards for faster decision making with Reporting and Analytics.

To request for a demo our offering, click here: https://www.compliancequest.com/online-demo

“We implemented ComplianceQuest (CQ) to replace our previous Complaint Management System. From the very first day, CQ went above and beyond to help provide expertise on how to automate our business processes, providing insight into how to properly migrate data to CQ, all while ensuring that our new processes were FDA compliant. They worked day and night to ensure our requirements were met”

- VP of Quality at a leading medical device company