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Complaint handling is a critical process for medical device manufacturers as it is often related to patient safety. Any complaint needs to be addressed with agility and efficiency to win the trust of patients and healthcare service providers. Often, though, the response to a complaint is slow and inconsistent because the company uses a manual system for complaint management.

In our recent webinar titled ‘Striking a Balance of Automation vs Regulations for Effective Complaints Management’, Wipro’s Rahul Ganar, enterprise operations transformation leader for the life sciences and medical device sector, mentioned that automation and digital transformation can help large device manufacturers save up to USD 10 million by introducing efficiency at every stage of complaint processing from in-take to regulatory submissions. These savings make their way into the balance sheet within a year of automation using cloud-based digital tools, robotic process automation (RPA) and AI.

ComplianceQuest has partnered with Wipro, to bring to the fore our software and capabilities in EQMS, that is integrated with Wipro Holmes, an AI and automation platform. While Wipro’s automation solution integrates with the CRM and handles the intake of complaints, the rest of the complaint handling workflow is automated with ComplianceQuest’s EQMS.

Thanks to this automation, a top 10 medical device company experienced 37% cost savings within a year and a half of implementing the solution. More importantly, automation made regulatory reporting and compliance easier by improving the response and resolution of complaints.

Automation: The only way forward

Dr. Rao Teki, Wipro’s Global Head of R&D Innovation and Transformation, says that organizations expect their complaints volume to increase by 15-20% year-on-year and business leaders are concerned about the associated costs as well as the inability of their systems to manage this increase.

Currently, businesses have higher no. of manual tasks and processes to do and this leads to inconsistent responses to similar complaints. This in turn can raise a red flag with regulatory authorities.

Given the criticality of complaints, regulatory bodies are introducing stringent guidelines to mitigate risks and improve compliance. Consistency and predictability are essential traits of a robust complaint management system.

Moreover, data from complaints offer a treasure trove of information on how businesses can improve their products and processes. With a manual system, it is impossible to quickly derive insights from complaint data.

Therefore, medical device manufacturers need a complaint handling system that can help them with the following:

  • Stay ahead of regulatory changes and automate regulatory reporting
  • Make it easy to meet geography-specific regulatory compliance
  • Automate data capture and power intelligent decision-making
  • Churn out effective and complete data sets for risk assessment and further data analytics
  • Use AI capabilities for both structured and unstructured data to predict risk levels and urgency of a complaint
  • Reduce compliance risk
  • Conduct comparative analysis to quickly identify previous or current related complaints and investigations
  • Support multiple languages for regional requirements
  • Maintain data quality and consistency due to less manual interaction
  • Connect easily to other key systems, such as CRM, ERP and QMS for complete data view of complaint lifecycle
  • Flexible and configurable to meet changing regulatory and business needs

Next Generation Complaint Handling

By embracing a next-generation solution for complaint management and overall quality management, medical device manufacturers can see an impact in three critical areas:

Rich customer service across the lifecycle: Patient safety is the most important factor in the whole process. A robust complaint management system must be flexible, scalable, and customizable. It must help the relevant stakeholder deliver a near real-time response to a customer complaint. Automation also leads to a reduction in complaint closure time, streamlined intake, reduction in investigation cycle time, and a 360-degree view of the customer from sales/quality perspectives.

Impact on bottom line: Automation leads to increased productivity of complaints/quality team with enhanced visibility of customer complaints across all channels. Having access to actionable insights from complaints data and enterprise-wide visibility of how a complaint is being handled directly contributes to profitability.

Digital transformation also helps with the following:

  • Improved regulatory compliance
  • Mitigation of regulatory risks and reduced fines through timely and consistent responses to complaints
  • Reduced cost of compliance through minimum time and cost of processing complaints
  • Better readiness for audits
  • Tracking and traceability of complaints

For more information, watch our webinar Striking a Balance of Automation vs Regulations for Effective Complaints Management by Dr. Rao Teki, Wipro’s Global Head of R&D Innovation and Transformation, Rahul Ganar, Wipro’s Life Sciences Enterprise Operations Transformation leader, and Nikki Willett, ComplianceQuest’s CSO/VP of Industry Solutions for Enterprise Quality Management Systems.

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