For medical device manufacturers across the globe, among their top priorities will inevitably include complaint handling. Continuous improvements in customer satisfaction, regulatory compliance, and the safety of consumers must remain top of mind.

In light of improving the complaint handling process and further emphasizing its importance, we sat down with Partha Marella (Executive Vice President of HCL Technologies), to obtain his insights and best practices.

Despite the well-defined requirements from different regulatory bodies, the number of complaints-related observations continues increasing year over year. Why do you believe this is the case?

Well-defined requirements from different regulatory bodies demand a more detailed approach to complaint handling and related documentation from medical device manufacturers.

Most regulators encourage the consumers, patients, and healthcare professionals to provide voluntary information on significant adverse events. Consumerization of medical devices has also led to an increase in customer feedback. In fact, digital transformation is making it easier to report product complaints, accessible via mobile apps! Regulators are gradually concentrating on handling customer complaints, product safety, and device vigilance. This is not only true in developed countries, but in emerging economies as well. Product surveillance and regulatory compliance emerged as the largest segment owing to a greater emphasis put on product surveillance by regulatory agencies.


Can you tell us about the common pitfalls that medical device manufacturers often make [when it comes to handling product complaints]?

Below are the most common failures that medical device manufacturers often experience when it comes to handling product complaints:

• Inability to cope with changing regulations for medical devices across global markets
• Inadequate process compliance by manufacturers to adhere to regulatory requirements
• Inappropriate handling of medical devices with their problems and solution implementation (CAPA aging)
• Poor complaint handling procedures which lead to user error, incomplete data, and complaints processing
• Inadequate training on risk management and clinical evaluation of medical records
  
  

In contrast, what are your best practices in complaint handling for medical devices?

HCL has a systematic approach to medical device complaints handling right from intake to the closure of complaints. Below are a few of the best practices that we follow at HCL, to ensure smooth and efficient complaints management:

• Strong identification of complaints from non-complaints and classification of complaints
• Detailed investigation of complaints and populating investigation summaries
• MDR/Vigilance reporting as per defined timeline for adverse events in the field
• Clinical evaluation of medical records and returned product 
• Deployment of qualified resources for clinical, quality, and regulatory assessments
  

What would you say is HCL’s value proposition, which sets you apart from competitors? Why do medical device manufacturers choose to work with HCL?

HCL has been uniquely positioned to bring out efficient and effective complaints handling for medical device manufacturers. HCL’s industry leadership position in engineering and sustaining complex Class 2 and Class 3 Medical Devices — as well as our expertise in the medical device manufacturing processes and supply chain — gives us great insight into the lifecycle of a product.

Other highlights include:

• Dedicated Center of Excellence i.e. Post-market Surveillance COE
• 500+ qualified and experienced resources in complaints handling
• SME in risk management, clinical assessment, and regulatory affairs for medical devices
• PMS Training modules created in HCL iSuccess portal
• Well-defined complaints handling processes, tools & templates in the HCL MQMS portal
• HCL’s focus on automation ( RPA / AI-ML )  to significantly improve productivity 
• Flexible engagement models – offshore / nearshore / onsite

All of the above HCL differentiators make it the only player to offer a one-stop solution for product complaints handling from the backlog, remediation to sustenance work.

Would you like to share a few case studies, outlining how HCL helped their clients improve product complaint handling at their respective businesses?

Absolutely. Below are three case studies, in which we worked with our medical device manufacturing clients to elevate their processes for complaint intake, evaluation, investigation, and/or reporting & closure. For confidentiality reasons, we’ll refer to them as Clover, Spade, and Diamond.

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For Clover, they were looking to increase the intake bandwidth of their Complaints Handling Unit that was choked with over 70,000 complaints in the backlog for 22 different product families. Additionally, they aimed to eliminate the compliance risk posed by the increasing number of complaints aging in the backlog for over approximately 800 days, through processing and taking them to closure. Finally, they also strived to reduce the total cost of running the Complaints Handling Unit while ensuring adherence to below listed Post-Market Surveillance Goals set by BU: 

• Optimize the complaint cycle time with a goal of fewer than 60 days
• Manage the number of complaints open in the backlog to be no more than two times the monthly average
• Ensure zero complaints open for more than 180 days per corporate goal

After partnering with HCL, Clover has had 575,000 + complaints processed since 2016, reduced their processing cost per complaint from $55 to ~$15, reduced their complaints’ cycle time from 55 to 25 days, and now average 75 or higher complaints per day, per person.

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Spade was also looking to decrease their Complaints backlog, and eliminate the compliance risk posed by the increasing number of complaints aging (due to multi-location, and multi-vendor communications overhead). They also needed to reduce the total cost of complaints processing — while ensuring adherence to the Post-Market Surveillance Goals set by BU — and transition the complaint handling activities of the entire BU.

With the help of HCL, Spade was able to process over 13750 complaints since 2019, close over 9000 backlog complaints, support 33 product families for three business divisions, lower their average MDR timeline from 30 days to 12 days, and finally, decrease their average complaint closure cycle time from 60 days to 41 days.

• 13750+ Complaints processed since 2019
• 9000+ Backlog complaints closed
• 33 Product families for 3 business division supporting
• Avg. MDR timeline 12 days < 30 days 
• Avg. Complaint closure cycle time is 41 days < 60 days

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Last but not least, our client Diamond required assistance across the board — in complaint intake, evaluation, investigation, reporting & closure. They needed to review its complaints and field service records retrospectively for 2.5 years, and process all of the complaints as per new findings. There turned out to be 126k existing complaints re-opened and processed within 6 months offshore, and 700k new complaints were processed from 1.8M to 2M field service records (by identifying the complaints within 1.5 years). Diamond needed to revisit regulatory reporting for all complaints as per the new enhanced complaints handling process, as well as manage an increased inflow of prospective complaints, reduce cycle time, and implement automation tools.

Through a partnership with HCL, Diamond onboarded an automation tool using AI/ML that HCL developed for complaint intake, investigation summaries, and MDR. Additionally, they enhanced MDR determination, reportability, and risk management pro. Overall, they acquired complete ownership of complaints handling from offshore, which brought forth enormous cost savings.

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Looking to reimagine your enterprise for the digital age? We invite you to learn more about HCL here.