Skip to main content
Skip to footer
Contact Us
We are taking you to another website now.
May 20, 2016

Complaints management in the medical device industry can play a key role in driving product innovation & quality improvements, giving companies a competitive edge.

Most medical device companies have an efficient complaints management system that helps achieve all-round regulatory compliance. However, is there more to complaints management than just resolving customer issues and meeting regulatory obligations? Can medical device companies squeeze additional benefits from their investments and efforts in this area? Of course, they can.

To do this, manufacturers have to fundamentally change the way they view and execute their complaints management process. This process needs to become a key driver of innovation, providing inputs for design improvements, which might ultimately result in a competitive edge due to improved product quality and lesser complaints.

So what does a typical complaints management setup look like?

Medical device manufacturing companies have products spanning multiple domains, technologies, and therapy segments. Such a varied portfolio calls for substantial time and effort investments in resolving customer complaints. Moreover, as device companies expand their global footprint, their user base becomes diverse, leading to differing product experiences. Contributing factors include non-standard surgical techniques, inconsistent selection of products to address relatively similar surgical interventions, and varied post-operation recovery regimens.

So, how would a medical device manufacturer cope? They manage their complaints processing activities from several dispersed locations worldwide, with each site following its own procedures and practices. In some cases, a centralized site takes care of a large region, such as the Americas or the EU. Processes are carried out manually, and there is not enough documentation on standard operating procedures (SOPs). Often, there is the unavailability of adequately skilled resources and poor visibility into end-to-end complaints management. All this put together, and we have a considerably inefficient process.

Making customer complaints a driver for product improvement

Can we make complaints management setups more efficient, such that they drive superior product development? Sure, we can.

Complaints management is part of an interconnected loop of post-market quality functions that comprise Corrective and Preventive Action (CAPA), change management, post-market risk assessment, and field actions. Most companies resolve complaints with the sole intent of complying with regulatory requirements. Only complaints with confirmed design issues trigger formal changes to product design. This is where there needs to be a change in approach. While continuing to meet regulatory mandates, the complaints management system should step up to the next level. It should become a lever for product design enhancement by feeding useful inputs to the change management system.

Viewing every complaint as an opportunity to improve product design, regardless of the nature of the complaint or the quantum of information supplied along with it, is our best bet. The underlying idea is not to associate a design change with every complaint, but to consciously attempt to explore design improvements in a timely manner. Changes triggered by confirmed design issues should continue to be notified to regulatory agencies and other stakeholders. However, all other design tweaks can be given an internal go-ahead, of course, post a comprehensive cost-benefit evaluation.

So how do medical device manufacturers establish a complaint management process that is conducive to supporting innovation? They must implement an efficient, unified system that covers all the elements of a complaint workflow, apart from continually generating design inputs. Heres what we feel should be done:

  • Institute standardized processes with well-defined intake, follow-up, and evaluation protocols, applicable to all complaints originating from anywhere across the globe
  • Set up a centralized complaints processing unit to maximize efficiency and ensure consistency
  • Deploy a team of knowledgeable and experienced resources with necessary skills and training
  • Observe trends to determine if a particular user group tends to experience unexpected events more than the others
  • Most importantly, introduce a feedback loop to supply continuous data to product development and engineering teams on off-label use, misuse, unexpected performance, and alleged malfunctions
  • Encourage R&D teams to improve products based on the feedback, and constantly monitor improvements and outcomes in the field, based on parameters such as reduction in the number of complaints or repairs

Reengineering complaints management

Transforming complaints management requires an overhaul of the current way of thinking. By leveraging an integrated and unified complaints handling system, medical device manufacturers can derive significant value from complaints. With a strategic approach to complaints management, firms can shift their attention from only regulatory compliance (which is inherently built into efficient complaints management systems) to improving product quality. A high-performing complaint management system can provide timely access to metrics and trends that are crucial to the continuous improvement of product and process quality.

We believe that reorienting the complaints management process will spell the next wave of success for medical device manufacturers. What do you think? What is your organizations complaints management strategy? Are you looking to repackage the whole process such that it delivers more than it has so far?

Hari Sreenivasan Nadadur is a Medical Device Functional Consultant with the Engineering and Industrial Services (EIS) business unit at Tata Consultancy Services (TCS). He has 19 years of experience across industries such as heavy engineering, ship engine design, and medical devices and diagnostics (MD&D). Haris areas of expertise include new product development, sustainable engineering, regulatory submissions, complaints management, and technical documentation. He holds a Bachelors degree in Mechanical Engineering from Sri Jayachamarajendra College of Engineering, University of Mysore, India.


Thank you for downloading

Your opinion counts! Let us know what you think by choosing one option below.