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.
Complaints Handling with CQ
The aforementioned medical device company opted for ComplianceQuest’s Complaint Handling Software, for five key reasons:
- ComplianceQuest is built on the highly scalable and flexible Salesforce platform. Our solution could be customized to fit the process needed by the customer.
- The customer wanted a complaint handling solution that will easily integrate with Rootstock ERP and Salesforce CRM. This integration ensured there were no gaps in the entire workflow. Data stored in the ERP system (inventory, lot numbers, transaction dates, etc.) was key for effective resolution of complaints and future actions.
- Our dashboards were world-class. Business leaders could easily track no. of open complaints, risk levels of complaints and status of action taken.
- It was easy to track complaints by “component” – which enabled the medical device manufacturer to focus on “problematic parts” and proactively drive change to prevent similar complaints in the future.
- With ComplianceQuest’s Complaint Management, quality assurance leaders could automate the process of regulatory submissions – MDR and FDA in the U.S; MIR forms in the EU. The solution is also designed to automate the process of generating and submitting the MedWatch Form FDA 3500 and ESG reports through our approved and validated AS2 Gateway.
These were all key features that increased overall efficiency of the complaint management process.
Automating Regulatory Requirements
Be it FDA 21 CFR 820.198, ISO 13485:2016 section 8.2.2, MDR or MDSAP, all regulatory standards require medical device companies to establish a process for complaint handling – right from intake to resolution.
Regulators demand that clear procedures are established for the following:
- Receive, review, and evaluate complaints carefully
- Investigate complaints in a timely and consistent manner
- Assess the need to report a complaint to relevant regulatory bodies
- Periodic audits of the complaint management process as otherwise you will be issued warning letters
- Document management related to complaints
Regulations are stringent even for software-based medical device companies. One of our customers, a software medical device manufacturing company headquartered in Miramar, Florida, was founded as a collaboration between the Red Cross and One Blood. Their software tracks each unit of donated blood from collection to transfusion, streamlining the complete blood donation process for quality and safety.
From day one, it wanted an FDA-compliant business and opted for ComplianceQuest’s EQMS software for its flexibility, scalability, and in-depth experience in medical device quality management.
Our Complaints Module offered a reporting feature that fit with the client’s needs perfectly. The module provides best practices for life sciences combined with decision tree functionality, which supports the identification of adverse events and report types by various regions. This unique, out-of-the-box feature helps the company determine if an event is reportable, provides a form to fill in details need by the FDA, and automatically creates the XML file to load into the FDA’s reporting system once done. This is the kind of automated reporting that medical device manufacturers are looking for.
End-to-End Complaints Lifecycle – Automated
A NASDAQ-listed high-tech medical device company that designs, develops, manufactures, and markets advanced silicone-filled breast and body shaping implants, has offices across Brazil, Belgium, and the USA. It markets and sells its products to physicians, hospitals, and distributors in over 80 countries across the globe.
Founded in 2004, the company began with a paper-based quality management system to establish the core of its quality process. But by 2017, it realized that it needed a more robust and scalable Quality Management System (QMS) if the company had to maintain its quality as it grew rapidly. With a manual system, tracking of quality metrics and visibility into operations (including complaints handling) became complex.
The quality leaders at the company quickly realized that a single complaint may not be a reflection of just one unit of the product. Rather, it may have an implication on an entire batch. They also realized that data from complaints provided access to much needed intelligence. If the company could garner insights from complaint data and take action as needed, it would help them proactively address quality issues ahead of time.
It is an opportunity to drive continuous improvement and, therefore, needs to be documented and shared across the supply chain. The impact of the change being made also needs to be analyzed for risk and any other complexity that may arise. This needs a view into the end-to-end product lifecycle and that is possible only with a next-generation solution such as the one from ComplianceQuest.
For any business, having a well-designed process for not only for complaints handling but also gathering insights from complaints data will be a game-changer.
For a more detailed perspective of the complaints management process and how to use the power of automation and digital transformation better, download this Whitepaper titled “Getting Complaint Management Right : Automation and Collaboration hold the key” here: https://www.compliancequest.com/whitepaper/getting-complaint-management-right/
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
