The Case for Streamlined Complaints Management in Medical Devices. Consulting

Transcription

1 The Case for Streamlined Complaints Management in Medical Devices Consulting

2 Increasing challenges in the evolving medical industry will require a more integrated complaints management approach The medical device industry is heavily regulated and inadequate product complaint handling accounts for a large percentage of FDA inspection findings. Complaint handling represents an emerging issue that device companies need to address. Increasing regulatory and public scrutiny as a result of numerous product issues that impact patient safety have jarred the public s trust. Companies have various functional groups that interact with the complaint which leads to a complex process with multiple handoffs, and therefore a lack of control i. This complexity leads to several variations in the way complaints are being handled by different companies. In order to get out front of this complaints handling exposure, companies need to implement a streamlined complaints management process in medical devices that stresses accountability and ensures compliance with regulations. Products are becoming increasingly complex requiring regulations for combination products, various device classification, borderline products, etc. Even though the regulations are driving towards clarity and transparency; harmonisation in terms of regulatory requirements across regions is still elusive. This creates a unique set of challenges such as having different categorisation (drug vs. device) in different regions, lack of common complaint coding standards or having different sets of requirements for receiving the information in different formats. Moreover, device reporting requirements are generally more inclusive, leading to reporting of complaints which haven t resulted in an Adverse Event (AE). This leads to the creation of complex algorithms to determine reportability, further complicating the complaint management process outputs.

3 Over the past decade, the medical device industry has seen healthy growth in revenues with evolving product complexity. This has led to increased regulatory scrutiny with growing occurrences of recalls and field safety notifications (please see Exhibit 1). Regulatory push has led to an unprecedented increase in safety related complaints ensuring organisations are keeping patient safety high on the agenda. Serious adverse event reports have grown significantly over the years, leaving medical device companies feeling the pressure of compliance requirements. Organisations are actively rethinking their strategy on how to address complaints more efficiently while ensuring customer safety. Medical Device development is very much an integrated process that includes both manufacturing and development. During the development phase, risk management plans are created and carried through to the commercial phase. This kind of integration can be seamless as long as the process stays in the engineering phase. However, a siloed structure can arise with combination products or when a device causes an adverse event(s). At this point, another part of the business becomes involved which traditionally has been excluded from the engineers circle and therefore a more siloed approach is developed. This siloed structure effects all parts of the organisation, including people, process, and technology. On the people side, there is a lack of cross-functional governance bodies and personnel tend to work in isolation. On the process side, data (i.e. FMEAs (Failure Mode and Effects Analysis), tolerance data, and product risk files) aren t shared among the necessary groups and there are deficient benefit-risk assessments for devices. On the technology side, systems used within each silo are not aligned which leads to data inconsistencies across the organisation. Exhibit 1 Medical device companies have struggled to keep pace with evolving product complexity and compliance regulations Although the number of complaints gathered in recent times has increased significantly, one can question whether patient safety has been improved at all. The additional gathering of complaints has led to more work but not increased patient safety because companies are not evaluating the complaints holistically as they are busier processing the complaints rather than understanding the implications. As a result, the device industry at present is where the pharmaceutical industry was several years ago in regards to being reactive vs. proactive in nature. Years ago, the pharma industry focused on processing Adverse Events Reports (reactive) rather than on signal detection (proactive). Over time, the streamlining of AE processing helped pharma companies focus more on proactive Pharmacovigilance (e.g. Signal Detection and Evaluation, Benefit-Risk Management).

4 Many organisations today deploy processes which lead to multiple rework efforts and handoffs during the course of a complaint, leaving them ill-equipped to handle the challenges of the industry. Such a complaints management approach requires the need for multiple resources to act on a complaint during its processing. The process is handled by different organisational entities, which often from a reporting perspective, don t meet up until they reach the CEO (e.g. complaint received by commercial call centre, technical complaint dealt with by QA, while GMP and PV deal with the safety aspects of the complaint). Organisational complexity exacerbates inefficient processes which are littered with handoffs and bottlenecks throughout the lifespan of a complaint. This results in delays in complaint closure, regulatory report submission, and inconsistent documentation. With increasing case volumes, complex regulations, and the medical device industry being traditionally siloed, how can a complaints management process be set up to decrease the number of handoffs and ensure compliance? Similarly, how can the device industry follow pharma and become more proactive in its quality and safety model? A Streamlined Complaints Management Process Can Counterbalance Industry Complexity The solution involves the successful implementation of a streamlined complaints management process that minimises handoffs across the organisation and emphasises accountability and compliance. The benefits of implementing such a system stretch across three core aspects of business operations, which include people, process, and technology. A streamlined process allows for less rework and bottlenecks, which saves time for the resources responsible for completing the case. Less handoffs and better communication between owners in the process can lead to less friction between engineer and safety managers. Above all the process stresses accountability, which has a positive domino effect throughout the organisation. On the process side, harmonising of process steps can lead to more efficient cross functional cooperation across the organisation. The process can also help identify and correct deficiencies internally before they are discovered by audit or inspection. A way in which this can be achieved is through increased knowledge share through appropriate governance bodies of device data captured in product development. This should lead to product lifecycle files for each product, so that the reason behind a complaint is quickly understood and never much of a surprise. An integrated complaints management process will protect the patient and increase compliance with evolving and future regulations. Best practice complaints management technology can ensure accurate intake and timely reporting. Increased automation leads to an efficient process flow and fewer opportunities for bottlenecks. The system must be able to support the integration of several systems at intake and allow for outputs which are acceptable to regulators and downstream applications. Exhibit 2, illustrates Navitas best practice complaints management process. Organisations Must Adapt to Ensure Regulatory Compliance and Patient Safety

5 Complaint Source Manufacturing Investigation Medical Review Intake Evaluation Medical Assessment Distribute/Submit emdr/mdv Final QC Closure Follow-Up Rules Request for follow-up Track Follow-Up/Send or Letters Safety Risk Management Follow-Up Integrated tracking of receipt, follow-up, and communications Product Master Integration Decision tree for triage (criticality, seriousness, etc.) Decision tree for accurate coding Reporting rules built in the system System QC, no peer review emdr/emdv capability Risk analysis input fed back to complaint process Exhibit 2 Navitas Best Practice Complaint Management Process Organisations must address the challenges that are adversely affecting the industry and implement a complaints management process that stresses accountability and reduces handoffs. Case volume will continue to increase, headcount will not increase at the same rate as volumes, and regulations are going to become more stringent. The following principles are essential for streamlined complaints management: Integrated product master Efficient coding aided by automated decision tree Minimum hand-offs System integration across the process from intake to risk management Defined accountability for a complaint through the lifecycle Companies are required to align product safety, product quality, and customer service functions with device design and engineering. This can be only made possible if people, process, and technology are aligned efficiently which can drive compliance and reduce delays in complaint resolution. A risk-based, proactive approach is key to a solution that focusses on planning ahead to deal with the greatest potential product issues. Streamlined complaints management in medical devices that stresses efficiency and accountability can help companies ensure compliance with regulations and promote patient safety. i Pharma Complaint Management: Emerging Challenges and Solution. Prabuddha Kumar Biswas, Ramesh J. Chougule. Nov 2009

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