In the midst of an extraordinary transformation of medical device industry regulation, regulatory enforcement activity appears to be at an all-time low. This presents an opportunity for medical device companies to transition away from an outdated ‘culture of compliance’, and transform their organizational culture into one of a ‘culture of quality’. Failure to take advantage of this opportunity would be a significant mistake, ensuring the potential for costly enforcement actions in the future. Will the opportunity be utilized? There exists a classic comedy sketch by Peter Cooke and Dudley Moore. It ends with Moore asking his friend, “Do you feel you've learnt by your mistakes here?” “Yes,” Cooke replies, “and I think I can repeat them almost perfectly.”
The path to implementing a ‘culture of quality’ begins with transforming Post-Market Surveillance (PMS), which is a component subsystem within the Quality Management System (QMS), and continues through the remainder of the transformation of the QMS subsystems. A patient-centric post-market surveillance process, focused upon product quality, enables this transformational process to occur in a business friendly manner. This approach addresses high risk products and processes as a priority.
Management responsibility requires that a Quality Management System (QMS) is established and maintained in such a way that is defined, planned, implemented and controlled in accordance with a risk-based approach. Responsible managers ensure the resources that execute the work of the organization are skilled, trained, and competent to do so. Responsible managers ensure ongoing operations are managed in conjunction with relevant data that is planfully collected and analyzed such that it provides crucial information that supports daily management decisions, and the continual improvement of operations. This can be accomplished with a patient-centric and quality focused culture. It is possible, and it begins with effective post-market surveillance.
Robust post-market surveillance (PMS) activity provides for the early detection of device issues and enables the opportunity to protect patient/user safety such that only devices proved to be ‘as safe as possible’, remain on the market.
Prior to bringing medical devices to market, manufacturers are required to minimize the risks and ensure patients' safety through design, production and process controls. This inherent risk is typically monitored by regulatory authorities and notified bodies during authorization and conformity assessment activity. However, once devices are placed into the market, the residual risk shifts and/or manifests over time, as medical devices are used daily by practitioners. Therefore, post-market surveillance activity must:
systematically identify these risks when occurring during practical usage
monitor the products' performance afield
detect product faults and safety issues left undetected
constantly update the benefit-risk assessment
quickly initiate necessary corrective action measures, such as CAPA and FSCA
The avoidance of costly corrective action measures is dependent upon shifting management emphasis onto more proactive approaches rather than relying on reactive systems, such as complaints monitoring. One such approach is to ensure the implementation of a risk-based and continual cycle of improvement of the quality of the marketed devices and/or their production and process controls. A strategy of continual improvement requires, as a foundational element, an effective PMS system, making sure that any issue with a medical device is identified and addressed as soon as possible.
The effective identification of device issues are of paramount importance in facilitating an effective PMS system. It is for that reason that Mgmt-Ctrl believes a focused product surveillance management (PSM) solution is required to ‘feed’ post-market surveillance activity. Many, many opportunities exist that have not been well utilized in past due to outdated paradigms of complaints management as primary activity required for post-market surveillance. European Medical Device Requirements (EU MDR) have now shifted those paradigms, or should have.
Managed product surveillance activity, derived from vastly different sources, would act as input into EU MDR post-market surveillance activity. The sources of post-market information include:
feedback and/or complaints from patients & users, providing input into complaints management
external economic operators feedback, providing input into complaints management
internal functional groups within the manufacturers organization
QMS surveillance activity that determines impact level to product quality, per MDSAP scoring
production and process control measures of the capability and variation of CtQ controls
traditional (past paradigm) PMS activity:
audits / inspections - FDA, ISO NB, other (manufacturer and industry)
adverse events - vigilance reporting, recalls (manufacturer and industry)
literature review - scientific journals, healthcare articles, healthcare guidelines, health-tech assessments, etc.
user feedback - focus groups, customer surveys, etc.
maintenance activity - maintenance, parts usage, failure trends, etc.
post-market clinicals - registry studies, marketing studies, etc.
misc. other product information - end user buy back activity, etc.
If you are interested in a PMS & QMS transformational strategy that can be utilized within your EU MDR transition efforts, please e-mail info@Mgmt-Ctrl to begin a discussion that will begin to make clear the pathway to achieving a ‘culture of quality’ that will satisfy regulatory and business stakeholders alike.