The EU MDR Opportunity
Across industry, the requirements for managing quality are now becoming better defined and highly regulated. Medical device manufacturers have now been confronted with significant changes in the regulatory framework that governs access to the European Union (EU) markets. The EU Medical Devices Regulation (MDR 2017/745) was officially published on May 5th, 2017 and came into force on May 25th, 2017. With no provision for ‘grandfathering’, medical device organizations are now working to ensure their products will remain available to the European market after the 2020 deadline.
One of the most significant changes is in the requirement for improved quality measurement in the form of post-market surveillance (PMS) of product performance and the requirement to conduct active Post-Market Clinical Follow-up (PMCF) activity for Class III and implantable devices. PMCF must provide an ongoing summary of the safety and clinical performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks (benefit-risk) and of detecting emerging risks on the basis and analysis of factual evidence. There is also a requirement that a device specific Periodic Safety Update Report (PSUR) be provided and updated annually. Additionally, EU MDR requires improved management of systemic quality measurement in the form of ongoing QMS process performance assessment activity to identify QMS process improvement needs. These requirements represent a higher level of quality management towards the end-result of improved management over patient safety.
Quality Management has been a term that has been utilized for decades, however, with significant variation in how organizations define the term. For the purposes of this article, I will simply define Quality Management (QM) as being comprised of two components: 1) measurement, and 2) improvement. Quality Management is the measurement and improvement of product and process performance.
What then is the EU MDR opportunity? It is the opportunity for accountable leaders to implement meaningful changes in quality management through the measurement, monitoring, reporting, review, and improvement of their product and process quality. Implementing a smart strategy today will provide an ongoing return for the investment in improved Quality Management for EU MDR. There has never been a better opportunity to improve patient safety through the expansion your strategic data collection paradigm, improvement in your post-market surveillance and performance assessment activities, and focused management of product and process quality improvement initiatives. This can only occur through performance measurement efforts that enable leaders to understand product and process performance issues within the Quality Management System. Performance management begins with the measurement of product and process quality.
Product Quality (PMS) in the form of post-market surveillance (PMS) of the quality of product through the assessment of the ongoing benefit-risk of product provided to the market, and to identify emerging opportunities for improvement.
Process Quality (QMS) measurement of the quality of the Quality Management System through the aggregation of process quality by measuring compliance to requirements, effectivity in producing results and efficiency in operational execution.
Cost of Poor Quality (COPQ) measurement of the failure costs of product and process quality issues, enabling the management of improvement initiatives to provide stakeholder value in the form of a return on the investment (ROI) in quality improvement. Maintaining profitability in an ever-increasing value-based environment will require the use of a patient centric business measures focused on the cost of poor quality (COPQ).
These measurement components will identify operational constraints associated with the management of product and process quality. Transformational performance improvement can best occur by targeting these identified constraints, through focused performance improvement initiatives, enabling your organization to satisfy its regulatory/business stakeholders in providing the safe and effective products the market expects, for the patients we serve.
Finally… regulation, standards, and guidelines only address the ‘what’ that organizations must comply with, not the ‘how’. The ‘how’, however, is extremely important to the effectivity of the QMS within your organization. Your Quality Management processes must be appropriately designed such that they can be executed in a manner that is compliant in meeting defined requirements, effective in continually confirming the ongoing benefit-risk of the products you market, and efficient in the execution of the processes within the operations of the organization. It is extremely important that your Quality Management System works properly to enable you to manage and control the quality of your products and processes, as your stakeholders expect, since quality management is necessary to minimize risk to the patient, manage the regulatory risk to the organization, and provide ongoing value to the market.