A complex system requires a strategic plan that ensures management control over the outcome of its processes. Quality Systems are a series of disparate processes joined to ensure devices meet user requirements. Analytic technology joins processes for measurement through business rules and statistical techniques to derive meaning from large data sets.
The capability to extract useful information from data that can be utilized strategically for the management of product and process quality is essential. The European Union Medical Device Regulation (EU MDR) PRRC responsibilities make it essential to conduct Post Market Surveillance (PMS) and Quality Management System (QMS) surveillance activities. Life sciences companies (medical device, diagnostic, and pharmaceutical companies with combination products) have an obligation to ensure their PMS and QMS surveillance systems are state-of-the-art for regulatory and business stakeholders alike, and most importantly… for the patients and users they serve.
PMS and QMS surveillance systems must provide visibility of potential outcomes, in terms of product and process quality, based upon analytical technology data models.
Organizations utilizing analytic technology can provide responsible leadership with the needed ‘visibility of potential outcomes’ that is necessary to enable them to make effective decisions, however, it requires a disciplined approach to make this happen.
The first step in utilizing an analytical technology approach for business purposes, such as defining product and process quality, is to identify the ‘unknown’ that the solution seeks to clarify. In developing the
Mgmt-Ctrl applies analytical technology through a Quality System(s) Management (QSM) solution targeting constraint in product and process quality to provide a risk-based approach to effectively and efficiently identify:
product quality constraints, measured in terms of failure modes driving patient harm, associated with marketed products;
critical to quality (CtQ) production control adequacy, to identify quality constraint associated with the product failure modes driving patient harm;
the compliance, effectiveness and efficiency of the Quality Management System (QMS) processes that are intended to ensure the quality outcome of the marketed products.
Each of these measures were designed to enable direct comparison between what is being measured, with the ability to aggregate and disaggregate the information appropriately in relationship to the organizational structure of the Enterprise.
The resultant QSM solution provides analytics-driven insights, focused on the product and process ‘quality’ constraint, delivering a solution in the form of a PMS and QMS) surveillance toolset. These extremely important elements of an organizations data ecosystem enable responsible leadership within the medical device industry to successfully identify patterns and trends in product and process quality, enabling them to better manage and improve the constraint(s) identified. Isn’t this essentially what business and regulatory stakeholders require? Isn’t this what is expected by the patients and users who place their trust in the products marketed by medical device companies?
An industrial revolution is underway within the medical device industry that has already occurred within other industries such as automotive and semiconductor. It is a revolution that requires the merging of human talent with technological capability to enable organizations to leverage data-driven insights for improved business performance. Medical device companies must improve their analytics maturity in order to improve patient outcomes, and they must do so urgently. Many organizations are currently faced with the challenges associated with sourcing talent and skillsets to both build the data environment and facilitate analytical solutions. Current organizational capability and/or leadership was not hired with a background necessary to merge strategic design with the technical approach and technological data processing solutions that are required. The Mgmt-Ctrl QSM solution resolves this analytical maturity conundrum associated with PMS and QMS surveillance. What is the maturity conundrum? The increasing sophistication of data analytics, and associated business value, escalates the maturity of an organization as their solutions transcend the various levels of analytical capability:
Level 1 - Descriptive Analytics - Describe, analyze and summarize relevant data-sets (What happened?)
Level 2 - Diagnostic Analytics - Identify causes of trends and outcomes (Why did it happen?)
Level 3 - Predictive Analytics - Predict future outcomes based on the facts of the past (What could happen?)
Level 4 - Prescriptive Analytics - Report, review, and propose optimal actions for improvement (What could be done about it?)
Level 5 - Adaptive Analytics - Monitor and act… autonomously and/or semi-autonomously (what needs to be addressed?)
The Mgmt-Ctrl QSM solution normalizes data assets that are provided as an input to seamlessly integrate with the QSMs analytical technology toolset, providing for the active measurement of product and process quality to identify and report the systemic constraint(s), enabling the responsible management of emerging issues and the ability to act in the facilitation of continual improvement initiatives.
1. Active measurement of product and process quality through a descriptive, diagnostic and predictive analytical technology toolset that enables the effective and efficient transformation of product and process data, for utilization by responsible decision makers;
2. Responsible management of emerging issues is made possible through prescriptive analytics and interactive reporting, for those who are held accountable by regulatory and business stakeholders alike for the results obtained by the Enterprise;
3. Continual improvement of targeted constraint(s) is made possible through adaptive analytics to provide value in the form of a return on the investment (ROI) in compliant operations that are effective in obtaining the required results, and efficient in doing so.
The Mgmt-Ctrl QSM solution is available to medical device companies for the implementation and utilization of analytical technology to facilitate the active measurement of product and process quality. Systemic quality constraint(s) are identified enabling the responsible management of emerging issues and facilitation of the continual improvement that stakeholders expect. Utilization of the Mgmt-Ctrl QSM solution provides a significant advantage to the management capability of the organization and resolves to the maturity conundrum of increasing the organizational sophistication of data analytics. Additionally through the measurement of cost of poor quality (COPQ) the business value can be monetarily defined with the return on investment (ROI) directly resultant from the management and improvement of product and process quality, and the reduction in the COPQ.
Additional information can be found by e-mailing info@Mgmt-Ctrl.com to request a more detailed ‘white paper’ to learn more about the use of analytical technology in association with the Mgmt-Ctrl QSM solution.
 (EU) 2017/745 of the European Parliament and of the Council, 117 Official Journal of the European Union 1 (Apr. 5, 2017) [hereinafter EU MDR]
 Advanced analytics fuel tomorrow’s commercial strategy for drugs and devices, March 16, 2019; https://www.pwc.com/us/en/industries/health-industries/health-research-institute/commercial-pharma-analytics.html