Mastering QMS Transformation

Introduction

Medical device manufacturers are facing a myriad of market challenges and pressures, including 1) the growing, fast-changing and complex global regulatory environment; 2) an increase in risk and cost of compliance; 3) greater demand for innovation and fast delivery of products; and 4) an increase in complexity of product portfolio and supply chain processes. To remain competitive in the dynamic and demanding global marketplace, manufacturers should invest in their quality management system (QMS) and incorporate new capabilities to increase their operational agility and effectiveness, while driving continuous improvement, maintaining a grip on compliance, improving product quality, fostering innovation, and increasing customer satisfaction. Moreover, QMS investments can be a strategic decision to improve financial performance and gain competitive advantage*. QMS maturity evolution unlocks a spectrum of benefits that go well beyond the baseline. Embracing this transition emphasizes the crucial understanding that quality is not a static benchmark but a dynamic aspiration that propels organizations toward a future of agility, resilience and distinction.

Medical device companies can start implementing quality management systems, that evolve beyond mere compliance, by emphasizing more on innovation, patient safety, sustainability, and data-driven decision-making. For example, advanced analytics are being embedded for risk-based proactive issue resolution, and Artificial Intelligence (AI) capabilities are emerging for real-time device monitoring, enabling predictive maintenance and continuous product improvement. Other advantages arise from sustainability efforts, collaboration with healthcare professionals, user engagement, and increased focus on innovation opportunities. These approaches not only meet regulatory requirements but also enhance product quality, improve patient outcomes and support environmental responsibility. Those who pursue quality beyond compliance, and adhere to quality requirements surpassing mere legal obligations, should encompass a holistic approach that strives for excellence in every facet of business operations. A truly optimized quality management system incorporates the needs of both external customers (e.g. patients, Health Care Professionals, Regulators) and internal customers (e.g. Business Units, Leadership), by providing better information faster, that not only improves compliance, but also improves user experience and provides valuable information to the business, that enhances the bottom line and leads to Quality being a value-added partner at the table with Business.

QMS design

Manufacturers must operate a QMS to ensure that the quality of their products or service meet, and keep meeting, customer expectations and regulatory requirements. The QMS describes the applicable device life-cycle stages and operations of an organization in a structured manner, through the construction of documented quality policy and objectives, quality manual, procedures, and other quality documents. The QMS design should consider the size and structure of the organization, the complexity and interaction of the processes, the type of activities involved, and the competence of personnel. Manufacturers often struggle with finding the right balance between compliance and efficiency; such as, preventing operations from becoming overly complex due to excessive quality measures. To avert unnecessary complexity, companies should follow a risk-based approach for the control of processes, to ensure that the QMS design remains proportionate to the risks associated with the products or service.

QMS maturity

When your QMS is in an early phase of maturity, it can be inefficient and ineffective, manually intensive, and can struggle for compliance as you respond to issues rather than anticipating potential problems early. At this stage, most quality metrics utilize lagging, historical indicators resulting in an environment where the organization is primarily reactive and not proactive, leading to suboptimal compliance, a more stressful work environment, and more regulatory actions – such as customer notification and Field Safety Corrective Actions (FSCA). For instance, an ill-established CAPA process is unable to address observed nonconformities within a suitable timeframe, identify root causes nor verify the effectiveness of taken actions. As regulatory demands become more complex and the external market pressure increases, companies easily fall (back) into a state of crisis management, where compliance issues and other problems keep coming back in rapid succession. The characteristics of an immature QMS include processes that have many unnecessary steps, there is a lack of clarity of the governance structure leading to failed and delayed decision making, and the interface between systems and people is poor causing inefficient and laborious accessibility and usability of data. Moreover, a reactive approach is often adopted meaning that improvement and/or optimization opportunities are taken as a response to compliance issues, and employees do not feel empowered to initiate changes to their day-to-day activities.

By monitoring processes and products through integrated systems and tools, collecting and analyzing production and post-market information, identifying and eliminating root causes, and conducting trend analyses, organizations can leverage their QMS as a proactive tool to become more data-driven, which enables prevention of future problems. Processes are, then, able to provide proactive and value-added insights prior to the onset of the problem, a quality mindset is enforced within the lower-levels of the organizations, automation solutions are initiated in some error-prone processes, and trends can be identified and monitored. By moving up the maturity ladder towards a predictive QMS, organizations shift from an inward-looking to outward-looking perspective, they can better anticipate future market and regulatory developments, use digital tools and advanced data analytics, and adopt predictive trends. Improvement and/or optimization opportunities for processes and training initiatives are taken in anticipation to expected outside changes, automation is widely used and validated, and information sharing is facilitated through improved system integration, enabling data to be effectively used to enhance decision making.

Ultimately, organizations reach a state of maturity in which they influence and positively impact the health ecosystem and its key players (such as the regulators, industry groups, healthcare providers and patients). This is achieved through enhanced dialogue, collaboration and information sharing platforms, and by driving quality-accelerated business, operating innovative business models, and early-adoption of new developments in science and technology (e.g., advanced RPA and generative AI capabilities). The organization moves from internalizing and concealing information to openly sharing information with both Regulators and the industry at large, moving from a reactive state to being proactive and, ultimately, influencing. At this stage, QMS processes are at a state-of-the-art level, they enable effective identification of improvements, and organizations are quick to adapt to new opportunities. There is bandwidth available to take on additional activity and operational demand, as automation is leveraged to alleviate administrative burdens and improve error-prone processes. There are tools in place for continuous identification and monitoring of trends, allowing decisions to be made with respect to your organization’s influence on the market.

POTI approach

The POTI approach focuses on enhancing Quality Management Systems through a holistic approach, by conducting a review of and making adjustments to processes, organization, technology and information (POTI). It is about understanding where you are today, defining where you need be in the future, and executing a cross-functional plan to achieve your Target Operating Model (TOM). The POTI methodology is a preferred way to assess the current situation, identify the key risk areas and opportunities for improvement, and to create an actionable roadmap for implementing the desired changes into the organization. POTI stands for Processes, Organization, Technology and Information, which collectively define your TOM. To significantly speed up your journey, to optimize your stakeholders’ time and effort, and to successfully achieve your goals within budget and timelines, excellence in project management and stakeholder communication are key factors for success.

Process

Processes and governance models should be fit for purpose and provide added value to the business. They should focus on driving to process endpoints rather than focusing too much on contingencies. Complex processes are more difficult to follow, making compliance harder to achieve. Hence, organizations should focus on optimization and simplification of their processes by following a risk-based approach and by prioritizing quality measures and controls if patent risk is involved. Ensuring agility and flexibility while maintaining compliance is a key consideration when establishing and transforming a QMS design. This creates opportunities for compliant, simplified and agile processes based on your organization’s risk appetite.
 

Organization

People and culture are at the forefront of an organization. Importance should be placed on clear roles and responsibilities and job architecture within an effective organizational structure. Ensuring procedures outline clear decision-making responsibilities as well as decision-making rights is a key element to achieving clarity of roles within your organization. Your transformed QMS should enable an effective organizational structure, there should be commitment and buy-in across all levels in your organization, and your people should adopt a quality mindset and have the right skillsets, experience, and training to perform their work.
 

Technology

Technology addresses the interfaces between people and processes, in addition to, the employment of tools and analytics to better understand key focus points and potential areas of improvement. Importance should be laid on the usability, integration and interoperability of systems and to enable effective information management and sharing. Moreover, any automation opportunities should be identified to facilitate the execution of error-prone repetitive or simple tasks. It is important to employ QMS-validated solutions that support people and processes to work efficiently, facilitate decision making, automate manual tasks, identify trends, and return value to your business.
 

Information

Finally, information pertains to the analysis and interpretation of data and should be suitable to support the decision-making process. Effective information management and timely availability of the right information is critical to quality and business success. Data analyzed becomes Information; Information processed becomes Knowledge; Knowledge improves compliance, efficiency and value. The quality of the data from which the information is derived should be appropriate for its purpose in terms of accuracy, validity, reliability, completeness, consistency, and relevance. These days, data come from many sources, both external and internal across the entire product lifecycle. Just like physical materials, data are part of the supply chain and should be subject to the same checks and controls. The QMS must adopt appropriate procedures, methods and tools to correctly collect and analyze data, to exchange and store data in a safe and secure manner, and to make data available when and where needed, at the right time.

In summary, Quality Management System transformation requires a holistic view of your processes, organization, technology, and information and a cross-functional approach to achieve the desired changes to your business capabilities and key operations. The evolution of QMS maturity increases your grip on compliance and achieves improved product quality, cost savings, faster time-to-market, and enhanced customer satisfaction. This helps you to position yourself better for adapting to industry trends, managing risks effectively and maintaining a competitive edge in a dynamic market.

Speak to our experts

Allow us to help you find smart ways of improving your quality management system outcomes and compliance. Deloitte’s experts have vast experience with business processes, organization and IT design, and transformation programs in the various domains (including Quality, Regulatory, Clinical, Supply Chain, etc.) for large MedTech and pharmaceutical companies. Our team consists of qualified professionals with an excellent track record in developing, implementing, and auditing quality management systems for medical devices and in vitro diagnostics. Moreover, our global network enables and accelerates the involvement of local experts where needed. For any inquiries, reach out to our experts today!

*A Deloitte study from September 2023 concluded that manufacturers, who invest in their QMS and consistently are able to meet quality and regulatory requirements, better differentiate themselves strategically and financially in the MedTech market.