Mike King, Senior Director, Product & Strategy10.06.23
Companies operating in the medical device manufacturing sector are increasingly relying on data-driven technologies like artificial intelligence (AI), machine learning (ML) and natural language processing (NLP) to increase productivity, reduce redundancy and optimize efficiency across the cycle. However, deploying these solutions is challenging, and a robust change management program is essential to facilitate the process.
When specific product changes are needed, codified data in seamless workflows enhances process consistency, resource efficiency, compliance and decision-making speed. Managing the intricate variations of changes for each product type across different countries creates a large and complex data set. This aspect demands systems that are capable of handling meticulous attention to details, extensive traceability and integrations across databases, as what may be a simple change in one country could require sizable updates or even new registration in another. This highlights the importance of ensuring such transformation through defining and designing complete and effective implementations.
In medical device manufacturing, change management plays a crucial role in ensuring that technological advancements, regulatory compliance and operational efficiency are aligned and implemented smoothly. It is not just about introducing new technologies or methods; it is about managing the human, organizational and operational aspects of change to achieve lasting success.
A change trigger for manufacturing would typically include one of the following parameters:
How fast a company adapts its manufacturing activities to the change trigger and manages the consequences becomes a defining strategy. This impacts not only product supply but also regulatory launches across the globe. Including change management in the production of medical devices is critical for piloting the complex and diverging global regulatory landscape. It enables companies to quickly identify areas needing improvement and make the necessary adjustments. A change management program promotes compliance with regulatory standards, streamlines employee adaptation, helps manage risk and supports quality assurance. The process also plays a vital role in controlling costs, aligning with market demands, sustaining technological advancements over time and maintaining a competitive edge.
Conscious decision-making is key to answering questions such as whether to manufacture current stock volumes before a change, manage dual inventories during global registration updates or take immediate action if a safety issue arises. Managing these changes is essential because of the complexity of global registrations and the significant operational tasks involved.
Defining an integrated and robust system helps drive the decision making with thousands of product data points and regulatory statutes spread across multiple data systems. This can speed up the process of the change management implementation. Connected systems that churn data to produce a single source of truth across departments can help navigate complex processes and activities swiftly. These systems can also help to maintain quality controls and the required compliances without disrupting workflows.
A connected system-defined approach for collaboration activities to manage change brings transparency to the core of the implementation. It not only establishes traceability but ensures roles and responsibilities are easily assigned and managed by encouraging clear deliverables.
After the rollout of changes, reconnecting with stakeholders to evaluate effectiveness is equally vital. Proactive and structured feedback collection assesses employees' feelings about the changes and any efficiency gains, allowing for necessary adjustments to ensure sustainability. This continuous feedback turns into actionable insights that refine the change process, enhance alignment and drive continuous improvement. The full workflow and its implementation become a controlled measure that then auto facilitates learning and improvement.
The integration shapes product design, production and distribution, turning compliance from a challenge into an opportunity. The transformative AI/ML technologies automate complex tasks and intelligently distribute changes, aligning with both operational goals and regulatory standards. Medical device manufacturers embracing this data-driven strategy can actively monitor progress, pinpoint problem areas, and ensure improvements are reliable and timely. Change management fosters international collaboration and knowledge sharing, enhancing quality while reducing costs.
By adhering to a comprehensive process, companies can seamlessly integrate change management into their operational models, enhancing adaptability and competitiveness within the sector.
This alignment of innovation, efficiency and patient care sets the stage for a new era of medical excellence in a rapidly evolving industry. In the age of data-driven technology, it is not just about technological advancements but also human impact that turns challenges into milestones.
Michael King has around 20 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors.
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.
The Evolving Medical Device Market
The medical device market is vast, with over 500,000 product sites worldwide and varying regulations across numerous countries. Global and local standards required to ensure safety and efficacy add to this complexity. This makes incorporating advanced technologies a formidable task that cascades to a variety of changes and implementations of control systems.When specific product changes are needed, codified data in seamless workflows enhances process consistency, resource efficiency, compliance and decision-making speed. Managing the intricate variations of changes for each product type across different countries creates a large and complex data set. This aspect demands systems that are capable of handling meticulous attention to details, extensive traceability and integrations across databases, as what may be a simple change in one country could require sizable updates or even new registration in another. This highlights the importance of ensuring such transformation through defining and designing complete and effective implementations.
Why Change Management Matters
Change management is a systematic approach that helps organizations navigate transitions or changes within their processes, technologies or goals. It involves planning, executing and overseeing the process of change in order to help the organization move from its current state to a desired future state.In medical device manufacturing, change management plays a crucial role in ensuring that technological advancements, regulatory compliance and operational efficiency are aligned and implemented smoothly. It is not just about introducing new technologies or methods; it is about managing the human, organizational and operational aspects of change to achieve lasting success.
A change trigger for manufacturing would typically include one of the following parameters:
- A regulation or standard change – impacting the product or the process.
- A safety incidence requiring remediation followed up with change management activities.
- Customer feedback or in-pipeline development activities triggered by the market demands.
How fast a company adapts its manufacturing activities to the change trigger and manages the consequences becomes a defining strategy. This impacts not only product supply but also regulatory launches across the globe. Including change management in the production of medical devices is critical for piloting the complex and diverging global regulatory landscape. It enables companies to quickly identify areas needing improvement and make the necessary adjustments. A change management program promotes compliance with regulatory standards, streamlines employee adaptation, helps manage risk and supports quality assurance. The process also plays a vital role in controlling costs, aligning with market demands, sustaining technological advancements over time and maintaining a competitive edge.
Developing a Change Management Process
Developing a sound change management process begins with understanding the impact the transformation will have on employees and ensuring the right methods are in place to facilitate it. Involving the team and seeking their insights from the outset fosters a sense of ownership and increases the likelihood of successfully adopting innovative technologies.Conscious decision-making is key to answering questions such as whether to manufacture current stock volumes before a change, manage dual inventories during global registration updates or take immediate action if a safety issue arises. Managing these changes is essential because of the complexity of global registrations and the significant operational tasks involved.
Defining an integrated and robust system helps drive the decision making with thousands of product data points and regulatory statutes spread across multiple data systems. This can speed up the process of the change management implementation. Connected systems that churn data to produce a single source of truth across departments can help navigate complex processes and activities swiftly. These systems can also help to maintain quality controls and the required compliances without disrupting workflows.
Communicating Change to Stakeholders
Communicating change effectively is critical to getting buy-in from medical device manufacturing workers. Open communication with all stakeholders is essential, allowing them to understand the rationale behind the plan and become invested in the change process. Strategies for involving various participants, from internal teams to regulators and suppliers, require a tailored approach that encourages active involvement and collaboration.A connected system-defined approach for collaboration activities to manage change brings transparency to the core of the implementation. It not only establishes traceability but ensures roles and responsibilities are easily assigned and managed by encouraging clear deliverables.
After the rollout of changes, reconnecting with stakeholders to evaluate effectiveness is equally vital. Proactive and structured feedback collection assesses employees' feelings about the changes and any efficiency gains, allowing for necessary adjustments to ensure sustainability. This continuous feedback turns into actionable insights that refine the change process, enhance alignment and drive continuous improvement. The full workflow and its implementation become a controlled measure that then auto facilitates learning and improvement.
Reaping the Benefits of Change Management
Integrating a solid change management program into medical device manufacturing offers benefits across operations, compliance and innovation. Enhanced visibility through AI/ML analytics allows companies to comprehensively examine processes, identify areas for improvement and swiftly implement changes. Standardized solutions and advanced tracking ensure changes are well-planned, executed and sustained, raising quality to meet regulatory standards. This focus on continuous improvement leads to greater transparency and control.The integration shapes product design, production and distribution, turning compliance from a challenge into an opportunity. The transformative AI/ML technologies automate complex tasks and intelligently distribute changes, aligning with both operational goals and regulatory standards. Medical device manufacturers embracing this data-driven strategy can actively monitor progress, pinpoint problem areas, and ensure improvements are reliable and timely. Change management fosters international collaboration and knowledge sharing, enhancing quality while reducing costs.
By adhering to a comprehensive process, companies can seamlessly integrate change management into their operational models, enhancing adaptability and competitiveness within the sector.
Supporting Continuity in Global Healthcare
Ultimately, awell-integrated change control process that adeptly manages organizational, system, and process changes directly supports a company's continuity in providing global healthcare solutions. By embracing data-driven technologies to accelerate the delivery of medical devices, manufacturers are advancing their business and ensuring global patient access to safe and effective healthcare solutions.This alignment of innovation, efficiency and patient care sets the stage for a new era of medical excellence in a rapidly evolving industry. In the age of data-driven technology, it is not just about technological advancements but also human impact that turns challenges into milestones.
Michael King has around 20 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors.
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.