Change Management in the Medical Device Industry

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Author: John Campbell | July 5, 2022

Change management means different things to different people depending on the industry they work in. Thinking about it broadly, change management is the ability to track changes and implement them strategically. Change management in the medical device industry can be prompted by several scenarios – including updates to documents or document sets, products, and business processes as well as overall organizational change management.

Having a robust change management strategy is critical in the medical device industry. With the health and safety of patients hanging in the balance, the stakes are high, and change management enhances your ability to develop the best product you can. Change management in the medical device industry is also an expectation of regulatory bodies, both in the United States and abroad. When they evaluate whether the device is safe to be sold in their respective countries, they will require you to show evidence of your change management.

Best Practices for Change Management in the Medical Device Industry

Even though change management is an industry-standard, there are some key considerations to ensure it will ultimately improve the lifecycle of your medical device.

Have a change management plan. Having a plan in place is key to any endeavor, but especially in design, development, and change management in the medical device industry. Your plan should outline your goals, requirements, and how change management will be incorporated into each development phase, as well as your post-market activities. Your plan should also help you identify any change management gaps to avoid serious challenges later in the process. Every change you make may have ripple effects throughout your project and your plan should reflect that. Your plan should be recorded, reviewed, and shared with your leadership and change management team so they are all operating based on the same playbook.

Ensure traceability and version control. These are fundamental components of change management in the medical device industry. Traceability, or the ability of manufacturers to trace artifacts across an entire project, is crucial in compliance industries like the medical device industry. It includes tracking which artifacts are related and how, what changed, when it changed, by whom, and why. Version control, the process of locking in the specifications of a particular iteration of a product before making revisions, supports effective traceability and makes it easy to pull back changes if they are not successful.

Don’t neglect risk management. Risk management ensures that all identified risks have been evaluated and reduced to an acceptable level, or justified through risk-benefit analysis, throughout the life of the product. Just like change management in medical devices, regulatory bodies require it. Since changes to other development phases impact risk, risk management requires change management as well.

Choose the right tools. Like all product lifecycle management processes, change management in the medical device industry can be done manually. But it is much more efficient and effective to utilize intuitive tools that will automate processes and reduce errors. In today’s global medical device industry, a company’s ability to bring an innovative, cost-effective product to market quickly is dictated by how well they manage the processes that govern its design and development.

Following these best practices for change management in the medical device industry will help reduce product iterations, costs, and time to market. Sterling PLM has the expertise and knowledge of medical device product development lifecycle management tools to propel your change management to excellence. We offer tools where you can quickly and easily review and manage changes without having to hunt down related project artifacts and documents manually as well as mark links for impact analysis as things change. Our services can provide a framework for systematic change management that identifies every location where a specific change must be made and manages that change through approval and implementation. Please contact us today to get started.