Farida Ali, CEO and President of Dynamic Technology Solutions06.03.22
Consider these real-life scenarios faced by three leading medical device companies:
- The company was enjoying great success with its automated diagnostic system, but was surprised to discover that several of the 28 integrated electronic components that powered the equipment were approaching end-of-life. Continued production of the instrument was suddenly at risk.
- A company’s system, designed for workflow efficiency, required a specific desktop model. That particular model was going end-of-life; so to plan for product transition and secure the necessary resources, additional testing and validation would be required, risking a stockout situation.
- As the company was about to launch a new product, it learned that a key technical component connected to the device was nearing its end-of-life. Replacing and re-validated the component would derail the launch and cost the company money and time it didn’t have.
Each of these challenges were addressed, but they could have been avoided altogether through a more thorough and disciplined approach to product End-of-Life (EOL) management.
In the first example, the company would have benefited had it established from the outset complete transparency into all product lifecycle roadmaps, including automated alerts on the EOL dates, changes to the EOL dates, and critical product updates. In the other two examples, having replacement stock on hand as parts reached end-of-life would have helped to bridge the gap, and avoided the need for time-consuming re-validation until a next-generation product could be identified and validated.
The cornerstone of effective product lifecycle management is proactive end-of-life awareness and planning. The starting point involves development of a comprehensive database of all devices, products and components, combined with a system that ensures notification for when these devices and products will become obsolete. This system must include a methodology to communicate EOL information throughout your organization, including stakeholders in product engineering, manufacturing, procurement, and marketing. Communication should also include your supplier network, to bridge the gap between a current component’s EOL and a new component’s validation date.
Industry Best Practices Guide EOL Management
Creating this internal discipline requires a company to understand and apply industry best practices for EOL risk management. Some of the relevant self-diagnostic questions include:
- Do we have multiple safeguards to protect against EOL supply issues and shortages?
- During the R&D process, are we routinely reevaluating the EOL prognosis of components we’re specifying for products we’re developing?
- Is there a formal protocol if a component unexpectedly reaches end-of-life?
Lacking this level of EOL planning, a medical device company risks missing crucial launch dates, and is subject to supply chain disruption, lost revenue and market share, and a damaged reputation. These outcomes can have long-lasting and even devastating consequences.
After resolving their respective challenges, each one of the three medical device companies described above took steps to avoid similar problems in the future.
In the first case, the company was able, by looking closely at the lifecycle roadmaps of each component, to optimize planning, smooth out transitions, and ensure that the lifecycle of each component was aligned with the highly regulated lifecycle of the instrument itself.
In the second case, the company was able to secure a large last-time buy of the soon-to-be- obsolete desktop. The equipment was then warehoused so that the company could keep shipping the device to its customers, avoiding the risk of stockouts.
And in the third case, in addition to warehousing equipment that was secured through a last-time buy, its research into replacement options allowed the company to be ready to easily transition to a new, validated component once the stock ran out.
The common lesson in all three of these stories is that passive EOL management represents a significant enterprise risk for companies that produce complex and highly regulated medical devices. Without a comprehensive, proactive plan to monitor and manage the lifecycle of each product component, a company will always have exposure to significant operational, financial and reputational damage. But with senior management support, proper planning, integrated communication, and organizational transparency, EOL-related liabilities can be minimized or avoided altogether.
Farida Ali is CEO and President of Dynamic Technology Solutions, a firm that provides technology lifecycle management solutions for companies in the medical device and pharmaceutical industries. Dynamic offers industry professionals an EOL PrepSM Self-Diagnostic tool designed to help them avoid the types of risks described in this article.
