Tag: medical device

Product End-of-Life (EOL) planning is often the most critical phase of technology lifecycle management, particularly for complex businesses – such as medical device manufacturing – where the consequences of disruption or product failure can be significant.

End-of-Life issues become a priority when an OEM no longer produces, sells, or provides upgrades, fixes or other related services for essential technology hardware or software. Without advance awareness and proper planning, these changes can make essential products or entire systems inoperable.

Most companies are well prepared for initial product lifecycle stages, involving research & development or market introduction of a new device or technology product. Relatively few companies, however, prepare for an orderly transition in advance of when its products, or connected product components, are phased out.

Without proper planning, a product’s EOL issues pose significant risks. If a product goes EOL without advance notification and preparation, it has the potential to disrupt the company’s supply chain, negatively impact revenue, and diminished customer loyalty. A company may also be required to pay a significant sum of money to secure a last-time buy of the necessary product or component.

Get Started on Product EOL Risk Management

With Dynamic’s 10-Question EOL Prep^SM Self-Diagnostic

For companies that do not have any EOL risk management disciplines in place, that task can seem complex and daunting. Conversely, for companies that do have relevant EOL-related processes and procedures, there is always the risk of operating with outdated or insufficient protection. In both cases, application of EOL Prep^SM provides a fast and effective way to either design or update an effective risk management strategy.

To address that need, and based on its deep experience in product EOL and lifecycle management, Dynamic has created the EOL Prep^SM Self-Diagnostic, consisting of 10 questions that will enable companies to:

• Identify specific protections and vulnerabilities related to their EOL-related risks;
• Understand the complete range of EOL best practices they should follow;
• Prioritize the EOL capabilities that need to be established or improved by their company;
• Create a tailored action plan designed to reduce their EOL-related risks.

Dynamic’s EOL Prep ^SM Self-Diagnostic is available on a complimentary basis to industry professionals on request, by clicking here. Dynamic’s product lifecycle management professionals welcome the opportunity to provide additional insight into the use of its EOL self-diagnostic tool, and to answer any questions regarding the firm’s product lifecycle risk management capabilities.

Current supply chain challenges – ranging from shipping and transportation delays, to labor shortages and unpredictable demand — force many companies to identify product end of life solutions to find alternative products and components. In turn, specifications in Bill of Materials (BOMs) are less rigid, as companies realize that the immediate supply chain challenges are unlikely to be resolved any time soon. The most enduring supply chain lesson of the pandemic may be that companies now understand that they can better manage disruptions and improve overall efficiency by identifying alternative, qualified products for major projects and new initiatives well in advance, as a means to reduce risks related to unexpected events of all types.

In advance of the pandemic, the industry began to apply greater rigor in supply chain risk management, by identifying risk factors that were either inherent in the manufacturing process, or that had a high likelihood to cause disruption based on geography, the political environment and other external factors. In fact, Dynamic has played a leadership role in creation of risk management tools, with the introduction of its Supply Chain Risk Scoring Process, which includes a detailed analysis of BOMs and the supply chains related to each material, as well as a risk scoring methodology to evaluate multiple risk categories associated with technology supply chains.

Companies seeking to manage risk by identifying alternative qualified products should begin that process by applying a supply chain risk scoring process to measure the viability of existing and alternative components against major risk factors including availability, ease of delivery and anticipated lifecycle.

Testing Product Options is a Secondary Benefit

Proactively identifying material or component alternatives also enables companies to test multiple product options. This capability is particularly relevant in industries — such as medical device, life sciences, and aerospace & defense — that have a greater complexity in product design and production methods. These companies often have First Article Identification (FAI) compliance and stringent documentation requirements. Finding component alternatives in advance that match specifications, and testing them in parallel, enables those companies to swap out pre-qualified components if supply becomes constrained.

Product End of Life Alternatives in Action

Dynamic has helped several clients mitigate supply disruption by providing viable alternatives. A medical device manufacturing client was preparing for a product launch when it learned that a key technical component connected to their device was nearing the end of its lifecycle. Introducing a next-generation or replacement part at that late stage would have required re-validation. To manage the risk, Dynamic made a last time buy of the entire component stock; provided comprehensive research and recommendations for available replacement options that met specifications, and integrated those into the customer’s transition change management processes. The client evaluated and tested the replacement and was able to seamlessly transition to the new component, minimizing its revenue generation risk.

To better manage supply disruption, a greater number of companies are identifying alternative components proactively. What’s now being done out of necessity in the aftermath of the pandemic needs to become standard practice. Companies that did not learn from the lessons of the pandemic, or that relax their risk management standards as the memory of those lessons fade, will likely pay the price (again) for their inability to prepare for the risks inherent in an interconnected supply chain.