Software Is Not a Panacea for Product End-of-Life Management

software laptop user

Many companies involved in the medical device and pharmaceutical industries use software to monitor the lifecycle of products and components, particularly those items nearing their specified end of life (EOL). But is this approach effective? Sometimes managers don’t realize that software is not necessarily a reliable lifecycle management tool until it is too late, after device decommissioning has had an impact on patients and public health safety.

Most large suppliers have designated EOL dates for products and components, but the end of life for certain medical device components is not as simple as just replacing the components. It requires a company to evaluate what’s being replaced, identify the impact, make necessary updates, and conduct rigorous testing and reviews to verify and validate the new product.

As we previously reported, if a product goes EOL without proper advance planning, it has the potential to disrupt the company’s supply chain, negatively impact revenue, diminish customer loyalty and incur unexpected costs. Companies failing to track EOL effectively also risk using technology that is no longer supported by its manufacturer, which can be dangerous and incur liability.

Managers may rely on software to plan for EOL, to be notified of upcoming EOL dates, and to manage change requests during an EOL migration. However, software solutions alone fall short, because the necessary end-of-life information often must be manually supplied by product manufacturers or suppliers. This human factor introduces risk and negates the accuracy of the software.

In those cases, the software designed to track EOL issues can provide companies with a false sense of security, leaving them in danger of being caught unprepared. Because software solutions always present an inherent risk of not delivering essential EOL information, companies need a reliable and automated means through which to obtain timely and accurate EOL information from their suppliers and OEMs.

Human Involvement Required for Complete EOL Transparency

Dynamic Technology Solutions has developed EOL and lifecycle management services to meet this need. We deliver on this requirement by proactively contacting the product suppliers regarding EOL issues to gain accurate, first-hand insights into current conditions and forecasts.

Armed with these insights, we can provide a consolidated view of lifecycle roadmaps with data integrated from our 800+ OEM and technology partners, enabling us to deliver automated alerts to key company stakeholders to inform them of EOL dates, which trigger a proactive EOL transition process.

Dynamic helps ensure seamless transitions and continuity for any changes that affect the components in our customers’ devices, while reducing risk. Learn more about Dynamic’s proactive EOL planning services by clicking here.

Software solutions provide efficiencies for countless business applications across different industries. But until there is a 100% reliable means to collect and disseminate EOL information from hundreds of suppliers, software applications for EOL management can never be expected to provide the level of safety and assurance required for medical device and pharmaceutical applications, where lives and human welfare is at stake. That’s why Dynamic invests the time necessary to ensure complete EOL transparency.

Don’t Be Taken by Surprise: The Case for Proactive End-of-Life (EOL) Planning

Proactive Product End of Life

Not long ago, the manufacturer of an automated, high-performance medical device was getting ready to introduce a new system. The new product had been validated, and the company had scheduled the launch. But in a last-minute review, the product development team realized that one of the device’s key technical components was nearing the end of its lifecycle. There was no way the company could release the product with components that were about to expire but replacing them with a next-generation version would have required revalidation—and that would have significantly delayed the product launch.

The dilemma this company faced points to the critical importance of taking a proactive approach to end-of-life planning. Without that, this type of surprise can result not only in operational disruptions but also in financial loss and, perhaps more critically, an undercutting of customer loyalty—which could be long-term.

Too Little, Too Late

While most companies know they need to pay attention to product lifecycles, many rely on notifications from OEM vendors to alert them that the end of a product’s life is approaching. However, a recent study by SiliconExpert indicates that those notifications may not be coming soon enough. As SiliconExpert reported, “companies typically fall victim to a high demand and limited availability situation.” As a result, the study found that “28% of product change notices (PCNs) were for part numbers with last time buy dates of ‘immediately,’ meaning that waiting for a PCN may result in a costly redesign.”1

How can you avoid being the “victim” in this scenario? The key is starting by taking an integrated approach across engineering, product management, and the supply chain that not only includes a view of the entire product lifecycle but is also a critical part of the product management process. This requires understanding, identifying, and tracking each of the assemblies, parts, and raw materials that will become part of a finished good—capturing end-of-life data along the way.

Rank and File

While products with an active status might not have a published EOL date, it’s possible to estimate EOL by determining the normal lifecycle for each type of part and then subtracting the amount of time during which the product has been in production.

All the components should be ranked based on both their estimated lifecycle and their supply chain vulnerabilities—but it’s also important to consider how consequential each component is to the business and the disruptions that could occur should the part reach its EOL.

Understanding all of that will allow you to plan future updates proactively and look for substitute products or components well before you need them.

An important part of being proactive is qualifying second sources for the parts and components you’ll need. This involves validating alternate parts, identifying additional sourcing options, and planning two generations of a product or instrument simultaneously. By doing this, you can avoid potential supply constraints, long before you’re faced with either EOL or product obsolescence.

For the medical device manufacturer faced with a part at the end of its life, Dynamic was able to help by making a last time buy of all the stock of that product then available and holding it in the Dynamic warehouse. This allowed the company to make its launch date. At the same time, however, Dynamic was able to help the company prepare for the future by providing research and recommendations for available replacement options that met specifications and integrating those into the customer’s change management processes.

To better understand your company’s EOL risk and exposure, consider utilizing Dynamic’s newest tool, the EOL PrepSM Self-Diagnostic, which is available on a complimentary basis to industry professionals by clicking here.

 

1 https://www.siliconexpert.com/wp-content/uploads/2020/10/SiliconExpert-White-Paper-How-Reliable-is-EOL-Forecasting.pdf

Managing the “Big 3” Product End-Of-Life (EOL) Risks

Managing Product End of Life Risks

Managing End-of-Life (EOL) transitions of components or products is a challenging business discipline. Some OEMs provide advance notice of product EOL dates, which can alert your company to trigger a transition process. However, sometimes external factors – including technology shortages or supply chain constraints – can shorten or negatively impact transition time.

Addressing the Three Biggest EOL Risks

To address risks, your company should proactively identify and prepare for the three biggest product EOL risks, which include:

  • Operational Disruption often results from the staff’s lack of time to support the research, procurement and testing of alternate solutions. In complex industries, the testing and validation of a new component often involves multiple internal and external stakeholders and can take months, often pulling resources from other key projects.
  • Financial Loss can occur from an inability to ship product or provide a service. This is a major concern, particularly in regulated industries, where even a minor component change can halt an entire system, and have significant balance sheet implications.
  • Customer Loyalty is always tested when a significant product delay or outage occurs. There is often little tolerance from customers, who expect technology to function without disruption, and customer loss is a tangible risk.

Mitigating the “Big 3” Product EOL Risks: Your Change Management Plan

The most effective course of action your company can follow to avoid the “Big 3” EOL risks is to proactively plan for them. The initial step in this process is to ensure proactive notification of upcoming EOL dates. It’s essential to maintain a view of product lifecycle roadmaps; to understand exactly what is in each Bill of Materials (BOM) for each finished product; and to automatically receive notifications at the product, component and accessory levels. As an EOL date approaches, a transition process can be triggered, and a Change Management Plan created.

Your Change Management Plan should address how the component or product change could impact or disrupt the business. It should also include the estimated timeline, and information about replacement options. Often the EOL product or component will have a direct replacement or next-generation option. If a direct replacement is not available, satisfactory options will need to be researched, and supply chain risk and availability for those options will need to be analyzed. Depending on industry regulations and the differences with the replacement product, a re-validation process might be required.

As part of its change management plan, your company should also consider making a last time buy of available stock for an EOL component or product.  This can be an effective strategy to bridge the transition and prevent potential business interruption. Last time buys often involved warehousing of the inventory and potential price increases of the component due to limited supply.

How Dynamic Can Help with EOL Risk Management

Managing the “Big 3” EOL risks across multiple products and platforms is a labor-intensive undertaking that requires proactive planning and process management. As an initial step in evaluating EOL risk exposure, Dynamic has created the EOL PrepSM Self-Diagnostic. This tool consists of ten questions that can help your company identify and prioritize specific vulnerabilities and opportunities related to its EOL risks; to understand the complete range of EOL best practices it should follow; and to create a tailored action plan designed to reduce its EOL-related risks.

Dynamic’s EOL PrepSM Self-Diagnostic is available on a complimentary basis to industry professionals upon request, by clicking here. Dynamic provides a broad range of services related to product lifecycle management, including EOL risk management, and is prepared to answer any questions you may have.

Evaluate Your Company’s Product End-of-Life (EOL) Risk With a 10-Question Self-Diagnostic Tool

Medical Device Product End-of-Life (EOL) Management

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 PrepSM 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 PrepSM 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 PrepSM 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.

Find Product Alternatives in Advance to Minimize Supply Chain Disruption

product end of life cycle managament

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.

How to Manage the Diagnostic Medical Device Technology Lifecycle

How to Manage the Diagnostic Medical Device Technology Lifecycle

One of the key challenges facing diagnostic medical device manufacturers involves alignment of their product’s lifecycle with the lifecycle of the device’s connected or embedded technology. This occurs because medical devices – which are affected by stringent government regulations – typically have long lifecycles, compare with most other product categories.

Conversely, a hardware or software technology product that’s embedded within or connected to the medical device will often reach its End-of-Life (EOL) relatively faster, which initiates a replacement and can pose other more significant issues.

For example, a medical device manufacturer may discover that its aging diagnostic product relies on integrated technology components that are approaching EOL, and as a result, conclude that minimal technical support will be required. But the opposite is true. Manufacturers must ensure that customers will receive complete product support, even when some of their diagnostic product’s critical technology components may soon become outdated and obsolete.

The Importance of Technology Asset Lifecycle Management

At all times in a medical device’s history — from project management through process optimization — manufacturers must maintain an awareness of the connected technology driving their product. The challenge is to match the medical device’s evolving hardware and software lifecycle with the device’s own improvements. This coordination is essential, in order for the medical device work effectively over its entire lifespan.

This is a complex task for most medical device manufacturers. They may lack the resources and expertise — or even the desire — to make technology asset lifecycle management a core competency within their organization. Effective lifecycle management first requires evaluation of potential technology solutions, in order to maximize the lifespan of essential hardware and software electronic components. Additionally, product obsolescence management and advance planning for product transitions are critical. This proactive planning is essential, in order to avoid the impact of any supply chain disruptions, and to have the option to conduct last-time buys and identify replacements for components.

Technology asset lifecycle management is an integral part of maintaining stability in the diagnostic medical device supply chain and ensuring continuity for manufacturers and the end users of their products. Through proactive EOL planning, Bill of Materials (BOM) management and last-time buying, medical device manufacturers can make better business decisions, gain critical insights into total cost of ownership, plan more effectively and reduce risks.

4 Best Practices for Effective Product End-of-Life Management

Technology Products End-of-Life (EOL)

The technological landscape is continuously evolving. This ongoing change limits the lifespan of all technical devices, and makes End-of-Life (EOL) planning one of the most critical phases of the technology lifecycle.

While many companies are well prepared for the initial lifecycle stages – involving introducing of a new device or tech product – few companies are prepared for what will happen when it’s time for those products, or a product component, to be phased out.

End-of-life product management is a critical element in product lifecycle management; and becomes a priority when an OEM no longer produces, sells or provides upgrades, fixes or other related services for specific technology hardware or software — making them obsolete.

Here are a few best practices your organization can apply to navigate product end-of-life challenges.

1. Develop a pro-active, in-depth strategy for ending the product.

Having a lifecycle management plan in place is essential to phase out a product effectively, and to avoid disruption within an organization. The plan should cover all aspects of product development, from conception to end-of-life. Preparing for product / component end-of-life reduces cybersecurity vulnerabilities; facilitates seamless product platform and configuration transitions; mitigates the risk of downtime; and avoids safety and stockout situations for manufacturers.

The plan also helps companies in highly regulated industries to remain compliant with complex requirements; aligns the lifecycle of IoT products with connected technologies; and prevents disruption to essential enterprise infrastructure platforms.

When considering whether to phase out a product, some key questions to consider are:

  • Does the product still bring in sufficient revenue to support the cost of maintenance?
  • Does the company still want to maintain a presence in that specific market?
  • Does the company have a better solution available?

Organizations should consider whether a specific product continues to make sense in the context of its existing product portfolio. If the product no longer aligns with the company’s market strategy, phasing it out should be a consideration. Data and analytical proof are required to rationalize any decision to obsolesce a product.

Assuming at least one technician is required for the company to maintain a particular product, consideration should also be given to whether the related personnel costs are worth preserving the product. Costs associated with of delivery and maintenance of the product should be examined.

2. Monitor end-of-life status for any component that’s critical to the product, which cannot be easily replaced or substituted.

Most major suppliers have lifecycles for product components and designated EOL dates, which indicate when a part will become obsolete. This provides insights into the projected lifespan of a component, which should guide the transition strategy. Having EOL notifications well in advance of the impending dates enables customers to act with time sensitivity, and to capitalize on the early stages of a lifecycle and ensure the longest lifespan possible.

Regular monitoring of EOL status typically provides sufficient time to validate new parts and establish seamless transitions. Best practices call for organizations to become aware of the end-of-life dates of products in advance of selecting them for their build. Further, they should also evaluate long-life options in most circumstances. This helps maintain business continuity and avoid supply disruptions.

3. Communicate with customers early and clearly regarding EOL issues.

Maintaining regular communication with customers and updating them on upcoming EOL issues and solutions provides transparency in the customer-manufacturer process. Demonstrating the ability to seamlessly manage a transition from an old product version to a new one is essential to maintain and grow customer confidence and loyalty.

4. Research and develop multiple EOL options.

Given the pace of technological change, manufacturers need to develop their plan of action for minimizing EOL interruptions well in advance of product or component obsolescence. For example, when a medical device manufacturer is developing an instrument, they must build two versions simultaneously. Otherwise, the original version – both instrument and technology – may be outdated by the time the instrument is released.

A pacemaker manufacturer, for instance, may use a particular type of battery, as well as specific technology they purchase from a supplier. That technology may be designed with a 10-year lifecycle, but the battery may only have a 2-year lifecycle. So when the manufacturer brings the pacemaker to market, it will need to be working on the next version of the product, to match the new battery that will be implemented. The business risk involved in not developing two generations of an instrument simultaneously is that the manufacturer is likely to lose out to competitors who planned ahead.

Potential Risks Involved in End-of-Life

Without careful consideration and proper planning, a product’s EOL issue can pose significant risks. For example, in advance of going to market, many products require completion of a validation process; and if a product goes EOL without proper warning and preparation, it has the potential to disrupt the company’s supply chain.

Additionally, companies must ensure they have the ability to perform last-time buys on specific parts or products that are becoming obsolete. By failing to leverage that purchasing opportunity, a company could find itself without stock of a necessary component, halting production and related revenue. There is also the potential that a company may be required pay a large sum of money to secure a last-time buy. In turn, this would require them to calculate much stock they needed, and an inaccurate decision could result in either wasted supply or a product outage.

How Dynamic Can Help

Successful transition through a product’s end-of-life requires strategic, well-informed planning and lifecycle management. Dynamic’s end-of-life and lifecycle management solutions ensure seamless transitions for any changes that affect the technology components in your products. This helps companies to make better business decisions, to gain critical insights into total cost of ownership, to plan more effectively and reduce risks.