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.

Supply Chain Cybersecurity: The Ukrainian War Increases Your Company’s Risk

Supply Chain Cybersecurity: The Ukrainian War Increases Your Company’s Risk

The war in Ukraine has brought the issue of cybersecurity into the mainstream of public opinion, with increasing media coverage of actual and potential Russian cyberattacks on businesses and infrastructure—often, far from the fighting.

These threats are very real, but for many companies they are not entirely new. Supply chain cyberattack risks, in particular, have been growing for some time, especially for companies in life sciences and other industries with sophisticated supply chains. And they can come from states like Russia, or from criminals.

A sampling of recent articles sheds light on the threats. The digital technologies that have made supply chains more efficient and responsive also make them vulnerable to bad actors. “The level of automation in the pharmaceutical industry makes it a prime environment for attacks. These environments are complex, and they haven’t been built to defend against nation-state attacks,” one security expert recently told the Biospace news site. The growing connection of operational technology to the network is also a factor, because it means bad actors can not only steal or damage data, they can also disrupt production and operations.

The variety of partners typically involved also makes the supply chain an attractive target. That’s because it increases the number of potential entry points, and it also means that a single attack can quickly move through the network to affect numerous partners.

Recent events have made this even more of a problem, as COVID and Ukraine have disrupted supply chains and forced companies to quickly turn to new, and often unknown, suppliers. As one security expert recently told Supply Chain magazine, this is a problem for medical devices manufacturers, “because on-time production and delivery can be a question of life or death. Supply chain is already the weakest link in any organization, even at the best of times. But for complex medical devices, where there is a multi-layered supply chain of hardware and software? For them, changing suppliers, or adding to them, significantly increases the exposure to risk.”

In short, cybersecurity will be a key supply chain concern for years to come. As a recent Forbes article noted, “Cybercriminals will continue to capitalize on the world’s heavy reliance on supply chains, infiltrating entire chains and not just individual companies…. More than ever, cybersecurity vulnerabilities are showcasing how interconnected we all are—as well as the fragility of many of these connections.” As a result, the article explained, supply chain cybersecurity should be a board-level issue.

Staying on top of the threat will require a multipronged defense.

Companies need to continue to harden their information and operational technology landscapes, through everything from zero trust security and education to combat social engineering, to security assessments, improved vetting of suppliers, and the comprehensive inventory of supply-chain assets. At the same time, they should prepare for the real likelihood that there may be a cyberattack on their supply chain and build the resilience to get back up and running quickly in the event of a problem.

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.

Dynamic Technology Solutions Attends Diversity Supply Chain National Education and Training Event: ACCELERATE 2022

Dynamic Technology Solutions showed a strong presence at ACCELERATE 2022, the premier education and training conference of the Diverse Manufacturing Supply Chain Alliance (DMSCA). Dynamic was represented by Vice President of Business Development, Tami Schultz and Business Development Director, Bob Werner at the convention which featured over 30 leading organizations in the manufacturing space.

The event, held in Scottsdale, AZ last month, addressed practical small-midsize manufacturer development solutions, with a focus on digitalization of supply chain management in the current, ever-changing environment.

“There was a strong emphasis on passion,” said Schultz, as she shared her impression of the event. “Passion for digitalized supply chain, passion for the importance of diverse suppliers that innovate and drive results for leading manufacturers.”

The panel discussion around “Supply Chain Collaboration Through Advanced Manufacturing Technologies” proved to be a highlight of the conference. Featuring special guest, Felipe Bezamat Kuzmanic, Head of Advanced Manufacturing and Global Leadership Fellow at the World Economic Forum, this session addressed current supply chain constraints due to COVID-19. This topic has been a point of emphasis for Dynamic over the last two years, as the organization published multiple resources to aid suppliers and manufacturers in navigating the pandemic, including a proprietary methodology, Supply Chain Risk ScoringSM.

Another interesting session was a demonstration on the “Use of Augmented Reality (AR) and Virtual Reality (VR) and the Connected Worker” by Brian Townley, Business Development Associate at MxD. Brian detailed the use of VR and AR in the workplace, enabling non-technical associates to make repairs on complex technologies without in-depth knowledge of the devices. Dynamic has identified an increase in the use of virtual reality in the design and design for manufacturing phases of product development in its clients and the life science industry. This session was a welcome addition to the conference and educational for the DTS team.

The event was well attended and served as a homecoming of sorts for one of the prominent diversity-led supplier development organizations in the supply chain strategy sphere. After a long and patient wait, an in-person event provided meaningful interactions and networking opportunities.

“This was a great opportunity to collaborate with members of DMSCA face-to-face,” Bob Werner reflected in reviewing the event. “I was impressed with participation by leading manufacturers with key Sr. Leaders and staff in attendance. I look forward to growing the relationships we made and implementing what we learned into our day-to-day functions.”

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.

Dynamic Technology Solutions Further Expands Coverage of Life Sciences Industry; Adds Robert Werner as Business Development Director

Experienced Global Procurement Executive Will Drive Business Development and Account Management for Dynamic’s Life Sciences Clients


FARMINGTON HILLS, Mich.March 9, 2022 /PRNewswire/ — Dynamic Technology Solutions – a nationwide provider of customized computing solutions, and supply chain and technology lifecycle-related services – announced today that Robert Werner has joined the company as Business Development Director, responsible for expanding and managing relationships with the company’s life sciences clients, which also includes medical device and pharmaceutical companies.

Mr. Werner brings to Dynamic more than 30 years of related experience, having held leadership positions in engineering, procurement, and general management at leading companies, including General Electric, Perkin Elmer, and at Roche Diagnostics, where he served as Vice President of Global Supply Management. His responsibilities at those firms included development of strategic programs designed to improve operational efficiencies within manufacturing and procurement functions. He also led strategic restructuring of the procurement function while building high performance teams to manage global supply and procurement operations.

Dynamic Technology Solutions CEO and President, Ms. Farida Ali, said, “I’ve worked with Bob for nearly two decades, and have first-hand insight into his deep understanding of the life sciences industry. He will be an invaluable asset to Dynamic and our clients.”

Mr. Werner noted that, “Having been on the client side during my tenure at Roche, I understand and appreciate the value that Dynamic can deliver to life sciences companies. They are a unique organization, and I look forward to representing them.”

Mr. Werner hold a degree in Industrial Engineering from Purdue University, and is a graduate of General Electric’s Operations Management Leadership Program. He is an active supporter of community social programs, including Habitat for Humanity, Gleaners Foodbank and Catholic Ministries.

About Dynamic Technology Solutions:

Established in 1979, Dynamic is recognized as the leader in sourcing, testing, configuration and End-of-Life (EOL) transitions for electronic technology within highly regulated industries, notably for life sciences companies. Dynamic delivers asset and lifecycle management services as an integrated solution that is compliant, consistent, and controlled. Dynamic is ISO 9001 and ISO 13485 certified. As a benchmarked member of the Diverse Manufacturing Supply Chain Alliance (DMSCA), Dynamic has a strong commitment to diversity, and to maintaining high On-Time, In-Full (OTIF) and Right First Time (RFT) scores. Dynamic Technology Solutions is the trade name and a registered service mark of Dynamic Computer Corporation. Visit www.DynamicTech.Solutions

Contact: 
Gordon G. Andrew
Highlander Consulting Inc.
331221@email4pr.com 
(609) 987-0200

SOURCE Dynamic Technology Solutions