How to Manage Medical Device Verification and Validation Risks

Validation

Verification and validation ensure that medical devices meet appropriate standards and will provide intended benefits. Both steps are essential in meeting regulatory requirements, so it’s important to consider verification and validation early in the design stage when developing requirement specifications for the product.

“Inadequate process validation is one of the most common issues leading to warnings from the U.S. Food and Drug Administration (FDA),” notes Regulatory Focus, a publication of the Regulatory Affairs Professionals Society, which reported that the problem may be difficult to address if regulatory and quality professionals don’t understand what validation consists of.

It’s important to recognize the ways in which validation can be defined, as well as how it differs from verification. Under Code of Federal Regulations 21CFR820, the FDA has separate definitions for process and design validation. Design validation ensures that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions. Process validation gives evidence that a process consistently produces a result where specified requirements continue to be met.

While validation is concerned with the end product, verification ensures each element of a device meets specifications and standards. For this reason, verification should always be the primary consideration. Regulatory Focus provides a helpful cooking metaphor to remember: verification involves the meal’s ingredients and the recipe, and validation involves how the meal tastes.

Managing Validation Tools is Essential

Medical device validation is a complex process that requires specific expertise across a broad range of technical issues. If a company doesn’t employ at least one qualified validation professional on staff, it should consider outsourcing the role.

“Process validation is a key element of identifying and mitigating risks for medical devices,” which is a significant focus of the FDA and other global regulators, said Regulatory Focus. Additionally, today’s connected medical devices require software validation in addition to traditional forms of device validation to help identify and mitigate risk and reduce vulnerability to cyberattacks for these products.

Even the tools used to validate medical devices require their own validation. According to Intland Software, tool qualification in medtech development is the process of evaluating, documenting, and demonstrating whether a tool used to create a medical device is up to standards. They note that best practices in medtech tool validation include:

  • Use industry guidelines – Industry guidelines with accepted standards will make the validation process easier and clearer.
  • Involve stakeholders from the outset – Identify team members and set expectations for the project up front, to ensure that input and approvals can be quickly and easily obtained as the project progresses.
  • Use vendors as a resource – Ask service providers to review validation documentation before it’s executed and to provide expert guidance on their tools.
  • Document everything – This serves as evidence that shows the intended use of the tool and that it’s been tested to ensure functionality, which provides proof if needed by customers or auditors later.
  • Future-proof your setup – Once validated, a tool must maintain its validated status. Place all tools under change control processes so when they’re upgraded, they can retain validated status.

What happens at the medical device verification and validation stages can have an impact on cost, final design, and overall manufacturability. To manage these risks in an effective manner, company leadership and product designers must proactively invest the time and resources that are required.

Medical Device Tech Trends to Watch: AI / ML, Cybersecurity, and Medical Robots

robot and medical digital image

After a pause in progress during the pandemic, medical device companies are once again making strides to innovate in many areas of emerging technologies as a way to manage data and perform services more effectively and securely. Some of the most exciting trends to watch in medical device technology right now involve artificial intelligence, cybersecurity, and medical robots.

Artificial Intelligence (AI) and Machine Learning (ML): New AI and ML tools are increasingly being used to collect, curate, and analyze patient information to increase the speed and accuracy of data analysis while freeing up employees for other crucial tasks. “The new AI and ML features provide workers with new and important insights deriving from the growing amount of data from medical records,” reports Med Device Online, resulting in improved diagnostic decision-making with high levels of precision and more efficient doctor interventions.

Cybersecurity: With emerging technologies comes new and greater security risks, including more sophisticated attacks by hackers, so cybersecurity for medical devices has never been more important. The number of cybersecurity attacks targeting U.S. healthcare organizations “doubled in the first half of 2022 compared to 2021,” according to Med Device Online, which said this increase is mainly due to lack of cybersecurity expertise among employees.

Those purchasing and managing medical devices must be concerned with two aspects of device security, according to product design company Plexus. First, they must understand how devices are designed to control and protect customer information. It’s essential for companies to protect sensitive patient medical information as it is shared within an organization or with other trusted stakeholders. The wider medical networks are, the greater the risk of a cyberattack that can quickly spread from one device to another.

Companies also must have a plan to provide security for medical devices against external threats once put into use. Aside from implementing proven cybersecurity measures such as authentication requirements, limiting the duration of user sessions, and checking for data compliance, among others, some organizations are also adopting blockchain as a solution to enable safe interactions and facilitate secure cryptocurrency transactions.

Medical Robots: When the pandemic prompted shortages of qualified staff due to burnout or other causes, medical device companies invented new robots to help perform tasks, and those robots are here to stay, says Med Device Online. Robots can perform routine medical tasks such as performing venipuncture, monitoring patient vitals, and disinfecting rooms.

Surgical robots in particular are by far the leading category of robotics currently in use, and demand for this technology has seen immense growth in recent years, according to tech trend analysis site Exploding Topics. It is widely reported that surgical robots such as the da Vinci and Hugo systems are becoming more capable and continue to increase the types and level of sophistication of the tasks they perform. This industry is expected to exceed $20 billion by 2028, according to Verified Market Research.

Accelerated Speed to Market

The COVID-19 pandemic forced many medical device companies to learn new ways of accelerating design, development, and testing of products to respond to pandemic threats more effectively, and they now benefit from these lessons when developing new diagnostic instruments. “The life science companies that are prepared to offer that kind of rapidly developed, rapid-response technology at the point of use are the ones who will be better positioned to handle the next global health crisis,” notes Plexus.

Ultimately, though the lessons learned during the pandemic were difficult, they resulted in many useful innovations that will continue to benefit the medical device sector for years to come.

How Artificial Intelligence Is Driving Product Lifecycle Management

How Artificial Intelligence Is Driving Product Lifecycle Management

Today artificial intelligence (AI) is increasingly being integrated into platforms across industries, and the healthcare sector is no exception, with AI being used to support medical device Product Lifecycle Management (PLM).

The ability to apply machine learning to PLM systems can help medical device manufacturers drive insights more effectively from product data that has been collected over many months, or even years, said digital transformation provider Kalypso. This sort of “product lifecycle intelligence” applies AI and automation to help users develop predictions and to recommend improvements, ultimately allowing manufacturers to prevent costly product delays and failures.

Kalypso detailed how one top medical device manufacturer addressed its global challenges by using AI and machine learning to drive measurable business results. “By combining PLM with product lifecycle intelligence,” they said, “companies can bridge the gap in PLM analytics capability today, allowing them to understand current performance, historical averages, and the variances across different business units and functions. These insights can help them develop more meaningful customer experiences, while driving business and product value.”

A Higher Level of Guidance

AI-powered product insights platforms now exist that help companies create and market their products more effectively, and they can contribute meaningfully to every stage of the product development cycle, said AI innovator Rodrigo Pantigas, CPO and co-founder of AI-driven insights startup Birdie, in a recent article for technology news site VentureBeat. Using the right platform during the different stages of the product development cycle can help companies maximize their return on investment.

For example, when conducting competitive assessments and evaluating trends during the initial development stage, AI-driven product intelligence can provide a higher level of guidance beyond human concept testing and social listening. “Instead of latent indicators caused by surfacing reading of comments today, product intelligence platforms can crunch the totality of conversations to understand where customer preferences are going,” reported Pantigas.

Once a product has been built and is ready to launch, “the right intelligence platforms can tap into existing conversations to understand existing customer perception both about the anticipation of this launch and consumers’ ongoing opinions about the product category and competition—which can also help to identify product issues and crises early on,” said Pantigas. “It allows you to contrast your product against the competitive set, as well as identify channels that could help get your product in front of a much wider audience.”

Real-time Metrics

AI offers the ability to generate real-time metrics on a product’s health, growth, and risk factors, which is “important for successful product managers to add an additional layer of efficiency with strategic and operational decision-making,” noted Skyjed, an AI platform provider for product teams. The ability to access data about a product’s health on the fly helps teams make more effective decisions as market conditions evolve, providing them with a competitive advantage.

Dynamic Technologies has a role to play in helping your company identify and manage the lifecycles of connected hardware and software in your supply chain. Our technology supply chain management services include product sourcing, supply chain design, and management, and product procurement. Review our case studies and learn more about how we can help you with your next project.

Medical Device Cybersecurity Challenges and How to Counter Them

Cybersecurity Challenges

As cyber threats to the healthcare sector continue to ramp up in frequency and severity in the U.S. and globally, they increase the risk of rendering medical devices inoperable and disrupting patient care. In a worst-case scenario, ransomware attacks on medical devices can put protected health information at risk or even threaten lives. In this environment, healthcare cybersecurity experts report the need for improved standards and better efforts by hospitals and manufacturers to share responsibility for medical device security.

One of the challenges healthcare organizations face is defending older legacy medical devices – which often were not built with security in mind—against the growing threats of hacker attacks, according to a recent MedTech Dive article. Hospitals contend that as the end users, they bear a heavier burden for securing medical devices than medical device manufacturers do, and the American Hospital Association wants to see the Food and Drug Administration (FDA) mandate lifetime support of medical devices by manufacturers.

MedTech Dive also says the FDA has warned that unpatched medical devices “will become increasingly vulnerable to cyberattacks over time and has called for more communication from OEMs when they can no longer support software upgrades and patches needed to address their devices’ cybersecurity risks.” 

Mitigating Risk Throughout the Product Life Cycle 

According to the FDA, the need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, internet- and network-connected devices; portable media like USB drives; and the frequent electronic exchange of medical device-related health information.

The agency in April released draft guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which is intended to provide recommendations to agency staff and the industry regarding cybersecurity device design, labeling, and the documentation that the FDA recommends be included in premarket submissions for devices with cybersecurity risk.

This new draft guidance replaces an earlier 2018 draft version and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the total product life cycle, and to outline more clearly the FDA’s recommendations for premarket submission content to address cybersecurity concerns. The draft was shared for public comment between April 8 and July 7 as Docket Number FDA-2021-D-1158-0001 on the Regulations.gov website, but as of this writing, it is not yet considered final or ready for implementation.

When securing medical devices, some of the primary challenges IT departments face include non-secure device designs, standardized configurations, patching restrictions, and insider threats, according to cybersecurity solutions provider Cybeats. They recommend the following four best practices to help healthcare organizations improve the security of their medical devices:

  • Endpoint protection – Securing not only the medical device but also the endpoints they connect to, such as workstations
  • Access management – Binding device authentication to the corporate authentication system
  • Asset management – Maintaining a reliable inventory of medical devices and software components
  • Vulnerability management – Conducting a vulnerability assessment of the software deployed on medical devices and reviewing vulnerability disclosures provided by vendors

For more medical device security guidance, visit:

Read Related Dynamic Technology Solutions Content:

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

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.