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.

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.