How to Prevent Component Obsolescence From Becoming Serious Medical Device Obsolescence Risks

Medical Device Obsolescence

The global reliance on electronic components is ever increasing, and consumers today are accustomed to seeing electronic devices become obsolete in less than 2 years. However, for medical devices, the current climate of rapid obsolescence is unacceptable leaving OEMs struggling to manage the resulting medical device obsolescence risks.

The unpleasant reality is that when a component of a medical device is unavailable, or becomes obsolete, there can be serious repercussions. Device production may halt, delaying crucial patient treatments. Replacing the component may require costly redesigns and regulatory approvals. And in most severe instances, the device itself may be rendered obsolete.

Addressing this challenge is a crucial concern for today’s medical device companies.

What you’ll see in this article:

  • The impact of component obsolescence on medical devices.
  • Why has electronic component obsolescence become such a problem for the medical device industry?
  • What OEMs can do to navigate component obsolescence challenges.
    • Obsolescence forecasting
    • Sustaining engineering
    • Supply chain management

The Impact of Component Obsolescence on Medical Devices

Health diagnostics, medical procedures, and chronic disease management are increasingly dependent on modern, electronic medical devices. For instance, approximately 3 million Americans live with a pacemaker, nearly 40 million MRI scans are performed each year, and 2.4 million rely on implanted glucose meters to manage diabetes.

When an electronic component of a device becomes obsolete, several negative effects on healthcare can occur, such as:

  • Disruption of production: Obsolescence of a critical component can halt production lines, causing delays in manufacturing, impacting delivery schedules and even patient care.
  • Increased costs: Managing and replacing obsolete components requires significant investment in redesign, requalification, and inventory management, straining the financial resources of manufacturers and the device’s end users.
  • Regulatory compliance challenges: Devices that need to replace obsolete components may struggle to meet updated regulatory standards, leading to costly compliance and development issues.
  • R&D setbacks: Obsolete components necessitate new rounds of research and development to find suitable replacements, delaying product innovation and time-to-market.
  • Customer dissatisfaction: Frequent obsolescence can lead to frustration among healthcare providers and patients, damaging the manufacturer’s reputation and customer loyalty.

Why Has Electronic Component Obsolescence Become Such a Problem for the Medical Device Industry?

Electronic component obsolescence has become a significant problem for the medical device industry due to a combination of technological, regulatory, cybersecurity, and market factors that include the following.

Technological Advancement and Innovation

The electronics industry is characterized by rapid innovation, with new and improved components continually being developed. Medical devices, which often have long development and approval cycles, struggle to keep pace with this rapid turnover.

Shortened Component Life Cycles

The life cycle of many electronic components is relatively short. For instance, smartphones last 2 – 3 years on average. This contrasts sharply with the life cycle of medical devices, which are designed for long-term use and must remain reliable and safe over extended periods.

The mismatch between the short life cycle of electronic components and the long life cycle of medical devices creates a persistent obsolescence challenge.

Regulatory Compliance

Medical devices, especially Class III devices, are subject to rigorous regulatory standards to ensure patient safety and efficacy. Any changes in a device’s components, including those necessitated by obsolescence, require extensive testing, validation, and regulatory approval.

Cybersecurity Concerns

As medical devices become more interconnected and reliant on electronic components, cybersecurity has become a critical issue leading to new FDA requirements for medical devices. Components that lack the latest security features may be rendered obsolete.

Global Supply Chain Complexity

The supply chain for electronic components is global and highly complex. The global semiconductor shortage is a good example of the effect component shortage can have; it has impacted the production of many electronic devices, including medical equipment, leading to significant production delays and increased costs. Plus, 50% of electronic medical devices require semiconductors.

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How Can OEMs Navigate Component Obsolescence Challenges?

Despite the challenges rapid component obsolescence presents to medical device suppliers, they can be managed effectively.

Obsolescence Forecasting

Obsolescence forecasting is a proactive strategy that helps medical device companies manage component obsolescence risks. By predicting when critical components may become obsolete, manufacturers can mitigate potential disruptions.

How it helps:

  1. Early risk identification: Track the life cycle of components to foresee obsolescence.
  2. Strategic planning: Develop alternative solutions and redesigns well in advance.
  3. Cost management: Reduce costs associated with emergency replacements or redesigns.
  4. Inventory control: Strategic bulk or last time buys of critical components to avoid shortages.
  5. Regulatory compliance: Ensure planned changes comply with stringent regulatory standards.
  6. Supplier collaboration: Foster stronger relationships with suppliers for better insights and planning.

Sustaining Engineering

A device’s lifespan is, on average, 5 – 20 years. However, that lifespan can be cut short if there isn’t a plan to manage component obsolescence risks. Applying sustaining engineering practices to a device’s ongoing maintenance and life cycle management can lower instances of obsolescence in medical devices.

Sustaining engineering involves ongoing activities that ensure devices remain functional, compliant, and effective throughout their life cycle, specifically addressing the challenges posed by component obsolescence.

These practices include:

  • Proactive obsolescence monitoring: Continuously track the availability and life cycle status of critical components to anticipate obsolescence issues before they impact device functionality.
  • Redesign and requalification: Develop redesigns and requalifications for devices well in advance of component obsolescence. This process includes rigorous testing and validation to ensure new components meet all safety and regulatory standards.
  • Strategic inventory management: Build and maintain strategic inventories of critical components that are prone to obsolescence. This stockpiling helps mitigate immediate impacts and provides time to plan for long-term solutions.
  • Supplier partnerships: Establish strong relationships with component suppliers to gain insights into their production plans and receive early warnings about potential obsolescence, allowing for proactive planning and response.
  • Comprehensive documentation: Keeping thorough documentation of all components, including their specifications, alternatives, and regulatory compliance, to facilitate easier transitions when obsolescence occurs.

Outsourcing sustaining engineering services allows OEMs to focus on new product development while ensuring that existing products receive the necessary updates and support.

This approach helps medical device companies manage the complex and resource-intensive process of addressing component obsolescence, ensuring that their devices remain reliable, safe, and compliant over time.

Supply Chain Management

The supply chain crisis during the COVID-19 pandemic revealed how healthcare systems can be severely disrupted by component shortages and logistical challenges.

Proactively managing the supply chain by diversifying suppliers, securing long-term agreements, and continuously monitoring component availability is crucial to mitigate electronic component obsolescence risks.

To effectively manage supply chains and safeguard against component obsolescence, consider the following strategies:

  • Multiple suppliers: Source critical components from multiple suppliers, ideally from different regions, to mitigate the risk of a single supplier’s discontinuation or regional supply chain disruptions. This diversification ensures a more resilient supply chain.
  • Long-term agreements: Establish long-term agreements with suppliers to secure a continuous supply of essential components. These agreements can include clauses for early notifications of any discontinuations, allowing manufacturers to plan and adapt accordingly.
  • Supply chain monitoring: Implement continuous monitoring of the supply chain to track component availability and potential risks. Utilizing advanced analytics and supply chain management tools can help in identifying early signs of obsolescence or supply disruptions.
  • Strategic inventory management: Maintain strategic inventories of critical components to buffer against sudden shortages. This approach can involve stocking up on components that have a higher risk of obsolescence or are crucial to device functionality.
  • Supplier collaboration: Foster strong relationships with suppliers to enhance communication and collaboration. Regular meetings and transparent communication channels can help in anticipating and addressing potential obsolescence issues before they become critical.
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Manage Electronic Medical Device Obsolescence with Vantage MedTech

Bringing a medical device to market is an enormous success often reflecting years of work and financial investments. However, once in service, ensuring that device stays in service requires ongoing vigilance and proactive management of potential obsolescence issues.

Partnering with the qualified team at Vantage MedTech can help. With decades of experience in medical device development, compliance, and risk management, we know the importance of ensuring devices remain in service.

We’ve brought over 1,600 medical devices to market and have what it takes to make sure they avoid becoming obsolete as long as possible.

Contact us today to learn more about how to manage your device’s obsolescence risks.

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