Change is inevitable in medical device manufacturing, and how well change is managed often separates industry leaders from those plagued by quality deficiencies and recalls. Today, medical device organizations are under increasing pressure to keep costs down while maintaining the highest possible product quality. However, experience would suggest that a formal, systematic approach to change control is not only a regulatory requirement but also a business imperative. As the saying goes, “measure twice, cut once.”

The Price of Unmanaged Change

When medical device organizations implement many changes simultaneously without proper controls, they often do not foresee the full cost of poor quality. And it can be very expensive. For example, the medical device market incurs as much as $5 billion annually in non-routine quality events, like recalls, according to McKinsey.

In 2024, there were 1,048 total medical device recalls, an increase of almost 25% from the 840 recalls in 2023, with Class I recalls, those with significant health consequences, numbering 114 and affecting millions of units, according to the FDA. IMA Financial Group reports that design-related issues, manufacturing defects and device failure are the leading causes of medical device recalls. PubMed Central also published data from research studies demonstrating that design flaws and manufacturing errors are the two most common reasons for recalls.

These figures underline a basic fact: the value of effective implementation of change control systems is high, with delivery and maintenance cost of such systems minimal compared to the cost of failure.

Learning from Challenges in Manufacturing

Recent reviews of medical device change management show that validated changes are unlikely to adversely affect the safety, effectiveness, or performance of a device. For example, material changes to implant devices that are not appropriately tested for biocompatibility can cause adverse patient reactions, device failure, or even death.

The Problems Are Real: The Sterilization Supplier Crisis

In 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) discovered that an industry supplier had falsified a sterilization record. While devices had been sterilized, the quality of the process could not be guaranteed. The MHRA issued warnings to 88 medical device manufacturers and required full risk assessments on affected products.

This incident illustrates how change control weaknesses cascade throughout supply chains and why change control must extend beyond organizational walls to key suppliers—particularly for devices with contracted sterilization, packaging, or component suppliers.

The Insulin Pump App Failure

In August 2024, a major insulin pump manufacturer recalled an insulin pump app due to an issue that could have caused the app to crash and reboot, potentially draining the pump battery and causing premature shutdown of the pump. The FDA said this would “cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.” As of April 15, 2024, there were 224 reported injuries and no reports of death.

Here, the change control process had failed to adequately test all user scenarios around the app. Patient injuries demonstrated how even minor changes to connected devices require rigorous validation.

Key Principles for Effective Change Control

Industry experts recommend two approaches to change control:

• The “lift and shift” approach: To isolate variables, existing processes are reassigned before any enhancements are installed. This is particularly valuable when moving Class III device production lines.
• Incremental change management: Each phase is completed and validated before moving to the next, which prevents cumulative risk while maintaining Design History File (DHF) and Device Master Record (DMR) integrity.

The basic rule of thumb is simple but commonly broken: do not change more than one variable at a time. Despite this, device organizations often think they can shorten timelines by implementing multiple changes at once, a decision that proves problematic and may trigger new 510(k) submissions or PMA supplements in the U.S. Additionally, a cascade of expensive and resource-intensive worldwide registration activity may be needed to ensure continued market access of commercialized products that are subject to these manufacturing changes. In some cases, changes that are seen as non-significant in the U.S. and EU require registration remediation activity in other markets.

Even a single proposed change that may be complex requires strict adherence and control when using waterfall or iterative change models to ensure all change activities and elements have been considered and fully evaluated. Allowing for and balancing timely and effective identification of change criteria, activities, and review regardless of implementation goals/milestones is paramount.

Change control within medical device companies is highly regulated. FDA 21 CFR Part 820 requires that any change that affects the safety or effectiveness of the device shall be subject to validation and documentation. ISO 13485:2016 calls for documented processes for change control. EU MDR and IVDR demand formal change control, including specific requirements for alerting Notified Bodies where significant changes are made.

A Word on Change Control

Change control is the structured process used to manage proposed alterations to a project’s scope, schedule, budget, or deliverables, the goal being to minimize disruption, ensure alignment, and maintain accountability. Each project management methodology (Waterfall, Iterative, Agile, Hybrid, etc.) defines how and when changes are reviewed, approved, and integrated. The following table summarizes common change control methodologies.

Effective change control systems share a number of key traits:

• Clear classification of changes:
  • Minor changes: Little likelihood of affecting device safety or regulatory status, requiring routine documentation
  • Major changes: Requires detailed analysis and validation, and may require organizations to notify regulatory authorities
  • Critical changes: Significant potential to affect safety or effectiveness, requiring thorough review, validation, and regulatory submission
• Cross-functional change control committees, including:
  • Quality assurance and regulatory affairs (QARA) representation from global markets, as well as U.S. and EU expertise
  • R&D/design engineering
  • Manufacturing and process engineering
  • Risk management and clinical affairs
  • Post-market surveillance
  • Supply chain and supplier quality
  • Software and cybersecurity specialists
• Systematic documentation, including:
  • Change description with Design History File (DHF) and Device Master Record (DMR) impact
  • Risk assessment using ISO 14971
  • Regulatory submission impact assessment
  • Validation protocols and acceptance criteria
  • Implementation schedule
  • Post-implementation verification
  • Labeling and Instruction for Use (IFU) updates

The Technology Advantage

Digital transformation is revolutionizing change control. According to Grandview Research, “the global quality management software market size was estimated at USD $11.14 billion in 2024 and is projected to reach USD $20.66 billion by 2030, growing at a CAGR of 10.6% from 2025 to 2030.” Such software must provide:

• Predictive analytics: Machine learning anticipates issues, enabling proactive change management
• Automated documentation: Systems generate DHF, DMR, and validation reports automatically, ensuring 21 CFR Part 820 and ISO 13485 compliance
• Real-time monitoring: Continuous monitoring of critical parameters serves as an early warning system
• Improved traceability: Complete change traceability from design through post-market surveillance simplifies CAPA investigations
• UDI integration: Platforms integrate with Unique Device Identification systems, ensuring proper labeling and GUDID submissions
• Global insights: Impact assessments need to be considerate of requirements that include U.S. and EU requirements and extend beyond these geographies to capture true global variations in LATAM, EMEA, and APAC

Measuring success requires tracking specific measures to gauge the effectiveness of change control initiatives. Organizational KPIs may include:

• Implementation accuracy (changes with no deviations)
• Approval cycle time
• Accuracy in regulatory submissions
• Cost of quality versus non-quality
• Deviation and CAPA rates
• Validation cycle time
• Post-market field action rates following changes

The Culture of Change Control Excellence

Of course, technology alone cannot ensure device quality. Building and maintaining a culture that embraces quality control requirements is essential. To facilitate that, enterprises can implement the following:

• Training and engagement: Educate everyone about, not just procedures, but also the underlying principles of device safety and regulatory compliance, including actual recall case studies and patient impact.
• Proactive risk management: Encourage early identification of potential safety concerns using ISO 14971 principles before they become field actions.
• Balance speed and safety: Streamline processes to eliminate unnecessary delays without compromising device safety. The goal is “right the first time,” particularly for implantable and life-sustaining devices.

Future Trends and Implications

With the medtech market projected to reach $886.68 billion by 2032 and the pharma market expanding at a projected 4.71% annually and reaching $1.45 trillion by 2029, the context of change control continues to evolve rapidly. Key trends in the sector include:

• AI integration: The healthcare AI market is expected to grow from $20 billion in 2025 to over $187 billion by 2034, with almost 80% of pharma CEOs expecting AI to significantly impact manufacturing within five years. In line with this, the FDA’s proposed framework for AI/ML-based Software as a Medical Device (SaMD) recognizes the need for adaptive change control.
• Predetermined Change Control Plans: The FDA’s 2024 draft guidance allows manufacturers to request pre-authorization for specific post-market changes, potentially eliminating new 510(k) submissions for pre-specified changes while maintaining safety oversight.
• Supply chain digitization: As supply chains become interconnected, change control must encompass supplier changes. Blockchain technologies are emerging for supply chain transparency.
• Catering for connected devices: Software updates, cybersecurity patches, and cloud-based components require new change control approaches that balance rapid deployment with safety validation.

The Business Case

Besides ensuring compliance, effective change control offers several tangible competitive benefits:

• Reduced risk: Getting it right from the start minimizes quality failures, product recalls, and regulatory complaints.
• Faster implementation: Organizations that have mature change control systems deploy beneficial changes faster and more predictably than their competitors.
• Global market access: Conformity with global regulations breeds regulatory confidence. Controlled processes ensure consistent adherence to industry regulations and standards, preventing costly penalties that could affect uninterrupted access to markets.
• Operational excellence and efficiency: Enhanced efficiency means less rework. Structured change protocols will enhance operational performance and eliminate waste from the manufacturing process.
• Innovation enablement and acceleration: A formalized change control framework actually speeds innovation by providing a stable, repeatable pathway for device evolution and testing, and implementing new ideas.
• Improved patient safety: An effective process provides protection from device failures and adverse events.
• Knowledge management and synthesis: Expanded understanding within the organization of the breadth and depth of its products enhances effective collaboration and speeds innovation.

That’s a Wrap

The world of medical device quality is evolving at an increasing rate, steered by the wheels of digital health transformation, regulatory changes, and rising performance expectations. The ability to manage change effectively separates successful manufacturers from those struggling with quality issues and regulatory actions.

Organizations that resist simultaneous changes and focus on systematic change management are positioning themselves for success. Merging tested practices with digital technologies, AI capability, and adaptive frameworks, such as Predetermined Change Control Plans, puts companies in a position to not only handle today’s challenges but to build a foundation for future innovation. Investment in effective change control yields an exceptional value by avoiding risk, driving operational excellence, and securing an advantage over competitors.

In a marketplace that is increasingly complex and where the pace of change is accelerating from AI integration to connected devices, it’s organizations with strong competencies in change control that will thrive. The future belongs to medical device companies that balance rapid innovation with systematic change management discipline. Quality and regulatory practitioners who embrace these competencies can help their organizations realize the promise of technological advancement without jeopardizing what matters most: device performance, regulatory compliance, and patient safety.