Amidst a period of geo-political turbulence and fundamental shifts in traditional alliances, European nations have made a clear and urgent call to increase defence capacity, capabilities, and spending.

The European Defence Manufacturing industry is arguably facing its’ greatest need to create a stronger industrial base and develop the necessary production capabilities in the EU.

This report presents an analysis of the urgent need for European defence manufacturers to rapidly increase production capabilities and capacity in response to significant geopolitical shifts. The lessons that we take from history is that the time to prepare is now, as the world is moves regardless of our readiness.

How Seraph Delivers Sustainable Value 

Seraph’s four-phase methodology – Understand, Stabilize, Sustain, and Transition – has been instrumental in helping medical device clients achieve supply chain excellence and operational resilience. With an average ROI of over 300% and a payback period of less than six months, Seraph delivers both rapid stabilization and long-term improvements. 

Whether your organization is navigating a post-merger integration, responding to increased regulatory scrutiny, or countering tariff-driven cost surges, Seraph’s MedTech expertise ensures a tailored approach to solve your most complex inventory and supply chain challenges. 

Contact us today to schedule a discovery call, or see our case studies for more information. 

Webinars and Our View

Register for April 3rd: https://www.linkedin.com/events/tariffwebinarformanufacturingce7307462042838347779/theater/ 

Past Webinar March 4th:
https://www.linkedin.com/events/tariffandtradeupdateformanufact7300211965736497152/theater/

Past Webinar February 20th: https://www.linkedin.com/events/tariffandtradeupdateformanufact7295547804259688448/theater/

Past Webinar February 11th: https://www.linkedin.com/events/seraphtariffupdateformanufactur7293303559796756481/theater/

2025 Trump Tariffs Summary For Manufacturers

Auto Tariff:

• Effective April 3 (cars, light trucks) and no later than May 3 (engines, transmissions, electronics)
• USMCA relief available only with verified U.S. content
• No drawback allowed
• FTZs seem functional for exports, but no tariff benefit for US consumption
• See more details in the (Full Seraph Briefing)

Canada and Mexico:

• Current Blanket Tariff Rates for products that qualify for duty-free status under the USMCA:
• Canada: 0% 
• Mexico: 0%
• Rates for non-USMCA covered products will remain at the previously defined levels.
• Determining USMCA Coverage: Refer to General Note 11 of the Harmonized Tariff Schedule for specifics.
• Example Local Content Requirements:
  • Products must meet strict local-content rules, including minimum thresholds for North American materials and labor.
  • For automobiles, a majority of parts (including steel and aluminum) must be sourced from North America. Additionally, 40–45% of the vehicle’s value must be produced where workers earn at least $16/hour.
• Recent Tariff Adjustments:
  • March 5: President Trump granted a one-month exemption for automakers importing within the USMCA framework. (White House)
  • Morning of March 6: President Trump removed tariffs on Mexico until April 2. (White House)
  • Afternoon of March 6: President Trump formalized the removal of tariffs for Canada and Mexico. (White House – Canada) (White House – Mexico)
  • Trump threatened to impose additional tariffs on Canadian steel and aluminum in retaliation to a proposed Ontario electricity surcharge. However, he did not follow through with these tariffs after the surcharge threat was withdrawn.

Previous Mexico and Canada Tariff Levels Defined in the February 1st Executive Orders:

• A 25% tariff was announced via executive order on nearly all goods from Canada and Mexico, with a reduced 10% tariff on Canadian energy imports. (White House)
• The tariffs were justified by the administration as measures to address illegal immigration and the flow of fentanyl into the United States. (White House)

China:

• Current additional blanket tariff rate: 20%
• A 10% tariff was imposed on Chinese goods (in addition to any preexisting duties). (The American Presidency Project)
• On February 27th President Trump posted that an additional 10% tariff is coming on Chinese goods on March 4th (Truth Social).

Steel and Aluminum:

• On February 10, 2025, an extra 25% tariff on imported steel and aluminum from all countries (including Canada and Mexico) was implemented, it will take effect March 12. (White House)
• These tariffs will compound on top of other tariffs (Argus).

Escalation Clause:

• The executive orders include provisions for tariff increases if trading partners retaliate. (White House)

Reciprocal Tariffs:

• On February 13, 2025, President Trump signed a memorandum directing the development of a “Fair and Reciprocal Plan” to address trade imbalances. (White House)
• The plan aims to impose tariffs on countries equivalent to those they impose on U.S. goods. (White House)
• Non-monetary trade barriers, such as value-added taxes and subsidies, will be treated as tariffs. (White House)
• The administration has tasked officials with calculating these tariffs, with recommendations due by April 1, 2025.

Potential Tariffs on Automobiles, Semiconductors, and Pharmaceuticals:

• On February 14, 2025, President Trump announced potential tariffs of 25% or more on imports of automobiles, semiconductor products, and pharmaceuticals.
• These tariffs are proposed under the justification of “national security.”
• The President suggested they might increase over time and mentioned a possible phase-in period to allow companies to shift production back to the U.S.
• These proposals are currently under discussion and have not been formalized into an executive order.
• Recommendations regarding these tariffs are expected by April 2, 2025.

Potential Tariffs Related to Venezuela:

• On March 25, Trump announced 25% tariffs on buyers of Venezuelan oil (effective April 2, 2025) to pressure Venezuela into repatriating gang members—mirroring his past Colombia tactic. (Source)
• Key buyers of Venezuelan crude: China, the U.S., Spain, Cuba, and re-exporting Asian countries. (Our Analysis Here)
• Venezuela now makes up just 2.8% of OPEC exports; tariff unlikely to significantly affect global manufacturing, but may open space for increased U.S. energy exports.

Predictions Around the World

The medical device sector is expected to exceed $800 billion in annual revenue by the end of the decade. Yet, recent disruptions – such as heightened geopolitical tensions, tariffs, and supply chain volatility – have created unprecedented inventory and logistics challenges. Medical device manufacturers now face mounting pressure to balance operational excellence with cost control and patient care. 

Given that supply chain and inventory management are the second largest expenditure for medical device manufacturers, the stakes are high. Optimizing inventory isn’t just about cost savings – it’s about safeguarding healthcare outcomes by ensuring critical medical devices are delivered on time, every time. 

Emerging Challenges in Global Inventory Management 

While traditional pain points like poor supply chain visibility and system disintegration remain prevalent, recent developments have exacerbated inventory inefficiencies: 

Geopolitical Instability and Tariffs 

Global uncertainty, shifting trade policies, and punitive tariffs have disrupted material sourcing and logistics routes. Manufacturers reliant on specific regions (e.g., Asia-Pacific) for key components now face added layers of risk, including volatile costs and sudden supply interruptions. 

Regulatory Complexity 

The growing regulatory burden, such as compliance with evolving FDA, EU MDR, and ISO 13485:2016 standards, has added strain to already overextended operations. Misalignment between inventory strategies and quality systems (QMS) can result in costly non-conformances and even product recalls. 

Supply Chain Capacity Constraints 

The post-pandemic landscape continues to see bottlenecks across freight networks and raw material supply chains, forcing manufacturers to hold more buffer inventory than optimal, driving up carrying costs. 

The Evolving Role of Seraph in Inventory Optimization 

To address these evolving challenges, Seraph has expanded its service offerings for medical device manufacturers, focusing on supply chain resilience and inventory efficiency. Leveraging our hands-on, data-driven approach, Seraph specializes in operational and supply chain transformations that stabilize operations, unlock trapped working capital, and ensure regulatory compliance. 

Here’s how Seraph can address the latest inventory and supply chain issues: 

Integrated Digital Systems & Production Data Collection 

Seraph’s operational software enhances real-time production transparency, enabling early detection of inventory shortfalls or inefficiencies. Combined with QR-coded material traceability linked to ERP systems, manufacturers can drastically improve forecasting accuracy and responsiveness. 

Supply Chain & Logistics Transformation 

Our logistics experts lead targeted initiatives to build supply chain resiliency, including supplier diversification, lean material flow improvements, SIOP processes, and regulatory-compliant traceability systems. These strategies help mitigate geopolitical risks while reducing waste and excess inventory. 

Strategic Consolidation & Relocation 

Seraph supports clients in reshoring or nearshoring production and consolidating supply networks to reduce dependency on volatile trade regions. Our structured approach ensures a seamless transition, including MDR readiness, process validation, and supplier qualification. 

Assessment & Appraisal for Risk Mitigation 

Through our comprehensive 170+ point assessment process, Seraph identifies operational gaps in inventory and supply chain systems, benchmarking against FDA, EU MDR, and ISO standards. This method uncovers potential regulatory risks and capacity issues before they affect production. 

Updated Best Practices for Inventory Management 

In light of today’s environment, here are refined strategies for medical device manufacturers: 

1. Build Multi-Tier Supply Chain Visibility

Go beyond Tier 1 suppliers. By enhancing end-to-end transparency – including sub-tier suppliers – manufacturers can better anticipate risks from upstream disruptions, tariffs, or raw material shortages. 

2. Prioritize Agile Inventory Strategies

Adopt flexible inventory models such as postponement, decentralized stocking for critical SKUs, and hybrid JIT solutions. This will allow manufacturers to respond swiftly to demand fluctuations or regional disruptions. 

3. Strengthen Internal Collaboration

Close the gap between Quality, Operations, and Supply Chain teams. Unified decision-making helps ensure that inventory strategies not only optimize costs but also uphold patient safety and regulatory standards. 

4. Embed Continuous Improvement Culture

Equip teams with lean methodologies and standard work practices to improve material flow, reduce cycle times, and consistently meet KPIs tied to inventory performance. 

How Seraph Delivers Sustainable Value 

Seraph’s four-phase methodology – Understand, Stabilize, Sustain, and Transition – has been instrumental in helping medical device clients achieve supply chain excellence and operational resilience. With an average ROI of over 300% and a payback period of less than six months, Seraph delivers both rapid stabilization and long-term improvements. 

Whether your organization is navigating a post-merger integration, responding to increased regulatory scrutiny, or countering tariff-driven cost surges, Seraph’s MedTech expertise ensures a tailored approach to solve your most complex inventory and supply chain challenges. 

Contact us today to schedule a discovery call, or see our case studies for more information. 

In the fast-paced and highly regulated world of medical device manufacturing, an effective Corrective and Preventive Action (CAPA) System is more than a compliance requirement—it’s a strategic necessity. A robust CAPA System forms the backbone of quality management, ensuring that product issues, process deficiencies, and regulatory risks are identified, addressed, and prevented from recurring. Yet many MedTech organizations find themselves burdened by CAPA processes that are slow, bureaucratic, and ineffective, leading to wasted resources, compliance risks, and potential product recalls.

By treating your CAPA System not as a reactive, one-off process but as a well-managed project, you can adopt a structured, proactive, and data-driven approach. With the right mindset, MedTech companies can elevate their CAPA Systems into powerful catalysts for continuous improvement and operational excellence.

Five Key Changes for Revamping your CAPA System

Your organization can accelerate by making these five transformative changes to optimize your CAPA System:

1. PMO-Led CAPA Management: Shift CAPA oversight from SMEs to professional project managers (PMs) within a Project Management Office (PMO) for structure, accountability, and cross-functional collaboration.
2. Integration of Modern Project Management Tools: Move beyond QMS platforms alone by incorporating advanced software for planning, tracking, and collaboration.
3. Agile Methodologies for CAPA Processes: Replace rigid Waterfall with Agile or other iterative frameworks to enable incremental improvements, faster feedback, and adaptive risk management.
4. Dynamic CAPA Timelines Based on Effort and Risk: Move away from fixed timeframes; tailor each CAPA’s milestones to its complexity, risk factors, and resource needs.
5. High-Caliber Talent Driving CAPA Projects: Ensure the most experienced team members lead CAPAs, improving efficiency, quality, and ROI.

1. PMO-Led CAPA Management

Relying solely on Subject Matter Experts (SMEs) to manage your CAPA System can limit effectiveness. SMEs tend to focus on their specific technical domains, which may hamper cross-functional coordination and rigorous project execution. Project Management Offices (PMOs), however, excel at structured governance, resource planning, and consistent best-practice application.

The Role of a PMO in CAPA Management

• Governance and Methodology: A PMO ensures standardized project approaches, formal risk assessments, and best-practice execution.
• Resource Alignment: PMOs allocate skilled personnel effectively, avoiding bottlenecks and ensuring CAPA initiatives receive necessary attention.
• Cross-Functional Coordination: PMOs orchestrate communication among departments like Quality, Engineering, Manufacturing, and Regulatory, aligning CAPA efforts with broader business goals.

Why Project Managers Should Lead CAPA Projects

• Holistic Oversight: PMs integrate diverse perspectives—Quality, Engineering, Manufacturing, Sourcing, etc.—resulting in more robust solutions.
• Expert Project Execution: Proficiency in planning, scheduling, resource allocation, and risk management boosts CAPA efficiency.
• Objective Prioritization: Project managers avoid departmental silos, focusing on CAPA items with the greatest business impact.
• Improved Accountability: Dedicated project leadership prevents fragmented ownership that can cause delays.
• Better Communication: PMs provide consistent updates, keeping stakeholders informed and engaged.
• Methodical, Data-Driven Approach: Systematic resolution of CAPA issues leads to sustainable improvements.

High-performing companies that transition CAPA oversight to professional project managers within a PMO framework see more structured, strategic, and efficient execution of their CAPA Systems.

2. Integration of Modern Project Management Tools

Many organizations rely on Quality Management Systems (QMS) CAPA modules that focus primarily on documentation and compliance. While important, these systems often lack robust functionality for complex project tracking, collaboration, and resource management—all vital for an optimized CAPA System.

Key Tools for CAPA Optimization

• Project Planning & Scheduling: Microsoft Project, Smartsheet, Asana, Trello, Wrike
• Collaboration & Communication: Slack, Microsoft Teams, Zoom
• Time Tracking & Resource Management: Harvest, Toggl, Resource Guru
• Documentation & File Sharing: Google Workspace, Microsoft 365, Dropbox
• Reporting & Analytics: Tableau, Power BI, Jira (for dashboards and metrics)
• Risk Management: RiskWatch, Active Risk Manager (ARM)
• Agile & Workflow Tools: Jira, VersionOne, Rally

Benefits of Integrating Project Management Tools

• Real-Time Visibility: Gantt charts, Kanban boards, and dashboards track CAPA progress and resource usage.
• Enhanced Collaboration: Tools like Slack and Microsoft Teams help cross-functional teams communicate seamlessly.
• Accountability & Transparency: Automated notifications and activity logs clarify responsibilities.
• Data-Driven Insights: Advanced analytics identify bottlenecks and potential risks earlier.
• Scalability: Flexible platforms accommodate simple and complex CAPAs alike.

Optimizing CAPA performance through the right mix of project management, communication, and analytics tools not only streamlines workflows but also transforms your CAPA System into a true strategic asset.

3. Agile Methodologies for CAPA Processes

Many engineering sectors have adopted Agile, Spiral, or V-Model methodologies due to their flexibility and iterative feedback loops. However, Waterfall still dominates CAPA processes, often resulting in slow reaction times and a lack of adaptability.

Why Agile Beats Waterfall for CAPA

• Flexibility & Adaptability: Agile accommodates new information about product flaws or regulatory changes mid-project.
• Continuous Improvement: Iterative sprints allow teams to test solutions quickly, revise them, and validate faster.
• Faster Time-to-Resolution: Shorter feedback cycles resolve issues before they escalate into bigger problems.
• Enhanced Collaboration: Regular check-ins and stand-ups align cross-functional teams, from engineering to quality.
• Resource Efficiency: Agile prioritizes high-impact corrective actions first, expediting urgent fixes.
• Risk Mitigation: Spiral and Agile approaches integrate risk checks at multiple stages.

Comparing Development Models

• Waterfall & V-Model: Suited for well-defined, single-root-cause CAPAs with minimal scope changes.
• Agile & Spiral: Ideal for complex CAPAs with multiple potential causes or evolving regulatory demands.

Shifting from Waterfall to Agile methodologies empowers your teams to act swiftly on emerging issues, improving both compliance and operational excellence—ultimately strengthening your CAPA System.

4. Dynamic Timelines Based on Effort and Risk

Many organizations still use standardized phase durations (e.g., 30 days for root cause, 30 days for corrective action, etc.) in their CAPA workflows. This can lead to needless delays for simpler cases—or frantic deadlines for more complex ones.

Why Static Timelines Don’t Work

• They ignore individual CAPA complexity.
• They create artificial slowdowns if the phase window is too long.
• They rush work if the phase window is too short.

Transitioning to Effort & Risk-Based Timelines

• Precision in Planning: Use project management methodologies to estimate hours based on complexity.
• Risk Analysis: Assign shorter or longer time windows depending on the severity and potential impact of the issue.
• Real-Time Adjustments: If new root causes emerge or a fix proves insufficient, timelines adapt accordingly.
• Focus on High-Risk Areas: Concentrate resources where they matter most, preventing compliance crises.

Aligning timeline durations with actual effort and risk severity keeps your CAPA System agile and effective, ensuring each issue receives the right level of attention.

5. High-Caliber Talent Driving CAPA Projects

One of the most significant indicators of CAPA success is who is running the project. Experienced professionals with deep industry expertise and strong regulatory know-how can drastically reduce resolution times while boosting quality.

Advantages of Experienced CAPA Teams

• Faster Root Cause Analysis: Veterans recognize patterns and diagnose issues quickly.
• Higher-Quality Solutions: Seasoned experts devise robust corrective and preventive actions that hold up under scrutiny.
• Better Risk Management: Past experience with FDA, ISO, and other regulatory bodies informs proactive planning.
• Efficient Resource Utilization: Skilled leads know how to allocate budgets and team bandwidth efficiently.
• Stronger ROI: Investment in top talent often yields faster and more sustainable CAPA outcomes.

One prevented product recall because of a Preventive-Action CAPA is priceless.

Treat CAPA like a high-priority initiative—because it is. Assigning your best people ensures swift, cost-effective, and lasting solutions that reinforce your CAPA System.

Maximizing CAPA ROI

By implementing these five key changes, your organization can significantly enhance CAPA efficiency, reduce compliance risks, and improve overall product quality. When viewed as a continuous improvement and operational excellence strategy, a revamped CAPA System ceases to be a reactive function and becomes a proactive driver of innovation and competitive advantage.

Implementing These Changes

Seraph Consulting specializes in operational excellence, quality management, and regulatory compliance within the medical device industry. With a proven track record of driving measurable improvements, Seraph’s hands-on approach ensures that organizations not only design effective CAPA strategies but also execute them successfully. Below is how Seraph’s expertise aligns with the five transformative changes:

1. PMO-Led CAPA Management

Seraph’s Project Management Services provide industry-leading expertise in coordinating complex quality initiatives, ensuring compliance, and driving CAPA projects with efficiency. Our dedicated project management teams help MedTech companies transition from SME-led CAPA management to a structured PMO model, ensuring:

• Alignment with organizational goals and cross-functional collaboration.
• Clear governance structures for CAPA execution.
• Strategic resource allocation to ensure effective issue resolution.

2. Utilization of Project Management Tools for Capa Systems

Many MedTech firms rely solely on their QMS for CAPA tracking, which lacks advanced capabilities like real-time reporting, task dependencies, and cross-team collaboration. Seraph integrates best-in-class project management tools (e.g., Microsoft Project, Asana, Jira) into CAPA workflows, offering:

• Real-time tracking of CAPA progress and bottlenecks.
• Automated dashboards for improved transparency.
• Enhanced communication and resource management capabilities.

3. Adopting Agile Methodologies for CAPA Processes

Traditional CAPA processes using a linear Waterfall approach often struggle with slow responses to quality issues. Seraph’s Agile implementation framework enables:

• Iterative problem-solving cycles that accelerate corrective actions.
• Adaptive workflows that adjust to changing regulatory and operational needs.
• Cross-functional collaboration and continuous feedback loops.

Seraph’s expertise in QMS process development ensures that Agile methodologies are integrated seamlessly without compromising regulatory compliance.

4. Dynamic CAPA Timelines Based on Effort and Risk

Instead of fixed CAPA phase durations, Seraph employs data-driven effort and risk-based planning to:

• Identify high-priority CAPAs that require urgent attention.
• Optimize resource allocation based on complexity and impact.
• Provide real-time adjustments to CAPA timelines to prevent unnecessary delays.

Through Seraph’s Quality Management Services, companies can adopt dynamic scheduling frameworks that improve CAPA effectiveness while maintaining compliance.

5. Assigning the Most Experienced Team Members to CAPAs

Seraph’s Quality and Operational Excellence experts bring decades of experience in resolving complex quality and compliance challenges. We ensure that CAPA projects are managed by seasoned professionals who:

• Identify and eliminate recurring quality issues.
• Develop sustainable preventive action plans.
• Implement process improvements that drive long-term compliance and efficiency.

By leveraging Seraph’s Refinement & Turnaround services, organizations can build high-performance CAPA teams that deliver superior results.

Revamping Your CAPA System: From Compliance to Competitive Edge

When optimized, a CAPA System is far more than a compliance checkbox—it becomes a catalyst for continuous improvement, reduced risk, and operational resilience. By embracing PMO-led management, modern tools, Agile methods, dynamic timelines, and expert leadership, MedTech companies can realize more efficient CAPA processes and protect their products, reputation, and bottom line.

Ready to revamp your CAPA System? Let Seraph help you design and implement a world-class CAPA strategy that goes beyond regulatory compliance to deliver measurable operational success.

WEBINAR

Want insights into the biggest challenges in MedTech supply chains? Join Seraph’s MedTech team for a live session, where we’ll help manufacturing executives navigate upcoming changes.

Register below!

The 2027 EU Battery Regulation is set to reshape the battery value chain, placing new requirements on traceability, carbon footprint reporting, and end-of-life management for all batteries above 2kWh. Any company making or importing batteries into the EU will have to comply – there is no way around it.

While many businesses view compliance as a regulatory burden, those that prepare early will gain a competitive edge in supply chain management, operational efficiency, and cost reduction.

One of the most critical changes? The Digital Battery Passport (DBP). This digital record for each battery will contain essential data on origin, composition, performance, and lifecycle status. Beyond satisfying compliance, smart manufacturers, suppliers, and OEMs can leverage DBPs to optimize operations and reduce risks.

Why Early DBP Adoption is a Competitive Advantage?

Adopting the Digital Battery Passport (DBP) early is not just about meeting regulations – it is about gaining a real business edge. With DBP, companies can track materials more effectively, ensuring responsible sourcing and streamlining supplier verification. This reduces risk, minimizes waste, and improves overall supply chain efficiency.

Businesses that prepare for DBP now will be ahead of regulatory pressure, positioning themselves as industry leaders while strengthening relationships with customers and suppliers. Instead of reacting to compliance demands, they can proactively build trust and credibility in the market.

Operationally, integrating DBP early allows manufacturers to optimize lifecycle planning, improve second-life battery applications, and reduce long-term costs. By embedding traceability and efficiency from the start, companies not only future-proof their production lines but also create leaner, more profitable operations.

Why Seraph? Driving Manufacturing & Cost Efficiencies

The 2027 EU Battery Regulation and Digital Battery Passport (DBP) rollout won’t just affect compliance teams—it will significantly change day-to-day manufacturing operations. For battery producers, OEMs, and supply chain managers, the manufacturing floor will need to adapt to new data tracking, reporting, and operational efficiency requirements.

Seraph helps manufacturers prepare for these changes, integrate DBP requirements into their workflows on the manufacturing floors, and turn compliance into operational efficiency gains.

What might change on the manufacturing floor?

With DBP becoming mandatory, battery manufacturers will have to introduce new data capture points, traceability systems, and reporting mechanisms across production lines. The key changes might include:

Enhanced Data Capture & Traceability at Every Stage

Imagine you are on the factory floor, assembling battery units as usual – but now, every single battery must have a unique digital identity from the moment it is made. This is not just a sticker or a serial number – this ID links to where the materials came from, the energy used in production, and its entire lifecycle, from first use to recycling.

• Because manufacturers will need to assign these digital IDs (DBPs) to every battery unit, this means new scanning, labeling, and data entry steps will be built into production lines

• Also, because real-time tracking tools like QR codes, RFID tags, or blockchain-based systems may become standard, this means operators and machines must ensure each unit is correctly tagged and its data is instantly uploaded

• Finally, because suppliers of lithium, nickel, and cobalt must now provide traceability data, this means procurement teams and factory systems need better integration—so materials with incomplete records don’t slow down production

What does this mean for manufacturers? Production systems (MES, ERP) will need upgrades to handle DBP data without causing bottlenecks. The challenge is making this seamless, so compliance does not come at the cost of efficiency.

Adjusted Production Workflows & Quality Control

Picture this – you are working on the battery assembly line, but now, at every stage, the system needs to confirm compliance before moving forward. It is no longer just about meeting production targets; if data does not check out, that battery won’t make it to market.

• Because compliance checks must happen in real time at multiple stages – raw materials, cell production, and final assembly – this means operators and machines will need to verify and log data at each step before moving on
• Also, because carbon footprint calculations are now part of live production tracking, this means energy use, material consumption, and emissions data must be automatically captured and reported as part of daily operations
• Finally, because end-of-line testing must ensure DBP compliance, this means any inconsistencies in traceability or reporting could result in production delays or batteries being blocked from EU markets

What does this mean for manufacturers? Balancing production speed with compliance will be critical. Automated data collection systems must work smoothly to prevent bottlenecks, ensuring traceability doesn’t slow down efficiency.

Integration of Battery Lifecycle & Circularity Considerations

Now, think about how batteries are built today – for the most part, they are (still) designed for first use, with a little thought about what happens after. With DBP, manufacturers must start considering a battery’s entire lifecycle right from production.

• Because DBP will track battery lifespan, usage history, and second-life potential from the start, this means manufacturers must input long-term performance data, not just initial quality checks
• Yet, because battery designs must shift to allow easier material recovery, e.g. replacing adhesives with modular components, this means design teams must rethink how battery packs are structured, using fewer permanent adhesives and more modular components
• Finally, testing is not just about first use anymore. Manufacturers will need to assess how well batteries perform for reuse, whether in energy storage or other applications

What does this mean for manufacturers? Battery design and production will need to evolve – moving away from one-time use models toward modular, repairable, and recyclable designs that extend value beyond the first life cycle.

How DBP Will Reduce Manufacturing & Compliance Costs

DBP is not just a compliance tool – it is a way to future-proof operations and cut long-term costs. Manufacturers that integrate DBP early will avoid expensive last-minute adjustments and reduce manual compliance efforts by automating data collection and reporting.

Real-time tracking of materials and production steps will help eliminate inefficiencies, reducing waste and optimizing supply chains. By designing batteries for second-life reuse from the start, manufacturers can cut material costs and extend profitability beyond first use.

Seraph Turns Compliance into Operational Excellence

Regulations don’t have to be a roadblock – if integrated correctly, they can drive efficiency and cost savings. Seraph works with manufacturers to ensure DBP adoption enhances production workflows instead of disrupting them. From real-time data tracking to streamlined compliance, we help businesses turn regulatory requirements into a competitive advantage. The companies that move early won’t just meet 2027 standards – they will lead the future of battery production.

Ready to make DBP an advantage for your business? Let’s talk  https://seraph.com/contact/ 

About Seraph  

Seraph is a global operations and strategy consulting firm, that leads value chain improvements, restructurings, and turnarounds. We unite the disparate roles in operationally intensive businesses to create efficient operations, bridging the divide from concept to production. High-level decision-makers in manufacturing and industrial organizations rely on us to solve complex issues and launch initiatives that ensure success and sustainable change.

Seraph is a member of the BASE Battery Passport for Transparency and Circularity consortium.

The BASE project has received funding from the Horizon Europe Framework Programme (HORIZON) Research and Innovation Actions under grant agreement No 101157200 

Visit the BASE website here: https://base-digibattpass.eu/

Standard Work Instructions are the backbone of consistent, efficient, and high-quality manufacturing processes in many industries, including medical device manufacturing. However, in the hundreds of manufacturing plants we’ve supported, the vast majority had neglected work instructions – leaving money on the table.

When dealing with legacy medical devices, challenges can emerge that threaten operational efficiency, compliance, and product quality. This article shows how Standard Work is a powerful tool to mitigate those challenges and drive operational excellence.

Read on to understand the foundations of standard work, their importance, the challenges associated with legacy devices, and solutions for mitigating these pitfalls.

What Is Standard Work?

Standard work, often referred to as standardized work, is a foundational concept in Lean methodology. It involves identifying the best current method for completing a process and establishing it as the standard. In manufacturing, standard work provides consistency in production, minimizes waste, and ensures repeatability across operations.

Key Elements of Standard Work:

• Takt Time: The rate of production required to meet customer demand.
• Work Sequence: The best-practice steps to complete a task, typically documented Standard Work Instructions, easy-to-read diagrams and visualizations support the step-by-step documentation.
• Inventory: The materials and tools needed to execute the process efficiently.

The Role of Standard Work Instructions

Standard Work Instructions are detailed, task-specific documents designed to ensure that work is executed consistently and correctly. These documents are especially critical in the medical device industry, where precision, compliance, and safety are non-negotiable.

Why Standard Work Instructions Are Important:

• Clarity: They provide explicit details on the “what,” “why,” and “how” of tasks, minimizing ambiguity and reducing errors.
• Training: They serve as an invaluable resource for onboarding new employees, ensuring that new hires quickly align with established practices.
• Consistency: Standard Work Instructions ensure reproducibility, which is critical for quality control and compliance in regulated industries.
• Continuous Improvement: They provide a baseline for process evaluation and improvement, supporting Lean, Six Sigma and operational excellence initiatives.

Standard Work Instructions in the Medical Device Industry

In medical device manufacturing, work instructions are often part of the “Production Process Specification” and are linked to the Device Master Record (DMR). Unlike other industries where Standard Work Instructions focus on efficiency, in MedTech, their primary focus is on quality and repeatability to meet stringent regulatory standards.

Key Elements of a DMR:

• Device Specifications: Materials, dimensions, and other critical features.
• Production Processes and SOPs: Step-by-step manufacturing instructions.
• Quality Assurance Procedures: Standards to ensure compliance and performance.
• Labeling and Packaging Details: Specifications for safe distribution.

The Pitfalls of Legacy Devices and Standard Work Instructions

Legacy medical devices present unique challenges, many of which stem from outdated processes and documentation. These issues are compounded when work instructions fail to evolve alongside technological, regulatory, and operational changes.

Common Problems with Legacy Device Standard Work Instructions:

Outdated Work Instructions:

• Issues: Legacy work instructions often reference obsolete equipment, materials, or processes.

• Impact: Increased production errors, inconsistencies, and compliance risks.

Skills Gap:

• Issues: Knowledge of legacy processes resides with a few experienced workers, who may retire or leave.
• Impact: A steep learning curve for new employees and a loss of institutional knowledge, which often is clearly measurable in longer training ramp-up timelines and greater quality and performance losses.

Compliance Gaps:

• Issues: Legacy manufacturing processes may not align with updated regulations, such as ISO 13485 or FDA requirements.
• Impact: Increased risk of fines, product recalls, and regulatory warnings.

Inefficient Quality Control:

• Issues: Older inspection processes often rely on manual methods rather than modern tools like automated optical inspection (AOI).
• Impact: Higher defect rates, increased labor costs, and delayed issue resolution.

Resistance to Change:

• Issues: Teams accustomed to legacy methods may resist adopting new Standard Work Instructions or process improvements.
• Impact: Slow implementation of Lean initiatives and missed efficiency gains.

Signs It’s Time to Update Legacy Standard Work Instructions

Keeping standards and training resources current is essential for maintaining compliance, quality, and operational efficiency. Here are key indicators that it’s time to review and update Standard Work Instructions:

• Frequent Production Errors: Increasing defects or rework indicates gaps in clarity or accuracy.
• Regulatory Non-Compliance Risks: Audit findings highlight documentation gaps or misalignment with standards.
• Introduction of New Equipment: Legacy WIs may not reflect updated tools or technologies.
• High Employee Turnover: Outdated or unclear instructions make onboarding challenging.
• Changes in Materials: Supply chain adjustments or material substitutions require updated handling instructions.
• Feedback from Operators: Workers express confusion or frustration with outdated instructions.
• Transition to Digital Systems: Legacy paper-based WIs are incompatible with modern Manufacturing Execution Systems (MES).
• Lifecycle Changes: The product or process undergoes significant updates.

Seraph’s Approach to Improvement

Seraph, a consulting firm focused on operational excellence, offers a range of services to help organizations modernize and optimize their Standard Work Instructions while incorporating Lean principles:

• Comprehensive Work Instruction Audit: Identify gaps and prioritize updates.
• Work Instruction Standardization and Modernization: Align Work Instructions with modern templates, Lean principles, and regulatory requirements.
• Lean Process Integration: Embed Lean tools like takt time, kanban, and visual management.
• Operator-Centric Development: Involve workers in creating user-friendly Work Instructions with visual aids.
• Digital Transformation: Transition to digital Work Instructions with features like embedded videos and real-time updates.
• Compliance Alignment: Ensure adherence to ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR standards.
• Training and Change Management: Provide customized training to ensure smooth adoption.
• Continuous Improvement Framework: Establish a system for periodic WI reviews and Kaizen events.

Conclusion

Legacy medical devices and outdated Standard Work Instructions pose significant challenges, but these are not insurmountable. By recognizing the pitfalls and proactively addressing them, organizations can improve compliance, quality, and efficiency. With expert guidance from Seraph, businesses can modernize their Standard Work Instructions, integrate Lean principles, and achieve operational excellence in medical device manufacturing.

WEBINAR

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The 2025 Seraph Automotive Manufacturing Report highlights three critical themes shaping the industry: tariffs, talent, and technology. Based on industry data and Seraph’s Auto Leaders Survey, the report outlines key challenges, economic pressures, and strategic responses for OEMs and suppliers in North America and Europe.

Strategic Takeaways

• OEMs and suppliers must prepare for tariff impacts: Reviewing footprint strategies and supply chain risk mitigation is essential.
• Cost-cutting and operational efficiency will be a priority, with a focus on reducing scrap, downtime, and logistics costs.
• EV investment strategies need recalibration, as regulatory changes and shifting consumer demand reshape long-term viability.
• Talent development is critical, requiring apprenticeship programs, workforce training, and hiring strategies for reshoring initiatives.

Key Trends in Automotive Manufacturing

1. Volumes & Financials

• Demand remains weak, impacting factory utilization and financial performance.
• Publicly traded suppliers are seeing stronger margins than OEMs for the first time in four years, largely due to improved cost structures and negotiation power.
• OEMs continue to struggle with low volumes, program delays, and a reliance on luxury and high-margin vehicles to sustain profitability.
• Consumers resist high prices, forcing increased incentives such as 0% APR financing and rebates to boost sales.
• Inventory levels have surged to 3.15 million vehicles, nearly triple 2022 levels, causing downward pricing pressure.

2. Tariffs & Geopolitics

• The incoming Trump administration is expected to introduce sweeping tariffs, particularly on China, Mexico, and Canada. At the time of publishing, Trump has threatened (latest tariff updates will be at Seraph’s tariff tracker here):
• China: 60-100% tariffs on all imports, 100-200% on vehicles, aiming to protect U.S. manufacturing.
• Mexico & Canada: 25% tariffs if border issues persist.
• Other trade allies: 10-20% tariffs across industries.
• Tax incentives for reshoring: A 15% corporate tax rate for U.S. manufacturers and 20% for domestic companies.
• European OEMs face pressure as Chinese automakers increase market share with competitive pricing and strong product quality.
• Supply chain disruptions remain a concern, with trade wars impacting component sourcing and potential production shifts.

3. Talent & Workforce Challenges

• Talent shortages dominate strategic planning for 2025.
• Relocations and consolidations are forcing companies to navigate hiring difficulties, wage inflation, and skill gaps. We believe tariffs and resilience objectives will require companies to develop talent cultivation programs as skilled trades are already in short supply.
• Manufacturing hubs like Mexico are struggling to meet skilled labor demand, with concerns over worker retention and availability.
• Plant closures and consolidations are expected to rise as companies optimize footprints to offset demand reductions and uncertainty. .

4. Technology & EV Transition

• EV infrastructure remains a bottleneck: Public fast-charging networks are inadequate outside of major cities.
• We analyzed county level data and determined EV adoption rates are mostly driven by three factors (see the report for deeper analysis):
  • Cost (household income, tax credits)
  • Convenience (charging density)
  • Politics (Democratic-leaning counties adopt EVs at higher rates)
• Tesla remains the only Western EV OEM profitable without subsidies, while other automakers struggle to achieve cost parity, pressure through reduced subsidy or tariffs will further exacerbate this price differential due to the relative concentration of Tesla’s assembly and supply chains in the U.S.
• China leads in charging infrastructure, adding 734,000 public chargers in 2024 alone, while the U.S. remains fragmented, 
• Trump’s policies may cut federal EV incentives, further slowing adoption and impacting EV-focused suppliers.

For more insights, visit Seraph.com or contact meet@seraph.com.

Seraph is pleased to share the webinar of our quarterly industry report—an insightful discussion about the prevailing trends shaping the automotive sector. During this webinar, Seraph’s Founder and CEO Ambrose Conroy and VP of Client Development Jay Butler, and more of the Seraph team provide an outline of the report, accompanied by engaging interactions with fellow leaders who participated in the discussion.

For decades, the linear model of battery production—“extract, use, discard”—has dominated the industry. Batteries are designed, used, and discarded, leaving behind a trail of wasted resources and environmental strain. This approach is no longer sustainable. The industry has reached a turning point. 

The current linear model doesn’t just deplete resources—it borrows from future generations, creating a debt of waste and resource depletion. However, the circular economy offers a powerful alternative—a vision where resources are reused continuously, and waste is minimized. Imagine a world where 90% of battery materials are recycled, and only 10% are new. This isn’t just a distant possibility—it’s a pathway we are already forging together. 

The value definition is shifting. The future of batteries isn’t about being the biggest, strongest, the fastest, or the company that produces the most. It’s about producing the most durable, most recyclable, the most repurposed and yet efficient batteries. Success will belong to the companies that adapt—those that embrace stewardship over ownership, align with sustainability, and redefine how value is created in a circular economy. 

Innovation: The Key to Unlocking Circularity 

To achieve this vision, innovation must tackle three critical drivers: 

1. Traceability: Knowing the origin and journey of every material within a battery builds trust and ensures ethical sourcing. 
2. Optimized Lifespan: By maximizing battery performance and durability, we extend usage and reduce waste. 
3. High Recyclability: Designing batteries for second and third lives reduces dependency on raw materials and minimizes environmental impact. 

These drivers go beyond compliance—they create a blueprint for a sustainable, transparent, and efficient ecosystem. They also reflect a shift in corporate culture, encouraging behaviors that prioritize accountability, durability, and adaptability. 

The Digital Battery Passport: A Unified Framework for Change 

For those in the industry, the question arises: “We already have tools like traceability and optimization—what’s new here?” The answer lies in integration. 

The Digital Battery Passport (DBP) goes beyond isolated tools, offering a unified platform that connects every stage of a battery’s lifecycle. From sourcing to end-of-life recycling, the DBP consolidates critical data into a single framework that enhances transparency, lifecycle efficiency, and regulatory compliance. 

With the DBP, companies can: 

• Centralize data for seamless reporting and better decision-making. 

• Align with global standards, reducing complexity and inefficiencies. 

• Unlock new business opportunities, transforming compliance into a competitive advantage. 

This is more than a tool—it’s a catalyst for aligning innovation with sustainability and profitability. 

Data as the New Currency 

In the circular economy, data is the currency that drives accountability, transparency, and value creation. Metrics like traceability, lifecycle optimization, and circularity credits are no longer optional—they are the foundation of success. 

Through the DBP, companies can capture and share the data required to meet regulatory demands, enhance consumer trust, and unlock new market opportunities. This data-centric approach ensures that every stage of the battery lifecycle is optimized, from raw material sourcing to recycling. 

This isn’t just about compliance—it’s about making compliance work for you. Data doesn’t just support your business; it drives it. 

Shifting from New to Renewed 

The transition from “new” to “renewed” is reshaping how value is defined in the battery industry. This shift prioritizes durability, transparency, and circularity. 

• Recyclable products will dominate: Batteries designed for multiple lifecycles will become the norm. 

• Durability will define success: Longer-lasting batteries reduce costs and environmental impact. 

• Efficiency will drive decisions: Batteries that perform better while using fewer resources will lead the market. 

These changes don’t just benefit the environment—they strengthen companies by building resilience, reducing costs, and fostering stronger relationships across the value chain. 

OEMs as Enablers and Catalysts 

Economic operators, particularly OEMs, play a pivotal role in this transformation. They act as both: 

• Enablers, driving internal value through performance optimization and cost efficiency. 

• Catalysts, extending their influence outward to support recyclers, second-life applications, and logistics providers. 

By embracing the DBP, OEMs not only adapt to new models but actively shape the future of the battery industry. 

A Call to Action 

The battery industry is at a crossroads. The question isn’t whether the shift to a circular economy will happen—it’s about how quickly and effectively companies can adapt to lead the way. 

The future isn’t about producing the most batteries—it’s about producing the best batteries: the ones that last the most recyclable, repurposed, yet last longest, perform the best, and contribute to a sustainable future. 

The time to act is now. The tools are here. The opportunity is undeniable. Let’s shape the future of batteries together.

Learn more about Seraph’s work with the BASE Battery Passport project by viewing this webinar

Follow Seraph on LinkedIn. 

 Contact us to schedule a discovery call 

 see our case studies for more information. 

About Seraph  

Seraph is a global operations and strategy consulting firm, that leads value chain improvements, restructurings, and turnarounds. We unite the disparate roles in operationally intensive businesses to create efficient operations, bridging the divide from concept to production. High-level decision-makers in manufacturing and industrial organizations rely on us to solve complex issues and launch initiatives that ensure success and sustainable change. 

This project has received funding from the Horizon Europe Framework Programme (HORIZON) Research and Innovation Actions under grant agreement No 101157200 

Visit the BASE website here: https://base-digibattpass.eu/

Leveraging lead and lag indicators to drive performance 

For medical device manufacturers implementing new (or trying to measure existing) production and process controls, understanding the lead and lag indicators is critical to meeting production and performance goals. This is particularly important when doing so to meet ISO 13485 and FDA 21 CFR part 820 requirements. 

A lag indicator is a performance measurement that reflects the outcomes or results of processes after they have occurred.  Manufacturers need to measure the success of a process to understand if the controls they’ve put in place are effective. Otherwise, you may be adding controls that add cost, don’t add value, and worse, don’t meet those critical requirements.  Lag indicators are often used to assess the effectiveness of production processes, identify areas for improvement, and make informed decisions for future actions. 

Conversely, a lead indicator is a performance measurement that provides early signals about future performance or potential issues in the production process. Lead indicators are critical in understanding if performance is starting to drift before serious issues occur. They are proactive and predictive, helping organizations anticipate and prevent problems, optimize processes, and improve overall efficiency.  However, lead indicators can be some of the most difficult to identify correctly. 

The Worst Indicator 

The worst indicator for any medical device manufacturer is being under an FDA consent decree. In this situation, you have lost control over your own plant and decision-making processes.  Getting in front of the problem with the right measures will ensure you aren’t getting into this situation. 

What is an FDA Consent Decree? 

An FDA consent decree is an agreement made between an entity and the U.S. Food & Drug Administration (FDA) to enforce rules and regulations set by the FDA. It typically involves a negotiated, court-approved order barring an FDA-regulated firm from violating the FDCA, subject to certain pre-specified remedies. The FDA works with the Department of Justice (DOJ) to file a complaint against a business in Federal District Court to obtain a consent decree. A consent decree is the maximum enforcement action the FDA can take. Violating a consent decree can be devastating to a business. 

Potential Lead Indicators Leading to an FDA Consent Decree 

Typical lead indicators include an increased number of product recalls (a lag indicator of poor quality) and 483 warning letters (a lag indicator of an FDA inspection). 

Lead Indicators for FDA Inspections and Recalls 

What are the lead indicators for a potential FDA inspection or a looming product recall? These often include an increase in Corrective and Preventive Actions (CAPAs) driven by customer complaints and a high number of Medical Device Reports (MDRs). It is no surprise that while MedTech recalls are piling up fast in 2024, CAPA issues (21 CFR Part 820.100) are the highest contributor to inspection citations.

Connecting Quality Issues and Lead Indicators 

While CAPAs are a lead indicator for potential FDA inspections and recalls, they are also a lag indicator driven by quality issues such as high scrap rates and Non-Conformance Reports (NCRs). Often, quality problems start with unmeasured repair or rework to fulfill customer requirements, known as “The Hidden Factory.” Measuring and acting on trends in repair/rework is an essential starting point for connecting the dots from lag to lead indicators. 

The Importance of Gemba Walks 

Your morning Gemba walk should include reviewing your product lead and lag indicators and their trend lines. This practice helps you maintain a continuous improvement cycle and stay ahead of potential issues.   

How Seraph’s Services Support Lead and Lag Indicators 

Seraph helps clients solve their most challenging operational problems by leveraging a proactive, hands-on approach that directly impacts output, product quality, efficiency, and cost balance. Seraph can also help to identify which metrics will be most effective in not only avoiding significant issues but also avoiding costly production-related delays and missing customer deadlines.  Here’s how Seraph’s services align with and enhance these crucial performance metrics: 

1. Quality Management 

Seraph’s Quality Management services are instrumental in addressing lead indicators like CAPAs by identifying potential quality issues early.   Identification of potential or ongoing issues and implementing effective corrective and preventive actions are how Seraph can help prevent minor issues from becoming major ones that can lead to potential product recalls and customer complaints. 

2. Turnaround 

Seraph’s turnaround services stabilize operations when falling behind, missing targets or failing to achieve goals. By improving production line efficiency, optimizing material flow, and maximizing performance, Seraph helps convert low production rates and missed shipments into actionable improvements that serve as a blueprint for operational stability. 

3. Mergers, Acquisitions & Spinoffs 

During mergers and acquisitions, Seraph’s approach mitigates risks that can otherwise lead to disruptions in production or quality issues. Implementing value-creation plans and detailed risk assessments ensures the success of these major transitions, ensuring future operational integrity and profitability. 

4. Relocation and Consolidation 

Relocating and consolidating production lines can be fraught with risk, negatively impacting output and product quality if not appropriately handled. Seraph’s structured approach ensures that these transitions are smooth and compliant, preventing potential missed MDR compliance or supply interruptions. 

5. Project Management 

Seraph’s project management services help medical device manufacturers stay on track with planned product or production milestones and process improvements. Properly managed projects reduce the likelihood of delays and quality problems. 

6. Logistics and Supply Chain Optimization 

Inefficient logistics and supply operations can lead to delays, missed customer deadlines and increased costs. Seraph’s expertise in supply chain management, including lean material flow and supplier qualification, reduces the risk of disruptions, preventing delayed shipments or compliance issues from materializing. 

7. Production Data Collection 

Seraph’s operational software provides real-time data transparency, which highlights process deviations early on. Learn more here Production.net Services | Seraph

8. Strategy Development and Implementation 

By providing strategic guidance, Seraph helps manufacturers establish or refine production goals, addressing resource allocation and supply chain resilience. Effective strategy execution helps avoid lagging performance metrics such as profitability drops or operational inefficiencies. 

9. Assessment & Appraisal 

Through comprehensive assessment and appraisal services, Seraph identifies risks and creates clarity regarding operational gaps. This rigorous evaluation ensures adherence to regulatory standards and ultimately can assist companies in avoiding serious issues like FDA consent decrees or major compliance failures. 

By focusing on early detection, process optimization, and risk mitigation, Seraph helps manufacturers maintain a balance between addressing existing challenges and preventing future ones, driving sustainable operational excellence. 

Would you like help? Please Contact | Seraph

WEBINAR

Want insights into the biggest challenges in MedTech supply chains? Join Seraph’s MedTech team for a live session, where we’ll help manufacturing executives navigate upcoming changes.

Register below!