Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights

Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights

By Denis Katz, MD — Founder & Principal, Katz Medical Affairs Consulting | Specialist in Medical Device Compliance & Post-Market Surveillance

In today’s MedTech landscape, post-market surveillance (PMS) has evolved from a regulatory checkbox to a strategic driver of patient safety, clinical evidence, and market success. Advanced wound care devices, given their complex patient populations and diverse surgical applications, demand tailored PMS approaches that address unique clinical and regulatory challenges.

Drawing on extensive experience in medical affairs and compliance, this analysis outlines practical strategies for effective PMS implementation, illustrated through the case study of Solventum’s Prevena Restor Incision Management System the first negative pressure wound therapy device to receive FDA clearance to aid in reducing superficial surgical site infections in certain high-risk patients.

Why Post-Market Surveillance is Critical in Advanced Wound Care

Unlike pharmaceutical development, where randomized controlled trials often provide definitive evidence, medical device outcomes are heavily influenced by real-world variables including surgical technique variations, patient adherence patterns, and complex comorbidity profiles. For advanced wound care devices, PMS provides essential insights into safety, effectiveness, and clinical value across diverse settings.

Four critical PMS objectives include:

· Monitor safety signals including infection rates, device malfunctions, and unexpected adverse events across diverse patient populations

· Generate longitudinal effectiveness data that complements pre-market clinical evidence and supports evidence-based medicine

· Maintain regulatory compliance with FDA, EMA, and global regulatory requirements

· Demonstrate real-world value to clinicians, payers, and healthcare systems through robust outcome data

The Regulatory Landscape: Global PMS Requirements

Post-market surveillance requirements have intensified significantly across global markets, with regulators increasingly viewing PMS as an essential, continuous process:

FDA 21 CFR Part 822 (Section 522) — This framework enforces Section 522 orders requiring manufacturers of certain class II and III medical devices particularly those with potential serious adverse health consequences, pediatric use, implants over 1 year, or life-supporting devices to conduct structured postmarket surveillance studies. These studies collect real-world evidence to complement premarket data, addressing safety and effectiveness concerns throughout the device lifecycle.

European Union MDR (Medical Device Regulation) — The MDR significantly raises PMS expectations, requiring manufacturers to implement continuous surveillance systems, develop and update Post-Market Surveillance Plans (PMSP), generate Post-Market Surveillance Reports (PMSR), and produce Periodic Safety Update Reports (PSURs). MDR Articles 83–86 mandate lifecycle surveillance activities that integrate market and customer feedback, vigilance data, and literature review for ongoing safety and performance validation.

ISO Standards Integration — International standards provide frameworks to embed PMS within quality management systems. ISO 14155 outlines requirements for clinical investigations of medical devices ensuring clinical data quality and integrity, while ISO 13485 mandates quality management principles emphasizing consistent device manufacturing practices linked to PMS data. These standards assure credible, scientifically valid evidence generation and regulatory acceptance.

Evidence-Based Best Practices for Advanced Wound Care PMS

1. Implement Comprehensive Real-World Evidence (RWE) Systems

Effective PMS relies on sophisticated data infrastructure leveraging multiple sources:

Registry Development: Partner with surgical societies and healthcare systems to establish disease-specific registries tracking long-term outcomes. For devices like Prevena Restor which delivers continuous -125mmHg negative pressure therapy over closed incisions for up to 7 days while protecting incisions from external contamination surveillance should encompass surgical site infection rates, wound healing progression, and patient-reported outcomes across diverse surgical procedures.

Claims Database Analysis: Utilize administrative healthcare data to identify usage patterns, complication rates, and economic outcomes at population scale.

Electronic Health Record Integration: Develop standardized data collection protocols enabling seamless capture of clinical outcomes, adverse events, and device performance metrics.

2. Standardization and Quality Assurance

Consistency across sites and regions is fundamental to reliable PMS:

Standard Operating Procedures (SOPs): Develop comprehensive protocols for adverse event reporting, usability assessments, and performance monitoring that align with international regulatory standards.

Training Programs: Implement systematic education for clinical sites covering proper device use, outcome assessment, and reporting requirements.

Quality Assurance: Establish regular auditing processes to ensure data integrity and regulatory compliance across all surveillance activities.

3. Stakeholder Engagement Strategy

Successful PMS methodology requires active collaboration with key stakeholders:

Clinician Engagement: Partner with surgical teams to understand real-world usage patterns, identify optimization opportunities, and capture clinical insights that inform product development.

Patient-Centered Outcomes: Incorporate patient-reported outcome measures (PROMs) including comfort, satisfaction, quality of life, and functional recovery metrics increasingly valued by regulators and payers.

Regulatory Alignment: Maintain ongoing dialogue with regulatory agencies, providing transparent updates on safety signals and effectiveness data.

4. Risk-Stratified Monitoring Methodology

Device risk profiles evolve as real-world usage expands:

Population-Specific Analysis: Stratify outcomes by patient demographics, comorbidity profiles, and surgical indications to identify high-risk populations and optimize clinical protocols.

Geographic Considerations: Monitor regional variations in outcomes that may reflect differences in surgical techniques, healthcare infrastructure, or patient populations.

Signal Detection Systems: Establish automated monitoring for safety signals enabling rapid response to emerging risks through labeling updates, clinician education, or product modifications.

5. Framework for Continuous Improvement

PMS data should drive actionable improvements:

Clinical Education: Translate surveillance insights into targeted training programs addressing identified usage issues or optimization opportunities.

Product Enhancement: Use real-world performance data to inform design improvements and next-generation product development.

Evidence Communication: Develop systematic approaches for sharing surveillance findings with clinical communities through peer-reviewed publications, conference presentations, and educational materials.

Case Study: Prevena Restor Incision Management System

The Prevena Restor system provides a comprehensive example of effective post-market surveillance implementation. This closed-incision negative pressure wound therapy (ciNPWT) device demonstrates several key PMS principles:

Clinical Evidence Generation: Multiple international studies involving several hundred patients across diverse surgical specialties have evaluated the Prevena system and related ciNPWT technologies. Evidence suggests that ciNPWT may support incision edge approximation, exudate removal, edema reduction, and improved local perfusion mechanisms associated with better healing outcomes and fewer wound complications.

Multi-Site Data Collection: The international scope of Prevena studies conducted across the UK, Ireland, Germany, Italy, the US, and Canada demonstrates how global PMS programs can capture regional variations in outcomes while maintaining standardized data collection protocols.

Risk-Benefit Monitoring: Comprehensive PMS programs successfully identified optimal patient populations (high-risk surgical patients) and clinical applications, leading to specific FDA clearance that reflects real-world evidence rather than just pre-market trial data.

Regulatory Success Through PMS: Robust post-market surveillance enabled the Prevena system to achieve FDA clearance to aid in reducing superficial surgical site infections a regulatory milestone that demonstrates the strategic value of comprehensive PMS programs beyond basic compliance requirements.

Compliance-Forward PMS Framework

Regulatory compliance requires systematic approaches spanning the entire product lifecycle:

Documentation and Reporting Standards

· Maintain comprehensive adverse event databases with standardized reporting timelines aligned with FDA’s automated tracking systems

· Develop periodic safety update reports (PSURs) and Post-Market Surveillance Reports (PMSR) demonstrating ongoing risk-benefit monitoring

· Create audit-ready documentation systems supporting regulatory inspections and MDR compliance requirements

International Harmonization Approach

· Align PMS activities with global regulatory requirements including EUDAMED database integration and Notified Body data sharing requirements

· Participate in international standardization efforts advancing PMS best practices through ISO 14155 and ISO 13485 frameworks

· Leverage harmonized outcome measures facilitating cross-border data sharing and regulatory acceptance

The Strategic Value of PMS Excellence

Organizations that view PMS as a strategic opportunity rather than a regulatory burden gain significant competitive advantages:

Clinical Differentiation: Robust real-world evidence supports clinical value propositions and facilitates market access discussions with payers and healthcare systems.

Innovation Pipeline: Surveillance insights inform next-generation product development, ensuring new devices address unmet clinical needs identified through real-world experience.

Stakeholder Trust: Transparent, proactive surveillance approaches build confidence among clinicians, patients, and regulators, supporting long-term market success.

Conclusion

The Prevena Restor example demonstrates how advanced wound care devices achieve clinical and regulatory success through strategically designed post-market surveillance programs. The system’s journey from innovative device to FDA-cleared therapy for superficial SSI reduction exemplifies the impact of robust PMS implementation.

By implementing evidence-based methodologies encompassing standardized data collection, proactive stakeholder engagement, risk-stratified monitoring, and continuous improvement processes medical affairs leaders can transform regulatory requirements into competitive advantages. The Prevena case study illustrates how devices delivering continuous negative pressure therapy can achieve specific therapeutic clearances through comprehensive real-world evidence generation.

Post-market surveillance represents far more than regulatory compliance it embodies our commitment to patients, clinicians, and evidence-based medicine advancement. When executed with scientific rigor and strategic vision, PMS drives innovation, builds stakeholder trust, and ultimately advances patient care.