后市场监查的未来：数字化、集成化、以患者为中心

The Future of Post‑MarketSurveillance: Digital, Integrated,and Patient‑Focused MIKE KING, Senior Director, Product & Strategy, IQVIA Table of contents Introduction: Why Post-Market Surveillance must be proactive1The interplay: PMS insights fuel clinical evaluation, risk management, and market actions2From reactive to proactive: Multi-source data, trending, and signal management3Digitizing the PMS Core: Connecting plans, risks, NC/CAPA, complaints,recalls, and document management4The SmartSolve®difference: A single, AI-enabled platform that unifies QMS and RIM6Conclusion7References8About the author9 Introduction: Why Post‑Market Surveillance must be proactive Regulators concluded that broader, earlier, and moresystematic evidence is required to detect underlyingsignals of poor product performance. In the case ofMoM hip systems, risk understanding evolved overtime, ultimately shifting the devices into the PMApathway and necessitating mandated post‑marketstudies. Similarly, UK authorities emphasized structuredfollow‑up and imaging for early detection of soft‑tissuereactions.3,4For PIP breast implants, reviews integratedtoxicology, rupture, and clinical evidence to guide patientmanagement and underline the need for surveillancebeyond traditional complaint handling.5 Post‑Market Surveillance (PMS) is the continuous,proactive, and systematic collection and analysis ofreal‑world data on device quality, performance, andsafety throughout the product lifecycle. Under theEU Medical Device Regulation (MDR) and the In VitroDiagnostic Regulation (IVDR), Post‑Market Surveillance(PMS) is not a standalone process. It is an integralcomponent of the manufacturer’s Quality ManagementSystem (QMS), with explicit obligations to plan,execute, analyze, and act on field data.1In practice, thismeans manufacturers must maintain a documentedPMS system and PMS plan, define data sources (e.g.,complaints, trend reports, literature, registries), alignmethods and thresholds, and then feed conclusionsinto design control, clinical evaluation/performanceevaluation, risk management, and, where necessary,create CAPAs and launch fieldactions.2 Global regulators echo this trend. In the U.S., Post‑Market Surveillance orders under Section 522 requirescientifically valid plans capable of generating usefuldata that identify unforeseen adverse events and informpublic health decisions.6,7Collectively, these frameworksreinforce a modern expectation: PMS must be proactive,multi‑source, and fully closed‑loop to ensure timelyaction and improved patient safety. Heightened PMS expectations emerged from severalhigh-profile safety issues, including Metal-on-Metal(MoM) hip implants and PIP breast implants, whichexposed the shortcomings of complaint‑driven vigilance. High public awareness of product quality issues A dual focus on patient safety and commercial performance is universally beneficial Metal-on-Metal hips PIP breast implants Impact Impact • Patient— 1.5 million implants worldwide,revision surgery for those with an abnormalreaction to metal ions• Company— One company settled for around$1 Bn USD, others concluded settlements forseveral million dollars• Brand— Rarely used since 2012, U.S. FDAchanged to PMA • Patient— 300,000 women affected in a10‑year period to 2020 with implants up to6 times more likely to rupture• Company— Shut down in March 2010,founder jailed, French courtawarded damages• Brand— Discontinued Conclusions Conclusions • “…adverse incident reportingis aninherentlyimperfectway of collecting data…”•“…obtain evidence from awider and moredetailed set of sources, including robustoutcomes data from clinicians…” • “… reports in orthopaedic literature, datafrom international orthopaedicimplantregistriesandpresentationsfromprofessional/scientific meetingsthat haveincreasingly noted complications andpotential problems of early failure of MoM hipsystems, often requiring revision surgery...” These PMS feedback loops have direct clinical relevance.For example,UK MHRA guidance on Metal-on-Metal(MoM) hip replacementsprioritizes MARS MRI orultrasound over isolated metal ion levels for earlydetection of soft tissue reactions, demonstrating howPMS evidence reshapes clinical follow‑up and improvespatient outcomes.11Similarly, analyses ofPIP breastimplantsintegrated toxicology, rupture, and clinical datato guide patient communication and risk management— showing how the breadth and quality of PMS inputsstrengthen clinical decision‑making.12 The interplay: PMS insightsfuel clinical evaluation,risk management, andmarketactions EU MDR and IVDR require PMS outputs to updatebenefit-risk determinations, risk management files,clinical evaluation/performance evaluation, labeling/IFU,and the summary of safety and clinical performance,informing trend reporting and any necessary correctiveor preventive actions, including field actions.8 ISO/TR 20416:2020 codifies this in a manufacturer-friendlyprocess model: Plan PMS, collect from appropriatesou