AMCP’s Post

For my #CSIMGT725 #GradStudents - #ValueAnalysis is central to #healthcaremanagement and our #supplychainmanagement discussions this semester. #ProfTimRN #chazanoffschoolofbusiness City University of New York-College of Staten Island Association of Healthcare Value Analysis Professionals (AHVAP)

Association of Healthcare Value Analysis Professionals (AHVAP) Treasurer, Sharon Roberts, was one of the major contributing authors to the FDA's Critical Medical Device List Report. As part of the National Strategy, the government sought to develop a Critical Medical Device List (CMDL) to help government, business, and healthcare leaders focus supply chain resilience resources on those devices where disruptions can lead to serious injury or death to patients or providers. The intent of the CMDL is to facilitate resilience through policy, regulatory, procurement, production, and inventory decisions across the medical device supply chain. Thank you Sharon Roberts for being a tireless advocate for patient safety and the healthcare value analysis profession. #AHVAP #valuebasedcare #valuebasedhealthcare #valueanalysis #FDA #criticalcare Premier Inc.

𝐖𝐡𝐚𝐭 𝐢𝐬 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐅𝐨𝐥𝐥𝐨𝐰-𝐔𝐩 (𝐏𝐌𝐂𝐅)? 🤔 Dive deep into the essentials of PMCF under the EU Medical Device Regulation (EUMDR) in our enlightening webinar hosted in partnership with MedTech Intelligence, featuring insights from industry experts Parvathi Nambiar and Smridula Hariharan 💡 PMCF is a crucial component of the medical device lifecycle mandated by the EUMDR to ensure ongoing safety and efficacy of devices post-market. Learn about the objectives, scope, and critical importance of PMCF in maintaining regulatory compliance and safeguarding public health. 💻 Access the full webinar on-demand to gain a deep understanding of PMCF and its impact on the medical device industry: https://lnkd.in/gbskJ7ff 𝐊𝐞𝐲 𝐏𝐨𝐢𝐧𝐭𝐬 𝐂𝐨𝐯𝐞𝐫𝐞𝐝 𝐝𝐮𝐫𝐢𝐧𝐠 𝐭𝐡𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐚𝐫𝐞:  ▶ 𝐃𝐞𝐟𝐢𝐧𝐢𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐏𝐮𝐫𝐩𝐨𝐬𝐞 𝐨𝐟 𝐏𝐌𝐂𝐅: Understand what PMCF is and why it is a regulatory requirement under the EUMDR.   ▶ 𝐒𝐜𝐨𝐩𝐞 𝐚𝐧𝐝 𝐈𝐦𝐩𝐚𝐜𝐭 𝐨𝐟 𝐏𝐌𝐂𝐅: Explore how PMCF plays a vital role in continuous assessment of medical device performance and safety after they have entered the market.   ▶ 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐏𝐌𝐂𝐅: Gain insights into effective strategies for conducting PMCF, ensuring your devices comply with the latest regulatory standards.   ▶ 𝐄𝐱𝐩𝐞𝐫𝐭 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐏𝐌𝐂𝐅: Benefit from the expertise of seasoned professionals who outline best practices and methodologies for successful PMCF execution. Leverage Celegence’s expertise as you navigate the complexities of #PMCF to ensure your medical devices meet stringent regulatory standards and contribute to public safety. #EUMDR #MedicalDevices #RegulatoryAffairs #MedicalCompliance #MedTechInnovation #HealthcareRegulation #ClinicalDataManagement #MedicalDeviceCommunity #RegulatoryStrategy #MedicalSafety #ClinicalEvaluation #RegulatoryCompliance #PostMarketSurveillance #Celegence 

Do you know what PMCF is? In the world of medical devices, Post-Market Clinical Follow-up (PMCF) plays a pivotal role. It's not just a regulatory requirement, but rather an opportunity to continually enhance and improve the safety and performance of the devices. PMCFs are more than just a check in the box. They provide real-world evidence of a product and can be a powerful tool for product development, improvement, and market positioning. They bridge the gap between clinical trials and actual use, offering insights that can significantly impact product design and patient outcomes. However, conducting a PMCF is not without its challenges. Collecting and analyzing data, navigating regulatory barriers, and managing costs are just a few of the considerations. Nonetheless, the reward of a successful PMCF is worth the effort. By actively engaging in the PMCF process, manufacturers are not only compliant, but are also equipped with data and insights to their product. What do you think of PMCF? #MedicalDevices #PMCF #Medicine

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Collecting Post Market Clinical Follow-up (PMCF) data is essential for medical device manufacturers to become and remain MDR certified. Sponsored content from Purdie Pascoe: There are many ways to collect PMCF data, each varying in the level of evidence collected, cost, time and resource, with PMCF Surveys being a common but often poorly executed option. There are companies, such as Purdie Pascoe, who focus on the design, implementation and data analysis of PMCF Surveys, collecting both Level 4 and Level 8 data. Ensuring sufficient time is spend in the planning and the design of PMCF Surveys, ensures that they can be utilized as a cost-effective data collection method and not just a cheap option. That being said, with there being limited resources and guidance on how to best implement PMCF Surveys, they can often be challenging and many pitfalls can arise. To help Medical Device manufacturers with this, Purdie Pascoe has written an article on Level 4 high-quality PMCF surveys and recorded a webinar on PMCF implementation. The key learning objectives are outlined below: -Proper PMCF planning -Best practices for PMCF survey design  -PMCF survey implementation (from programming to recruitment)  -Key considerations & common pitfalls -What to do with the PMCF survey data? Download the article and watch the webinar recording here: https://bit.ly/4bpQaQu #pmcf #pmcfsurveys

Understanding medical billing is one thing – knowing which tools can help you efficiently drive reimbursement revenue is another. A comprehensive pharmacy medical billing solution can optimize reimbursement for an expanding array of services covered under the medical benefit. Discover which technologies can help ensure your pharmacy maximizes its revenue potential. Learn more: https://hubs.li/Q02nYctT0 #ForPharmacy #NavigatingMedicalBilling #PharmacyRevenue #PharmacyStrategy

Unlocking the Mystery of Sample Size Calculation for PMCF Studies in Medical Devices! Determining the sample size for Post-Market Clinical Follow-Up (PMCF) studies mirrors the approach used in calculating sample size for traditional clinical investigations. However, it's crucial to note that this process can vary from one study methodology to another. While this overview simplifies the process, it sheds light on the essential steps required: 🔍 Identify the requisite data/evidence to align with device claims.   📋 Identify specific PMCF activities/methods for data collection.   🎯 Define the objective of each activity clearly.   📊 Identify primary endpoints and variable types.   📈 Determine statistical tests and hypotheses to validate objectives.   ➗ Employ equations tailored to calculate sample size, considering relevant attributes/constants.   🔢 Utilize the sample size to estimate the required number of cases for each PMCF activity. It's imperative to document (and justify) the sample size calculation process meticulously within your PMCF plan. #PMCF #MedicalDevices #SampleSize #ClinicalResearch #DataAnalysis   

Conducting a risk-benefit assessment for your medical device is a crucial component of the clinical evaluation process, ensuring patient safety, Regulatory compliance, and effective lifecycle management. Moreover, documenting the analysis in the CER is an important task that you must undertake. To get a thorough understanding of risk-benefit analysis in the context of CERs, PMS, and PMCF activities, read our whitepaper! https://lnkd.in/dwrP5WkA #RiskAssessment #PatientSafety #ClinicalEvaluationReport #RegulatoryCompliance #Marketplace #DataCollection #ClinicalEvidence #LifecycleManagement #Whitepaper #Freyr