The FDA recently announced an update on the Payor Communication Task Force, which facilitates communication between medical device manufacturers and payors (insurance companies) to expedite patient access to innovative medical devices. Source: https://lnkd.in/gcmX2FBf The task force offers two programs: 1. Early Payor Feedback Program (EPFP): Allows manufacturers to receive feedback from payors on clinical trial design and data collection to support coverage decisions. 2. Parallel Review: Enables the FDA and CMS to review clinical trial data simultaneously, reducing the time between FDA approval and CMS coverage determination. The impact? - Manufacturers can design clinical trials to meet both regulatory and payor requirements, potentially expediting patient access. - Payors can provide input on data requirements, enabling them to make informed coverage decisions. - Patients may gain faster access to innovative medical devices. We support this effort from FDA by providing Real World Evidence (RWE) solutions that deliver actionable insights, support strategic decision-making, and improve patient outcomes. Visit our website to learn more about our RWE offerings: https://lnkd.in/gDeXU5YD Interested in discussing RWE projects? Schedule a consultation with Khooshbu Singh, our Business Development Director, RWE & Digital Transformation: https://lnkd.in/gj6P9yqV #FDAUpdate #MedicalDevice ##PayorCommunicationTaskForce #RealWorldEvidence #RWE #MaxisClinicalSciences
Maxis Clinical Sciences’ Post
More Relevant Posts
-
Clinical Writing Specialist | Clinical Evaluation Report | Clinical Strategy | Regulatory Compliance | Medical Devices | Startups
𝗠𝘆 𝟮𝟬𝟮𝟯 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗥𝗲𝗽𝗼𝗿𝘁 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴𝘀 𝗮𝗻𝗱 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗼𝗿 𝟮𝟬𝟮𝟰! 2023 was an interesting year in the clinical regulatory landscape. As more manufacturers have been audited under MDR, we have received new input from the Notified Bodies and are now understanding better the MDR requirements. 𝗛𝗲𝗿𝗲 𝗮𝗿𝗲 𝘁𝗵𝗿𝗲𝗲 𝗺𝗮𝗶𝗻 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝘁𝗼 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗳𝘂𝘁𝘂𝗿𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗥𝗲𝗽𝗼𝗿𝘁𝘀: • 𝗦𝘁𝗮𝘁𝗲-𝗼𝗳-𝘁𝗵𝗲-𝗮𝗿𝘁 (𝗦𝗢𝗧𝗔) 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 – I cannot emphasize this enough, it is essential to predetermine, while planning the Clinical Evaluation, the outcome parameters that will be later used to identify whether the clinical data collected on the evaluated device is at least as good as SOTA in medicine. And I can assure you and highly recommend that there is no other way to collect SOTA data, but systematically 😊 • 𝗦𝗶𝗺𝗶𝗹𝗮𝗿 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 – These are obviously part of the SOTA mentioned above but require their own emphasis. Different sections of the MDR allow the use of data on “equivalent or similar devices”. However, the similar devices review is needed as part of the regulation on Technical Documentation (Annex II), and it is therefore reasonable to include it under the Clinical Evaluation Report. To fulfill this requirement, I recommend you to provide a convincing demonstration of similarity table, literature review and vigilance review, and to use the same search methodology set for the device under evaluation. • 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟯-𝟳 – Unfortunately this valuable guideline is only applicable for Class III and implantable devices. MDCG 2023-7 took the complicated instructions presented in sections 4 to 6 in Article 61, and broke them down into separate cases in which exemption from clinical investigations is allowed. Many regulatory insights can be extracted from this text: one of them is permission to use the equivalency root for legacy devices (certified under MDD) without a business agreement with the other manufacturer. THIS IS WHAT I CALL GOLD. I hope the above is valuable and wishing you all a happy 2024! Please do not hesitate and contact me about your upcoming challenges 🧗♀️ We continue to pray for the hostages to return home ❤️ #HealthcareInnovation #ClinicalWriting #ClinicalandRegulatory #CER
To view or add a comment, sign in
-
Is Real World Evidence (RWE) the future of medical device compliance? In today’s fast-paced regulatory environment, RWE offers a game-changing opportunity for medical device manufacturers. By leveraging real-world data (RWD) collected from everyday healthcare settings, companies can speed up approvals, cut down on trial costs, and gain broader insights into patient outcomes. 🔍 In our latest carousel, discover: - What RWE is and how it works - The benefits of using RWE to streamline compliance - Key challenges you should know before diving in - The regulatory landscape: U.S. vs. Europe - How to maximize RWE for your devices with best practices Want to learn more? Check out our full video breakdown on https://lnkd.in/dZtJaKZN How do you see RWE shaping the future of medical device approvals? Let us know in the comments! 💬 #ClinicalResearch #RealWorldEvidence #MedicalDevices #RegulatoryCompliance #HealthcareInnovation #ClinicalTrials #MedicalResearch
To view or add a comment, sign in
-
Software for MedicalDevice | Health Data Interoperability | FHIR | IEC 62304 | FDA | HIPAA | Digital Healthcare | Security | Cloud | Mobile | EMR | Epic Integrations | Healthcare Data Warehousing | AI | CDSS | Telehealth
Software as a medical device (SaMD) has become prominent in healthcare, promising to enhance diagnostic and treatment capabilities through advanced digital solutions. This retrospective data analysis, leveraging US FDA databases, offers a comprehensive overview of SaMD integration, risks, and regulatory dynamics. It illuminates the crucial aspects of how these digital tools shape the medical device regulation and safety landscape. 1️⃣ Growth and Registration. SaMD has not registered at a significantly different rate from other medical devices, highlighting steady but modest growth within the regulatory framework. 2️⃣ Risk Classification. Most SaMDs are categorized as moderate to high risk, requiring specific pathways for regulatory approval. 3️⃣ Adverse Events. Despite the integration of SaMD into healthcare, adverse events related to these devices represent only a tiny fraction of total medical device reports. Thus, it’s possible to suggest a relatively safe integration into the market. 4️⃣ Regulatory Insights. The analysis of FDA databases, a goldmine of information, offers crucial insights into the classification and risk management of SaMD, guiding future regulatory strategies. 5️⃣ Safety Profile. The low incidence of adverse events associated with SaMDs underscores their potential for safe application in medical settings. 6️⃣ Market Dynamics. Grasping the market dynamics and regulatory pathways for SaMD is a strategic advantage. It equips manufacturers and regulators to align development strategies with compliance requirements. 🔗 This detailed review offers a thorough look into how SaMDs are managed within regulatory bodies. It sheds light on the challenges and advancements in integrating software-based solutions in healthcare. The findings from this analysis are pivotal for stakeholders aiming to navigate the complex landscape of medical device regulations. 📄 Aaron Ceross, Jeroen Bergmann. Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis. JMIR Biomed Eng, Vol. 6, Iss. 4, 2021. ✅ Subscribe to my newsletter and dive deeper into the digital transformation of healthcare: https://lnkd.in/eXV8wVFP Want to improve your healthcare practice and care delivery by creating robust SaMD solutions? Write to me to discuss the details, and my expert team will gladly assist you with your project! #medicaldevices #SaMD #medicalsoftware #healthtech #digitalhealth
To view or add a comment, sign in
-
Discover the insights on "Creating an Account in the SUGAM Online Portal and Leveraging the National Single Window System." Learn about CDSCO's SUGAM Portal in the medical device approval process in India, streamlining procedures, and fostering ease of doing business in the health sector. Read the full blog here: https://lnkd.in/grEXE_3g For expert guidance on navigating the NSWS portal or understanding regulatory requirements, reach out to 8C Healthcare today! #HealthcareRegulation #MedicalDevices #CDSCO #NSWS #SUGAM #HealthTech #Innovation #RegulatoryCompliance
To view or add a comment, sign in
-
Transformative technologies such as new implantable devices, artificial intelligence and software, and diagnostics have opened avenues for more efficient disease management. However, these demand a robust regulatory framework that facilitate innovation in medical technology (MedTech) while ensuring international harmonization and patient safety. Read about the UK MHRA's Regulatory Roadmap that covers some of the key milestones of 2021-2023 and planned activities for 2024-2025 to enhance the regulatory frameworks surrounding technological disruptors in healthcare https://lnkd.in/gDkkWiJ7 Reach out to DDReg for more information and support on medical device regulation & expertise regarding the UK regulatory landscape. Email us at [email protected] or submit your query here https://lnkd.in/dky_SKD7 #regulatoryservices #medicaldevice #artificialintelligence #MedTech #technology #pharma #MHRA #UK #patient #safety
Regulatory Roadmap for Access to MedTech - DDReg Pharma
https://resource.ddregpharma.com
To view or add a comment, sign in
-
#ICYMI Streamlined data collection offers several advantages that can significantly expedite the regulatory submission process for companies operating in regulated industries, particularly for medical devices with breakthrough device designation and through the Transitional Coverage for Emerging Technologies (TCET) pathway. We share four ways that a streamlined approach helps get innovative devices to market faster. https://lnkd.in/gJVTb3Kg #breakthroughdevicedesignation #medtech #FDApproval #regulatorystrategy #TCET #BDD #FDA
4 Ways Streamlined Data Collection Can Accelerate your Regulatory Submission — MedTech Impact Partners
medtechimpactpartners.com
To view or add a comment, sign in
-
🚀 Swissdamed Actors Module Go-Live in August 2024 🚀 We're excited to announce that the first module of the Swissdamed medical devices database will go live on 6 August 2024! This marks a significant step towards enhancing the registration and monitoring of economic operators in Switzerland. 🔹 Background: Due to the lack of an updated MRA with the EU, Swissmedic does not have access to the EUDAMED database. Since 26 May 2021, Swiss economic operators (manufacturers, importers, and authorized representatives) have been required to register with Swissmedic to obtain a Swiss Single Registration Number (CHRN). 🔹 Key Changes: End of PDF Forms: Applications for registration and CHRN changes will be accepted as PDF forms only until 26 July 2024. 🔹New Registration Process: From 6 August 2024, the registration of economic operators will be exclusively through the swissdamed portal at www.swissdamed.ch. 🔹 For Already Registered Operators: Data for approximately 3,700 registered operators will be migrated to Swissdamed. Registered operators will be informed by letter in early August and will need to verify their data once imported. 🔹 Device Registration: In June 2024, initial upload options for devices were tested by selected manufacturers and UDI agencies. The first sections of Swissdamed for voluntary device registration are planned for 2025, with compulsory registration to follow. This initiative aims to improve transparency, provide comprehensive information about medical devices on the Swiss market, and maintain an overview of the available range of devices. Have a look at our EU/UK/Swiss Rep services - https://lnkd.in/d23DMVjT #MedicalDevices #Swissdamed #Swissmedic #HealthcareInnovation #RegulatoryAffairs #ArazyGroup
To view or add a comment, sign in
-
Medical Science Liaison |Consultor científico |Medical Writer |Pesquisa Clinica| Medical Affairs| Analista de farmacovigilância Jr| Analista de pesquisa clínica Jr
Do you know about "State of the Art"? The expression "State of the art" or SOTA, describe products or advanced technologies in a specific area, such as medical devices and medications. It can refer to innovative and highly effective treatments for a specific medical condition. In summary, SOTA represents the most advanced and effective in a especific area. Have you ever done any work related to SOTA? Write in the comments. #SOTA #MSL #PesquisaClinica #MedicalDevice #
PhD, Biosensors | Regulatory Specialist | Helping Medical device manufacturers & health care companies build & execute their regulatory strategy.
🌟 Exploring the Significance of State of the Art (SOTA) Evaluation In our journey through the intricacies of #EUMDR, today we delve into an essential aspect: #StateoftheArt (SOTA) evaluation. Understanding and implementing SOTA is pivotal for manufacturers aiming to comply with regulatory standards and deliver safe, cutting-edge medical devices to the market. 🔎 What is State of the Art (SOTA)? As its core, SOTA refers to the latest technological and scientific advancements relevant to #medicaldevices. It encompasses not only current technologies but also foreseeable advances that could impact the safety and performance of devices. ✨ Why Does SOTA Evaluation Matter? Under EU MDR, evaluating SOTA isn't just a checkbox; it's a rigorous process that directly influences product safety and #regulatorycompliance. It guides manufacturers in: ♦ Defining and justifying the design and manufacturing choices ♦ Assessing risks and benefits based on the latest scientific knowledge ♦ Incorporating advancements to improve device effectiveness and patient safety 🛎 Outline of SOTA 1. Medical Condition and Treatment Landscape: Describe the medical condition that the device under evaluation addresses and overview of existing treatment options, including their limitations and effectiveness. 2. Positioning of Device Within Treatment Portfolio: Explain where the device under evaluation fits within the current treatment options. 3. Utilization of Data from Similar Devices: Analyze data from devices addressing similar medical conditions and use comparative data to justify design, performance claims, and risk assessments. 💡 Impact of SOTA on Product Lifecycle: By embracing SOTA, manufacturers can: ✔ Enhance safety: Implement the latest safety features and risk mitigation strategies ✔ Improve performance: Incorporate technological advancements for better device functionality ✔ Ensure Compliance: Align with EU MDR requirements, ensuring market access and patient safety 💠 Action Items for Manufacturers 🔲 Assess your current technology: Evaluate how your device design aligns with the latest technological advancements 🔲 Engage with experts: Collaborate with regulatory specialists and peers to stay updated 🔲 Conduct thorough assessments: Regularly update SOTA evaluations to maintain compliance and competitiveness 🤝 Join the Conversation 📌 Dive into the infographic to explore actionable insights for SOTA evaluation 📌 Share your thoughts on how SOTA impacts device development and regulatory compliance 📍 P.S. For insights into pre-clinical and clinical data requirements under EU MDR, explore my previous infographics here: https://lnkd.in/dEURxbCb, https://lnkd.in/d6r9Wbby
To view or add a comment, sign in
-
Have you read the FDA's recent draft guidance on RWE? In December 2023, the FDA released a Draft Guidance on Real-World Evidence (RWE) for regulatory decision-making, highlighting the increasing importance of RWE in understanding and regulating medical devices. "RWE is an important factor for understanding and regulating medical devices, and therefore, FDA encourages the medical community to learn more from routine clinical care to help support safety and effectiveness of medical devices. Use of relevant and reliable RWD to generate RWE can benefit stakeholders throughout the ecosystem, including but not limited to, patients, health care providers, manufacturers, and FDA." (Page 4 Lines 103 - 107) At 3Aware, we stand at the forefront of this paradigm shift, offering an aiSurveillance platform that not only aligns with but actively supports the FDA's vision. Our platform provides medical device manufacturers immediate access to clinical data, facilitating the filtering of device-specific data paired with longitudinal information sourced from patient records. This enables the generation of RWE that is both relevant and reliable. Want to learn more? Book a meeting with me here: https://lnkd.in/grpZ8YPp #FDA #RWE #Clinicalevidence #pmcf
meetings.hubspot.com
To view or add a comment, sign in
-
PhD, Biosensors | Regulatory Specialist | Helping Medical device manufacturers & health care companies build & execute their regulatory strategy.
🌟 Exploring the Significance of State of the Art (SOTA) Evaluation In our journey through the intricacies of #EUMDR, today we delve into an essential aspect: #StateoftheArt (SOTA) evaluation. Understanding and implementing SOTA is pivotal for manufacturers aiming to comply with regulatory standards and deliver safe, cutting-edge medical devices to the market. 🔎 What is State of the Art (SOTA)? As its core, SOTA refers to the latest technological and scientific advancements relevant to #medicaldevices. It encompasses not only current technologies but also foreseeable advances that could impact the safety and performance of devices. ✨ Why Does SOTA Evaluation Matter? Under EU MDR, evaluating SOTA isn't just a checkbox; it's a rigorous process that directly influences product safety and #regulatorycompliance. It guides manufacturers in: ♦ Defining and justifying the design and manufacturing choices ♦ Assessing risks and benefits based on the latest scientific knowledge ♦ Incorporating advancements to improve device effectiveness and patient safety 🛎 Outline of SOTA 1. Medical Condition and Treatment Landscape: Describe the medical condition that the device under evaluation addresses and overview of existing treatment options, including their limitations and effectiveness. 2. Positioning of Device Within Treatment Portfolio: Explain where the device under evaluation fits within the current treatment options. 3. Utilization of Data from Similar Devices: Analyze data from devices addressing similar medical conditions and use comparative data to justify design, performance claims, and risk assessments. 💡 Impact of SOTA on Product Lifecycle: By embracing SOTA, manufacturers can: ✔ Enhance safety: Implement the latest safety features and risk mitigation strategies ✔ Improve performance: Incorporate technological advancements for better device functionality ✔ Ensure Compliance: Align with EU MDR requirements, ensuring market access and patient safety 💠 Action Items for Manufacturers 🔲 Assess your current technology: Evaluate how your device design aligns with the latest technological advancements 🔲 Engage with experts: Collaborate with regulatory specialists and peers to stay updated 🔲 Conduct thorough assessments: Regularly update SOTA evaluations to maintain compliance and competitiveness 🤝 Join the Conversation 📌 Dive into the infographic to explore actionable insights for SOTA evaluation 📌 Share your thoughts on how SOTA impacts device development and regulatory compliance 📍 P.S. For insights into pre-clinical and clinical data requirements under EU MDR, explore my previous infographics here: https://lnkd.in/dEURxbCb, https://lnkd.in/d6r9Wbby
To view or add a comment, sign in
20,441 followers
More from this author
-
The Synergy of Adaptive Design and RWE in Modern Clinical Trials
Maxis Clinical Sciences 4w -
Indication / Label Expansion using Real-World Evidence
Maxis Clinical Sciences 1mo -
FDA Releases Final Guidance on Real-World Data from EHRs and Medical Claims Data to Support Regulatory Decisions for Drug & Biological Products
Maxis Clinical Sciences 2mo