Ariadna Navarro Aragall, PhD’s Post

A couple of weeks ago, my colleague Elisa San Isidro and I, attended AECIC’s annual event. The event covered a variety of topics - from the implementation of the #ClinicalTrialRegulation and the decentralization of clinical investigations, to the validation of electronic systems and the role of #ArtificialIntelligence tools in clinical research. These discussions were, however, mainly focused on the pharma sector. While these are important, the #MedTech sector is a rapidly evolving industry with an increasing number of dedicated CROs. Yet, in Spain, there are limited events addressing the unique challenges faced by MedTech and #IVD CROs. So, here’s an idea for next year, AECIC what about including a panel discussion for MedTech and IVD #CROs? This could be a good opportunity to encourage dialogue and collaboration across different sectors.

🔊 𝗢𝗿𝗽𝗵𝗮𝗻 𝗗𝗲𝘃𝗶𝗰𝗲𝘀: 𝗡𝗲𝘄 𝗱𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 📑 Yesterday, the MDCG released its latest guidance document, #MDCG2024-10, defining #OrphanDevices (ODs) and providing guidance on the #ClinicalEvaluation of these devices. After reading this 33-page document (it seems the MDCG is developing quite a taste for lengthy guidance documents…), it’s clear that many of the considerations provided in the guidance apply to all devices, not just ODs. However, here are some 𝗸𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: ⚡️ An OD is defined as a device intended to treat, diagnose or prevent a disease or condition that presents in no more than #12000 individuals in the EU per year as long as there are insufficient alternative options OR the device offers expected #ClinicalBenefits compared to the existing alternatives. The document also defines orphan subpopulations and orphan indications. ⚡️ ODs can be placed on the market with #AcceptableLimitations in the amount and quality of pre-market #ClinicalData, provided certain conditions are met, including a PMCF plan to collect long-term data. ⚡️ Robust and high-quality #NonClinicalData is of increased importance for ODs with limitations in clinical data. ⚡️ #Users of the OD need to be informed of the OD status and its known limitations in clinical data. ⚡️ The #CEP for devices claiming OD status should include disease—and device-specific factors to justify their status. ⚡️ #Legacy ODs should also follow MDCG 2020-6 and 20223-7. In some cases, clinical data from #OffLabel use can be used to provide clinical evidence. ⚡️ When designing a #ClinicalInvestigation for ODs, recruitment challenges and sample size implications should be considered. ⚡️ If available and appropriate, data from the device's use in other non-orphan populations/indications may be partially or fully #extrapolated for clinical evaluation. ⚡️ The #PMCF process is even more important in these devices, as limitations in clinical data should be filled through appropriate PMCF activities. The PMCF plan for ODs should include the limitations in clinical data, a justification of how the chosen activities will address specific limitations and an explanation of how the data will be generated (time frame, milestones, etc). ⚡️ #NBs should check the OD status as soon as possible and consider it when reviewing the #ClinicalEvaluation. NBs can evaluate issuing certificates with specific conditions or provisions (as detailed in MDCG 2022-14) for ODs. NBs should, in this case, monitor compliance with these conditions/provisions. ⚡️ Manufacturers or NBs may consult #ExpertPanels regarding the OD status and the clinical data needed for the clinical evaluation of certain devices. Depending on the situation, advice should be provided within 60-120 days. #MedTech #MDR #OrphanDevices #Healthcare

𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗩𝗗 𝘀𝗲𝗰𝘁𝗼𝗿 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻 🔬 📣 The article co-authored by Beatriz Rodriguez Grande, NAMSA and me has been featured in the latest issue of #PMFarma. 💡 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 ✅ IVDs represent the largest growing segment in the #MedTech sector worldwide in terms of CAGR and sales. ✅ Holding a robust 10.9% share of the #European market and approximately 2% of the global IVD market as of 2021, #Spain stands as the fourth major player in Europe, following Germany, France, and Italy. ✅ In Spain’s IVD sector, industry leaders such as Grífols and Werfen play a significant role, yet it’s the vibrant ecosystem of #SMEs that forms the backbone of #innovation and growth. ✅ The trends driving the #growth of the IVD sector include early diagnosis, growth of personalized medicine and emergence of artificial intelligence. Discover the full narrative and more in-depth analysis in the article available on pages 46-49 of the journal’s website version: https://lnkd.in/d-vhKCGy

Last week’s #HRC event in #Barcelona left a lasting impression. This second-year event attracted over 2000 professionals from 50+ countries, with 200+ speakers and 80+ companies in Digital Health. My colleague, Elisa San Isidro and I had the opportunity to meet innovators using AI in healthcare. Kudos to Barcelona Health Hub for the well-organized event👏. The venue (#SantPau) truly reflected the spirit of the event and the region. I’m eager to continue the interesting conversations we initiated during the congress and, with NAMSA expertise, support innovators in their way to achieve CE-mark and FDA clearance. #DigitalHealth #AI #HealthcareInnovation

Next Thursday, I will be in Barcelona with Elisa San Isidro, NAMSA, attending the #HealthRevolutionCongress organised by Barcelona Health Hub! This event is the largest European Summit in Digital health, and I am looking forward to networking with #startups and other #stakeholders and discussing the challenges of today's healthcare landscape. #MedicalDevice #MDSW #Innovation #DigitalHealth

I have recently participated in the preparation of 3 insightful blog posts for NAMSA website. Go check them! 🤩 📲 𝗥𝗲𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝗶𝘇𝗶𝗻𝗴 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲: 𝗧𝗵𝗲 𝗿𝗶𝘀𝗲 𝗼𝗳 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗮𝗻𝗱 𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 with Richard Vincins and Jorge Delgado López Link 🔗 https://lnkd.in/dQRyg-X7 🏥 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗠𝗗𝗖𝗚 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 𝗼𝗻 𝗖𝗜𝗣 𝗮𝗻𝗱 𝗜𝗕 with Sara Finocchietti Link 🔗 https://lnkd.in/d-yxhryN ✍ 𝗕𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗳𝗼𝗿 𝗠𝗗𝗥-𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻𝘀 with Laura Martínez Campesino, PhD Link 🔗 https://lnkd.in/dvMUZFBR #MDR #EURegulations #RAQA #MedTech

#ESCMIDGlobal was an enriching four-day experience! During the congress, Matías Fernández Calas and I had the pleasure to reconnect with familiar faces and establish new relationships within the IVD sector. The final day we took the opportunity to end the congress with some fun at the booths, coming close to setting new records! Key highlights: 🔹 The evolving regulatory landscape presents its challenges, yet manufacturers remain committed to prioritizing the #EUmarket for their product launches. 🔹 The extension of the #IVDR has been met with gratitude by manufacturers, who continue to strive towards certification to meet the new timelines. Notably, many devices we encountered had already secured their IVDR CE-mark. 🔹 The recent #FDA rule on #LDTs will introduce further challenges for numerous US laboratories. Collaboration between manufacturers, laboratories, and CROs is critical. 🔹 #Spain has some great IVD companies! We had the opportunity to engage with several manufacturers and start-ups from Spain, gaining insights into the latest advancements in the field, ranging from AI software to direct blood sepsis diagnosis. Companies like Pragmatech AI Solutions, deepull, VIRCELL S.L., Certest Biotec, S.L. and Sener are making significant strides. Keep up the good work! 🔹 The scientific talks provided a wealth of knowledge and were nothing short of impressive. In conclusion, the congress was a really valuable experience. Moreover, the sight of rain in Barcelona, after months of drought, was a refreshing change.💧🌎 #IVD #MedTech #ESCMIDGlobal

First day at #ESCMIDGlobal in Barcelona with Matías Fernández Calas, NAMSA. We’ve been meeting with several IVD manufacturers, getting to know the latest innovations in the diagnostic of infectious diseases, and learning about their challenges to meet the #IVDR clinical and regulatory requirements. Looking forward to the rest of the event!

𝟱 𝗱𝗮𝘆𝘀 𝘁𝗼 𝗴𝗼 𝘂𝗻𝘁𝗶𝗹 #𝗘𝗦𝗖𝗠𝗜𝗗𝗚𝗹𝗼𝗯𝗮𝗹 𝘀𝘁𝗮𝗿𝘁𝘀!🙌🏼 My colleague Matías Fernández Calas and I will be representing NAMSA at the 34th ESCMID Global Congress from the 27th to the 30th of April in #Barcelona. Let's meet and discuss regulatory pathways and clinical strategies for IVDs and Medical Devices in #ClinicalMicrobiology and #InfectiousDiseases. #ECCMID #ECCMID2024 #ESCMID #ESCMIDGLOBAL #NAMSA #IVD #InVitroDiagnostic #MedicalDevice #ClinicalTrials #ClinicalStrategy #RegulatoryStrategy #FDA #IVDR #MDR