Fern.ai’s Post

FDA inspections are nobody’s idea of a good time. However, proper planning can go a long way to not only ensuring baseline compliance, but also to establishing an effective corporate culture and building long-term company value. In this edition of Consultants Corner, we spotlight advice from Jamie Harris, MPH, RAC and Nancy Lince, RAC, who discussed the issue onstage last month at the MedTech Strategist Innovation Summit in Dublin: https://bit.ly/44EOS1y #medicaldevices #medtech #fda #InnovationDublin24

Conclusion of the 10th Annual Innovation Summit Dublin 2024 is a panel session you can’t miss out on: “FDA Inspections: Getting Prepped and Avoiding Pitfalls,” moderated by David Filmore, Executive Editor of Market Pathways, MedTech Strategist's sister publication focusing on regulatory, reimbursement and market access: • Nancy Lince, RACé, President and CEO, Lince Consulting • Jamie Harris, MPH, RAC, Senior Manager, Regulatory Affairs, ICON plc Key takeaways: • Given that the vagaries of MDR make the “FDA First” strategy more attractive, be prepared: avoid pitfalls around FDA inspections. • Build a quality system early, and remember, not all quality systems are alike. It depends on your size and business. Remain informed on new articles, conference updates and more with our helpful #medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

This summer is flying - last month, I had the opportunity to attend Drug Information Association's annual conference - where they celebrated 60 years of collaboration on drug development and the future of therapy development. There are some key trends happening in clinical research that is evidence of the greater healthcare landscape: 1) topics that we have TALKED about for years are finally receiving federal regulation where companies are needing to take action on change 2) a shift is happening from: a healthcare industry that traditionally dictated to patients vs. now where we are seeing a demand from patients to be involved and influencing every step of the way from clinical trial design to value-based outcomes in clinical care 3) healthcare is trying to figure out how to use technology to solve its biggest problems...but if we move with haste without thoughtful change management, technology can become a burden for business and a roadblock for patients...AI has clear promise and benefits, but humans are still needed for intentional implementation. A couple things I thought were missing from the conference - a conversation about mental health and metal health studies, and women's health. Women are represented in just 40% of studies, even in diseases that are female-dominant. And when you track the #1 issue when ranked by burden - it's mental illness, also female-dominant. Track that against funding, and it falls to #5. Harvard's Study shows females underrepresented in key disease clinical trials: https://lnkd.in/gJp8KWkX Nature's Women's health research lacks funding - these charts show how: https://lnkd.in/gF-7cXMF We need to do better 💪

🌸 𝐖𝐡𝐞𝐫𝐞'𝐬 𝐭𝐡𝐞 𝐒𝐩𝐫𝐢𝐧𝐠 𝐁𝐮𝐳𝐳 𝐢𝐧 𝐌𝐞𝐝𝐭𝐞𝐜𝐡? 🌸 We are excited to announce the publication of a new edition of "𝐁𝐨𝐥𝐥𝐞𝐢𝐧𝐢𝐧𝐠𝐞𝐫'𝐬 𝐁𝐞𝐟𝐮𝐧𝐝" by DeviceMed.   In his latest commentary, Stefan Bolleininger explores the current state of regulatory affairs in the medtech industry. Highlights include updates on postponed IVDR deadlines, insights from the latest regulatory events, and the practical application of new guidelines. As the industry navigates these changes, staying informed is key to compliance and innovation.   For the complete article, follow this link: https://lnkd.in/debeQV35 #MedTech #RegulatoryAffairs #IVDR #HealthcareInnovation #DeviceMed

💥 Excited to Present at the 2024 MedTech Regulatory Global Pathways Virtual Summit 🔊 Delighted to announce that I will be speaking at the free Virtual Summit tomorrow, February 7th, focusing on the U.K. and Northern Ireland.   ✅ Be sure to register now: https://lnkd.in/e-AHQTUP 🆓 This free webinar will be recorded and made available to all registrants. This 2-hour virtual summit is a unique opportunity to gain strategic insights into MedTech regulations across the EU, the U.S., and the U.K. 🎯 During my session, I will cover the following: - U.K. and Northern Ireland Regulations: Insights into the unique regulatory landscape. - Post-Brexit Changes: Strategies for adapting to the new regulatory environment. - Effective Market Entry: Tips for navigating and succeeding in the U.K. MedTech market. This is a must-attend for professionals in the U.K. MedTech space. See you there! Plus, offering an expert overview: Gert Bos, PhD, FRAPS Bos, Ph.D., (@)QServe Group, will cover the EU requirements Michelle Lott, RAC, leanRAQA, will explore the U.S. and FDA regulations. David Filmore, Market Pathways will moderate the discussions. #medtech #UKRegulatoryAffairs #Brexit  #mlv #UKRP IMed Consultancy Ltd OutspokenPR

🚀 Less than 24 hours... It's not too late to register for "2024 MedTech Regulatory Global Pathways Virtual Summit," presented by Market Pathways and MedTech Leading Voice. Register now: https://lnkd.in/gDSih8JR This is your opportunity to gain unique strategic insights into MedTech regulations across the EU, the U.S., and the U.K. It will feature presentations and discussions from three great experts: Matt Burton on UK and Northern Ireland, Gert Bos, PhD, FRAPS on the EU Michelle Lott, RAC on the US FDA - Expert Discussions: Guiding talks with top MedTech regulatory experts. - Global Perspectives: Synthesizing global and regional regulatory insights. - Roundtable Insights: Facilitating dynamic discussions on regulatory strategies. Join me (and moderator David Filmore!) for an exploration of MedTech regulations and their impact on the industry. *This free webinar will be recorded and made available to all registrants. hashtag #MedTechSummit hashtag #RegulatoryInsights hashtag #HealthcareModerator hashtag #mlv hashtag #fda hashtag #regulations

Looking forward to the insight shared on next week's webinar - Strategies for Navigating the EU #MDR Extensions Deadline! (Tues., June 11th at 9am EST) 1MED founder, Enrico Perfler, joins an impressive duo from GG - Etienne Nichols & Chris Rush - as they chat best practices in clinical data collection, navigating current and future regulatory challenges, the case for making the EU the first market of choice to launch your #MedicalDevice product, and more. 1MED SA Greenlight Guru #EU #MedDevice #MedTech #Quality #Regulatory #Clinical

🤝 The #RSIDM24 Forum is about to kick off! We're eager to connect with attendees at Booth 313 who are as passionate about regulatory affairs as we are. Let's make this summit an unforgettable experience together. See you at our booth! 🌐  #conference #regulatoryaffairs #healthcare #technology #innovation #productivity

🥂 Thank you to all 685 registrants and 201 people listening in live at the 2024 MedTech Regulatory Pathways Virtual Summit this morning! 💻 This was a free two-hour long webinar by Market Pathways and MedTech Leading Voice featuring conversations with: • Gert Bos, PhD, FRAPS, from Qserve Group, discussing EU regulations. • Matt Burton from IMed Consultancy Ltd, outlining the regulatory environment in the U.K. and Northern Ireland. • Michelle Lott, RAC, from leanRAQA, providing insights on U.S. and FDA compliance. • David Filmore of Market Pathways, who guided the conversations as ther moderator. 🌐 The sessions were chock full of in-depth intelligence about facts on the ground in the UK, EU, and US, and also included insights on where the three systems align and misalign, and how to approach global go-to-market strategies. Look for more detailed takeaways from the Summit soon in Market Pathways. #MarketPathways #MedTechLeadingVoice #medtechindustry #medtechinnovation #fda

The endorsement of KOLs can add credibility to your #MVP and reassure stakeholders. A solid quote from a recognized scientific authority can make an impactful impression. QualWorld's Experts Advice unit connects you with KOLs, market access experts and regulatory experts for one-on-one consultations. #medtech #investmentpitch #healthcaremarket #businessangels