Alexia Haralambous

Did you catch the Design For Manufacturability (DFM) Q&A between MRPC and Medical Product Outsourcing? If not, give it a read. Jeff Randall, PE, MRPC's Vice President and Sean Fenske, Editor-in-Chief at MPO discuss when DFM should take place in the medical device manufacturing process, "tools" involved, and how to properly leverage external resources to properly implement DFM. https://lnkd.in/gTdtxZs7 #medicaldevices #medicaldevicemanufacturing #medicalmanufacturing #designformanufacturability #medicalcomponents #medicalinnovation

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Discover why integrating human factors engineering early in the design process is crucial for medical device success. This MD+DI article shares insights from Virginia A Lang’s session at our recent Medical Device Playbook event and sheds light on how prioritizing human factors testing can lead to regulatory approval, marketability, and profitability. #medtech #humanfactors #medicaldevices

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An important read. Compliance to regulations are a critical starting point but going beyond will set medical device makers apart. Development teams should understand that meeting FDA HF guidance is not a final measure of overall usability and compliance with industry best practices. #impact #designleadership #humanfactors

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𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗨𝗽𝗱𝗮𝘁𝗲𝘀: 𝗪𝗵𝗮𝘁 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗡𝗲𝗲𝗱 𝘁𝗼 𝗞𝗻𝗼𝘄 𝗳𝗼𝗿 𝟮𝟬𝟮𝟱 𝗮𝗻𝗱 𝗕𝗲𝘆𝗼𝗻𝗱 𝗣𝗼𝗱𝗰𝗮𝘀𝘁 In this episode of the Global Medical Device Podcast, Etienne Nichols 🎙️ sits down with Leonard (Leo) Eisner, founder of Eisner Safety Consultants - a leading voice in #IEC60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, & how MedTech professionals can prepare for the future.

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Day 5/12 highlighting innovation and achievement in #medicalimaging Subtle Medical ✅ FDA Clearance for SubtleSYNTH™ - the industry’s first AI-powered synthetic imaging software, generating STIR images with zero acquisition time, boosting MRI efficiency and accuracy! 🚀 Launch of Subtle-ELITE™ Suite - unveiled at #RSNA2024, this suite of tools is revolutionizing #radiology workflows, making diagnostics faster, smarter, and better for both patients and providers. 🤝 Strategic Partnerships - partnered with 626 to upgrade aging MRI systems, improving access to state-of-the-art imaging. Collaborated with Telix Pharmaceuticals Limited Pharmaceuticals to enhance PET imaging speed and quality for cancer diagnostics. 🌍 Global Recognition - honored as CB Insights GenAI 50 and Top AI 100 company, 🔬 R&D Expansion - secured a $2.3M NIH grant to expand SubtleSYNTH to brain and musculoskeletal imaging, paving the way for even broader impact. Josh Gurewitz, MBA, Praveen Gulaka, Enhao GONG, Ajit Shankaranarayanan, Anand Shah, Lara Porterfield MBA, Anna Menyhart-Borroni, Sasikanth Battula, Ronny Elor, Brad Beeney, Greg Zaharchuk, Miriam Murase #medicalimaging #radiology

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Opportunity

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Discover how the InstadoseVUE dosimeter's advanced motion-sensing technology and unique compliance star feature provide immediate visual confirmation that dosimeters are actively worn. Learn more about how these innovations enhance safety and accountability in your radiation safety program. Read more [link] #InstadoseVUE #RadiationMonitoring #RadiationBadge https://hubs.li/Q02NQNWf0

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Only one month left! MDIC’s Annual Cybersecurity Maturity Benchmarking Assessment is closing soon. This confidential assessment provides vital insights into your organization’s cybersecurity posture, helping identify improvement areas and benchmark against industry peers. Gain actionable insights to protect patient safety, data privacy, and product integrity. Don’t miss this opportunity to strengthen your cybersecurity posture. Take the assessment now: https://lnkd.in/gaVUKFKK

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Security testing is important for connected devices, but should not be the only evaluation conducted to assess the security architecture. Remember, ‘layers’ of evaluations are best.

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Did you catch the Design For Manufacturability (DFM) Q&A between MRPC and Medical Product Outsourcing earlier this year? If not, give it a read. Jeff Randall, PE, MRPC's Vice President and Sean Fenske, Editor-in-Chief at MPO discuss when DFM should take place in the medical device manufacturing process, "tools" involved, and how to properly leverage external resources to properly implement DFM. https://lnkd.in/grPTw8fA #medicaldevices #medicaldevicemanufacturing #medicalmanufacturing #medicaldevice #medicalcomponents

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FDA issued PSA today titled "Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage." To be honest, I had no idea CT could interfere with implantable / wearable electromechanical devices, the issue at hand was typically MRI exposure and MRI compatibility. I wonder if this is something new with the affected devices in terms of an incompatibility, something new with CT machines (higher operating power or otherwise operating differently?) or a combination of the two. It appears according to the FDA the most issues arise with regions of body that are targeted for CT and also have some kind of electromechanical device in that targeted area (but not exclusively). But "high strength radiation therapy procedures" were also mentioned as an interference source, such as gamma ray therapies, which is different than a typical CT. Depending on how this all develops, this may result in future labeling statements for electromechanical products akin to MRI compatibility, but at this point it is way too early to determine if that may occur.

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The third blog in our series, "The Overtures of Human Factors Guidance for U.S. Submission, Part 1: Origins and History," is here! It's the first half of a two-part exploration into how medical devices get the green light from the FDA, focusing on human factors and usability. In this blog, Part One: Origins and History, we're diving into the backstory of how regulations for medical devices came about, the rise of human factors engineering, and the folks who paved the way for today's standards. Read the blog for more detail on: - Blast from the Past: We'll take you back to the 1960s and walk you through the major milestones that shaped the rules for medical devices. - Human Factors Unveiled: Find out how human factors engineering became a big deal in the 1990s and why it's crucial for making devices safe and user-friendly. - Who's Who in Regulations: Get to know some key players like AAMI, ISO, and IEC, and how they keep things legit in the medical device world. Read the blog here https://hubs.li/Q02vyk4Q0 #HFE #humanfactors #medicaldevices #medicaldevicedevelopment #FDA #blog

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Determining when a software change to an existing medical device requires a new 510(k) submission can be complex. Our latest article dives into the FDA's criteria, guiding manufacturers on assessing changes that may impact device safety, effectiveness, or intended use. Read the full article to learn more! #medicaldevices #510k #FDAcompliance #regulatoryaffairs #softwareupdates #medicaldeviceregulations #SaMd

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Take a minute to learn more about how Design for X (DFX) methodology is applied to address unmet needs when designing a new medical device product. Visit The Impact Blog from Boston Engineering: https://hubs.li/Q02R1fS-0

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Medical devices are rarely perfect, and complaints do happen. When they do, the manufacturer’s response is critical.    If a firm quickly investigates the issue, creates and implements a corrective action plan and successfully addresses the problem, then they are on the right path.   If they don’t, they may find themselves on the receiving end of an FDA enforcement action, which can range from an untitled warning letter or recall to injunction, criminal prosecution and - eventually - a consent decree. If your organization has been tasked with remediating a Form 483 or other FDA enforcement action, Reliant Life Sciences can help.    We provide tailored solutions to remediate non-conformances and implement sustainable processes that prevent future issues. With a proven track record, we’ve helped medical device manufacturers overcome complex regulatory and quality challenges, including Form 483 and consent decree remediation.    Our strategic expertise enables swift resolution of enforcement actions and device defects, reducing risks, safeguarding market share, and upholding consumer safety.    Don’t let FDA enforcement actions jeopardize your reputation. Reach out to Reliant today to restore compliance, reinforce trust, and secure your business’s success.     https://lnkd.in/eCcEdDSY    #lifesciences #qualityassurance #pharma #biotech #qualitymanagement #medicaldevices #compliance #pharma #medtech #remediation #form483 #warningletter

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What 'old school' medtech teaches us: 👉 Design devices for physician preference 👉 Stay stealth as long as possible 👉 Avoid FDA until submission 👉 Avoid clinicals (time, $) 👉 Take lowest bar through regulatory 👉 Hire VP, Sales to push product A better approach: 👉 Design devices for #valueanalysis 👉 Get customer feedback, constantly 👉 Conduct Q-Subs early, often 👉 Derisk through data collection 👉 Let marketing drive reg. pathway 👉 Promote outcomes for market pull

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Hello everyone, my name is matthew walker with medical device academy and this is the human factors tip of the week for the week of September 3rd. Usability requirements for the FDA can be confusing and that isn’t just for 510(k)’s with established predicate devices. It gets even more complicated with de novo submissions. The FDA actually has a dedicated Human Factors Team at the Center for Devices and Radiological Health. On their bio page you can see that the FDA views usability as part of your device’s Quality Management System, Design Validation, Medical Device Reporting and Post-Market Surveillance processes. They can be reached by email, and if you want to ask questions about how to apply their usability guidance to your device, their contact phone number is on the front page of the guidance document itself. #FDA #humanfactors #medicaldeviceregulations #humanfactors #usability #usabilityengineering #medicaldevices #medicaldeviceregulatoryaffairs #medicaldeviceacademy For those following along at home, the 'Usability Guidance' referenced is "Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: February 3, 2016" and the phone number is on the bottom left hand of the cover page. The FDA's Human Factors Team will also show up if you search "FDA Human Factors Team".

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Human Factors Engineering for Medical Device Design and Development During our in-person training over October 23 and 24, we will share and demonstrate how to apply human factors engineering techniques to the design and evaluation of medical and drug-delivery devices. You will learn best practices for learning about target users and their work environments and review how to use this information to support device safety, effectiveness, and ease of use. We will introduce three different methods for evaluating the safety and usability of devices, explain what items should be considered when selecting a method, and provide hands-on experience applying each of the methods through group activities. Register now: https://hubs.la/Q02MbrsR0 #medicaldevice #pharma #biotech #medicaldevice #biomedicalengineering #HFE #HumanFactorsEngineering #humanfactors #medtech #productdevelopment

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