George De La Rosa

The RADx Tech program propelled production of COVID-19 tests in the US during the pandemic by supporting developers with novel technologies through what is typically a multiyear process of development, validation, regulatory authorization, and manufacturing scale-up within a compressed timeline of six to 12 months; fulfilling the claim in its name, the “Rapid Acceleration of Diagnostics”. Now in the post-pandemic era, representatives of RADx have laid out how the program is transitioning and disclosed how it now aims to address many different conditions beyond respiratory diseases and with devices beyond in vitro diagnostics. The plan is for RADx Tech to "evolve into a broader medical technology accelerator platform” with several new programs in maternal health and fetal monitoring; and efforts that support diagnostics development for hepatitis C elimination, HIV viral load testing at the point of care, and mpox diagnostic lesion panel development. And these goals will need to be accomplished with an admittedly smaller budget. RADX had supported companies through "wraparound support” of the four verticals of technology development, regulatory, clinical, and commercialization. Testimonials from the innovators RADx Tech has supported, suggest the process was instrumental for commercialization; and many of these companies were academic spinouts, startups, and small- or medium-sized companies that may not have taken a product all the way through to marketing on their own. Now with less funding, RADX is adapting and for example, the HIV viral load program has a scaled down endpoint goal to de-risk the products rather than bring them all the way to market. An example of innovations in this area, is by a firm developing a system for the HIV viral load testing; that can perform molecular, immunoassay, enzymatic, and coagulation testing; using digital microfluidics and moving droplets about with electricity; that enables on-cartridge plasma separation from whole-blood samples; and can perform sample-to-answer PCR testing in 15 minutes. A company representative for this firm indicated that the most important aspect of the program is the "through line to FDA," adding, "I really think that with all government-commercial partnerships in the future, it should really be the standard." That facet is especially difficult with innovative technologies, he said, as the metrics and use cases often differ from predicate devices. "I think that more intention around paving the regulatory path is a key part of innovation that we could do better with as a whole."

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𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲: 𝗔𝗻𝗶𝗺𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 𝗳𝗼𝗿 𝗗𝗲𝗻𝘁𝗮𝗹 𝗕𝗼𝗻𝗲 𝗚𝗿𝗮𝗳𝘁𝗶𝗻𝗴 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 This draft document is hot of the FDA presses and ready for public comment. The devices within the scope of this draft guidance fall under regulations pertaining to one of the these product codes: LYC - Bone Grafting Material, Synthetic NPM - Bone Grafting Material, Animal Source NUN - Bone Grafting Material, Human Source Most bone grafting material devices are considered Class II devices by FDA, except those that contain a drug or biologic component, and are therefore subject to special controls, so plan your submission strategy accordingly. The draft guidance is open for public comment through May 28, 2024. Docket# FDA 2024-D-1242 (link in the comments below). #medicaldevices #regulatoryaffairs #FDA #compliance #quality #qualitymanagement #medtech #biotech #dentalimplants

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Threat modeling is a critical step in medical device cybersecurity, allowing you to proactively identify and mitigate potential threats. 🎯 FDA expects to see evidence of a thorough threat modeling process in premarket submissions. One common FDA objection we see is: "you did not provide threat modeling documentation." This makes it clear that threat modeling is not optional! It's a fundamental component of demonstrating a reasonable assurance of safety and effectiveness. The FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," emphasizes the importance of threat modeling to inform risk analysis activities (page 13). It should identify medical device system risks and mitigations and inform pre- and post-mitigation risks considered as part of the cybersecurity risk assessment. When conducting threat modeling, consider: - Potential adversaries: Who might try to exploit your device? - Attack vectors: How could they gain access to your device? - Vulnerabilities: What weaknesses could they exploit? - Potential impacts: What harm could they cause? Documenting your threat modeling process allows FDA to understand how you've identified and addressed potential cybersecurity threats, strengthening your submission. 📑

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If an ORM sells MRI’s for use on decade people, dogs, industrial or scientific manuals and software are not a trade secret. Uses Forensic Science MRI has a role in forensic science as well. In autopsies, MRI can provide a non-invasive way to examine the body, revealing details that might be missed in traditional autopsies. This is particularly useful when traditional autopsies may be culturally or religiously inappropriate. Studying Ancient Artifacts In a fascinating twist, MRI has been used to study ancient artifacts. For example, researchers have examined the internal structures of ancient Egyptian mummies without disturbing the wrappings. This has offered new insights into the mummification process and the health of ancient populations. Exploring the Ocean MRI technology has even been adapted for underwater research. Scientists use MRI to study marine life in their natural habitats, gaining insights into the physiology and behavior of various species without harming them. Diagnosing Emotional States in Animals Researchers have used MRI to study the brains of animals, such as dogs, to understand their emotional states. This research helps us understand how animals experience emotions, leading to better treatment and care practices. ISM 47CFR FCC § 18.213 Information to the user. Information on the following matters shall be provided to the user in the instruction manual or on the packaging if an instruction manual is not provided for any type of ISM equipment: (a) The interference potential of the device or system (b) Maintenance of the system (c) Simple measures that can be taken by the user to correct interference. (d) redacted § 18.207 Technical report. (b) A copy of the installation and operating instructions furnished to the user. A draft copy of such instructions may be submitted with the application, provided a copy of the actual document to be furnished to the user is submitted as soon as it is available, but no later than 60 days after the grant of the application. e) A statement of the rated technical parameters that includes: (1) A block and schematic diagram of the circuitry. (2) Nominal operating frequency. (3) Maximum RF energy generated. (4) Electrical power requirements of equipment. (5) Any other pertinent operating characteristics Waiting for an answer from the FCC on detailed questions. If CDRH isn’t interfering. FCC IG next. Abiy Desta Federal Communications Commission FDA Philips GE HealthCare Siemens Healthineers Federal Bureau of Investigation (FBI) United States Attorneys'​ Offices Marshall Shannon Tommy Geske IAMERS - INTERNATIONAL ASSOCIATION OF MEDICAL EQUIPMENT REMARKETERS AND SERVICERS American College of Radiology Radiological Society of North America (RSNA)

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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Providing a Software Bill of Materials (SBOM) has become increasingly important in demonstrating the cybersecurity robustness of a medical device. 📑 FDA now requires an SBOM for cyber devices, recognizing its value in managing cybersecurity risks. A frequent objection we see related to SBOMs is: "you did not provide a software bill of materials (SBOM), including commercial, open-source, and OTS software components as required by section 524B(b)(3) of the FD&C Act." This underscores the mandatory nature of providing an SBOM for applicable devices. It's no longer a "nice-to-have" but a critical component of your submission. The FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," details the importance of SBOMs for managing supply chain risk (page 17). A robust SBOM includes information on both device manufacturer-developed and third-party components, including purchased/licensed and open-source software. Ensure your SBOM includes: - Component identification: Name, version, and supplier for each software component. - Dependencies: Relationships between different software components. - Vulnerability information: known vulnerabilities associated with each component. - Known end of life dates: if known for the SBOM component. This can be impractical for software with a large number of open source libraries that do not have published end dates. Justify this to FDA. A comprehensive and well-structured SBOM not only helps FDA assess your device's cybersecurity posture but also contributes to transparency and trust in the medical device ecosystem. 🔐

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Blue Goat Cyber's Medical Device Cybersecurity Webinar Series Is Here! We’re thrilled to launch our first webinar in an ongoing series designed to tackle the most pressing challenges in medical device cybersecurity. This first session explored threat modeling, SBOMs (Software Bill of Materials), and risk management strategies—essential topics for protecting patient safety and healthcare data integrity. If you missed it, don’t worry! The replay is available now, so you can catch up on all our experts' insights and actionable strategies. 📺 Watch it here:(https://lnkd.in/gy_WhBnc). But we’re just getting started! Mark your calendars—our next webinar is coming up on December 23rd. Stay tuned as we continue to explore advanced cybersecurity practices to secure the future of healthcare innovation. 🔒 Whether in compliance, engineering, or leadership, this series is for you. Let’s work together to safeguard patient safety and fortify the healthcare ecosystem against cyber threats. #BlueGoatCyber #MedicalDeviceCybersecurity #CybersecurityWebinar #PatientSafety #SBOM #ThreatModeling #RiskManagement #HealthcareInnovation

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Our latest application note describes an automated headspace-SIFT-MS method that provides rapid, sensitive quantitation of benzene, 1,4-dioxane, and formaldehyde simultaneously in personal care products (PCPs). Results indicate that SIFT-MS holds an 8- to 30-fold throughput advantage over conventional gas chromatography (GC-MS) analysis. https://hubs.ly/Q02C7J_d0

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The FDA recently released its updated listing of all Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices cleared by the agency up to August, 8 2024. There is now a total of 950 such devices authorized for market use in the US. The vast majority of these devices are image based algorithmic devices cleared by the Radiology Panel, followed by Cardiovascular. The Orthopedic Panel has cleared a total of 6 AI/ML MSK since 2018 and another 28 MSK specific devices cleared by Radiology, bringing the total to 34 MSK specific AI/ML devices cleared as of the end of July 2024. This represents just over 3.5% of devices out of 950 total. I’ve combed through the current list to identify those clearances for AI/ML devices indicated for specific MSK applications. I hope those interested find this useful. I make no warranties regarding the accuracy of the content, as this is just my seasoned opinion based on my experience in the space. Of note: for the chart in the lower right, the category of “Bone Assessments” is a general catchall for those devices difficult to otherwise categorize. This includes devices that range in functionality from visual segmentation of spinal vertebral body anatomy to knee joint space measurements; all the way to only the 2nd De Novo awarded in this space for measuring low bone mineral density from x-rays. Key Takeaways: over half of the devices in this category were cleared in the last 18 months from January 2023 until mid-year 2024, and we still have 6 months to go for this year. I believe this period will be seen in hindsight as the inflection point the growth “hockey stick” bent northward as a pivotal moment in MSK AI/ML device development in the US. Also, the application ratios between Bone Assessments, Fracture Detection, and Pre-op Planning and Inter-op Navigation will shift as the latter is poised to experience significant market growth and demonstrate high clinical utility over the others going forward.     Speaking of which, congratulations to, and the first ever “Wicked Cool AI/ML FDA Device Clearance in MSK Award” is presented to Insight Medical Systems, Inc. (acquired by Enovis in June, 2024) for its ARVIS Shoulder 510k (K240062) cleared on April 29, 2024. This clearance seems to have hit the AI/ML device trifecta of a well-trained and constructed algorithm, cleared by FDA, with a real and impactful near-term clinical and commercial application. Also, AR/VR is just downright cool. I hope readers find this useful and I welcome feedback and collaboration on my approach for all the included FDA clearances and assumptions.

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Be careful when choosing a third-party testing lab, and if you do, be sure to review all the data they send to you before submitting to the FDA. Well, duh, Michelle, you might be saying. That's just plain old common sense. Apparently not. Earlier this year, FDA released a letter to industry regarding "𝘢𝘯 𝘪𝘯𝘤𝘳𝘦𝘢𝘴𝘦 𝘪𝘯 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘤𝘰𝘯𝘵𝘢𝘪𝘯𝘪𝘯𝘨 𝘶𝘯𝘳𝘦𝘭𝘪𝘢𝘣𝘭𝘦 𝘥𝘢𝘵𝘢 𝘨𝘦𝘯𝘦𝘳𝘢𝘵𝘦𝘥 𝘣𝘺 𝘵𝘩𝘪𝘳𝘥-𝘱𝘢𝘳𝘵𝘺 𝘵𝘦𝘴𝘵 𝘭𝘢𝘣𝘴. 𝘛𝘩𝘪𝘴 𝘢𝘭𝘢𝘳𝘮𝘪𝘯𝘨 𝘵𝘳𝘦𝘯𝘥 𝘩𝘢𝘴 𝘳𝘦𝘴𝘶𝘭𝘵𝘦𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘍𝘋𝘈 𝘣𝘦𝘪𝘯𝘨 𝘶𝘯𝘢𝘣𝘭𝘦 𝘵𝘰 𝘳𝘦𝘢𝘤𝘩 𝘢 𝘴𝘶𝘣𝘴𝘵𝘢𝘯𝘵𝘪𝘢𝘭 𝘦𝘲𝘶𝘪𝘷𝘢𝘭𝘦𝘯𝘤𝘦 𝘥𝘦𝘵𝘦𝘳𝘮𝘪𝘯𝘢𝘵𝘪𝘰𝘯 𝘰𝘳 𝘰𝘵𝘩𝘦𝘳𝘸𝘪𝘴𝘦 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘻𝘦 𝘮𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘧𝘰𝘳 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦𝘴 𝘸𝘩𝘰𝘴𝘦 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘪𝘯𝘤𝘭𝘶𝘥𝘦 𝘴𝘶𝘤𝘩 𝘥𝘢𝘵𝘢." In many cases, I bet this was a decision made solely on price, as so many pre-launch business decisions are. And I get it. Bringing a product to market is not cheap and I completely understand why a $15K testing budget is much more appealing than a $150K testing budget. So what should you keep in mind when selecting a testing lab? 𝗗𝗼 𝘁𝗵𝗲𝘆 𝗵𝗮𝘃𝗲 𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘀𝘆𝘀𝘁𝗲𝗺? Remember, YOU are still responsible for vendor/supplier/partner quality issues, so do your due diligence here, too. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲𝗶𝗿 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗰𝗮𝗽𝗮𝗰𝗶𝘁𝘆? Do they really have the capacity and the capability to perform mechanical, electrical, chemical, human factors and biocompatibility testing? And what about their turnaround times? 𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗵𝗶𝘀𝘁𝗼𝗿𝘆 𝗹𝗼𝗼𝗸 𝗹𝗶𝗸𝗲? I'll make this one simple: if they haven't had an FDA inspection (or competent authority/notified body assessment, or MDSAP audit, etc) and can't produce documents to prove it, walk away. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲𝗶𝗿 𝗰𝘂𝗿𝗿𝗲𝗻𝘁 𝗮𝗰𝗰𝗿𝗲𝗱𝗶𝘁𝗮𝘁𝗶𝗼𝗻? Just because they say they're accredited doesn't mean it's true, so do your due diligence and ask for proof before signing on the bottom line. There are other things to consider, of course, but these are the big ones. Choose carefully, and your submission will remain on course. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA

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This is a very important concept from the recent FDA draft guidance document on AI/ML. The Human-AI team is important because this reflects real world usage. What if an autopilot on an airplane flew seamlessly in test environments so the manufacturer removed all user interfaces? Would you want to sit in the back of this airplane? Or would you want the manufacturer to test the autopilot and human pilot in combination to ensure it makes the plane safer overall than the human pilot alone? What do you think? Comment below.

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Are you ready to dive deep into the FDA requirements for medical devices? We are thrilled to publish the first #blog of a five-part blog series on #security for #medical devices! For this exciting blog series, we collaborated with John Salvato, Ph.D. who has a 30-year career spanning quality assurance, manufacturing, and product development in the medical device and automotive industries. In this first blog, we give you lots of insight into how the security landscape for medical devices has evolved over the past years and the role the FDA plays in this. In the next blogs, which will be published over the course of November, we will detail each artifact requested by the FDA, such as Threat Modeling, Testing, and Vulnerability Management. Read blog #1 FDA Blog Series: The importance of Secure Product Development for Medical Devices: https://lnkd.in/dd2AX7V9

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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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Don't get trapped in the Regulatory Room. Locked door, no windows.. Happens all the time in early-stage MedTech. Regulatory is treated as the be-all, end-all. Teams take regulatory guidance as gospel. And ignore the most important factors -- around marketability. Don't get me wrong -- Regulatory Strategy is crucial. But, it needs to FOLLOW the right Market Strategy. ✅ Do the indications serve your target market? ✅ Do your medical claims provide differentiation? ✅ Does the intended use support the value prop? ✅ Will copycats easily follow the path you pave? These types of questions relate to the marketability of your medical device. And that's what you should care about. Your ultimate destination in MedTech is Market Adoption. Regulatory clearance is one of the hills to climb along the route. == Want to avoid the Regulatory Room? Join 1,500+ MedTech professionals for tips, tools, and insights at buff.ly/3xkxrXM #medtech #medicaldevices #regulatory #marketfirstmedtech

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Staying on top of clinical and device data + regulation is almost mission impossible. Not anymore (!), with BioT’s Regulatory-Aware Analytics Framework A game-changer for MedTech companies! Instead of juggling multiple platforms to manage compliance and data analysis, our framework provides a unified solution that automates regulatory compliance, enables customization of dashboards, and secure analysis of data - all while ensuring HIPAA and GDPR compliance within a single, integrated platform. And the best part? You don’t need to be a tech expert to use it. We use NoCode/LowCode. #Cloudconnect #Connectocloud #medicaldevices

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There's still time to register for our 𝙁𝙍𝙀𝙀 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗮𝗶𝗺𝘀 𝗠𝗮𝘀𝘁𝗲𝗿 𝗖𝗹𝗮𝘀𝘀: https://lnkd.in/gefHuRW4 Join us this 𝗧𝗵𝘂𝗿𝘀𝗱𝗮𝘆, 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝟬𝘁𝗵 𝗮𝘁 𝟭𝟮𝗻𝗼𝗼𝗻 𝗘𝗮𝘀𝘁𝗲𝗿𝗻 for a lively discussion of what the FTC and FDA will and will not tolerate.....er, accept. Before you put pen to paper, crafting the claims that will bring throngs of happy buyers to your website, be absolutely certain you know what you can and cannot say about your device. Don't fall prey to pressures to make the device sound more fantastical than it is. Stick to the truth, and what your data can support, and your sales will be just fine. Trust me - you may get away with grandiose claims and unsubstantiated marketing promises for a short time, but the FDA will ALWAYS catch up with you in the end. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA #510k #marketing

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💥 We have to acknowledge a new reality for medical devices. 👇 In this brief clip Randy Horton points out how we no longer have "direct control" over our devices, and that a new approach to risk management is needed. ============================== 💕 Love this quick insight? ♻ Repost and share with others. #letstalkrisk #riskmanagement #medicaldevices #livideo

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