Richard Counts

IOS Bite Alignment wisdom with Naren Rajan DMD, FAGD

9

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."

1

🚀 Starting Strong with Product Design! 🚀 A successful project begins with a solid foundation, and checking over product design is the critical first step. We start by detailing the user needs identified by your team, enabling the precise lower-level design necessary for compliance. Whether you use electronic traceability systems or prefer paper-based systems, we've got you covered for: * Systems Engineering & Architecture * User Needs, System Requirements, & Compliance * Scalable Architecture for Future Features * Mapping & Traceability from System Requirements to V&V Let's set your project up for success from the start! 💡 #tech #SystemsEngineering #Traceability #MedTechman #medtech #technews

18

This is optimal.

12

🤖 𝗦𝗵𝗮𝗽𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗥𝗼𝗯𝗼𝘁𝗶𝗰 𝗦𝘂𝗿𝗴𝗲𝗿𝘆: 🤖 𝗞𝗲𝘆 𝗗𝗿𝗶𝘃𝗲𝗿𝘀 𝗮𝗻𝗱 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗦𝘂𝗿𝗴𝗶𝗰𝗮𝗹 𝗥𝗼𝗯𝗼𝘁𝗶𝗰𝘀 𝗦𝗽𝗮𝗰𝗲... 💭 What’s fueling surgical robotics, and what barriers stand in the way? 💭 If you’re interested in the 𝗛𝗢𝗧𝗧𝗘𝗦𝗧 𝗧𝗢𝗣𝗜𝗖 𝗜𝗡 𝗠𝗘𝗗𝗧𝗘𝗖𝗛... 𝗦𝗨𝗥𝗚𝗜𝗖𝗔𝗟 𝗥𝗢𝗕𝗢𝗧𝗜𝗖𝗦, then this one's for you. I recently authored and published an article on Surgical Robotics Technology website. In this piece, I dive into the critical growth factors and the top challenges impacting surgical robotics. 𝗛𝗲𝗿𝗲 𝗮𝗿𝗲 3️⃣ 𝗺𝗮𝗷𝗼𝗿 𝗽𝗼𝗶𝗻𝘁𝘀 𝗜 𝗰𝗼𝘃𝗲𝗿: 🔬 How rapid technological advancements and #innovation are driving precision and efficacy in #surgical procedures.... 📈 What the current market dynamics for #surgicalrobotic systems mean for developers and investors alike... 📓 The implications of complex, changing, economic and regulatory landscapes on development timelines and market entry.... A huge thank you to the following for their collaboration, their insights and their wisdom into this piece: 🤖 Greg Roche, CEO Distalmotion 🤖 Jaume Amat Riera, CEO Rob Surgical 🤖 Jerry Chen, CEO Brain Navi Biotechnology Co., Ltd. 𝗖𝗵𝗲𝗰𝗸 𝗼𝘂𝘁 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝘁𝗼 𝗲𝘅𝗽𝗹𝗼𝗿𝗲 𝗵𝗼𝘄 𝘁𝗵𝗲𝘀𝗲 𝗱𝘆𝗻𝗮𝗺𝗶𝗰𝘀 𝗰𝗼𝘂𝗹𝗱 𝘀𝗵𝗮𝗽𝗲 𝘁𝗵𝗲 𝘀𝘂𝗿𝗴𝗶𝗰𝗮𝗹 𝗿𝗼𝗯𝗼𝘁𝗶𝗰𝘀 𝘀𝗽𝗮𝗰𝗲 𝗶𝗻 𝟮𝟬𝟮𝟱 𝗮𝗻𝗱 𝗯𝗲𝘆𝗼𝗻𝗱: ⤵ https://lnkd.in/ebtxgFpD As always, I’d love to hear your thoughts! How do you think these trends will impact the #Medtech landscape? #medtech #medicaldevice #surgicalrobotics #roboticsurgery #robotics #roboticassistedsurgery #minimallyinvasivesurgery #mis #surgical #executivesearch #executiverecruitment #healthtech #healthcare #innovation Surgical Robotics Technology Josef de Pfeiffer

53

3 Comments

I love all the folks over at Informa and am honored to present a webinar with Omar Ford called Beyond Human Limits: The Rising Role of Robots in Surgery We'll be chatting about surgical robotics, where it's come from, where it's going, and how AI may shape future applications. Register for free with the link below https://lnkd.in/eBZEiyPj #AI #INFORMA #SURGICALROBOTS #MEDTECH

9

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.

5

🤠 When should you document your medical-devices software architecture? A few years ago, I would have answered "start early and update it throughout the project!" Here's how I'd answer it today: It depends. It may be appropriate to wait until just before you submit your 510(k). The quality/regulatory people may go 🤯 what!? Let me explain. As with all documentation, there is a cost to creating and maintaining architectural views. Thus to answer this question you should ask: What problem are you solving with your software architecture documentation? Is it to 1️⃣ To plan and coordinate the software development of a new project? 2️⃣ To explain your software's architecture succinctly to to FDA reviewers? If the answer is 1️⃣, then perhaps except for very small projects or teams, doing some design is very useful early on! These are the design outputs and cybersecurity views that should be entered into your QMS. If it is for 2️⃣, you may want to wait until the end of the project. Let me explain. Not only will this avoid re-work as your software evolves (and it will), but also the architecture views that are useful to the FDA are often different than what is useful for your internal team. They are different audiences with different needs. It is often best to wait to create these diagrams in the context of the full submission and in a way that's useful to the FDA. I hope to get into this in a future post. When do you typically document your software architecture? What types of diagrams do you find useful? What tools do you use? I'd love to hear in the comments. I you like this content, you may enjoy other articles me and our team at Innolitics have written about medical-device software development and regulations at https://lnkd.in/etpxPeBg #medtech #medicaldevices #samd #simd #softwareengineering #softwaredevelopment #softwarearchiecture

46

17 Comments

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.

17

Great points Linas Beliūnas. The iPhone has seemed to have reached a stale plateau while Android devices have seemingly led the cellular market in feature innovation, both in software and hardware (I.e. folding displays, image editing etc.). The innovations you point to are worth noting however I would argue that none are so innovative that the change the game. Spend any time with their software products and you will soon experience the mediocrity of their designs. At some point we have to speak honestly and say out loud that the emporer has no clothes and that Apple’s incrementalism is what we should expect from now on. Apple is now just another bloated mega-corporation living on reputation and incapable of deep innovation, not the bright upstart they used to be.

3

1 Comment

Why the grooves? It's a question many have asked. They're patent pending, by the way. Others just want to know what this is. ;-) It's a side fire fiber cap where the reflective element is separate from the laser fiber. In this multiply patented design the reflective surface is between the grooved segments and it is curved (semi-parabolic) which gives it the warped appearance. The curvature is part of the output beam conditioning that provides a round output with a top hat profile instead of the usual asymmetric power profile ellipses of on-fiber TIR planes. If you look carefully behind the upper grooves, you can make out a convex lens -- another of the beam conditioning that provides the low divergence that is the source of the device's new name: DragonFire. Okay, so what about the grooves? Those grooves are far more than decorative and we're still optimizing them. They accelerate the formation of steam bubbles that serve to cool the fiber without resorting to a water-cooling jacket like used for our almost 20 year old MoXy design. The cooling goes beyond the increased surface area; the dimensions of the groove encourage bubble nucleation and release. It's so fast that we're struggling to capture it with our old, 80K frame/sec camera. One more thing -- if you choose to try one of our fibers, please use it at or near a full 200W. It's designed for high power and lower powers actually wear it out faster.

10

1 Comment

Congratulations to Samsung Medison and Sonio! Ultrasound AI is the future of medicine. Obviously at ThinkSono we’re heavily involved in this, and from what I can see, the entire industry will be transformed. The reason is simple. Ultrasound is non-invasive, portable, has dynamic real-time images, is used in nearly every medical specialty and is relatively inexpensive. The limitation of ultrasound has fundamentally been the need for specialist to scan patients and interpret the images. With AI, this barrier will be removed and the power of the technology truly unlocked. For those in healthcare, I suggest you watch this space closely. This is just the start.

41

1 Comment

It is exciting to bring new devices to market, but many find sourcing proper funding a stopgap in the process. We all can agree that securing proper funding is a critical step in that process— except actually understanding the complexities of that step seems to demystify even the most brilliant among us. It can be quite simple to find out if your device is ready for the next level of funding. Let's see. #startups #medicalequipment #medtech #innovation #medicaldevices

6

Trinity (Atomic Bomb) Test is the Root Cause of Kodak's “Fogging” X-ray Films in 1940s Soon after the first atomic bomb was detonated near Los Alamos, New Mexico, on July 16, 1945, Kodak started getting complaints that its X-ray film was unusable. Kodak researcher Julian H. Webb was surprised to find that the packaging materials was to blame. The contamination source was found in the strawboard mill along the Wabash River in Indiana and the issue was isolated to a batch produced on August 6, 1945. Webb made the connection clear in his report published in 1949: “The most likely explanation of the source of this radioactive contaminant appears to be that it consisted of wind-borne radioactive fission products derived from the atom-bomb detonation in New Mexico on July 16, 1945.” Essentially Webb discovered the detonation of atomic bomb within the United States before the general public's knowledge of the Trinity test which was disclosed after the bombings of Hiroshima and Nagasaki in August 1945! __________________________________________________ https://lnkd.in/gpbzSnJm

1

I wonder if we could set a record through the power of #linkedin and the #medtech community by helping two lucky Test Engineers land successfully....lighting FAST 👀 We are helping a Global Med-Tech org hire 2 Entry-Level Test Engineers for what intends to be a lengthy assignment. At least the rest of 2024 with the possibility to extend through all of 2025! Who do I hope will see this? Test Engineers with just a few (1-3 years) experience in Med-Tech Who can: -Write/run tests -Help with test planning -Work in collab with Systems Engineering to deliver their recommendations The catch? Need to be in MA or within commutable distance Not necessary to be on-site every day, but there will be extended periods required. The ask: -Would you kindly help spread the word to your network via A simple: -Like -Comment and/or "share" By doing so, as you know, it gives those who would be really excited by this opportunity a much better chance of seeing it! To those interested: A simple DM or email to [email protected] and I'll get you set up with the right person on our team. Many many thanks -MR #recruiting #medtech #contractstaffing #theanthonymichaelgroup #medicaldevices #medtechtalentlab

32

8 Comments

👥 Human Factors: Designing Devices for Real Users  Even the most sophisticated medical device is useless if users can't figure out how to use it safely and effectively. Integrating human factors engineering into your design process is crucial. 🧠 Consider the needs, abilities, and limitations of your intended users. Conduct thorough usability testing to identify and address potential use errors. 🧪 Remember, a user-centered design approach can improve safety, enhance effectiveness, and boost user satisfaction. 😊

9

All your #medicalimaging & #AI news, right here 💡 Heuron takes on the US! Their non-contrast CT #imaging analysis solution, Heuron ICH, has received FDA 510(k) clearance! This is the first FDA approved computer-aided triage from Korea. A huge well to done to the team & ChanIck Park! Larkai Healthcare has raised $500,000 from Qi Ventures, Faad Network Pvt. Ltd, Realtime (RTAF), and additional government funds. Their advanced ecosystem leverages real-time quantitative analysis and early disease detection, reducing the gold-standard diagnosis timeline by an unparalleled 40%. Congratulations Pritam Dhalla and Abhilash Chakraverty The FDA has cleared Siemens Healthineers MAMMOMAT B.brilliant Mammography System. Currently ScreenPoint Medical's Transpara is the ONLY Breast AI vendor ready to work with images from the B.brilliant. A win for women's health in the US! You won't have seen it here first, however Lunit Cancer Screening & Volpara Health seal the deal. Volpara’s presence is over 2,000 #US medical sites, another huge win for breast cancer care in the US! Brainomix received FDA clearance for their e-lung system, a lung imaging AI software! Congratulations Michalis Papadakis and team! Finally... Unfortunately, what looks like a 'reorganization' some lay-offs have been completed by Circle Cardiovascular Imaging in Canada, US and Europe. If you're effected, please get in touch to discuss new job opportunities. Get in touch to discuss hiring, news and jobs across the space : [email protected]

57

5 Comments

🚨 You think autonomy in surgical robots is a long way away don't you... You're probably wrong... Here I cover breaking research that gives an insight into what is happening at the fringe of robotics research into autonomy. Taking ML and AI and through transformers imitating surgical steps - it's real - you can watch the videos here>> https://lnkd.in/d-vSn92F This is coming to DV5 soon - in my mind. #surgicalrobotics #roboticsurgery #davinci5 #intuitive #AI #ML #transformers

32

3 Comments