James Hong

A Common Pitfall for MedTech / Medical device manufacturing Companies: 🚫 Mistake: Investing heavily in a product without customer feedback. 🚫 Risk: Channeling resources into development without a deep understanding of the target market, including cultural and societal norms. 📉 It's a frequent, costly error driven by arrogance and preallocated capital. ✨ Smart Strategy: Start with your MVP (Minimum Viable Product). 🌱 Why Gradual Growth? The most successful companies grow gradually because they take time to tailor their products to the markets they serve. Do not waste your time and efforts. Be quick to go to market but do your HW. Are you in Sales or Marketing and Part of the medtech/medical device manufacturing industry? Join our group! https://lnkd.in/g-EYhbSd #medicaldevice #medtechsales #medicaldevicemanufacturing #medicalsales #b2bsales #healthtech

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This is a very important concept from the recent FDA draft guidance document on AI/ML.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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Sirona Medical took a novel approach to reimagining diagnostic radiology. It's an approach I believe we will see future software companies replicate across the various specialties in medicine. First, they built, from the ground up, an "Epic" like operating system (RadOS) for diagnostic radiology, all in one unified cloud native platform. One system, one service provider...eliminating the need for servers, hardware, etc. This also eliminates the need for radiologists to move in and out of countless different software platforms to accomplish the day to day tasks associated with practicing medicine. They then built assistive AI programs into system, making physicians faster, and more effective. And finally, they allowed top 3rd party AI vendors to build the kind of diagnostic AI programs on top of their platform, that are the future product that radiology will provide. This is the path less traveled for sure. It's expensive, and takes a considerable amount of time. But the impact these types of platforms will have on physicians, patients, and the system as a whole is profound. I believe strongly that what Sirona Medical has done will revolutionize this space. Over the next couple weeks, I will post some additional clips to further inform the market on why what they have done is so unique...and just how transformative this technology will be. In the interim, episode 46 of The Bleeding Edge of Digital Health Podcast is now up for viewing on all the major podcast directories, and our YouTube channel (links in comments). Thank you Cameron Andrews for joining on the show, and sharing the incredible tech you and your team have built! Bill Corsten Greg Stock David Paik Kathryn Kovalenko Aidan Andrews Raghavendra Nyamagoudar Nathan Ayers Chris Calder Jon Gallez Francisco Gimenez Perry Kaneriya, MD, MBA Patrice JC Nedelec 🇫🇷🇺🇸🇺🇦 Daniel C. Liem Samir Mehta Kaitlin Daugherty Mark D. Longo, Ph.D. Mike McCormick Ryan Dougherty Fred Ong Tanner Trombly Vijay Yeluri Adam Prater Alex Mc Vey #radiology #medtech #digitalhealth

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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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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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A few of my clients transitioned from using larger medtech consulting firms to Devan MedTech Solutions. I don't question or assume why they did this because it could be for a variety of reasons (unless they would like to tell me). I have seen this trend developing for quite some time actually. Let me tell you how I attract clients & sustain + build relationships: ➡️ Authenticity ❤️ 🙏 ➡️ Flexibility 💪 ➡️ Creative Thinking 🤔 ➡️ Communication 🙂‍↔️😀 ➡️ Honesty 🙌 ➡️ Track Record 💯 ➡️ Delivery ⌚ ➡️ Understanding Perception vs Perspective 🔄 How are you building your client base for the long run? 🚀 P.S. A bit of comic relief definitely helps along the journey. 🤣

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Innovation in healthcare is usually fairly slow - to the great frustration of those behind the innovation at times. Seeing the partnership with Mevion Medical Systems move so quickly has been phenomenal. Proton therapy systems pretty much always used to require a new facility to be built given the 3 storey rotating gantry structure. That new facility brought with it the vast majority of the project cost and took protons out of reach for most hospitals. The S250-FIT is the ONLY complete proton therapy system where the accelerator, patient positioning and imaging system fit within the confines of a single linear accelerator vault. This first installation at Stanford redefines proton therapy and shows the world what is possible. Change is here. The future is bright - the future is upright.

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FDA finalizes AI-enabled medical device life cycle plan guidance The agency said it will review developers' modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions.

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MedTech is HealthTech - but not all HealthTech is MedTech. 🤨 MedTech is a synonym for Medical Devices & Diagnostics ❗️ Words. Buzzwords. Terms. Definitions. Yet another 🗣️ issue. Outsiders often confuse MedTech with HealthTech, pharmaceuticals, biotechnology, and consumer health solutions. Those who have worked with medical devices understand the differences. But for most people, this is yet another buzzword to learn. Patients don't even realize that most of the technology used in clinical settings are regulated products - just like pharmaceuticals. We take it for granted. I've met several founders who don't realize they are developing a solution that must comply with MedTech regulations before it can be used or sold to anyone I've also met investors who speak of HealthTech, but when, in fact, they only work with non-regulated DigitalHealth or lifestyle management solutions and don't want to touch "regulated products" due to the (implied) high risk. But what's the fun in that? 😎 Medical technology is one of the most exciting industries of our age. The potential to create life-changing medical solutions for all demographics is so rewarding. Yes, the pathway to success is steep and dangerous, but the risk is worth it. That's why so many do it. Take the risk 🌟 and create a medical device that's safe and makes a significant clinical impact. It might save somebody's life❤️‍🩹 #medtech #medicaldevices #healthtech

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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]

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The success of the MedTech industry in Israel is inherently tied to the mentality of its founders in 1948, that they could make Something from Nothing, as I discuss in this clip. We had a lot of fun reminiscing about the MedTech Mission to Israel with Joe Mullings and Nicole Ager of Dragonfly - A TMG Company, along with Adam Rosenwach, Avi Fischer, David Hochman and Tal Wenderow. https://lnkd.in/e5spq4SM

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Data driven targeting, omnnichannel content, intense market segmentation. If your medtech G2M strategy doesn't have these, you're falling behind. Paul-Lukas Hoffschmidt is doing incredible things with Alpha Sophia. I had a blast learning about his journey into medtech and how rigorous their customer discovery was during their development process. Watch the full episode, you don't want to miss it!

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What's the biggest risk facing medtech startups? An accomplished investor once told me this: - It's not clinical risk - It's not regulatory risk - It's not IP risk - It's definitely not technical risk No, it's none of those things.. Well, what is it then? - It's execution risk. What exactly is execution risk? - Not knowing the right questions to ask - Not having the right people on speed dial - Not thinking about the key test to run - Not knowing when to change gears #Execution isn't about having all the answers. It's about knowing when you don't. And having the processes, tools, network, and resourcefulness to the right answers, quickly. #medicaldevices #medicaldevices

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A hundred years ago, the editor of JAMA, Journal of the American Medical Association had a column where he wrote about hucksters and frauds in medicine. This is his piece on The Abrams Box, which is a great example of why medical device manufacturers are held to such high standards (and hold themselves to such high standards) for safety and effectiveness. This was 100 years ago, but you'll hear echoes of The Abrams Box in today's world: Theranos' fraud, Volkswagen's emissions measurement scandal or Boeing's quality woes. Or how about Stimwave, which garnered this horrific press release from the DOJ in 2023: "Former CEO Of Medical Device Company Indicted For Creating And Selling A Fake Medical Component That Was Implanted Into Patients" It's hard enough already to create safe and effective medical devices when we are trying to do our jobs well. So it's especially important that our regulators keep up their great work looking out for the next Abrams Box, and that industry keep up its work of creating cultures of quality, self-policing and collaborating on standards and other policy mechanisms.

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We have an innovation problem in Med Tech. A study published in JAMA Health Forum (2023) reported the median time for a medical device/diagnostic (approved by the FDA through premarket approval and de novo pathways) to achieve at least nominal explicit or implicit Medicare coverage was 5.7 years. This was a dominant talking point at the "Understanding The Reimbursement Landscape" town hall session this past Monday at TCT 2024. And it's an issue that is suffocating the cycle of innovation in Med Tech. Several panelists noted that historically FDA approval was the "end game". A disproportionate amount of an early stage company's risk was tied up in garnering regulatory approval. However, this is no longer the "beginning of the end" from a risk perspective. It now must be considered the "end of the beginning". The Market/Patient Access (Coding, Coverage, Payment) process now requires an equal amount of heavy lifting. It's often ambiguous, frustrating, seemingly impossible to navigate. It's a huge deterrent for innovators considering the development of a life saving technology that could address an unmet need in medicine. This issue is also contributing to the broken venture model we see in Med Tech at present. A typical venture fund has a 10 year time horizon. When you consider the time needed for research & development, regulatory pathway, market access, and establishment of meaningful ARR, many potential investments just simply do not "pencil out". Especially for those highly disruptive technologies that require longer regulatory approval processes. And unfortunately, those are the very innovations that we drastically need to solve really hard problems in healthcare at present. IS TCET the answer??? In June CMS released a final procedural notice intended to expedite Medicare coverage of novel medical devices and get the devices to Medicare beneficiaries faster, the Transitional Coverage for Emerging Technologies (TCET). “TCET gives device manufacturers what they have long asked for: a more efficient and transparent Medicare coverage review process,” CMS said in a statement. The program is intended to provide increased pre-market engagement with CMS and to allow evidence gaps to be filled with fit-for-purpose studies. This temporary national coverage decision status will be retained for an indefinite period of time, until they can generate sufficient evidence to determine permanent status. Unfortunately, this program will initially be limited up to 5 devices per year for review. Will that be enough to make a huge impact on problems outlined above? Probably not. But it's a start!

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Check out this article by Scott Nelson in MassDevice about achieving product-market fit in medtech. Thank you for including me in this discussion and hope I didn't give away too many secrets 😂 #medicaldevice #startups #betterdatasaveslives

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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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