Kavi Vyas

Another great episode on Delta: HealthTech Innovators on Precision in Surgical Oncology with Navigation Sciences CEO Alan Lucas In this episode, Alan shared how Navigation Sciences is transforming cancer surgeries with cutting-edge technology for clear surgical margins. Their system uses 3D imaging and electromagnetic sensors to guide surgeons, preserving healthy tissue and improving outcomes, especially in lung cancer. Key take home points points: Solve Critical Problems: Address unmet healthcare needs with impactful solutions. Protect Intellectual Property: Secure strong patents to safeguard innovations and attract investors. Keep Operations Lean: Start small, minimize costs, and focus resources efficiently. Tailor Fundraising: Align funding strategies with business milestones and investor goals. Validate Clinically: Prove safety and efficacy early through clinical trials. A must-hear for those passionate about medtech innovation! Another great episode on Delta: HealthTech Innovators on Precision in Surgical Oncology with Navigation Sciences CEO Alan Lucas In this episode, Alan shared how Navigation Sciences is transforming cancer surgeries with cutting-edge technology for clear surgical margins. Their system uses 3D imaging and electromagnetic sensors to guide surgeons, preserving healthy tissue and improving outcomes, especially in lung cancer. Key take home points points: Solve Critical Problems: Address unmet healthcare needs with impactful solutions. Protect Intellectual Property: Secure strong patents to safeguard innovations and attract investors. Keep Operations Lean: Start small, minimize costs, and focus resources efficiently. Tailor Fundraising: Align funding strategies with business milestones and investor goals. Validate Clinically: Prove safety and efficacy early through clinical trials. A must-hear for those passionate about medtech innovation! https://lnkd.in/eSfRsACq #DeltaHealthTech #SurgicalOncology #NavigationSciences #CancerInnovation #PrecisionSurgery

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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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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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“A world where patients are the CEOs of their health journey”. -Tom Hale It’s happening - everyone who knows me regularly hears me say that we will either create what is needed or someone else will create it themselves and disrupt everyone. If you are in HC do you know who Tom is? I’ve been quietly watching Tom Hale and ŌURA for a while (along with a handful of other true unicorns) and with their recent acquisition of Veri (acquired by ŌURA), Tom reinforces my belief that they are a (if not the) company I want to partner with to create the actual parallel healthcare system we need. One that shifts from looking like a crowded room of point solutions at #hlth2024 trying to fight for a sliver of the point solution budget, to one that sorts solutions by outcomes and makes it easy for the industry to see how they can combine the right solutions to create a healthcare model that delivers true outcomes by reversing disease not just treating it. You know the “outcomes pavilion” Spitball Sunday idea that lots of people liked… One that will deliver the platform Casey Means, MD is convictedly convincing the world we need. One that will drive behavioral change and link with root cause reversal interventions like food, lifestyle board certified physicians Ajay Joseph MD FACC DipABLM dieticians and health coaches Alex Sommers, MD, ABEM, DipABLM and less bricks and mortar reliant primary care relationships Geoffrey Rutledge HealthTap. We still need the tech stack to support it and I’m confident that with Carter Williams Peter Cranstone Robert Sundelius, FACHE Gary W. Druckenmiller, Jr. Josh Erndt-Marino Chris Geisler Kris Narayan Michael Mircea Bidu we will have that covered in spades - my brain isn’t big enough for that too! One where people WANT to create value based care contracts because they don’t want the payers to keep the savings they are generating. Tom also reiterates my platform for a parallel system “it's clear that continuous, high quality data can unlock outcomes, lower cost burdens, and provide patents agency”. Like I said last Saturday in reference to the most recent deal funding rounds Brendan Keeler shared that a whole new healthcare system is quietly being created while we point fingers at each other. Now can everyone help me convince Tom that he really should join BP2 Health on The Reverse Mullet Healthcare Podcast to share this himself so everyone in the industry can hear it from him?!

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Getting amazing contract manufacturing partners is everything, but navigating the RFQ process is hard. Learn how to ace this process in the new pod episode

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Alot of bad actors and a few good actors. $2.5T HC capital raised & $1T invested by PE in last decade. $31B in 2013 vs. $217B in 2021. We know the story. Misaligned incentives - unrealistic multiples, short-term profit focus, aggressive cost-cutting, unrealistic scaling, misunderstood market dynamics, just to name a few. However, our industry needs money. But our industry is more infrastructure asset class than tech start-up (James Nicholls gave me that epiphany). Mic drop on the lyrical genius of Alex Fair of MedStartr Ventures as he literally gives the whole story poetic justice as he reads HIS POEM on this "On The Road at VIVE" episode of The Reverse Mullet Healthcare Podcast w/BP2 Health. This is the perfect episode for a Friday afternoon! He and Paulo J Machado donned the actual reverse mullets and joined us back in February at #VIVE2024 to talk about the need for REAL change in healthcare, startup focus and investor expectations. It was one to remember and one that is in desperate need of a full-length follow-up episode. Give us a like and a watch or a listen https://lnkd.in/e4w4mjkv https://lnkd.in/egmK3kMB

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HUGE NEWS! - HeartBeam Inc. (NASDAQ: BEAT) Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology! American Heart Association Heart Rhythm Society #epeeps European Society of Cardiology EHRA President American College of Cardiology American College of Emergency Physicians MedTech Innovator LSI MedTech Strategist MedTech World Techstars Y Combinator

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ASCs are booming and they face new opportunities AND challenges. "New Year, New Trends" the cover story in this month's #ASCFocus explores the hottest trends in ambulatory surgery centers, including: + The rise of orthopedics & cardiovascular procedures + The impact of surgical robots + The evolving role of private equity + Regulatory hurdles & staffing shortages This article includes expert insights from Donnelle Jageman, Tony Guth, Joshua Aaker, Dr David Weinstein, Karly Bruss, and Taryn Nasr. It's a not-to-miss essential read for anyone involved in ambulatory surgery. Ambulatory Surgery Center Association mmbers can access the article here: https://lnkd.in/ehqHdU58 #ASC #AmbulatorySurgery #HealthcareGrowth #Investment #MarketTrends  #HealthcareTrends #HealthcareChallenges #SurgeonsPerspective #Orthopedics #SurgicalRobots

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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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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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Next (few) years ahead will get rather interesting in Medtech. Increasing uncertainty, or lower predictability doesn't lead to higher inaccuracy in planning. In fact, one should double down and build scenarios. Folks who plan well shall be able to allocate capital sensibly and deliver above average rate of growth.

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The biggest topics in healthcare last year? The two Gs. GPT and GLP-1s. We’re continuing to innovate our GLP-1 care track, which includes personalized care from care teams supported by AI tools, that can help maximize outcomes for someone on a GLP-1. And what’s to come? I expect this year we’ll see: ⭐ Measuring digital health programs will shift (check out Omada’s VOI report for more on this) ⭐ Consolidation in the market - not all digital health companies will survive ⭐ An uptick in PBM and health plan partners to help employers offer GLP-1s with sustainable coverage plans Anything I missed?

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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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Which founders fit the mold for success in healthcare? I spoke with Anne DeGheest, Founder and Managing Director at HealthTech Capital, about the key characteristics of successful #healthtech entrepreneurs. Listen to the full conversation here: https://lnkd.in/eqwUCkPx

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I've been closely following the rapid growth of AI-enabled medical devices in the US market. A recent article from MedTech Dive highlights some fascinating trends : ## US AI Medical Device Market Booming • The FDA has authorized 950 AI or machine learning-enabled devices as of August 2024[1]. • In 2015, only 6 AI medical devices were authorized. By 2023, this number skyrocketed to 221[1]. • Over 75% of these devices are in radiology, with cardiovascular applications coming in second[1]. ## Questions for the European Market This explosive growth in the US raises some important questions about the European landscape: 1. How does the number of AI-based medical devices approved in Europe compare to the US figures? Are we seeing similar trends in terms of specialties (e.g., dominance in radiology)? 2. What are the key differences in the regulatory and market-access pathways for AI medical devices between the US and Europe? 3. What will be the impact of the Digital AI Act on European Innovation? 97% of US AI devices cleared through the less rigorous 510(k) pathway[1], how does this compare to European standards? Are we striking the right balance between innovation and patient safety? 💡I'd love to hear insights from my European colleagues in the medtech space. How do you see the AI medical device landscape evolving in Europe compared to the US? #MedTech #ArtificialIntelligence #MedicalDevices #EuropeanRegulation Citations: [1] https://lnkd.in/ehiRszRm

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🏥 Transforming Healthcare with Biobeat's Hospital-at-Home Solution 🏥 Hospital-at-Home programs, supported by advanced Remote Monitoring (RPM) tools like Biobeat's innovative solution, are proven to be safer, more cost-effective, and more efficient than traditional hospital care. Our Hospital-at-Home solution offers comprehensive monitoring of 13 medical vital signs, backed by FDA and CE approvals. Leveraging advanced health-AI platforms, Biobeat enhances patient outcomes with real-time early warning scores and data-driven decision support. These innovations ensure Hospital-at-Home programs can deliver hospital-level care, reduce complications, lower costs, and improve overall patient satisfaction. Our devices are utilized by Hospital-at-Home program providers like Best Buy Health, who have integrated Biobeat’s platform to improve continuous monitoring for chronic disease management in both inpatient and outpatient settings. Dive into this insightful blog to learn more about continuous monitoring in Hospital-at-Home programs: https://lnkd.in/etvPfryZ To learn more about Biobeat’s offerings click here: https://www.bio-beat.com/ #HealthcareInnovation #RemotePatientMonitoring #HospitalAtHome #Biobeat #bestbuyhealth #PatientCare #HealthTech #MedicalDevices

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On October 10th I'm diving deeper into what makes MedTech startup projects unique and difficult to manage with traditional methodology, as well as sharing my tips for avoiding the most common pitfalls in MedTech product development.

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Here's a story about an innovative #medicaldevice company I worked at way back when that made up for crummy market positioning/timing by using value-added selling. With an obsessive focus on value-added selling, we achieved 60 percent CAGR, moved from 12th in market share to 4th, and reached a positive liquidity event/exit. Obsession with #sales and #selling is really important for innovators and their companies! It's woefully misunderstood & underemphasized at many early-stage companies. Let me know what u think, please. (The story is adapted from The Entrepreneur's Journey, the book I co-authored with Hambleton Lord and Christopher Mirabile, available on Amazon.) #entrepreneurship #innovation #valueaddedselling

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Back in Vegas this week for the HLTH Inc. conference! Looking to connect with companies with well-differentiated and well designed solutions to improve access to care and diagnostics. Please comment below if you know a startup we should learn about! Designing for health is complex: you need to address clinical and financial needs, align professional and patient incentives and experiences. When you're part of a product team in a startup, you also need to understand why your product will stand out. You don't have the advantages of scale that incumbents have. Your product has to be best-in-class in some dimension. In some cases - and I think that's what makes Hexoskin so special - what your product delivers has the potential to change existing standards of care. New instruments allow us to redefine how we look at diseases, how we develop new therapies, how we provide care, how we improve access to care, for the benefit of patients. Hexoskin, Carré Technologies Inc., Arizona BioIndustry Association (AZBio), Southern California Biomedical Council (SoCalBio), BIOQuebec, MEDTEQ+, Montréal InVivo, HLTH Inc. #HLTH #HLTH2024 #digitalhealth #wearables #diagnostics #digitalbiomarkers #clinicaltrials #innovation #startup #vc #productdesign #bloodpressure #cardiovascular #respiratory

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