Lisa Earnhardt

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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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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Based on what we've seen from the introduction of other technologies (digital and analog) into medicine and other industries over many decades, this is a dialogue/negotiation/argument that we're going to be seeing a LOT of in the coming years: Kaiser's nurses: "Human expertise and clinical judgment are the only ways to ensure safe, effective, and equitable nursing care," stated Cathy Kennedy, RN, a nurse at Kaiser Permanente Roseville (Calif.) Medical Center and a president of the state nursing association. "We know there is nothing inevitable about AI's advancement into healthcare. No patient should be a guinea pig and no nurse should be replaced by a robot." Kaiser management: "At Kaiser Permanente, AI tools don't make medical decisions — our physicians and care teams are always at the center of decision-making with our patients," the spokesperson said. "We believe that AI may be able to help our physicians and employees and enhance our members' experience. As an organization dedicated to inclusiveness and health equity, we ensure the results from AI tools are correct and unbiased; AI does not replace human assessment." I can't comment about the specifics of the deployment of clinical AI at Kaiser Permanente. However, I will say that the future success of healthcare outcomes will depend heavily on a successful negotiation of these differing perspectives between clinical professionals and "the bean counters."

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How did we successfully bring our medical device to the largest birthing hospital in the US, Northside Atlanta? I share this story and several others in my monthly newsletter. Sign up for free insights into building a medical device business in women’s health. I discuss my personal experience in: - Identifying key decision makers: Critical in shortening the sales cycle. - Conferences I attended: Regional meetings are often a great way to meet key clinicians from large hospital groups. - Gaining clinical buy-in: Often a department wide presentation to introduce your product makes the biggest impact. - Navigating the value analysis committee: Clinical data, user feedback, and a cost-benefit analysis all add weight. - Training & education: For devices used department wide, your education strategy is critical in driving adoption. Northside are now one of the largest users in the US, but it wasn’t easy getting there. A lot of research, relationship building, travel, enthusiasm, hard-work, and patience were needed. It was a valuable experience working through the sales cycle at one of the largest birthing hospitals in the country, and one which would be applied to several other large accounts throughout the country. We took our product from development to launch, and ultimately exited to a large player in women's health. You can sign up to the newsletter by visiting my new LinkedIn company page OBG Access. Is 18 months old too early to teach your child about business? I think he’s ready. From now on he comes on my business trips! #Business #Innovation #MedicalDevices #WomensHealth #Obstetrics #Newsletter #StartUp #OBGYN

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I think CEOs are naturally atypical (in a good way,) but Adam Elsesser isn't your typical #MedTech CEO. Why ❓ Well, 1️⃣ first , his career started in real estate, not #medicaldevices. He was a successful real estate attorney when he had dinner with a college friend/physician who couldn't stop talking wanting to create a new medical device. Elsesser essentially told him - stop talking and start a company. 🛑 His friend did and convinced Elsesser to join him as CEO. They sold the company to Boston Scientific in 2002. Two years later, this pair co-founded Penumbra, Inc., a medical device company now worth over $7 billion. Okay, that was all the FIRST part. Here's the 2️⃣ second - while Penumbra's business is built on #vascular and #neurovascular devices the company carries a broader mission - Transforming Patient Care through Innovative Therapies. Sounds like good marketing, except Elsesser spends more time talking about #innovation and #researchanddevelopment than most MedTech CEOs. I mean he puts a LOT of thought into the type of tech, the make-up of the #engineering teams, and the objective to overreach. Here's the bullet points the company sent over for his interview description. 💡 Rethink the structure of in research & development, by allowing teams the freedom to work through ideas unencumbered by stringent project schedules 💡 Break free from rigid/established hierarchy to empower contributions from wider teams and employees as it could lead to revolutionary product ideas 💡 Value incremental innovation and iteration to optimize your products and expand their impact We'll cover all this and more. We'll also talk about what happens when things don't work - Penumbra had to shutter its VR-business this summer, an area that Elsesser a few years ago had predicted would be huge.

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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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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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The WSJ misunderstands the three tenets of Theranos' dream, namely 1) 200+ blood tests 2) from a fingerstick, and 3) for under the reimbursement cost of regular tests. Basically, they were promising comprehensive, easy and low cost blood testing. Finger-stick testing by itself won't provide enough value: -Some analytes are susceptible to lysis resulting from milking the finger or are in too low concentrations. -Cell counting and general chemistries require different anti-coagulants, so are multiple finger-sticks needed? -Any volume of blood over say 50 microliters will require a trained technician to extract and the sample site will most likely need CLIA certification or the instrument will need a CLIA-waiver. -The cost per test and throughput limitation of a novel finger-stick analyzer approach will lead to little additional revenue or foot-traffic. -No killer application has been identified with the time sensitivity needed to justify the cost of installing a whole new system. -Most people have more nerves in their fingers than in their forearms making finger-stick testing more painful. And the number of people that have a hard time producing large volumes from a finger-stick is WAY higher than that for a venous blood draw. Theranos failed not because their minimally viable product was incorrect but because it was unachievable. The fraud was merely the manifestation of their deeply held delusion. Many still believe that there exists a more minimally viable product within reach. Best of luck.

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I have seen this in two areas I work in. Scanning mammograms for a second opinion and in dental with smart X-rays for early cavity detection. The rapid integration of AI into medical devices offers immense potential for improving patient care and outcomes. However, the growing prevalence of cyberattacks in the healthcare industry casts a shadow over these advancements. Also, many of these companies are startups potentially over hyping to get a valuation, raise money etc - maybe not completely thought out technology With a staggering increase in healthcare data breaches and the vulnerability of implantable devices, the risks are real and potentially catastrophic. The question is: How can we harness the power of AI while mitigating these cybersecurity threats? The future of medical devices hinges on a delicate balance of innovation and security. #AI #MedicalDevices #Healthcare #Patient

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New research by Vivalink shows that 84% of respondents are willing to participate in #HospitalatHome monitoring in order to return home sooner versus staying at the hospital to be monitored. And 84% also had a positive experience! The need was felt even more acutely for patients with three or more hospitalizations in the last 12 months, with more than 95% willing to participate in hospital-at-home programs. It is clear the demand for Hospital at Home solutions is growing and our advanced SURE Universal Ltd. remote care platform supporting continuous monitoring of vital signs is well positioned to address this need. Learn more about the survey results here https://lnkd.in/de8wwXhb #remotecare #healthcare #remotemonitoring mHealthIntelligence

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As Kimberly Powell puts it - Generative AI is poised to impact healthcare more profoundly than ANY other area of life. Everything from accelerating drug discovery to enhancing patient diagnostics and postoperative care is on the table. The only roadblock in front of us is the speed and efficiency with which we can implement AI on scale. Could Nvidia be the answer to these teething issues? #AIHealthcare #Healthcare #NvidiaAI #GenerativeAI #MedicalInnovation

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Private equity dollars have grown in the healthcare system over the years but some recent studies have highlighted potentially adverse effects. A study published in JAMA in December 2023 found that PE-owned hospitals are 25.4% more likely to report patient complications. So what's the solution here? I think we have to promote far greater oversight and accountability in order to strike a balance that allows for attracting investment and enhancing patient outcomes simultaneously. #Healthcare #PrivateEquity #HealthcareInnovation

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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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Lumicell was granted FDA approval for the first NDA & PMA in the last 10 years this past April. With 84% accuracy, this phenomenal combination product identifies residual cancer tissue in real time that could have been missed during surgery. Historically, 1 in 8 women developed breast cancer and due to the challenges of eliminating the entire tumor, up to 36% of women need a second surgery. This incredible technology can help create greater patient outcomes and increase healthcare efficiency by reducing the need for second surgeries. Most of us know or have known someone who has been affected by cancer and to understand that a loved one has gotten through surgery successfully without any residual cancer cells would provide an incredible peace of mind. https://lnkd.in/ekaNs8ny #innovation #breastcancer #oncology #medtech #FDAapproval #cuttingedgetechnology

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Unveiling the Potential of #GenerativeAI in #Orthopedics https://lnkd.in/g35gkKpE #AR #CustomImplants #diagnostics #healthcare #MedicalImaging #PatientData #PatientSpecific #PersonalizedTreatment #PredictiveAnalytics #RoboticSurgery #SurgicalNavigation #SurgicalPlanning #VR

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There is a new (substantial) market coming for video games and other forms of media that can positively impact mental health. The Digital Therapeutics Alliance has been working hard with congress to create new reimbursement pathways for media as medicine (Digital Therapeutics) - with a special focus on mental health. Reference Article: https://lnkd.in/gxWwQTks Many commercial video games have been proven to positively impact mental health. One of over 200 Reference Studies: https://lnkd.in/gSYzZKsi The Immersive Medicine Network - a collaborative ecosystem of game developers, experience designers and medical professionals has been created to help media professionals access this new market: The Immersive Medicine Network is building the following resources: - A resource website for creating media as medicine: www.immersivemedicine.org - A LinkedIn support group, the Immersive Medicine Network (IMN) where connections can be made and resources shared: https://lnkd.in/gW8M_vXN - A Podcast to help spread information (first episode coming this week) - A biweekly fireside chat, where questions can be asked and collaborative approaches developed. (Accessible through the IMN) Media holds the key to delivering vital mental and physical health interventions at scale. Now the industries must learn to combine capabilities to create the change we need to fight the #loneliness #stress #anxiety and #depression that are crippling our society. Please join us as we build this new world of Immersive Medicine, recognizing the therapeutic potential of media and bringing accessibility and affordability to mental health care. #videogames #immersivemedicine #powerofplay #stressrelief #resilience

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The Future of Artificial Intelligence in Orthopedics 🔑 The FDA witnessed a 39% increase in AI/ML submissions from 2019 to 2020. 🔑 AI is showing promise in reviewing implanted devices before revision surgery. A study in Arthroplasty found a deep-learning model accurately predicted knee implant types 99% of the time. This could save time in pre-op planning and improve procedure efficiency. 🔗 https://lnkd.in/g_wGp2kz #AI #ArtificialIntelligence #healthcare #ImagingData #MedicalDevices #orthopedics #radiology #RevisionSurgery

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