Allie Knauer

This is a *really cool* initiative announced today! The FDA is working with an architecture firm to develop an #AugmentedReality / #VirtualReality home environment to facilitate development of #MedicalDevices that are intended for use in the home. The "Home as a Health Care Hub" initiative "will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical #device developers, policy makers, and providers to begin developing home-based solutions that advance health equity." The initiative is going to start with a focus on rural and economically-disadvantaged home environments. Such a great idea...well done #FDA!! Hopefully once this is operational, the developers will be able to leverage the Hub as a tool for regulatory purposes. It would also be great if, in time, the Hub is applied more broadly. #AR #VR #DeviceInnovation #HealthcareInnovation #AI #RegulatoryAffairs

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Going for the medtech 'Hail Mary'? (Also known as MVP) Better catch it or else... Game over. There's a better path in medtech: - Define the key risks - Build prototypes FOCUSED on key risks - Collect data and iterate - Develop commercial design afterward Rather than the 'hail mary' (MVP)... Think about medical device development as a series of short passes where each one gets you closer to the endzone.

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Opportunity

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Finally, something that isn't all about AI! One news report says funding is shrinking, and another says it's expanding. Especially in M&A. Look, if you have a great project, a good team around you and a few takeaways from this article, success is imminent. The future is pulling us forward, lean in! #medtech #innovation #medicaldevices #healthtech #funding

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My oh my how far we've come! Stumbled on this article from 5 years ago with MedTech advances we'd be shocked or inspired to create. And now we have arrived! The list of future advances from today's standpoint seems shocking today, but will it be true in 3 years from now? Innovation moves fast! #innovation #medtech #technology

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I love Startups 😍 and they can be super rewarding 🏆 But it's not what everyone thinks - as I educate hundreds of founders and team members on how to build and Una. start up in Medtech. I've shared some of realities of working in a start up. #startup #founders #medtech https://lnkd.in/d-NGbWck

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Medtech founders - Your first $25k has one job to do: 🔐 Unlock the next $250k Here's what usually happens: 1. $25k landed through a microgrant 2. "Let's stretch this as far as possible.." 3. Tech focus -Design, proto, repeat 4. First 2 investors pass 5. Run out of steam - game over Instead, take this approach: 1. Put $5k into market strategy 2. Put $5k into regulatory strategy 3. Put $5k into clinical strategy 4. Put $5k into a polished deck 5. Put $5k into pitching 100 investors If you want to build a medtech business, then focus on the business.

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🎙️ Calling all #healthtech #entrepreneurs, especially those in the #femtech space! 🚀 Design is at the core of impactful products and successful companies. In our latest podcast episode, Theresa Neil, an award-winning #productdesign professional and founder of Guidea and Femovate by Guidea, dives deep into the world of product design in #healthtech. Key Takeaways: - The future of health tech: physical-digital convergence. - User constraints: a vital consideration for providers and consumers. - Strategies to evaluate competition and stand out in the market. - Insights on designing for inclusivity and accessibility. -What consumers should know about women's health products - Emerging trends in femtech for your next breakthrough idea! 💡 Whether you're an aspiring #founder or curious about women's health innovations, this episode offers valuable insights and real examples of products making a difference. Tune in to gain knowledge and inspiration! #healthcare #innovation #podcastepisode https://lnkd.in/gFk8i5iQ

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Commercial can wait, right? I could not agree more with the below. So many startups, especially in the current environment, de-prioritize go-to-market strategy and commercial insights. That means they’re operating on the assumptions many of which will turn out to be incorrect or incomplete and the funding may not be there to change course given the cost and timelines to alter the medical device once FDA cleared. Products don’t always fail because the tech doesn’t work. Most times they fail because the product market fit isn’t there.

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Yesterday I asked a small group of medtech engineers what their most valuable productivity tools were. Their answers surprised me: 1) Pen and paper 2) The Notes app on their smartphone (interestingly, this person added that they don't use email or social media on their phone and have all notifications completely disabled) 3) Babysitters This was a group of 2 men and 1 woman. Can you guess who gave "babysitters" as their answer? We still have work to do. Although these people are working to develop lifesaving technology, tech isn't dominating their lives. I find that so reassuring. I'm really enjoying working with LIHE to build and strengthen their community during their Medtech Accelerator Bootcamp this week. Three days; three lunches; three opportunities to get this new cohort participating and exchanging value. I'm in my element! #medtech #accelerator #communityofpractice #bootcamp #strategy #valueexchange

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🚀 Embarking on creating a new Medical Device or launching a startup around your new idea? Consider This First... In the exciting world of new product development and medical device startups, it's easy to adopt the "if we build it, they will come" mentality. However, the landscape is filled with landmines, and understanding the various critical factors beyond technical risk is crucial for success. Many of my new R&D and enthusiastic entrepreneurial clients I come across are primarily focused on the technical aspects of their products. While this is undoubtedly important, it's just one piece of a much larger puzzle. Here are the key areas you must consider thoroughly to avoid pitfalls and steer your innovation to success: 1️⃣ Regulatory Compliance: Understanding the regulatory requirements early on can make or break your entry into the market. 2️⃣ Clinical Adoption: It's not just about creating a functional product but one that clinicians are willing to adopt and use regularly. 3️⃣ Reimbursement Strategies: Ensuring that there are clear paths for reimbursement will define your product’s financial viability. 4️⃣ Technical Risk: While important, this should be balanced with other risks associated with bringing a medical device to market. 5️⃣ Market Size Assessment: A realistic evaluation of your potential market size can significantly influence strategic decisions. 6️⃣ Net Present Value (NPV): Calculating NPV early can help you lock in your target price point and COGS. 7️⃣ Health Economics: Understanding the economic impact your device will have on the healthcare systems is crucial. 8️⃣ Intellectual Property (IP): Strong IP protection is a cornerstone for defending against competitors and establishing your market presence. 9️⃣ Budget and Timeline: Full understanding of the cost and time to get your product to market. Missing or underestimating any of these factors and its game over. Let’s ensure that your brilliant innovation not only sees the light of day but also thrives in a competitive marketplace. For anyone considering creating a new product or startup in the medical device field, let's connect. I’m here to share insights and guide you through the intricate journey of bringing transformative medical products to life.

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Recently, Beth Linker of the University of Pennsylvania published an article in Time Magazine entitled, "Actually, It's OK to Slouch." The biggest problem with Linker's article is right there in the title: she urges readers to slouch. Most people already spend their days hunched, collapsed and compressed over their devices, so how is this helpful? Why invite readers to double down on unhealthy postural habits, instead of telling them it's okay to care about posture? I offer a rebuttal to this article in my post, "Actually, It's OK to Care About Good Posture." Check it out on my website, here: https://lnkd.in/eA3aX_R7

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My key takeaways from 3 days of learning with Lasa Health during the National Science Foundation (NSF) Innovation Corps kickoff: ✅ A strong #valueproposition is crucial for selling your #healthtech product. Your ideal target customer doesn’t really care about the technical details of your product: they want to hear about the outcomes they can achieve by using it. 😫 Your product’s value prop must address key customer pain points. Focus on critical problems that lack existing solutions: this will make your solution irresistible to prospective clients. 😵‍💫 Don’t marry your ideas or your tech. If your current solution doesn’t resonate with your ideal customers, be ready to pivot and adapt based on customer feedback. 👂🏾Never assume you know what your customer is thinking. No matter how well you think you know what they are going to say, they’ll often surprise you. Listen carefully and avoid making assumptions. (Fellow #clinicians: does any of that #business jargon sound oddly familiar to you? That’s because #healthcareproviders think like this all day, every day. We listen, pivot, and focus on outcomes.) #femtech founders, innovators, and teams: this is your reminder to stay laser-focused on the outcomes that matter to your future clients. If you build it, they won’t just come: you have to show them why you’ll make their work better, faster, stronger. 💪🏽 #clinicalconsultant #womenshealth #lgbtqhealth #startup #medicalinnovation #consulting #mentor ~~~~~~~~~~~~~~~~~~~~~~~~~~ Hey there! I’m Dr. Caitlyn Tivy, a clinical consultant and medical writer for women’s and LGBTQ+ health companies. I help femtech and queer health organizations develop scientifically accurate information and products. Ready to take your femtech or queer health company to the next level? Let’s connect! ♀ 🏳️‍🌈

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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

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Most #wearables today work with light. Sending signals a few millimetres into the skin and observing the signal. But the next wave of wearables could use ultrasound to get much more information. Ultrasound is often used in standard #healthcare settings and we know of the tremendous insights that can be gathered from the images. The article below is a great summary of the field and its challenges. The technology can help revoluionlize disease management but also preventive care through deeper insights into the body. The key obstacles to make these successful are miniturization, skin connection, directionality, data analysis and transmission, translation, and regulation. But the field is seeing some great progress in all these areas as highlighted in the article. “Achieving these objectives will be key to transitioning wearable ultrasound from a promising prototype to an indispensable tool in personalized medicine. Ultimately, the widespread adoption of wearable ultrasound devices will transform not only how we monitor chronic conditions, but also how we understand the human body.” #healthtech

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In my last post, I mentioned the work I’m doing for TENGABLE to create partnerships for our tactile touch device. Here’s an example of a medtech partnership created by Dexcom that worked really well: Dexcom is a leader in continuous glucose monitoring, but does not create insulin pumps. As such, they partnered with top insulin pump makers like Tandem Diabetes Care, Insulet Corporation, and Medtronic – integrating their data into the pumps' dosing algorithms and enabling automated insulin delivery Business Impact: → Competitive Advantage - AID systems provide differentiation in the highly competitive insulin pump market → Appeals to patients seeking automated diabetes management solutions → Requires using Dexcom's disposable CGM sensors on an ongoing basis Clinical studies demonstrate improved outcomes

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The Equity Word Value-Based Care (VBC) 🌍 Diving into the transformative realm of healthcare, today's focus is on Value-Based Care (VBC) - a healthcare delivery model designed to uplift the quality of care over the quantity of services provided. VBC represents a fundamental shift towards rewarding healthcare providers for helping patients improve their health, reduce the impacts of chronic disease, and live healthier lives through preventive care. Why spotlight VBC? This model is a cornerstone for promoting health equity, ensuring that all patients, regardless of background, receive care that's tailored to achieve the best possible health outcomes. 🌟 🔍 Highlights: - Shifts focus from volume to value, emphasizing patient health outcomes. - Incentivizes providers to offer high-quality, efficient care. - Aims to reduce healthcare disparities by focusing on preventive care and managing chronic conditions. - Backed by the Centers for Medicare & Medicaid Services (CMS), encouraging a healthcare system that's fairer and more responsive to the needs of diverse populations. Discover more about how VBC is reshaping healthcare for the better at CMS.gov. Join the conversation: How do you see Value-Based Care impacting health equity in your community? Share your views! #TheEquityWord #ValueBasedCare #HealthEquity #PatientOutcomes #PreventiveCare

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It is Sunday, and that means its time to share a #MedTech news round up! MedTech Innovator, the #medtech industry's largest nonprofit accelerator, held their annual #innovatorsummit2024 this week. The future of healthcare is positive with innovators like these at the forefront. Paul Grand Renal Denervation, a treatment for #hypertension, is a focus of market interest after Recor Medical became the first company to win #FDA approval, followed quickly by Medtronic. deepqure has received #IDE nod to begin their study using a first of its kind #extravascular approach. Keewan Kim Aktiia received regulatory approval for the first optical blood pressure system that leverages sensors and doesn't require a cuff. Josef Sola Xeltis received #IDE approval for initiation of is US clinical trial, a team developing transformative vascular implants designed to allow gradual replacement of the patients own healthy tissue. Eliane Schutte Allurion Technologies, developer of the swallowable balloon for #obesity, reported data showing a 22% reduction in weight loss after a year, and Vivani announced the FDA approved an #IND application for a #GLP-1 drug eluting implant. Shantanu Gaur Adam Mendelsohn Avicenna.AI secured FDA clearance for #AI detection of #vertebral compression fractures, a condition often resulting from #osteoporosis which often goes undetected. Cyril DI GRANDI MEXBRAIN announced the start of a second clinical trial for their devices for Acute on Chronic Liver Failure, Thomas Brichart and Acarix announced the first patient enrolled in their study to compare workflows with traditional #stresstest and their system. Aamir Mahmood More progress in #structuralheart technologies as Foldax Inc. reports positive clinical results with their heart valve study, and CroiValve has a positive first in human repair data report Gregory Casciaro Lucy O'Keeffe Kardium Inc. had a big week as they shared their $104 Mil capital raise towards their #PFA ablation platform, a red hot space in the market. Congratulations to Kevin Chaplin and team Finally, although tough to choose, my favorite news story of the week is from Amber Therapeutics. They announced a $100 Mil Series A towards their fully implantable #neuromodulation system to treat #MUI mixed urinary incontinence, a difficult to treat condition affecting many women globally. I am encouraged by the opportunities to alleviate challenging conditions through neuromodulation and #bioelectric medicine. Hopefully Amber's successful raise will pave the way for continued innovation in this category. As always, I am grateful for news partners like Sean Whooley and the MassDevice team, Blake Matrone and LSI, Erika Gustavsson at The Mullings Group, and all friends who share good stories as they see them. Also, a big Happy Father's Day to all the Dads out there, including mine, and my awesome husband! Have a great week! https://lnkd.in/exDd6agN

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