christian pusateri

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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🔥💰️ 𝐒𝐨𝐜𝐢𝐚𝐥 𝐦𝐞𝐝𝐢𝐚 𝐚𝐩𝐩 𝐂𝐚𝐫𝐚 𝐥𝐞𝐚𝐫𝐧𝐞𝐝 𝐚𝐧 “𝐞𝐱𝐩𝐞𝐧𝐬𝐢𝐯𝐞” 𝐥𝐞𝐬𝐬𝐨𝐧 𝐚𝐟𝐭𝐞𝐫 𝐚 $𝟗𝟖𝐊 𝐬𝐞𝐫𝐯𝐞𝐫𝐥𝐞𝐬𝐬 𝐛𝐢𝐥𝐥 for a few days of high traffic, after their free app went viral. Here's how we did things differently at OmniCreator 👇️ Going "viral" and "scale at all costs" were over-glorified among VC-backed startups in ZIRP (Zero Interest Rate Policy) era. Daigo Tanaka, PhD and I hated this model. Serverless or not, we focused on creating a service many people find it worth paying the money from the beginning. As a result, Daigo went above and beyond to integrate a seamless payment processing system for users from the beginning. By doing this we made sure monthly fee could pay the server cost per user. We also controlled the signup quantity and quality via invitation-only system. This allowed us to manage bugs, focus on customer success, and grow at a sustainable rate. We never intended to raise money. Our growth is much slower but we are making more than we pay. IMO that's a pretty damn good business model these days. #medtech #technology #socialmedia #socialmediamarketing #entrepreneurship #entrepreneur

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I have been working in the XR space for the past couple of years, and one of the biggest debates about #Smartglasses is privacy. 2 Harvard students tinkered with #Meta smart glasses to build i-XRAY (link below) - a tool that can spit out personal information about any stranger you meet/direct your gaze with your smart glasses, and take a picture. It uses public databases (remember data brokers), currently available APIs, and Meta smart glasses. That leaves us with two fundamental questions: 1. Is this a risk that needs to be mitigated? 2. From a societal perspective, what does respect for privacy look like in the era of AR Smartglasses? Learn more about the project: https://lnkd.in/gChtEk_Z

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Bridging Today and Tomorrow: Quantum Technology Meets Scalable Cloud Infrastructure The quantum technology sector has grown rapidly, attracting over $7 billion in investments between 2020 and 2024. Investors are adopting a “barbell” strategy, balancing large investments in established companies with funding for startups to scale proven technologies while fostering innovation. Spectral Capital Corporation (OTC QB: FCCN) is leading this shift with its subsidiary, Vogon Technologies, and its Distributed Quantum Ledger Database (DQLDB). By using a “crawl-walk-run” strategy, Spectral is addressing current cloud needs while preparing for quantum advancements by 2028. Vogon’s decentralized, ESG-aligned cloud infrastructure offers scalable, quantum-resilient solutions, positioning the company as a leader in the trillion-dollar cloud market. The sector is consolidating, with a shift toward practical applications like quantum-safe cryptography and modular systems. Vogon’s infrastructure is designed to meet these needs while laying a foundation for future quantum integration, supporting sustainable growth and long-term innovation. As the industry transitions from theory to real-world applications, infrastructure investments like Spectral’s are key to unlocking quantum technology’s full potential. #SpectralCapital, @FCCN, Sean Brehm

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🚨 ❤️‍🔥 𝐇𝐞𝐚𝐫𝐭 𝐁𝐫𝐞𝐚𝐤𝐢𝐧𝐠 𝐍𝐞𝐰𝐬: Silk Road Medical Acquired by Boston Scientific for $1.26B. 𝑩𝒖𝒕 𝒕𝒉𝒊𝒔 𝒊𝒔𝒏'𝒕 𝒈𝒐𝒐𝒅 𝒏𝒆𝒘𝒔 𝒇𝒐𝒓 𝒎𝒆𝒅𝒕𝒆𝒄𝒉 𝒔𝒕𝒂𝒓𝒕𝒖𝒑𝒔. Here's why 👇️ 𝐓𝐡𝐞 𝐁𝐚𝐜𝐤𝐬𝐭𝐨𝐫𝐲: Silk Road Medical raised a hefty $500M+ over its lifetime. That's a lot of investor money, time, and faith. Now, after years of blood, sweat, and tears, Boston Scientific swoops in and buys them out for $1.26B. Happy ending right? Billion dollar exit so whats the problem? Simple math shows a modest return, but this deal hints at a darker trend for the medtech world. 𝐖𝐡𝐲 𝐓𝐡𝐢𝐬 𝐖𝐚𝐬𝐧'𝐭 𝐚 𝐆𝐫𝐞𝐚𝐭 𝐃𝐞𝐚𝐥 Silk Road Medical's highest valuation occurred around 2021 when their market cap peaked at approximately $2B. This peak valuation contrasts sharply with their recent acquisition by Boston Scientific for $1.26B, which shows a significant decline in their market value. So why is this bad news for medtech startups? It is part of a trend that shows that larger strategics can wait until startups face financial difficulties before acquiring them at a reduced valuation. 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜𝐬 𝐏𝐥𝐚𝐲𝐢𝐧𝐠 𝐭𝐡𝐞 𝐖𝐚𝐢𝐭𝐢𝐧𝐠 𝐆𝐚𝐦𝐞: Large companies like Boston Scientific are more than happy to sit on the sidelines, waiting for startups to mature and struggle. Why buy a promising but risky early-stage company when you can wait, let them iron out the kinks, and then pick them up for a relatively lower price when they’re desperate? 𝐁𝐥𝐞𝐞𝐝𝐢𝐧𝐠 𝐎𝐮𝐭: My good friend and mentor Bruce Cleveland wrote a book about what early-stage startups often face called the Traction Gap™ (worth buying). If they can't prove their product-market fit or generate significant revenue quickly, they become ripe for the picking by bigger fish, often at a fraction of their potential value​​​​. 𝐅𝐮𝐧𝐝𝐢𝐧𝐠 𝐅𝐚𝐭𝐢𝐠𝐮𝐞: This trend can deter VCs & angel investors from backing early-stage medtech because they might not get a 10x return. And trust me we're already seeing this in the markets as its been hard to raise money these days for everyone. 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐒𝐭𝐚𝐠𝐧𝐚𝐭𝐢𝐨𝐧: If startups know they’ll be undervalued later, where’s the incentive to push boundaries and innovate? As my surrogate grandfather Charlie Munger might say, “𝑰𝒇 𝒚𝒐𝒖 𝒅𝒐𝒏’𝒕 𝒌𝒏𝒐𝒘 𝒘𝒉𝒐 𝒕𝒉𝒆 𝒑𝒂𝒕𝒔𝒚 𝒊𝒔 𝒂𝒕 𝒕𝒉𝒆 𝒕𝒂𝒃𝒍𝒆, 𝒚𝒐𝒖’𝒓𝒆 𝒕𝒉𝒆 𝒑𝒂𝒕𝒔𝒚.” In this case, it’s the early-stage startups, playing a game where the house (strategics) always wins. While the headlines scream success, the underlying narrative is one of caution. If we want to foster true innovation, we need to rethink our approach to funding and acquisitions. 𝐈𝐟 𝐭𝐡𝐢𝐬 𝐫𝐞𝐬𝐨𝐧𝐚𝐭𝐞𝐬, 𝐫𝐞𝐩𝐨𝐬𝐭 𝐭𝐨 𝐬𝐡𝐚𝐫𝐞 𝐰𝐢𝐭𝐡 𝐨𝐭𝐡𝐞𝐫𝐬 ♻️ 𝐚𝐧𝐝 𝐟𝐨𝐥𝐥𝐨𝐰 𝐦𝐞 @[𝐎𝐦𝐚𝐫 𝐌. 𝐊𝐡𝐚𝐭𝐞𝐞𝐛] 𝐟𝐨𝐫 𝐦𝐨𝐫𝐞 𝐢𝐧 𝐟𝐮𝐭𝐮𝐫𝐞. #medtech #medicaldevices #medicaldevice #businessmergersacquisitions

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Tune in to the most recent episode of Funding Medtech Podcast to listen to Josh Nickols, PhD and Rich Mazzola discuss the details (the network, investment thesis, check size, etc.) of Boomerang Ventures. Links to the podcast, monthly newsletter, and website are in the comments below! Follow Project Medtech on LinkedIn for more great content or visit our website #medicaldevices #startup #medtech #projectmedtech #innovation #medicaldevice #podcast #strategy

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Digital Domination: A Look Back at 2024 🔑 This year, AI-enabled solutions and robotics defined the orthopedic industry as companies increasingly embraced healthcare’s ever-changing technological revolution. 🔗 https://lnkd.in/gvdW8dpd #AI #ArtificialIntelligence #RoboticSurgery #orthopedics #orthopaedics #healthcare #DataAnalytics #GenerativeAI #software #DigitalSurgery #technology #SurgicalPlanning By: Michael Barbella via ODT

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Well-designed video games and computer alerts appear capable of triggering #dopamine release. When they do this, they are appropriating our brain chemistry designed for physical space and leveraging it for their purposes. https://lnkd.in/ghrEqwxa #TechnologyAddiction #addiction

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Spentys Product Update 🥳 ➡️ New Closing System Step for A, H, W, and Q Products What has changed: A, H, W, and Q products now feature an additional design step that allows users to specify the exact locations for closures and combine multiple closing system configurations, providing unprecedented customization. How it affects you: This update significantly enhances the ability to tailor products to individual user requirements, ensuring a perfect fit and greater functionality. The new step offers the possibility to combine different closure types and positions, accommodating a wide range of needs and preferences. How to use it: Only available if you select the "Spentys designer" option. For A, H, W, and Q products, you'll encounter a new step dedicated to the closing system. Here, you can specify locations for closures and select from various configurations. This step offers intuitive tools to precisely define how and where the closures will be integrated into the product, allowing for detailed customization. #product #digital #workflow #3d #orthopedics #productupdate

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Forget what you know about startup success. It's all about embracing extremes or failing miserably. A successful startup is one of two extremes. The first extreme is a seemingly strange idea that people suddenly fall in love with. The second extreme is a well-known idea whose production and sales process has been perfected, saving costs at every turn and making money through scale. Everything in between these extremes is just obvious ideas with poor execution. By definition, that cannot be successful. So, which extreme does your startup fall into?

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The Decline of Attendance at Major Orthopedic Conferences: Analyzing the Trends https://lnkd.in/ggMMN-KJ #DigitalTechnology #healthcare #IndustryTrends #MedicalConferences #MedicalEducation #networking #orthopedics #orthopaedics #SurgicalTraining #VirtualLearning #MedicalDevices

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PLEASE listen to Randy about this crucial issue negatively affecting independent inventors and smaller R&D companies - and, damaging our country!

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AI and Med Tech in Focus   AI System Developed to Identify Pathology in Tissues Engineers at Washington State University have developed an AI tool that uses images of human and animal tissue to detect abnormalities faster and more accurately than people. The AI algorithm was trained using images from past studies that involved kidney, testes, ovarian, prostate, breast and lymph node abnormalities. The new model detected disease in minutes—current processes take humans several hours and require specialized teams to check each other’s work. It was also found to be more accurate, sometimes detecting instances that humans had missed. The engineers designed the system to handle the processing load of the high-resolution gigapixel images by breaking them down into smaller tiles but still retaining the overall context of the tissue sample—akin to the zoom feature on a microscope or phone camera. Aside from getting diagnostic results more accurately and quickly, the new system also shows promise in epigenetics (the study of molecular processes that change gene behavior without changing underlying DNA). Epigenetic researchers can perform analyses and get results that used to take a year or more in just a couple of weeks. VC Investors are always adjusting their "Play Book" with a variety of options for investing. Mikal Ventures is one of those alternatives, offering curated solutions to real world problems. Reach out if you have questions on how we can be of assistance and bookmark https://mikalventures.com/ for additional insights and information.

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“Vogon DQLDB: Redefining Financial Transparency Through Human-Centered Quantum Ledger Technology” In a recent interview, Spectral Capital’s Chairman, Sean Brehm, shared insights into the company’s innovative Vogon Decentralized Quantum Ledger Database (DQLDB) and its implications for financial markets. The Vogon DQLDB is designed to provide a transparent and secure record-keeping system, tracking each transaction based on human identity, reflecting the unique contributions of individuals within the market. By indexing transactions according to MSCI’s Global Industry Classification Standards (GICS), Vogon DQLDB categorizes every economic action (e.g., purchases, investments) into primary, secondary, and tertiary sub-industries. This approach mirrors the principles of the historic Buttonwood Agreement, enhancing transparency and accountability in financial markets. Brehm emphasized that Vogon DQLDB prioritizes data ownership and privacy, using advanced encryption to protect individuals’ data while keeping it accessible for regulatory oversight. This transparency could help reduce market manipulation and stabilize the economy by giving regulators real-time insight into economic trends and potential risks. Furthermore, by making individual contributions visible, Vogon DQLDB fosters a sense of inclusivity, allowing people to see their impact within the financial system. Spectral Capital aims to roll out pilot programs in retail and banking, bringing everyday users closer to the market’s operations. This human-centered approach aligns with Spectral’s vision of a fair, open, and stable financial future, where participants have control over their data and a visible stake in the market’s health. Spectralcapital.com #FCCN, #Vogon,#DQLDB

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Exciting to see startups aiming to use AI to discover chemicals, materials, drugs, etc. Semi companies have taken notice: AMD is investing in and Cadence is acquiring them. Semi/EDA companies have broken out by becoming critical path, whether it’s through critical software, packaging, IP, design kits from foundries, or user communities. Aside from just making it easy to make new materials, these “AI for making X” companies also need to articulate a vision as to how they can establish monopolistic positions in their industries.

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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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