Nathan Piland, M.Eng, MBA

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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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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An important read. Compliance to regulations are a critical starting point but going beyond will set medical device makers apart. Development teams should understand that meeting FDA HF guidance is not a final measure of overall usability and compliance with industry best practices. #impact #designleadership #humanfactors

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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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Who can help with logistics and initial importing? Today, I’m spotlighting three startup-friendly experts who can help you navigate initial importing, inventory tracking, and cost-efficient logistics: ➡️ Matthew Kyle (One Life Sciences,™ Inc. & Kuro Medical,™ LLC) Based in Minnesota, Matt is part of the Medical Alley ecosystem. His logistics solutions include advanced inventory tracking, which can be a huge asset for startups managing product distribution. ➡️ John Gargaro (RAF Solutions USA) Based in Florida, John’s company stands for Reliable, Accurate, Fast — three essentials for any logistics partner. His startup-friendly approach keeps cost control top of mind. ➡️ Stéphan Toupin (Dawa Medical LLC.) Also in Florida, Stéphan focuses on initial importing solutions and can even assist with product stocking if needed. A great option if you prefer to manage logistics directly. Having the right partners in place can make or break your US launch strategy. If logistics is on your radar, these are great people to reach out to. I’ll see you tomorrow for more insights. Have a great Monday! 

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🚀 Starting Strong with Product Design! 🚀 A successful project begins with a solid foundation, and checking over product design is the critical first step. We start by detailing the user needs identified by your team, enabling the precise lower-level design necessary for compliance. Whether you use electronic traceability systems or prefer paper-based systems, we've got you covered for: * Systems Engineering & Architecture * User Needs, System Requirements, & Compliance * Scalable Architecture for Future Features * Mapping & Traceability from System Requirements to V&V Let's set your project up for success from the start! 💡 #tech #SystemsEngineering #Traceability #MedTechman #medtech #technews

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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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Every medtech engineer knows the feeling: you're laser-focused on perfecting your groundbreaking medical device, but suddenly you hit a wall. Usability testing is kicking your butt, early prototyping is causing issues, and you're stuck identifying the right test subjects. ▶️ Sound familiar? You're not alone. Bringing innovative ideas to life is more complex than ever. But here's the truth: shaping tomorrow's medical realities depends on who you partner with today. Read the blog now and subscribe to our newsletter to stay on the cutting edge of medtech innovation. #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog

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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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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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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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🏥 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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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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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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We are proud to partner with JumpStart Ventures and JumpStart Inc. by being a gold sponsor of #OhioVCFest on September 17-18. Project Medtech will be hosting a workshop on September 17 at 3:00 pm!! This interactive workshop takes you beyond theory, diving headfirst into the real-life scenarios and challenges faced by HealthTech startups in their quest for funding. Experienced panelists will share firsthand stories and lessons learned, illuminating the diverse paths to success in this complex landscape. Discover how to navigate unexpected hurdles, adapt your strategies, and secure the capital you need to thrive. There's no one-size-fits-all solution, and this workshop will equip you with the insights and tools to chart your own unique course to investment success. Connect with leading investors, institutions, corporations and entrepreneurs from across the country through curated 1:1 meetings and networking sessions. We look forward to supporting and growing the region’s startup community and witnessing the latest innovation in tech. Secure your spot today: ohiovcfest.com #medicaldevices #startup #medtech #projectmedtech #innovation #medicaldevice #podcast #strategy

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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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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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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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