Avishek Mishra

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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Can AI enhanced health technology trained on data in rural Georgia be used in a large city like NYC? If there was another pandemic and volumes in hospitals changed, could the AI algorithm adapt or would it not work anymore? Earlier diagnosis, better access to care and improved communication can be results of AI solutions in our broken healthcare system. And from a clinician burnout perspective, generative AI stands to make a difference in helping doctors and nurses get time back with the patient. But with over 1000 AI enhanced health innovations being approved by the FDA, how can we ensure best products, data diversity, unbiased solutions and safety? The Coalition for Health AI (CHAI), VALID AI and other organizations are discussing safety guardrails, assurance labs and maintenance monitoring of ML powered technologies. Physician leaders such as Anthony Chang, MD, MBA, MPH, MS Brian Anderson, MD Ashish Atreja, MD, MPH Juan Espinoza Ami Bhatt, MD Daniel Kraft, MD and many others are enhancing education around this. This week the FDA issued a Comprehensive Draft Guidance for AI-enhanced medical devices. The aim of this? To ensure that the best product is developed and maintained with an eye to safety, transparency, maintenance and outcomes. As we integrate AI into health, we must ensure guardrails and understanding to reduce negative consequences. Take a look at the FDA draft and let me know your thoughts ! #health #ai #innovation FDA Healio Austin Lee Chiang, MD MPH Aditi U Joshi MD, MSc, FACEP Tina Shah MD MPH Mara Schenker, MD, MBA Navin Goyal MD Arlen Meyers, MD, MBA https://lnkd.in/ewyuY6Vz

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Hey medtech #founders and #investors - You're missing the mark on "design freeze". And it's a very big deal. I'm hearing from startups left and right that they're at "design freeze". And, unfortunately, a lot of the non-technical investors are taking the candy and going along for the ride. But after peeking under the hood, it turns out that almost all these companies proclaiming "design freeze" are nowhere close. So, what's "design freeze" and all the fuss about, #criticaleric? Design freeze is when you transition into #verification and #validation, affectionately known as V&V in medtech. At this point, the design should be mature from technical, usability, quality, and manufacturing perspectives. Wholesale changes after the start of V&V deliver a world of hurt 🤕 -- repeating biocomp, redoing reliability testing, throwing away clinical data, and more. Here's how the #designfreeze 'sell' typically goes: "We've completed several iterations of prototypes and have achieved the functionality that were are expecting. We're underway with design control and are ready for V&V. We've engaged manufacturers and are at tooling release." But, what they're really saying is: "We've built a 3D printed prototype, and it works (occasionally ). We've signed up for an eQMS package and hired a consultant to help us recreate design history. We've gotten some ballpark quotes for soft tooling from prototype-stage molders and manufacturers." I don't think startups are intentionally being deceptive here. Most of the time, it's just unclear. Like many things medtech, "design freeze" is often discussed but not clearly defined. So what's the big deal if design freeze gets kicked down the road a bit? Early-stage MedTech is iterative and high risk. Investors should get that, right? Well, if you succeed in raising funds based on 'design freeze' then investors are going to expect that the checks they wrote are actually going to be used for the activities you sold them-- manufacturing, design verification testing, clinical studies, regulatory clearance, etc. But if you instead deploy that capital to refine your design, then those activities you sold get kicked down the road. They don't go away and they don't get cheaper. They just get pushed out. So, the total amount of capital you need to achieve these milestones goes up. And what happens then..? Bridge round 🌉 The investors sold the "design freeze" are going to be holding the bag. If they don't want their investment to descend into the abyss, they'll need to pony up the additional funds you need to complete all the work that you originally sold them. And that leads to frustration and disappointment, understandably. Lots more to unpack on this key medtech topic. Want some more actionable tips on this key topic? Check out this article: https://buff.ly/3VJxULn

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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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What process takes the longest time in MedTech? It's not tooling. It's not biocompatibility studies. It's not design control. It's not design verification testing. 🔁 It's the redo loop. When teams make critical assumptions (and don't test them), that's usually when the redo loop occurs. Some of the common timeline killing assumptions: > Of course customers will pay - It his an unmet need. > We don't need usability studies - It's intuitive. > We won't need clinicals - It's a 510(k). > We don't need reliability studies - It passed bench testing. When these assumptions turn out to be false, the changes can be big. It can be a redo. Massive architectural changes that can take quarters or years to fix.

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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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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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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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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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Every Health Tech Innovation sounds great in theory… BUT health systems should “stress test” the idea to see if it works for YOU. Here’s how 👇 Suppose you were considering something like SeamlessMD to provide digital care journeys pre/post-surgery, oncology, chronic care, etc. Sure it sounds great on paper to provide every patient with a digital experience to guide them with reminders, education and symptom tracking. But before you get started, here are 5 questions your health system stakeholders need to ask yourselves: 1️⃣ Does the vendor’s product and track record give us confidence in their ability to deliver this great sounding innovation? If not, are we the right health system to take on this level of risk? 2️⃣ Do we have clinical champions across physicians, nurses, allied health, etc. willing to engage in the clinical content review process? Because you need to be aligned on the clinical content being delivered to patients. 3️⃣ Does IT have the resources to integrate with the platform to automate patient enrollment? Or are we willing to use it as a standalone platform and have staff willing to spend 30 seconds to enroll a patient in the backend? 4️⃣ Are we willing to train staff on how to educate and promote this initiative to patients and families? Remember that staff endorsement highly correlates with patient adoption. Digital Health doesn’t sell itself. 5️⃣ Do we want to take full advantage of the platform and enable alerts and dashboards to remotely monitor patients? It’s not a requirement but it has a bigger impact on outcomes, especially readmissions and ED visits. As you work through these questions, you will find out if your team is motivated and willing to engage fully in the Digital Transformation and change management process needed to make the Tech successful. Also, the better a Vendor Partner, the more they can actually guide you through these questions. In many cases they may make it easier for you to get to a “Yes” because they have proven playbooks and processes that make your staff more confident in the change management required. Now if you end up going through this “stress test” and realize the innovation isn’t the right fit, that doesn’t mean you’ll never do it… It just might mean it doesn’t make sense today. But better to realize that upfront than to buy a great Product… and then fail the implementation because you didn’t think about the People and Process aspects beforehand.

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Michael Seibel makes a great point about facing your fear.   For MedTech founders and CEOs, patient safety comes first!   A product in healthcare holds higher quality standards, which need to be maintained from the get-go while building your startup.   Here are some tips on taking the challenges head-on:   ✅ Prioritize user feedback: Engage healthcare professionals early during the development phase.   ✅ Engage with potential customers: These conversations provide crucial market insights.   ✅ Tackle complex tasks head-on: Deffering challenges to focus on your daily to-do list is not a great idea.   ✅ No shortcuts: Prioritize matters that can impact the safety and efficacy of the product.   ✅ Taking the core design challenges head-on often leads to more robust solutions.   Innovation means you don't have all the answers, but every decision matters, which leads to a safer product. Uncomfortable tasks often signal important areas for growth.   Face your fears head-on!   ——— ♻️ Repost this if someone needs to hear this!   🔔 Follow Golddy Kaur for daily posts   👇 Share your thoughts     📹VC YT: @EO

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"The days of launching new products with marginal feature improvements and expecting a price premium are largely over." I recently finished reading "Strategic Pricing for Medical Technologies: A Practical Guide to Pricing Medical Devices and Diagnostics" by Christopher Provines, MBA - highly recommend! This quote from the book (and many others) remains accurate 10+ years later. Here's what I see going on in advanced rehabilitation technologies: 1) Companies are dealing with the long-term consequences of poor pricing strategies, limiting their ability to innovate meaningfully. 2) Companies are entering the arena with technology that does nothing to advance practice. Clinicians need innovative solutions, not marginal improvements - they know the difference. 3) Companies with new technology that only marginally advances clinical practice expect to get paid the same or more than their competitors. Innovation resulting in lower-cost tech is also welcome. High-cost technology must bring clinical and economic value, and administrators are more savvy than ever in technology evaluation. #rehabtech #physicaltherapy #healthcare #technology

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🌟🌟🌟Thrilled to announce that the #Pregnolia device was used to collect cervical stiffness data to build one of the most comprehensive biomechanical datasets on human pregnancy! This research will reshape prenatal care and help predict preterm birth. Congratulations Kristin Myers and team! Read the full paper in NPJ | Women's Health (link below)! #Biomechanics #CervicalStiffness #PregnancyCare

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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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Big Tech is transforming healthcare, and the latest report from CB Insights breaks it down. Amazon, Google, Microsoft, and NVIDIA are not just dabbling in healthcare; they're revolutionizing it. Here is my take on some forensic profiling 😉 (based on the full report). 💡 Amazon is focusing on primary and specialized care, leveraging virtual platforms and partnerships to build a comprehensive healthcare ecosystem. Their goal? Making healthcare more accessible and efficient. 💡 Google is the data powerhouse, turning health data into gold for biotech innovations. With 90% of big tech activity in genetic therapeutics, Google is paving the way for groundbreaking advancements. 💡 Microsoft is the AI enabler, equipping healthcare organizations with cutting-edge tools to enhance clinical research, drug R&D, and care delivery. Their acquisition of Nuance Communications is a game-changer in integrating AI into healthcare. 💡 Nvidia stands at the forefront of smart hospitals and AI-driven drug discovery. Their powerful hardware and innovative AI solutions are set to redefine medical imaging and surgical applications. These tech giants are not just making waves—they're creating tsunamis in the healthcare industry. The future of healthcare is here, driven by relentless innovation and strategic investments. 👉 What are your thoughts on tech’s role in healthcare? 👉 How do you see these advancements impacting patient care and medical research? Let’s dive into this conversation! Share your insights and let’s explore the future of healthcare together. #HealthcareInnovation #TechInHealthcare #FutureOfMedicine

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What's the biggest risk facing medtech startups? An accomplished investor once told me this: - It's not clinical risk - It's not regulatory risk - It's not IP risk - It's definitely not technical risk No, it's none of those things.. Well, what is it then? - It's execution risk. What exactly is execution risk? - Not knowing the right questions to ask - Not having the right people on speed dial - Not thinking about the key test to run - Not knowing when to change gears #Execution isn't about having all the answers. It's about knowing when you don't. And having the processes, tools, network, and resourcefulness to the right answers, quickly. #medicaldevices #medicaldevices

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Straightforward advice on creating user needs. Always think about how users interact with the products and how you intend to validate!

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Here is Day 3 of 30 days of MedTech Matters: A series on our exploration of medical devices.   🚀 The Power of Storytelling in Medical Device Development & Marketing 🏥💡 In the world of medical device development, we often focus on technical specifications, compliance, and performance. But amidst the science, there's a powerful tool that drives innovation, engagement, and trust: Storytelling. 📖 Storytelling in medical devices goes beyond development and marketing. Big multinational comanies uses storytelling to sell great products. Here are several other areas where its importance shines: 1. Regulatory Approval: Simplifying Complex Data: Storytelling helps present complex clinical and technical data in a way that regulators can understand the real-world impact of a device. Patient-Centric Narratives: Framing the device’s value through patient stories can humanize the data and illustrate its necessity in improving quality of life. 2. Clinical Adoption: Building Trust with Healthcare Providers: Physicians are more likely to adopt new technologies when they can relate to the outcomes through real-life case studies and success stories. Training and Education: Storytelling can be used to create engaging and memorable training materials for doctors and nurses, showing them how the device integrates into patient care. 3. Investment and Funding: Attracting Investors: Investors aren’t just buying into a product; they’re buying into the mission. Compelling stories about the device’s potential to change lives can secure crucial funding. Demonstrating Impact: Sharing powerful narratives about unmet clinical needs and how the device addresses them makes the investment opportunity more tangible. 4. Customer Support: Humanizing Technical Support: Using stories to train customer support teams can help them better understand the user experience, allowing them to empathize with issues and provide better solutions. Empathy in Troubleshooting: Sharing customer success stories and challenges creates a knowledge base that resonates emotionally, improving user satisfaction. 5. Patient Engagement: Empowering Patients: Storytelling can help patients better understand how a device works and how it can improve their lives, driving higher adherence to treatment. Fostering Community: Patient testimonials and shared stories can build a community around a device, fostering loyalty and advocacy. 6. Internal Team Alignment: Driving Purpose: Within an organization, storytelling helps align teams by reminding them of the end goal—improving patient lives. This can boost motivation, cohesion, and innovation. Bridging Silos: Storytelling helps cross-functional teams (R&D, marketing, sales) see the bigger picture and how their work fits into the broader mission. 💬 How are you using storytelling to shape your medical devices? Let’s continue the conversation! #MedTech #Storytelling #Innovation #MedicalDevices #Marketing #HealthcareInnovation #ProductDevelopment

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