Sanjeev M. Kulkarni

Healthcare system first goal shall be finding the solution for detection the disease of a patient which is suffering from, within 30 days and not after 12 month and visiting 19 experts.

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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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Navigating Modern Quality Challenges with Ancient Wisdom: A Call for Critical Thinking In the lastest edition of Quality Progress Magazine, the article written by Brain Motter titled "History Lessons" discusses how incidents at notable companies like Ford Motor Co. and Philips Respironics underscore a broader industry trend that could signal trouble ahead for manufacturing as well as service industries. Despite their maturity and expertise, these companies faced significant setbacks due to quality issues—Ford with its multiple vehicle recalls and Philips with its CPAP machine hazards. This predicament invites a crucial question: How can organizations preempt such crises in the future? The answer might just lie in the educational approaches of the past. The Socratic method, renowned for fostering critical thinking through rigorous questioning, could be pivotal in equipping today's workforce. This method builds the necessary skills to not only anticipate, but address emerging challenges. Here are five key elements of the Socratic method that can enhance quality management: 1️⃣ Asking open-ended questions rather than stating opinions. 2️⃣ Probing gently for inconsistencies in reasoning. 3️⃣ Identifying underlying principles that drive decisions. 4️⃣ Using concrete examples to clarify points. 5️⃣ Avoiding claims of expertise to foster a culture of continuous learning and questioning. By encouraging more questions than answers, this approach promotes continuous inquiry along with deeper analysis, essential for navigating complex quality issues. Furthermore, incorporating empirical methods into training programs, as advocated by ancient Greek philosophers, could enhance decision-making skills. Reading along with application with the works of these thinkers can provide valuable insights that are surprisingly relevant to modern-day challenges. For instance, reintroducing basic geometry/metrics through Euclid's principles could strengthen problem-solving abilities, particularly in manufacturing contexts where precision is paramount. Seeing these problems arise from these two large companies gives rise to consider pivoting towards more rigorous, thoughtful approaches to quality management. Embracing the principles of the Socratic method, in addition to empirical learning will not only address immediate quality issues but also foster a culture of proactive problem-solving and continuous improvement. Let's not wait for the next crisis to rethink our strategies. The history of philosophy and science offers timeless lessons that can help steer our future toward greater reliability and innovation in manufacturing. #QualityManagement #CriticalThinking #EmpiricalApproach #ContinuousImprovement

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🔶64% : the increase in regulations between 2015-2022 for medical device manufacturers (reaching over 13,000 regulations) 🔶$30M: the approximate amount of funding to develop a Class II 510(k) cleared medical device 🔶$24M: the amount of that funding spent on FDA activities to support that development Challenged by increasing regulatory activity? Tackling higher costs with limited resources? Let’s chat. Learn more about how Veeva MedTech is helping companies like GE HealthCare ⬇ #MedDevice #FDA #Veeva #Regulatory #devicemanufacturing https://lnkd.in/eJgQrhAt

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The Unlikely Union: Bridging the Gap Between Software Quality and Medical Devices Discover how the principles of quality in software engineering can be applied to the medical device industry. Substack:https://lnkd.in/eeE83ry3 Youtube: https://lnkd.in/e6pKBXZF Learn how best practices, agile methodologies, and test-driven design can help create a strong foundation for medical device development. Embrace the cultural change, realizing that these worlds can work together for better outcomes. #BridgingTheGap #SoftwareQuality #MedicalDeviceIndustry #AgileMethodologies #TestDrivenDesign #BestPractices #CulturalChange #Collaboration #MedicalDeviceDevelopment #QualityAssurance

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Here's a video showing some of the applications where our products are commonly used. https://lnkd.in/eEjpmjT5

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Current medtech market trends and technological advancements that are influencing investment and acquisition decisions in the medical device sector: 1. Telehealth and Remote Monitoring: Surge in telehealth and wearable health tech due to the pandemic; devices enabling remote patient monitoring are increasingly sought after. 2. AI and Machine Learning: AI/ML are enhancing diagnostics and personalized medicine, driving investment in devices that improve accuracy and efficiency. 3. Minimally Invasive Surgery: Growing demand for minimally invasive surgical devices like robotic-assisted systems due to their benefits such as reduced recovery times. 4. Regenerative Medicine: Advancements in tissue engineering and 3D bioprinting are drawing attention for their potential to revolutionize patient care. 5. Wearable and Portable Devices: High demand for wearable health monitors and portable medical devices for continuous health tracking. 6. Health Data Analytics: Emphasis on devices that enhance data interoperability and provide actionable insights, supporting the shift to value-based care. Technological Advancements Driving Investment 1. Advanced Imaging Technologies: Innovations in MRI, CT, and PET scans are improving diagnostics, attracting significant investment. 2. 3D Printing: 3D printing is enabling customized implants and rapid prototyping, making it a key area for investment. 3. Smart Implants: Integration of smart technology in medical devices for real-time monitoring is boosting their market appeal. 4. Bioelectronics and Neurostimulation: Bioelectronic medicine and neurostimulation devices for pain management and neurological disorders are gaining traction. 5. Advanced Prosthetics: Innovations in prosthetics and exoskeletons, incorporating AI and robotics, are improving mobility and quality of life. Agree?

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After multiple years of data collection, our study on the impact of engineering outreach efforts was published in the PLOS ONE journal. The findings offer an intriguing assessment of how collaborating with science-focused digital content creators like Mark Rober and Derek Muller (Veritasium) and engaging with the wider maker community can amplify the influence of a particular field of research. Whether you're in industry or academia, the goal of this publication is to help bridge the gap by sharing a framework for ways to better leverage novel academic research into applications in industry. https://lnkd.in/dpR6KjSF

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Ever wondered how to create precise medical models with the Digital Anatomy Creator? 🏥 Join Catherine Wallace, Senior Medical Segment Application Engineer at Stratasys, and get started! Whether modifying existing templates or designing from scratch, this webinar will provide you with the knowledge you need to begin. 💡 Click the link below to sign up! 🔗 https://okt.to/Ly91j3 #3Printing #MakeAdditiveWorkForYou #AnatomicalModels #addstratasys

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Precision medicine is on the rise in the #healthcare sector. This AI-powered approach to treatment design tailors medical plans and leans on data to create personalization. As we continue to develop products that are human-centric and advanced, we must consider the trends of the industry, including that of precision medicine. Gone are the days of one-size-fits-all solutions. We now must focus on flexibility and accessibility. #FutureOfHealthcare #ProductDevelopment #AI #MedDevices

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🤠 When should you document your medical-devices software architecture? A few years ago, I would have answered "start early and update it throughout the project!" Here's how I'd answer it today: It depends. It may be appropriate to wait until just before you submit your 510(k). The quality/regulatory people may go 🤯 what!? Let me explain. As with all documentation, there is a cost to creating and maintaining architectural views. Thus to answer this question you should ask: What problem are you solving with your software architecture documentation? Is it to 1️⃣ To plan and coordinate the software development of a new project? 2️⃣ To explain your software's architecture succinctly to to FDA reviewers? If the answer is 1️⃣, then perhaps except for very small projects or teams, doing some design is very useful early on! These are the design outputs and cybersecurity views that should be entered into your QMS. If it is for 2️⃣, you may want to wait until the end of the project. Let me explain. Not only will this avoid re-work as your software evolves (and it will), but also the architecture views that are useful to the FDA are often different than what is useful for your internal team. They are different audiences with different needs. It is often best to wait to create these diagrams in the context of the full submission and in a way that's useful to the FDA. I hope to get into this in a future post. When do you typically document your software architecture? What types of diagrams do you find useful? What tools do you use? I'd love to hear in the comments. I you like this content, you may enjoy other articles me and our team at Innolitics have written about medical-device software development and regulations at https://lnkd.in/etpxPeBg #medtech #medicaldevices #samd #simd #softwareengineering #softwaredevelopment #softwarearchiecture

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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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Tune in to hear Vaishali Kamat explore how AI and automation are revolutionizing healthcare, even in maternity care deserts. Discover how these innovations are helping bridge the gap and improve access to care. #HealthcareInnovation #AI #MaternityCare

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Is there anyone in the MedTech industry who doesn't struggle with reimbursement (coding, coverage and payment)? Well, I was lucky to meet one such expert – Steve St George, a MedTech reimbursement guru that was willing to share valuable insights with me in QuickTalk Episode #6. In this episode of QuickTalk, Steve unveils the intricacies of securing payment for your device and shares strategic insights on navigating the commercialization process. Don't miss out on this invaluable conversation! #medtech #reimbursement #startups #quickvault #veeva

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🏥 MedTech with Maureen 🌟: Join me for CEO insights on running a small medical device company. Get tips, insights, and inspiration on navigating challenges and driving innovation. Stay tuned for more! 💡🎙️ #MedTechWithMaureen #CEO #Innovation #MedicalDevice #Entrepreneurship

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🏥 MedTech with Maureen 🌟: Join me for CEO insights on running a small medical device company. Get tips, insights, and inspiration on navigating challenges and driving innovation. Stay tuned for more! 💡🎙️ #MedTechWithMaureen #CEO #Innovation #MedicalDevice #Entrepreneurship

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🏥 MedTech with Maureen 🌟: Join me for CEO insights on running a small medical device company. Get tips, insights, and inspiration on navigating challenges and driving innovation. Stay tuned for more! 💡🎙️ #MedTechWithMaureen #CEO #Innovation #MedicalDevice #Entrepreneurship

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