NDR Medical Technology Pte Ltd’s Post

"The state of the art (SOTA) of a medical device blocks innovation." That’s what a CEO of a medtech company told me recently. ↴ We were discussing the concept of the state of the art, and he was clearly frustrated. He felt trapped by the need to validate his device against existing standards / literature, which he believed stifled innovation. He asked, "How do you validate benefits and claims that don't exist anywhere?" But here’s the thing—he’s not seeing the full picture. I see the state of the art as something far more valuable: → SOTA provides the essential groundwork for any medical device project. → It establishes the  foundation for product design, clinical evaluation, risk management and so on → It defines acceptance criteria, ensuring safety and performance. → It helps determine the acceptability of a device's benefit/risk profile → It offers a roadmap that can guide innovation, not block it. Think of the state of the art as a compass, not a cage. It’s there to steer you in the right direction, ensuring that your innovations are safe, effective, and aligned with what’s considered good practice in the industry. Here’s how I believe it should work for you: → Use it to set a solid foundation. → Let it guide your design and V&V processes. → Lean on it to clarify what’s acceptable and what isn’t. → Leverage it as a strategic tool, not a limitation. Remember, the SOTA reflects what’s generally accepted as good practice in technology and medicine. It doesn’t always mean the latest or most advanced solution, but what’s widely recognized as the best approach. What’s your experience with SOTA in your projects?

Unlocking Innovation in MedTech: The Power of Digital Twins 🚀 Amidst the fast-paced advancements in #MedicalTechnology, innovation is key to delivering better patient outcomes and efficient product development. #DigitalTwins. These virtual replicas of real-world systems with substantial investments projected to reach $48.2 billion by 2026 are revolutionizing industries, including #MedTech. 🔍 Digital twins offer unprecedented value across the entire product lifecycle, from #R&D to #ClinicalTrials. In the MedTech sector, companies are realizing significant benefits, including enhanced product performance, reduced development costs, and accelerated time-to-market by 20-50%. These advancements extend to clinical trials, where costs are cut by up to 75%, resulting in faster and safer outcomes. Imagine a digital twin of the human liver being used to test drug efficacy or optimize medical devices—this is no longer a distant future but a present reality. Despite these exciting advancements, adoption in MedTech is still in its early stages. Barriers such as limited data availability, insufficient digital capabilities, and data privacy concerns continue to pose challenges for many in the industry. Overcoming these obstacles requires a strategic approach focused on developing agile delivery models and leveraging strong data foundations. Additionally, companies should build the necessary capabilities by starting with high-impact use cases and fostering a test-and-learn culture. 💡 The future of MedTech innovation is here. Will you be a leader or a latecomer? 💥 It’s time for MedTech companies to seize this opportunity and drive the next wave of innovation. 🔗 Learn more about how digital twins are reshaping MedTech: https://lnkd.in/dx5Nfpkh #MedTech #DigitalTwins #HealthcareInnovation #DigitalTransformation #Innovation #PersonalizedMedicine #MedicalTechnology #AgileDevelopment #HealthcareFuture

What is a clinical study? A type of research study that tests how well new medical approaches work in people. Traditional #clinicaltrials rely on multiple, physical sites to recruit and see patients. It usually takes years to go through a full study and cost millions. However, there is an alternative approach that is particularly suitable for digital therapeutics companies (#DTx). Decentralized clinical trials replace physical sites with a single, virtual, central site. This allows for patient recruitment irrespective of their physical location, eliminating the need for patients to visit a physical site. Curavit offers decentralized, or "virtual," clinical trials, which streamline the complexity associated with traditional trials' extensive multi-site setup. Through a central virtual meta-site, patients can be accessed from anywhere, monitored remotely via #telehealth and #wearable technologies, and analyzed using modern data science techniques with the resulting larger and more robust datasets. This serves as an excellent example of how technology can accelerate and disrupt traditional medical procedures. Source: MedTech Pulse. Photo: Curavit. #innovation #healthcareinnovations #healthtech

Join LifeSciencesNY on Wednesday, June 5 at the University at Albany, SUNY where leading researchers, product developers, and cutting-edge startups will gather for a statewide artificial intelligence symposium on challenges, collaboration, and opportunities. Artificial intelligence is transforming all aspects of healthcare, from diagnostics to medical devices, and from drug development to care delivery. https://lnkd.in/eZN342tF   #makinghealthbettertogether

The commercialization of medical devices presents a mix of challenges and opportunities. While regulatory hurdles, market competition, and technological complexities pose significant obstacles, the growing demand for innovative medical technologies, coupled with advancements in digital health and AI, offer substantial opportunities for companies willing to invest in innovation and navigate the complexities of the healthcare landscape. Purushotham Taduka Shashi Reddy #MedicalDevices #Commercialization #HealthcareInnovation #MedTech #RegulatoryCompliance #MarketAccess #MedicalTechnology #HealthcareIndustry #Innovation #MedDevice #BusinessStrategy #ProductDevelopment #MedicalInnovation #HealthcareEntrepreneurship #IndustryTrends #NeotechSolutions #Neotech #India #US

In this webinar (https://hubs.li/Q02xY03X0), Deepthi and Kirti will discuss the convergence of science fiction and reality, where thoughts seamlessly control devices and individuals find newfound freedom through neural prosthetics Presented by: Deepthi Balan An experienced life science strategist focusing on emerging trends, innovative technologies and business opportunities that are driving the future landscape of healthcare, medical devices & diagnostics, pharmaceuticals and personal care industries. Kirti Vashisth A passionate and experienced biotechnologist possessing profound insights into the ever-evolving field of life sciences, MedTech and healthcare, with a keen awareness of emerging trends, disruptive technologies, and inventive methodologies. #NeuralImplants #AssistiveDevices #ArtificialIntelligence #BrainMachineInterfaces #Neurotechnology #MedicalAdvancements

Developing a medical device is no easy feat. That's why partnering with the right experts can make all the difference in creating a successful design that can be effectively manufactured. Our Innovation Center Manager, Nick Coburn, recently sat down with Medical Product Outsourcing to discuss the critical role of involving CDMO partners early in the process. Read the full interview to discover how we're helping our customers efficiently bring their ideas to life. #MedicalInnovation #RapidPrototyping

The state of the art (SOTA) of a medical device blocks innovation." That’s what a CEO of a medtech company told me recently. ↴ We were discussing the concept of the state of the art, and he was clearly frustrated. He felt trapped by the need to validate his device against existing standards / literature, which he believed stifled innovation. He asked, "How do you validate benefits and claims that don't exist anywhere?" But here’s the thing—he’s not seeing the full picture. I see the state of the art as something far more valuable: → SOTA provides the essential groundwork for any medical device project. → It establishes the  foundation for product design, clinical evaluation, risk management and so on → It defines acceptance criteria, ensuring safety and performance. → It helps determine the acceptability of a device's benefit/risk profile → It offers a roadmap that can guide innovation, not block it. Think of the state of the art as a compass, not a cage. It’s there to steer you in the right direction, ensuring that your innovations are safe, effective, and aligned with what’s considered good practice in the industry. Here’s how I believe it should work for you: → Use it to set a solid foundation. → Let it guide your design and V&V processes. → Lean on it to clarify what’s acceptable and what isn’t. → Leverage it as a strategic tool, not a limitation. Remember, the SOTA reflects what’s generally accepted as good practice in technology and medicine. It doesn’t always mean the latest or most advanced solution, but what’s widely recognized as the best approach. What’s your experience with SOTA in your projects?

Is our medical software a SaMD (Software-as-a-Medical Device), a SiMD (Software-in-a-Medical Device), or an accessory? It's more than a technical distinction; it's the guiding force behind our design, development, and commercialization journey. Drawing inspiration from Xenophon Papademetris, we view medical software development as an act of regulated design - undeniably creative! Curious to know more? Let's chat! Our team has a mix of hands-on expertise and regulatory strategy experience with electro-mechanical, health data systems and SaMD🚀 Visit us at www.eliomedica.com and drop us a message.  💡💼 #SaMD #MedicalDevice #RegulatoryAffairs #Eliomedica #RegulatoryStrategy #MedTech #ArtificialIntelligence #AI

💡Sunday Spotlight on innovation: Care.Trials, powered by TuumIO, is revolutionizing clinical research: ⚡ Projected $2.36 billion revenue over 5 years ⚡ Decentralized infrastructure for secure, efficient trials ⚡ Patient-centric approach with data sovereignty ⚡ Streamlined processes for faster medical breakthroughs Care.Trials exemplifies how TuumIO's technology is reshaping critical industries. By decentralizing clinical trials, we're accelerating the path from research to life-saving treatments. The future of healthcare is decentralized, secure, and efficient with TuumIO. #TuumIO #CareITrials #DecentralizedHealthcare #ClinicalTrials #HealthTech #Web3InHealthcare