Biomedical Engineering Device Development

Real-Time Heart Rate Monitoring Using Computer Vision & Signal Processing ❤️📊 I’ve been working on an exciting project that combines computer vision, signal processing, and real-time data analysis to estimate heart rate (BPM) from facial detection using a webcam. 🎥💡 How It Works: ✅ Face Detection: Using cvzone‘s FaceDetector, we accurately locate the user’s face in real-time. ✅ Color Magnification: A Gaussian Pyramid is applied to amplify subtle color changes caused by blood flow. ✅ Fourier Transform: We extract frequency components corresponding to pulse rate. ✅ Bandpass Filtering: Only relevant heart rate frequencies (1-2 Hz) are retained. ✅ Visualization: BPM values are plotted dynamically for real-time monitoring. Tech Stack: 🖥️ OpenCV | 🧠 cvzone | ⚡ NumPy | 🎛️ FFT | 📈 Signal Processing Key Learnings & Challenges: 🔹 Fine-tuning parameters like Gaussian levels & frequency range significantly impacts accuracy. 🔹 Efficient real-time processing is critical to avoid lag. 🔹 Signal noise handling is essential for reliable BPM estimation. 🚀 This technique has potential applications in health monitoring, fitness tracking, and remote diagnostics. Would love to hear your thoughts on its real-world applications! #MachineLearning #ComputerVision #HealthTech #SignalProcessing #OpenCV #Python #RealTimeAI #BPMDetection

Quality isn’t expensive. Poor quality is. Most quality systems look good on paper. Reality tells a different story. ISO 13485 isn’t just another standard. It’s how you keep patients safe. Lost in the ISO maze? Here’s your practical guide through it: 1. Quality Management System (QMS) ↳ The foundation of everything you build • Design Controls  • Training management • Requirements management • Supplier Qualification • Product Record Control  • Quality Management 2. Risk-Based Thinking (RBT) ↳ Spot problems before they happen ↳ Put smart solutions in place early ↳ Stay ahead of what could go wrong 3. Design Controls ↳ Track every step with purpose ↳ Verify before moving forward ↳ Turn ideas into trusted products 4. CAPA Process ↳ Fix issues at their root ↳ Make solutions stick ↳ Learn from each problem 5. Post-Market Surveillance ↳ Your eyes in the real world ↳ Listen to what users tell you ↳ Turn feedback into improvement 6. QMS Structure ↳ Build consistency into everything ↳ Keep records that tell the story ↳ Make quality automatic 7. Implementation Best Practices ↳ Get real leadership commitment ↳ Train until it becomes natural ↳ Never stop improving 8. Smart Audit Strategy ↳ Keep internal checks honest ↳ Stay ahead of regulators ↳ Build trust through transparency These parts work together. Each one makes the others stronger. Remember: ISO 13485 builds more than compliance. It builds trust that saves lives. Which part challenges you most? ♻️ Find this valuable? Repost for your network. Follow Bastian Krapinger-Ruether expert insights on MedTech compliance and QM.

ICMR-MDMS, AIIMS Bhopal, NIMHANS Bengaluru and Bioscan Research have jointly developed a hand-held brain scanning device #CEREBO which can detect intracranial bleeding and edema within minutes.   The device has already passed clinical validation and has received approval from the Drugs Controller General of India (DCGI) as well.   Based on infrared waves technology, CEREBO is non-invasive #diagnostics tool which can be simply put over various parts of the head of the patients who have suffered brain injuries to detect internal bleeding.   This is a very important development for a country like #India where access to healthcare remains out of bounds or limited for people, specially those living in rural and far-flung areas where facilities like CT scans or MRI are often not available.   Researchers say even CEREBO is not meant to replace CT scans, however, it can prove beneficial in cases where CT scans are unavailable to study deep tissues non-invasively and bring hospital-grade diagnosis to the point of care.   https://lnkd.in/gVP2wuae

The Medical Device Iceberg: What’s hidden beneath your product is what matters most. Your technical documentation isn’t "surface work". It’s the foundation that the Notified Body look at first. Let’s break it down ⬇ 1/ What is TD really about? Your Technical Documentation is your device’s identity card. It proves conformity with MDR 2017/745. It’s not a binder of loose files. It’s a structured, coherent, evolving system. Annexes II & III of the MDR guide your structure. Use them. But make it your own. 2/ The 7 essential pillars of TD: → Device description & specification → Information to be supplied by the manufacturer → Design & manufacturing information → GSPR (General Safety & Performance Requirements) → Benefit-risk analysis & risk management → Product verification & validation (including clinical evaluation) → Post-market surveillance Each one matters. Each one connects to the rest. Your TD is not linear. It’s a living ecosystem. Change one thing → It impacts everything. That’s why consistency and traceability are key. 3/ Tips for compiling TD: → Use one “intended purpose” across all documents → Apply the 3Cs: ↳ Clarity (write for reviewers) ↳ Consistency (same terms, same logic) ↳ Connectivity (cross-reference clearly) → Manage it like a project: ↳ Involve all teams ↳ Follow MDR structure ↳ Trace everything → Use “one-sheet conclusions” ↳ Especially in risk, clinical, V&V docs ↳ Simple, precise summaries → Avoid infinite feedback loops: ↳ One doc, one checklist, one deadline ↳ Define “final” clearly 4/ Best practices to apply: → Add a summary doc for reviewers → Update documentation regularly → Create a V&V matrix → Maintain URS → FRS traceability → Hyperlink related docs → Provide objective evidence → Use searchable digital formats → Map design & mfg with flowcharts Clear TD = faster reviews = safer time to market. Save this for your next compilation session. You don't want to start from scratch? Use our templates to get started: → GSPR, which gives you a predefined list of standards, documents and methods. ( https://lnkd.in/eE2i43v7 ) → Technical Documentation, which gives you a solid structure and concrete examples for your writing. ( https://lnkd.in/eNcS4aMG )

This paper explores the transformative impact of wearables and AI on healthcare workflows and patient care, focusing on enhanced efficiency, personalization, and cost-effectiveness. 1️⃣ IoMT (Internet of Medical Things) market is rapidly growing, projected to increase from $50.3 billion in 2020 to $135.87 billion by 2025, highlighting a significant shift toward digital health adoption. 2️⃣ Wearables have diverse applications, monitoring both biological factors (e.g., saliva, sweat) and utility-based measurements (e.g., smart fabrics, implants) to enhance patient data collection. 3️⃣ Real-time monitoring through wearables and AI supports early disease detection and continuous tracking, facilitating better treatment adherence and fewer hospital visits. 4️⃣ Patient interest in remote monitoring is strong, with 79% willing to use mobile ECG tools, and 74% feeling safer with constant monitoring, demonstrating growing acceptance of self-managed care. 5️⃣ AI-assisted monitoring with wearable sensors achieves high accuracy, including 97% accuracy in detecting atrial fibrillation, outperforming traditional methods. 6️⃣ AI models like deep learning and neural networks enable predictive diagnostics and personalized treatments, demonstrating 80% accuracy for heart disease, 80% for blood infections, and 94% for cancer detection. 7️⃣ Integration challenges include data management, EHR integration, privacy, bias, and transparency, all of which must be addressed to foster trust among healthcare providers and patients. 8️⃣ Automation potential is significant, with AI transforming tasks like medical billing, coding, and lab workflows, reducing errors and freeing up resources for patient care. 9️⃣ Future healthcare will increasingly depend on AI and wearables, reshaping patient management, especially for aging populations, and enabling personalized, real-time care delivery. 🔟 AI and wearables promise a comprehensive transformation of healthcare, enhancing efficiency, personalizing treatments, and reducing costs while overcoming obstacles to data integration and physician-patient trust. ✍🏻 Perry LaBoone, PE, CPA, PMP, Oge Marques. Overview of the future impact of wearables and artificial intelligence in healthcare workflows and technology. International Journal of Information Management Data Insights. 2024. DOI: 10.1016/j.jjimei.2024.100294

When empathy meets design, magic happens. Doug Dietz's story is proof. Discover how he did it. As product managers, we are constantly looking for ways to improve user experiences and create meaningful results. At GE Healthcare, Doug Dietz transformed the MRI experience for paediatric patients, providing a compelling example. The Problem Despite building a cutting-edge MRI scanner, Dietz noticed a young patient's tremendous anxiety while using it. This revealed a key flaw in the machine's design: it did not account for children's emotional needs. The Use of Design Thinking Dietz used design thinking to redesign the MRI experience. 1/ Empathise: He spoke with kids in daycare centres and sought advice from child life experts to understand their viewpoints. 2/ Define: It was shown that 80% of young children needed anaesthesia because they were afraid of the MRI process. 3/ Ideate: To generate creative ideas, a varied team comprising volunteers, hospital employees, and specialists from a nearby children's museum worked together. 4/ Prototype: Developed the "Adventure Series," which turned MRI rooms into spaceships and pirate ships. 5/ Test: The Children's Hospital of Pittsburgh piloted the updated experience, which resulted in notable enhancements. The Results ↳Patient satisfaction scores increased by 90% ↳The need for sedation dropped from 80% to 10% ↳Anxiety levels in children decreased, making it easier for them to remain still during procedures ↳The reduced need for anesthesiologists allowed more patients to be scanned each day, improving efficiency and reducing costs The Key Takeaways for Product Managers 1/ Innovation Is Driven by Empathy: A thorough comprehension of user experiences can reveal unmet requirements and stimulate game-changing solutions. 2/ Reframe the problem: Dietz switched from focussing on the machine to developing the complete patient experience. 3/ Holistic Problem-Solving: More thorough solutions result from addressing the user experience's emotional and functional elements. 4/ Collaborative Ideation: Including a range of stakeholders encourages innovation and reveals fresh viewpoints. 5/ Iterative prototyping: Creating and testing prototypes in real-world contexts to validate ideas and inform necessary refinements. 6/ Measurable impact: The redesign enhanced operational effectiveness and patient experience. Doug Dietz's case study highlights how effective design thinking leads to transformative solutions for challenging problems in healthcare and beyond. Dietz and his colleagues developed a solution that not only soothed children's anxieties but also enhanced operational effectiveness and medical results by prioritising empathy and rethinking the entire process. Your Turn: ↳ How have you applied design thinking principles in your projects?  Share your thoughts in the comments below! 👍 LIKE this post, 🔄 REPOST this to your network and follow me, Monica Jasuja

🤩 Sensor Interface Circuit for Biomedical Devices & Biosensors 💥 💝 Learn How to Interface Glucose, Lactate and other Sensors with MCU 🧐 At the heart of most of these biosensors is LMP91000 by Texas Instruments which is a programmable analog front-end for use in micro-power electrochemical sensing applications. It provides a complete signal path solution between a sensor and a microcontroller that generates an output voltage proportional to the cell current. It supports multiple electrochemical sensors such as: 3-lead toxic gas sensors and 2-lead galvanic cell sensors. The core of the LMP91000 is a potentiostat circuit. It consists of a differential input amplifier used to compare the potential between the working and reference electrodes to a required working bias potential (set by the Variable Bias circuitry). The error signal is amplified and applied to the counter electrode (through the Control Amplifier - A1). Any changes in the impedance between the working and reference electrodes will cause a change in the voltage applied to the counter electrode, in order to maintain the constant voltage between working and reference electrodes. A Transimpedance Amplifier connected to the working electrode, is used to provide an output voltage that is proportional to the cell current. The working electrode is held at virtual ground (Internal ground) by the transimpedance amplifier. The potentiostat will compare the reference voltage to the desired bias potential and adjust the voltage at the counter electrode to maintain the proper working-to-reference voltage. How to build a circuit for your biomedical application? Orlando Hoilett built KickStat, a miniaturized potentiostat using LMP91000 with the processing power of the Arm Cortex-M0+ SAMD21 Microchip Technology Inc. microcontroller on a custom-designed 21.6 mm by 20.3 mm circuit board. By incorporating onboard signal processing via the SAMD21, h he achieved 1mV voltage resolution and an instrumental limit of detection of 4.5nA in a coin-sized form factor. He measured the faradaic current of an anti-cocaine aptamer using cyclic voltammetry and square wave voltammetry and demonstrated that KickStat’s response was within 0.6% of a high-end benchtop potentiostat. To further support others in electrochemical biosensors development, he has made KickStat’s design and firmware available in an online GitHub repository. 📢 KickStat Project: "KickStat: A Coin-Sized Potentiostat for High-Resolution Electrochemical Analysis" doi: https://lnkd.in/eFjdpWjQ GitHub repo: https://lnkd.in/eJAvT_kR Datasheet: https://lnkd.in/eKvkGWCt 💜 Share it with your biosensors, biomedical wearable network 👌 #biosensors #wearables #sensors #electronics #Potentiostat #lmp91000

At 3 AM one night, a teenager in Hyderabad woke up to find his grandmother outside the house. She thought she was on a train. She had Alzheimer’s. And for 17-year-old Hemesh Chadalavada, that moment raised a chilling question: “What if I hadn’t woken up in time?”  Instead of leaving it at fear, Hemesh turned it into action.   He built the Alpha Monitor, a wearable that:  Alerts caregivers if patients wander or fall  Tracks pulse and temperature  Reminds patients to take medicines  Uses LoRa technology so it works up to 5 km away, far beyond WiFi or Bluetooth Over 20 prototypes later, and countless hours spent at Alzheimer’s care centres to understand real needs, Hemesh is now ready to take Alpha Monitor into manufacturing. His work has already earned him the Pradhan Mantri Rashtriya Bal Puraskar and global recognition. This isn’t just a story of tech.  It is a story of empathy fueling innovation. A teenager’s love for his grandmother has created a lifeline for families facing the hardest parts of Alzheimer’s. Sometimes the biggest breakthroughs don’t come from labs or boardrooms. They come from a simple, human question:  “How can I protect the people I love?” #innovation #healthtech  

Biocompatibility Testing in Medical Device Manufacturing When it comes to medical device manufacturing, ensuring patient safety and regulatory compliance is paramount. That's where biocompatibility testing plays a crucial role. Biocompatibility testing involves assessing the compatibility of medical devices with living tissues and the body's physiological responses. It helps manufacturers identify potential risks and evaluate the safety of their products, such as inflammation, toxicity, and immunological reactions. By conducting comprehensive biocompatibility testing throughout the product development cycle, manufacturers can make informed design and material choices, enhancing overall product quality and performance. Moreover, compliance with international standards, such as ISO 10993, is essential for conducting thorough biocompatibility testing. It not only ensures regulatory compliance but also instills confidence in healthcare professionals and patients. As the medical device industry evolves, biocompatibility testing continues to advance. Innovations in non-animal testing methods, personalized biocompatibility assessments, and continuous monitoring hold great promise for the future. Let's prioritize biocompatibility testing to create safer and more reliable medical devices, ultimately benefiting patients worldwide. #biocompatibility #medicaldevicemanufacturing #patientsafety #regulatorycompliance #innovation