Artificial Intelligence | Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
Aided by 5G technology, artificial intelligence (AI) and machine learning (ML) -based medical device software hold a lot of promise.
Expectations include AI-based medical devices accomplishing things like:
- Automate tasks, synthesize data from multiple sources, and pinpoint trends
- Process and analyze information from wearable sensors and identify disease or the onset of medical conditions
- Predict which patients are at an increased risk for disease, complications, or negative outcomes based on their medical records
- Support research by evaluating large amounts of data and monitoring treatment efficacy
With advancing technology, medical device companies are developing AI medical devices that serve multiple functions such as those that can manage chronic disease.
Medical devices with artificial intelligence could monitor patients and deliver treatment or medication as needed. For example, diabetes patients could wear sensors to monitor their blood sugar levels and administer insulin to regulate them.
AI-based medical imaging devices are also being developed. Companies are producing medical devices with artificial intelligence to conduct medical imaging with better image quality and clarity. These devices would also reduce a patient’s exposure to radiation.
Additionally, companies are using the Internet of Things (IoT) in collaboration with medical devices with artificial intelligence to improve patient outcomes.
Machine Learning as well is particularly helpful in areas where the diagnostic information a doctor examines is already digitized, such as:
- Detecting lung cancer or strokes based on CT scans
- Assessing the risk of sudden cardiac death or other heart diseases based on electrocardiograms and cardiac MRI images
- Classifying skin lesions in skin images
- Finding indicators of diabetic retinopathy in eye images
Artificial Intelligence | Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Training Course by Tonex
Artificial Intelligence | Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) is a 3-day special training course covering Artificial intelligence (AI)- and machine learning (ML)-based technologies used to transform healthcare and medical industry including applications for earlier disease detection, more accurate diagnosis, identification of new observations or patterns on human physiology, and development of personalized diagnostics and therapeutics.
Audience:
This course is intended for individuals who are interested in developing, commercializing, or using AI/ML-based SaMD products, including medical device engineers, clinical researchers, regulatory professionals, and healthcare providers.
Course Outline:
Introduction to AI and ML
- What is AI?
- What is ML?
- Types of ML algorithms
- Benefits of using AI/ML in medical devices
- Challenges of using AI/ML in medical devices
Machine Learning Algorithms
- Supervised learning
- Unsupervised learning
- Reinforcement learning
- Popular ML algorithms
- How to choose the right ML algorithm for your problem
Deep Learning
- What is deep learning?
- Neural networks
- Convolutional neural networks (CNNs)
- Recurrent neural networks (RNNs)
- Autoencoders
- Transfer learning
Natural Language Processing (NLP)
- What is NLP?
- NLP tasks for medical devices
- Text classification
- Named entity recognition (NER)
- Question answering
- Machine translation
AI/ML for Medical Device Development
- AI/ML for medical image analysis
- AI/ML for signal processing
- AI/ML for clinical decision support
- AI/ML for drug discovery
- AI/ML for personalized medicine
AI/ML for Clinical Practice
- AI/ML for remote patient monitoring
- AI/ML for early disease detection
- AI/ML for diagnosis and treatment planning
- AI/ML for surgery and other procedures
- AI/ML for clinical research
AI/ML for Remote Patient Monitoring
- Wearable devices and sensors
- Collecting and transmitting patient data
- Using AI/ML to analyze patient data
- Generating alerts and recommendations
- Improving patient outcomes
AI/ML for Personalized Medicine
- Using genetic and other data to tailor treatments to individual patients
- Predicting patient risk of developing certain diseases
- Identifying the best treatment options for individual patients
- Improving patient outcomes
Regulatory Considerations for AI/ML-based SaMD Products
- The FDA’s regulatory framework for AI/ML-based SaMD products
- Key requirements for developing and marketing AI/ML-based SaMD products
- How to prepare for a regulatory submission
Case Studies of AI/ML-based SaMD Products
- Case study 1: AI/ML for medical image analysis
- Case study 2: AI/ML for clinical decision support
- Case study 3: AI/ML for remote patient monitoring
- Case study 4: AI/ML for personalized medicine
The Future of AI/ML in Medical Devices
- Emerging trends in AI/ML for medical devices
- Challenges and opportunities for AI/ML in medical devices
- How AI/ML is transforming the future of healthcare
Artificial Intelligence | Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Training