recorded Medical Device Development Immersion
Medical Device Development Immersion showcases the fascinating aspect of medical device development. Beginning with an overview of the dynamic medical device industry, this course quickly navigates the changing regulatory environment and pathways devices undertake for FDA or EMA marketing approval. Throughout this course an interactive activity of building a medical device prototype reinforces the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The strategies that drive successful medical device businesses, including reimbursement considerations that ensure these game-changing inventions reach patients, complete the course. Learn from an industry expert with 30 years of experience in both large and start-up medical device companies―register today!Â
Week 1: Medical Device Overview
Explore the history of device regulation and gain insights into the FDA’s mission and organizational structure. Understand what constitutes a medical device and discover special categories, including software, in vitro diagnostics, radiation-emitting products, mobile medical devices, and wellness products in this informative course.
Week 2: Regulatory Approval Pathways
Navigate the FDA’s classification system for regulatory controls, including Class I, Class II, and Class III devices. Explore 510(k) submissions, predicates, de novo 510(k), and exemptions for Class III devices. Gain insights into device classification complexities, combination products, and the EU device approval pathway in this comprehensive course.
Week 3: Medical Device Regulation
Gain insights into quality systems regulations, regulatory compliance including GMP, GLP, and GCP, risk management evaluation, and human factors and usability considerations. Learn about risk analysis plans, post-market surveillance, MedWatch reporting, and FDA’s post-market actions and penalties in this informative course.
Week 4: Phase I: Market Opportunity Evaluation
Get an overview of the medical device development process, explore product development timelines, and delve into the regulatory aspects of medical device design. Learn the key requirements for evaluating market opportunities, including customer requirements, with practical activities like assessing customer needs for the Bionic Walker.
Week 5: Phase II: Concept Evaluation
Explore the essential aspects of concept evaluation, including risk analysis planning and the development of a risk acceptability matrix. Learn how to quantify risks and apply these principles through activities like assessing the Bionic Walker concept and risk assessment.
Week 6: Phase III: Engineering Design
In this phase, understand the crucial elements of engineering design, including specifications, iterative design processes, software design, and comprehensive documentation. Gain insights into the key requirements that drive successful product development.
Week 7: Phase IV: Verification and Validation
Dive into the critical aspects of product verification and validation. Learn about key requirements, strategies for testing, labeling verification, human factor testing, and standards compliance. Explore FDA process validation guidance, biocompatibility considerations, and hands-on activities to create specifications and test plans for quality assurance.
Week 8: Phase V: Manufacturing
Discover the critical factors in pharmaceutical manufacturing. Explore essential aspects like manufacturing key considerations, efficient manufacturing transfer, and effective manufacturing scale-up processes. Get the insights you need to optimize pharmaceutical production for success.
Week 9: Medical Device Approval
Uncover the key aspects of gaining FDA approval for medical devices. Learn how to initiate pre-submission discussions with the FDA, navigate clinical trials, and understand the Investigational Device Exemption (IDE) process. Explore expanded pre-approval access, approval timelines, and various FDA submission types. Stay up-to-date with MDUFA III and grasp the intricacies of submission approval timelines.
Week 10: Commercialization
Gain insights into the complex world of reimbursement strategies in healthcare. Analyze the distinct roles of CMS (Centers for Medicare & Medicaid Services) and FDA (Food and Drug Administration) in shaping reimbursement policies. Examine critical factors influencing private payers and their effects on healthcare innovation commercialization.
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Five Takeaways
- Master medical device terminology.
- Create your own toolbox for designing a top-notch medical device prototype.
- Paraphrase the steps of multiple approval pathways for each medical device class.
- Conduct a risk mitigation exercise during the medical device development process.
- Summarize the pain points of commercializing a medical device and including reimbursement.
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