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Mike Raxworthy

Most FutureLearn courses run multiple times. Every run of a course has a set start date but you can join it and work through it after it starts. Find out more This course is appropriate for anyone interested in MedTech and product design. The course will be of particular interest to undergraduate students studying engineering, product design, and disciplines related to healthcare, and professionals working in the healthcare sector in a medical capacity or as MedTech designers. You can use the hashtag #FLmedtechtrends to talk about this course on social media.

Topics Covered

Read more

Most FutureLearn courses run multiple times. Every run of a course has a set start date but you can join it and work through it after it starts. Find out more This course is appropriate for anyone interested in MedTech and product design. The course will be of particular interest to undergraduate students studying engineering, product design, and disciplines related to healthcare, and professionals working in the healthcare sector in a medical capacity or as MedTech designers. You can use the hashtag #FLmedtechtrends to talk about this course on social media.

Topics Covered

  • History of MedTech and how MedTech products have been developed.
  • The forces driving innovation in the MedTech sector.
  • Challenges for MedTech products to overcome.
  • How do we make sure MedTech products are safe?
  • Establishing a patient and clinical need for a product.
  • Designing products with regulations in mind.
  • Bringing a product to market.

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Reviews summary

Medtech trends and product design overview

According to learners, MedTech: Trends and Product Design offers a highly beneficial overview of the MedTech sector, particularly strong in covering regulatory considerations and the process of bringing products to market. Students appreciate the engaging lectures, often featuring insights from industry experts, and find the content to be up-to-date and patient-centric. While it provides a solid foundation for those new to the field or seeking a broad understanding, some existing professionals found it lacking in technical depth or wished for more detailed case studies. Overall, it's considered an excellent introduction for career-focused individuals in healthcare and engineering.
Features engaging lecturers and current industry trends.
"The lecturers were engaging."
"The guest lectures from industry experts were a huge plus."
"The content is up-to-date and presented clearly, emphasizing patient-centric design."
Focuses on practical aspects like regulations and market entry.
"The modules on regulatory considerations and bringing a product to market were incredibly insightful."
"I gained practical tools and strategies that I could apply immediately to my work."
"It covers a lot of ground from regulations to market access."
Provides a strong foundation in MedTech trends and product design.
"This course was fantastic for understanding the broader landscape of MedTech."
"I found it perfectly pitched to give me a solid foundation without getting lost in overwhelming detail."
"A truly comprehensive introduction to MedTech product design."
Some areas could benefit from more in-depth case studies or interactive elements.
"Some topics, like specific biomaterial considerations, felt a bit rushed."
"I felt some case studies could have been more detailed to better illustrate the points."
"The course could use more interactive exercises."
Excellent for beginners but may lack advanced technical detail.
"My only minor critique is that some topics, like specific biomaterial considerations, felt a bit rushed."
"I was hoping for more technical depth, particularly in product development methodologies; it felt more like a survey."
"I already work in the industry, and it didn't offer much new insight; it's better for those with very little prior knowledge."

Career center

Learners who complete MedTech: Trends and Product Design will develop knowledge and skills that may be useful to these careers:

Reading list

We've selected 50 books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in MedTech: Trends and Product Design.
This foundational report cornerstone in the patient safety movement, highlighting the magnitude of medical errors in the US healthcare system. It provides essential historical context and a compelling call to action for systemic change. is crucial for gaining a broad understanding of why patient safety critical issue and is often cited as a seminal work in the field.
Is widely considered a foundational text in clinical trials. It provides a comprehensive overview of the principles and practices, covering design, conduct, analysis, and reporting. It is commonly used as a textbook in academic institutions and is an excellent resource for gaining a broad understanding of the field.
A crucial resource for understanding the complex regulatory landscape of medical devices worldwide. This handbook covers global requirements from development to postmarket activities, including cutting-edge topics like AI, machine learning, and digital health. It is an essential guide for regulatory professionals at all levels and provides detailed insights into the medical device lifecycle. is highly valuable as a current reference tool.
Provides a comprehensive overview of the statistical principles and methods used in the design and analysis of clinical trials. It is an excellent resource for those looking to deepen their understanding of the quantitative aspects and is highly relevant for students and professionals in biostatistics and clinical research.
This comprehensive handbook provides an international perspective on medical device regulatory affairs, covering systems in different countries, ISO standards, clinical trial requirements, and documentation. It includes contributions from experts in major international regulatory bodies and addresses the needs of startups. This valuable reference for anyone involved in the global medical device market. The latest edition is particularly relevant.
This highly popular book explores the power of checklists in improving performance and reducing errors in complex fields, including healthcare. It provides compelling examples and a clear argument for the implementation of simple tools to enhance safety and efficiency. is valuable for understanding practical strategies to improve patient safety and is widely read by healthcare professionals.
Offers a comprehensive systems-based approach to medical device technology, integrating technical operation, clinical need, regulatory issues, and standards. It is suitable for a broad audience, including students and professionals, providing a solid foundation in the field. The book includes exercises and laboratory experiments to reinforce concepts, making it a valuable resource for both learning and reference. It covers current research, design issues, and engineering standards, bridging the gap between engineering design and medical device development.
This comprehensive manual provides a step-by-step guide to the regulatory process for both pharmaceuticals and medical devices. It covers topics such as pre-clinical development, clinical trials, and marketing approval.
Quality management and regulatory compliance are paramount in the medical device industry. focuses on these critical areas, providing guidance on establishing and maintaining quality systems and navigating the regulatory landscape. It's a key resource for professionals involved in quality assurance and regulatory affairs.
Delves into the crucial ethical and regulatory considerations in clinical research. It is essential reading for anyone involved in clinical trials to understand the principles of protecting human subjects and complying with ethical guidelines and regulations.
Delves into the critical concept of a just culture in healthcare, examining how organizations can balance accountability with the need to learn from errors. It challenges traditional blame-oriented approaches and provides insights into creating an environment that promotes reporting and improvement. This is essential reading for those interested in the human and organizational factors of patient safety.
This handbook offers a comprehensive reference on the basics and practices of clinical trials, covering each phase, technique, and issue. It valuable resource for gaining a thorough understanding of the operational aspects of conducting trials and is suitable for graduate-level students and practicing clinicians.
Focusing specifically on the regulatory aspects, this book delves into FDA-CDRH manufacturing policies and regulations. It practical handbook for navigating the regulatory pathways for medical devices in the United States, providing essential information for compliance and market entry.
Explores the application of High Reliability Organization (HRO) principles and Six Sigma methodologies to healthcare to improve patient safety and outcomes. It provides practical tools and strategies for reducing variability and standardizing processes. This is particularly relevant for those interested in process improvement and systems thinking in healthcare.
An expansion of the R-only version, this book includes implementations of statistical analyses using both R and SAS, two widely used software packages in clinical trial data analysis. It practical guide for those who need to work with either or both of these platforms.
This recent publication explores emerging theories of safety science and their practical application in patient safety incident investigation and management. It includes contributions on topics such as SEIPS, AcciMaps, and Human Factors, reflecting contemporary approaches in the field. is valuable for those looking to deepen their understanding of current safety science applications.
Focusing specifically on medication safety, this guide provides a comprehensive overview of principles and practices for preventing and identifying medication errors. It offers recommendations for implementing a medication safety program across healthcare settings. This valuable resource for understanding a critical area of patient safety.
Provides a practical guide to the regulatory affairs process for pharmaceutical products. It covers topics such as drug development, manufacturing, and marketing. The author leading expert in pharmaceutical regulatory affairs.
Serves as a concise and accessible step-by-step guide to the principles and practices of clinical trials. It is ideal for those new to the field or seeking a broad understanding of the entire process, from study design to reporting findings. It demystifies terminology and uses real-life examples.
Understanding and mitigating the risk of user error is crucial for medical device safety. focuses on the principles and methods for analyzing and reducing use errors, a key aspect of human factors engineering in medical device design. It's highly relevant for ensuring patient safety.
This manual offers practical insights and lessons learned from the Duke Clinical Research Institute's experience in conducting clinical trials. It provides a real-world perspective on the operational aspects and challenges of clinical research.
This sourcebook serves as a practical, step-by-step guide through various topics in clinical research, including trial conduct. It useful reference manual with practical tools and guidance on regulations and Good Clinical Practice.
This handbook discusses the core elements of high reliability organizations and their application in healthcare to address patient safety and quality concerns. It provides tools for healthcare professionals to enhance patient safety. This practical guide for implementing HRO principles.
Addresses the design and analysis of quality of life studies within clinical trials, a increasingly important aspect of evaluating treatment outcomes. It provides practical guidance and statistical methods for incorporating quality of life endpoints into trials.
Provides a practical guide to applying human factors principles to improve patient safety and quality of care. It examines how the design of the healthcare environment, processes, and tools can impact safety. This useful resource for understanding the cognitive and environmental aspects of medical errors.
Presents a collection of case studies illustrating preventable healthcare errors from the patient's perspective. Each case includes a structured analysis to identify lessons learned and strategies for prevention, helping readers develop core patient safety competencies. This valuable resource for applied learning in patient safety.
Presents a collection of timeless principles and guidelines for creating effective and aesthetically pleasing designs.
Explores the role of emotions in product design and how to create products that elicit positive emotional responses from users.
Presents strategies and practical solutions for achieving zero harm in healthcare, drawing on best practices from high-reliability industries. It focuses on creating a culture of safety that protects both patients and the workforce. This relevant read for organizations striving for the highest levels of safety.
Provides a comprehensive overview of the key concepts and principles of product design, covering topics such as user research, ideation, prototyping, and manufacturing.
Provides a comprehensive guide to the basic concepts and protocols in pharmaceutical regulatory affairs, including aspects related to clinical trials and submissions to regulatory agencies. It valuable resource for understanding the regulatory landscape surrounding clinical research.
While not solely focused on medical devices, this book outlines a structured process for identifying unmet clinical needs and inventing new medical technologies. It is highly relevant for those interested in the innovation and entrepreneurial aspects of the medical device field, providing a framework for product development.
Explores the life and work of Dieter Rams, one of the most influential product designers of the 20th century, and his minimalist approach to design.
Brings together contributions on the theory, methods, and application of patient safety culture. It covers the background, theories, assessment tools, and challenges in the field of patient safety culture, which critical component of creating a safe healthcare environment.
This handbook offers a practical overview of the clinical research industry, providing insights into various aspects beyond just the trials themselves. It can be helpful for those seeking to understand the broader context of clinical trials within the industry.
This guide focuses on promoting safety throughout the medication process, including prescribing, dispensing, and administering drugs. It addresses adverse reactions, dosage calculations, and error reporting, providing an evidence-based approach for healthcare professionals involved in medication delivery.
This handbook provides a practical guide to patient safety for frontline staff and trainees. It covers the rationale and theories behind patient safety and offers practical methods for reducing harm in daily clinical practice. This useful reference tool for healthcare professionals at all levels.
This handbook serves as a concise guide for those involved in the research and development of medical devices. It covers a range of topics relevant to bringing new products to market, including intellectual property management, operating room observation, and the use of new technologies and materials. It's a practical resource for R&D professionals.
Offers a critical perspective on the patient safety movement, arguing that the focus on individual errors has overlooked systemic issues. It delves into the complexities and challenges of truly improving safety in healthcare. This book is valuable for gaining a deeper, more nuanced understanding of the political and organizational challenges in patient safety.
This handbook offers a broad perspective on the role of clinical engineering, which involves the application of engineering principles to healthcare technology, including medical devices. It covers topics such as technology management, patient safety, and regulatory compliance from a clinical context. It provides valuable insights into the practical aspects of medical devices within a healthcare setting.
This concise manual covers essential information on patient safety and quality improvement, focusing on improving systems and processes, preventing errors, and promoting transparency. It addresses PS/QI in various clinical settings and provides models, measurements, and tools. This practical reference for healthcare providers at all levels.
This compelling book explores the ethical implications of using biological materials in research without informed consent, centered around the story of Henrietta Lacks and her immortalized cells. It provides crucial historical context on ethical lapses in research and underscores the importance of ethical guidelines in clinical trials.
Brings together articles and case studies on various aspects of medical device R&D, design, and manufacturing. It covers materials, specific device applications, and related issues like precision machining. While the first edition is from 2012, it offers practical approaches and covers a diverse range of subjects within the field.

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