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Xenophon Papademetris
In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications.
Read more
In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications.
Read more
In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications.
We begin by discussing medical device regulatory structures, data privacy and cybersecurity regulations, and key support technologies such quality management systems and risk management. We then take a detailed look at the medical software life cycle, starting with identifying user needs, mapping these to system requirements and then the process of software design, coding, testing and validation. We continue by exploring issues related to the use of machine learning techniques in medical applications from both a software engineering and a regulatory perspective. We conclude with a discussion of the business and management issues in this area focusing on the impact on digital health on modern healthcare and issues related to starting new ventures.
This is a class aimed at either third- or fourth-year undergraduates in computer science, biomedical engineering, and related fields, and to junior software engineers currently either working in, or interested in moving to, the medical device industry.
Register for this course and see more details by visiting:
OpenCourser.com/course/2hud0i/introduction
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What's inside
Syllabus
Introduction to Medical Software and Digital Health
Welcome to week one of our Introduction to Medical Software class. Here we will set the set the stage for what will come in the rest of the course. This week will introduce what medical software is, and we will discuss relevant regulatory issues. We will also dive into the opportunities in medical software and digital health, and finally we will discuss the regulatory process and the US health care environment.
Read more
Syllabus
Introduction to Medical Software and Digital Health
Welcome to week one of our Introduction to Medical Software class. Here we will set the set the stage for what will come in the rest of the course. This week will introduce what medical software is, and we will discuss relevant regulatory issues. We will also dive into the opportunities in medical software and digital health, and finally we will discuss the regulatory process and the US health care environment.
Read more
Medical Software Regulation (FDA and IMDRF)
Welcome to week two of our introduction to Medical Software class. Our focus is this week is going to be on the regulatory aspects of medical software.
What are the procedures one must follow? What is the process that they follow? We will discuss some emerging issues when it comes to things like artificial intelligence and machine learning. Lectures will discuss the history of medical device regulation and the history of the Food and Drug Administration in the United States. We will also take a look at the regulatory environment in the EU and China.
The Healthcare Environment (EHR, PACS, Data Privacy, and Cybersecurity)
Welcome to week three of our introduction to Medical Software class. In this week's lectures, we will look at the clinical environment and the constraints that come with it. We will look at constraints that come from the environment itself, the stakeholders involved, and also the associated technology that is present there, the databases that we have to interact with, the electronic health records, the parks, the imaging databases, and then issues to do with the regulations that are in this area regarding data privacy and security issues, and the increasing emphasis on cybersecurity.
Quality and Risk Management
In this week’s lectures we will talk about two management technologies that support the development of medical software: quality management systems and risk management.
Software Development Life Cycle
This week, we will start looking at the design of software and introduce the medical software life cycle. In particular, we will introduce the international standard for medical software life cycles IEC 62304 and provide a guided tour of the process. We will also introduce our example project which we will use to anchor our discussions over the next few weeks.
User Needs & System Requirements
In this week's segments, we will focus on user needs and the system requirements specification process. We will discuss how to identify user needs and how to communicate with medical experts. In the second half of this week's segments, we will describe the systems requirements specification document and present an example outline of such a document for our image guided neurosurgery project.
Software Architecture Design and Usability Engineering
This week, we will primarily focus on the process of designing the software, i.e. the creation of a plan that will allows us to from requirements to something that now can be implemented on a computer. We will also discuss usability engineering -- the process of designing user interfaces to improve ease-of-use and to avoid user errors. Finally, we have a segment from Dr. Licholai on Digital Behavioral Health to give you an example of a use case for medical software.
Construction and Testing
In this week, we get to the most concrete components of the medical software lifecycle, coding and testing. In many ways, this is the part of the lifecycle that is most similar to any other kind of software engineering you may have had exposure to. We will present some advice on coding, especially in the medical software domain and introduce source code management. In the second half of this week's content, we will introduce software testing and discuss what a testing plan looks like.
Probability and Statistics
This week, we will take a detour from the software lifecycle process to cover some mathematical background before returning to the software lifecycle next week when we talk about software validation. The goal of this week is to introduce key concept from probability and statistics. We will talk about the critical area of signal detection, and then we will present some methods that are necessary to understand how clinical trials are designed.
Software Validation, Deployment, Maintenance and Retirement
This week, we will cover the last steps in the medical software lifecycle. We will spend most of our time talking about validation, where we will also present a brief introduction to clinical trials. We will also have short segments discussing deployment, maintenance, and retirement.
Machine Learning
In this week's lectures, we focus on artificial intelligence and machine learning, the use of this technology, the challenges they produce as we integrate them into software, and the challenges of regulating these technologies in order to protect patients and caregivers.
Business and Management Issues
In this section of our course, we will step away from the technical aspects that you have been learning and really think about how to get your medical software or your lab prototype out into the hands of people in the real world. For those of you interested in enterpreneurship, it is just as important to get an basic overview of the business side of things so that you can launch your venture. First, we will discuss the changing models in health care. Then we will go into the nuts and bolts of starting a new health care venture, a broad overview to speak. And then we will end with when and how to raise capital.
Optional Supplement: Case Studies
In this optional supplementary module we will present examples of what happens when software development goes wrong. When this class is taught at Yale, the students are assigned to present these (and other) case studies in small groups. We follow this tradition for the online class as the case studies will be presented by the four Yale undergraduate students who worked as student assistants in the creation of this online course.
Optional Supplement: Expert Interviews
Throughout the creation of this course, Prof. Papademetris conducted interviews with an array of industry experts. Many of these conversations apply to multiple of the weeks' topics - please take a look and enjoy!
Good to know
Good to know
Know what's good ,
what to watch for , and
possible dealbreakers
Designed for a niche audience of third or fourth year undergraduates in computer science, biomedical engineering, and related fields AND students with a bachelor's degree who are currently working in the medical device industry
Suitable for junior software engineers currently working in or interested in moving to the medical device industry
Features a range of speakers including Yale University professors who are recognized for their work in the field of health care and a series of industry experts who can connect the course concepts to real-world applications
Covers fundamental principles to the medical device industry including software development and quality management
Offers a comprehensive overview of the field of medical software and the medical software life cycle
This course requires basic programming fundamentals
Save this course
Save Introduction to Medical Software to your list so you can find it easily later:
Save
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Activities
Be better prepared
before
your course. Deepen your understanding
during
and
after
it. Supplement your coursework and achieve mastery of the topics covered
in Introduction to Medical Software with these
activities:
Read 'Introduction to Biomedical Engineering' by Joseph J. Carr and John M. Brown
Show steps
Reinforce foundational concepts in biomedical engineering prior to beginning coursework.
View
Melania
on Amazon
Show steps
-
Obtain a copy of the book.
-
Read the first three chapters, focusing on the history and scope of biomedical engineering.
-
Complete the end-of-chapter exercises for the first three chapters.
Review basic probability and statistics
Show steps
Review the basics of probability and statistics to strengthen foundational knowledge
Browse courses on
Probability
Show steps
-
Read the relevant chapters from a textbook or online resource
-
Complete practice problems and exercises
-
Take a practice quiz to assess understanding
Coding exercises and challenges
Show steps
Enhance coding skills and apply them to medical software development scenarios
Browse courses on
Coding
Show steps
-
Solve coding challenges on platforms like LeetCode or HackerRank
-
Participate in coding competitions related to medical software
-
Build small software projects to implement medical software concepts
Three other activities
Expand to see all activities and additional details
Show all six activities
Solve Medical Software Coding Challenges
Show steps
Help build a strong foundation in medical software coding practices and reinforce understanding of concepts learned in class.
Show steps
-
Choose a coding challenge platform or website.
-
Select medical software-related challenges.
-
Solve the challenges and debug your code.
-
Review and analyze the solutions of others (optional).
Participate in Medical Software Design Competitions
Show steps
Challenge students to apply their skills in a competitive environment and gain recognition for their work.
Show steps
-
Identify and register for relevant competitions.
-
Form a team or work individually.
-
Develop a solution and prepare a submission.
-
Submit the project and wait for results.
Develop a Medical Software Prototype
Show steps
Provide practical experience in the design and implementation of medical software applications.
Show steps
-
Identify a healthcare problem or need.
-
Design and plan the software architecture.
-
Develop and test the software prototype.
-
Document the design and development process.
-
Present the prototype and get feedback.
Read 'Introduction to Biomedical Engineering' by Joseph J. Carr and John M. Brown
Show steps
Reinforce foundational concepts in biomedical engineering prior to beginning coursework.
View
Melania
on Amazon
Show steps
Show steps
Show steps
- Obtain a copy of the book.
- Read the first three chapters, focusing on the history and scope of biomedical engineering.
- Complete the end-of-chapter exercises for the first three chapters.
Review basic probability and statistics
Show steps
Review the basics of probability and statistics to strengthen foundational knowledge
Browse courses on
Probability
Show steps
Show steps
Show steps
- Read the relevant chapters from a textbook or online resource
- Complete practice problems and exercises
- Take a practice quiz to assess understanding
Coding exercises and challenges
Show steps
Enhance coding skills and apply them to medical software development scenarios
Browse courses on
Coding
Show steps
Show steps
Show steps
- Solve coding challenges on platforms like LeetCode or HackerRank
- Participate in coding competitions related to medical software
- Build small software projects to implement medical software concepts
Three other activities
Expand to see all activities and additional details
Show all six activities
Solve Medical Software Coding Challenges
Show steps
Help build a strong foundation in medical software coding practices and reinforce understanding of concepts learned in class.
Show steps
Show steps
Show steps
- Choose a coding challenge platform or website.
- Select medical software-related challenges.
- Solve the challenges and debug your code.
- Review and analyze the solutions of others (optional).
Participate in Medical Software Design Competitions
Show steps
Challenge students to apply their skills in a competitive environment and gain recognition for their work.
Show steps
Show steps
Show steps
- Identify and register for relevant competitions.
- Form a team or work individually.
- Develop a solution and prepare a submission.
- Submit the project and wait for results.
Develop a Medical Software Prototype
Show steps
Provide practical experience in the design and implementation of medical software applications.
Show steps
Show steps
Show steps
- Identify a healthcare problem or need.
- Design and plan the software architecture.
- Develop and test the software prototype.
- Document the design and development process.
- Present the prototype and get feedback.
Career center
Learners who complete Introduction to Medical Software will develop knowledge and skills
that may be useful to these careers:
Medical Software Engineer
Medical Software Engineer
A Medical Software Engineer designs, develops, tests, and maintains software used in medical devices and healthcare applications. This course provides a comprehensive overview of the field of medical software, including the medical device regulatory process, data privacy and cybersecurity regulations, and the medical software life cycle. It also covers the use of machine learning techniques in medical applications from both a software engineering and a regulatory perspective. Taking this course will help you build a strong foundation in the principles and practices of medical software development and prepare you for a successful career in this field.
Medical Device Regulatory Affairs Specialist
Medical Device Regulatory Affairs Specialist
A Medical Device Regulatory Affairs Specialist ensures that medical devices comply with regulatory requirements. This course provides an overview of the medical device regulatory process, including the history of medical device regulation, the regulatory environment in the US, EU, and China, and emerging issues such as artificial intelligence and machine learning. Taking this course will help you understand the regulatory landscape for medical devices and prepare you for a career in this field.
Quality Assurance Analyst
Quality Assurance Analyst
A Quality Assurance Analyst evaluates and ensures the quality of medical software and devices. This course covers quality management systems and risk management, which are two key technologies that support the development of medical software. Taking this course will help you build a strong foundation in the principles and practices of quality assurance for medical software and devices.
Clinical Research Coordinator
Clinical Research Coordinator
A Clinical Research Coordinator manages clinical trials for medical devices and drugs. This course covers the medical software life cycle, including software validation, which is a critical step in the development of medical software. Taking this course will help you understand the process of software validation and prepare you for a career in clinical research.
Healthcare Data Analyst
Healthcare Data Analyst
A Healthcare Data Analyst collects, analyzes, and interprets data to improve the quality and efficiency of healthcare. This course covers the healthcare environment, including electronic health records, PACS, data privacy, and cybersecurity. Taking this course will help you build a strong foundation in the principles and practices of healthcare data analysis and prepare you for a career in this field.
Health Informatics Specialist
Health Informatics Specialist
A Health Informatics Specialist uses technology to improve the delivery of healthcare. This course provides an overview of the field of medical software, including the medical device regulatory process, data privacy and cybersecurity regulations, and the medical software life cycle. Taking this course will help you understand the role of technology in healthcare and prepare you for a career in this field.
Biomedical Engineer
Biomedical Engineer
A Biomedical Engineer designs, develops, and tests medical devices and systems. This course provides an overview of the field of medical software, including the medical device regulatory process, data privacy and cybersecurity regulations, and the medical software life cycle. Taking this course will help you build a strong foundation in the principles and practices of biomedical engineering and prepare you for a career in this field.
Software Developer
Software Developer
A Software Developer designs, develops, and tests software applications. This course covers the medical software life cycle, including software design, coding, testing, and validation. Taking this course will help you build a strong foundation in the principles and practices of software development and prepare you for a career in this field.
Computer Scientist
Computer Scientist
A Computer Scientist researches, designs, and develops computer systems and applications. This course provides an overview of the field of medical software, including the medical device regulatory process, data privacy and cybersecurity regulations, and the medical software life cycle. Taking this course will help you build a strong foundation in the principles and practices of computer science and prepare you for a career in this field.
Data Scientist
Data Scientist
A Data Scientist collects, analyzes, and interprets data to solve business problems. This course covers the healthcare environment, including electronic health records, PACS, data privacy, and cybersecurity. Taking this course will help you build a strong foundation in the principles and practices of data science and prepare you for a career in this field.
Entrepreneur
Entrepreneur
An Entrepreneur starts and runs their own business. This course covers the business and management issues in the medical software industry, including the impact of digital health on modern healthcare and issues related to starting new ventures. Taking this course will help you understand the challenges and opportunities of starting a business in the medical software industry.
Product Manager
Product Manager
A Product Manager manages the development and launch of new products. This course covers the medical software life cycle, including user needs, system requirements, software design, and testing. Taking this course will help you build a strong foundation in the principles and practices of product management and prepare you for a career in this field.
Technical Writer
Technical Writer
A Technical Writer writes documentation for software and other technical products. This course covers the medical software life cycle, including user needs, system requirements, software design, and testing. Taking this course will help you build a strong foundation in the principles and practices of technical writing and prepare you for a career in this field.
User Experience Designer
User Experience Designer
A User Experience Designer designs the user interface for software and other products. This course covers software design, usability engineering, and human-computer interaction. Taking this course will help you build a strong foundation in the principles and practices of user experience design and prepare you for a career in this field.
Healthcare Consultant
Healthcare Consultant
A Healthcare Consultant provides advice to healthcare organizations on how to improve their operations. This course provides an overview of the field of medical software, including the medical device regulatory process, data privacy and cybersecurity regulations, and the medical software life cycle. Taking this course will help you understand the challenges and opportunities facing healthcare organizations and prepare you for a career in this field.
For more career information including salaries, visit:
OpenCourser.com/course/2hud0i/introduction
Reading list
We've selected six 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
Introduction to Medical Software.
Provides a comprehensive overview of quality management systems for medical software, including requirements gathering, design, development, testing, and maintenance. It also covers regulatory requirements and standards.
Provides an overview of the medical device design process, from concept development to regulatory approval. It valuable resource for anyone involved in the design or development of medical devices.
Save
Provides an overview of artificial intelligence in medicine, including topics such as machine learning, natural language processing, and medical image analysis. Useful as additional reading on the use of AI in medicalソフトウェア.
Provides a practical guide to the Lean Startup methodology, which process for developing and validating new products and services. Useful as additional reading on starting a medical software company.
Discusses the challenges that large companies face when trying to innovate, and provides advice on how to overcome these challenges. Useful as additional reading on the business of medical software.
Provides a comprehensive overview of the medical device quality assurance process, including design control, production control, and postmarket surveillance. It also covers regulatory requirements and standards.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/2hud0i/introduction
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Effort
12 weeks of study, 5-7 hours/week
Level
Intermediate
Via
Coursera
Institution
Yale University
Instructor
Xenophon Papademetris
Language
English
Transcripts
Español
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中文
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Good to know
Designed for a niche audience of third or fourth year undergraduates in computer science, biomedical engineering, and related fields AND students with a bachelor's degree who are currently working in the medical device industry
Suitable for junior software engineers currently working in or interested in moving to the medical device industry
Features a range of speakers including Yale University professors who are recognized for their work in the field of health care and a series of industry experts who can connect the course concepts to real-world applications
Covers fundamental principles to the medical device industry including software development and quality management
Offers a comprehensive overview of the field of medical software and the medical software life cycle
This course requires basic programming fundamentals
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