Imaging modalities in radiology produce ever-increasing amounts of data which need to be displayed, optimized, analyzed and archived: a "big data" as well as an "image processing" problem. Computer programming skills are rarely emphasized during the education and training of medical physicists, meaning that many individuals enter the workplace without the ability to efficiently solve many real-world clinical problems.

This book provides a foundation for the teaching and learning of programming for medical physicists and other professions in the field of Radiology and offers valuable content for novices and more experienced readers alike.

It focuses on providing readers with practical skills on how to implement MATLAB® as an everyday tool, rather than on solving academic and abstract physics problems. Further, it recognizes that MATLAB is only one tool in a medical physicist's toolkit and shows how it can be used as the "glue" to integrate other software and processes together. Yet, with great power comes great responsibility. The pitfalls to deploying your own software in a clinical environment are also clearly explained. This book is an ideal companion for all medical physicists and medical professionals looking to learn how to utilize MATLAB in their work.

Features

Encompasses a wide range of medical physics applications in diagnostic and interventional radiology
Advances the skill of the reader by taking them through real-world practical examples and solutions with access to an online resource of example code
The diverse examples of varying difficulty make the book suitable for readers from a variety of backgrounds and with different levels of programming experience.

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Yes, you can access Diagnostic Radiology Physics with MATLAB® by Johan Helmenkamp, Robert Bujila, Gavin Poludniowski in PDF and/or ePUB format, as well as other popular books in Medicine & Radiology, Radiotherapy & Nuclear Medicine. We have over one million books available in our catalogue for you to explore.

Information

Publisher

CRC Press

Year

2020

ISBN

9781351188173

Edition

Topic

Medicine

Subtopic

Radiology, Radiotherapy & Nuclear Medicine

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Problem-solving: examples from the trenches

CHAPTER 10

Applying Good Software Development Processes in Practice

Tanya Kairn

Cancer Care Services, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia

Science and Engineering Faculty, Queensland University of Technology, Brisbane, Queensland, Australia

CONTENTS

10.1Introduction
10.2The trench in question: radiochromic film dosimetry
- 10.2.1General features and applications
- 10.2.2Film calibration and analysis
- 10.2.3Why treat this software as a medical device?
10.3An in-house software validation checklist
10.4Before writing the code
- 10.4.1Defining the purpose
- 10.4.2Identifying the users and their requirements
- 10.4.3The risk assessment
- 10.4.4The software design specification
- 10.4.5The development plan
- 10.4.6The validation, review and approval plan
10.5While writing the code
- 10.5.1Independent design review
- 10.5.2Coding, de-bugging, testing and logging
- 10.5.3Commenting
10.6After writing the code
- 10.6.1Developer testing
- 10.6.2User guide and supporting documentation
- 10.6.3User acceptance testing
- 10.6.4Validation against specification and final report
- 10.6.5Maintenance and software changes
10.7Summary of validation process and outcomes
10.8Regarding certification
10.9Conclusion

THIS chapter demonstrates how processes of good software development and validation provide opportunities for software to be efficiently focused on intended outcomes, for errors to be detected early and for users to thoroughly understand the code. Further, it also allows for revisions to be made and verified easily by individuals not involved in the initial code writing process, so that the usefulness of the software can be extended and the associated risks can be reduced.

10.1Introduction

The key to adopting a good software development process, for any software development project, is the identification and use of a suitable software validation framework. While software verification, or the testing and de-bugging of each new element of the code, is an inherent part of software development, software validation is an additional, overlying process, which can require substantial additional planning, documentation and time. Software validation involves “confirmation by provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”[71]. While any software can function correctly, properly validated software has the additional advantages of being demonstrably complete, useful and robust.

Comprehensive software validation involves developing the processes and documentation needed to demonstrate quality management, which is necessary in order to certify or register software as a medical device. Depending on the features and intended use of the software as well as the jurisdiction in which it will be used, certification or registration as a medical device may be required in order for software to be sold, distributed, shared across national borders or shared between different institutions within one nation[71,72,73]. However, even if the software is developed in-house, for use within one institution, the software development process benefits from being managed under an appropriate quality management system, and this is even a requirement under the new EU Medical Device Regulation for Medical Device Software.

More than 15 years ago, the United States’ Food and Drug Administration (FDA) published an influential report[71] providing guidance on software validation that, although intended to apply to software related to regulated medical devices, was based on established software validation principles and remains applicable to software development projects today, even when the software is not classed as a medical device. Two important aspects of the FDA’s guidance make this framework especially useful for radiology software projects. Firstly, the FDA’s guidance takes a risk-management approach to software development, emphasizing that the detail and extent of the planning, completion and documentation of software validation tasks should be commensurate with the complexity of the code and the risks associated with its use[71]. This emphasis on risk management is also apparent in the latest International Electrotechnical Commission (IEC) international standard on medical device software[72] and conforms with a broad trend t...

Cover
Half Title
Series
Title
Copyright
Dedication
Contents
SECTION I General topics
SECTION II Problem-solving: examples from the trenches
Index