Prone Crawl Breast Couch: analysis of the translational development of a patient support device for breast cancer radiotherapy

Abstract

Currently available prone support devices for breast cancer radiotherapy show different limitations, such as inconsistent patient positioning, patient discomfort and limited beam accessibility. Furthermore, medical devices tend to be developed with a top-down waterfall approach. For devices with complex use scenarios, this may impact efficacy. Therefore, we developed a patient support device with a Research through Design approach, supported by a co-design trajectory with different stakeholders. In this deductive case study, we analyze our development approach. We reflect on the NIH’s T-phases of translational research and the Stanford BioDesign Process. We conclude that the user-centred and iterative aspects of our approach were beneficial to the regulatory process and the quality of the product. Furthermore, cooperating with a university hospital enhanced the regulatory process by its access to clinical data. The outcomes of this interdisciplinary research may be beneficial to other types of cancer such as lung cancer.

Keywords:

• Breast cancer radiotherapy
• medical devices
• BioDesign
• new product development
• human factors engineering

Acknowledgements

During the conduct of this work, L. Veldeman held a post-doctoral Clinical Mandate of Stand up to Cancer (Flemish Cancer Society, Belgium) and a Clinical Mandate of Foundation against Cancer (Belgium).

Disclosure statement

Ghent University owns the patent application entitled Radiotherapy Board and Couch (WO2015144654A1) filed on 25.03.2014 for which W. De Neve and L.Veldeman are listed as inventors.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This research was supported by grant FAF-C/2018/1190 of the Foundation against Cancer (Belgium), a Career Catalyst Grant from Susan G. Komen (grant 377841), and the Cancer Plan Action 29 of the Federal Public Service of Health, Food Chain Safety and Environment (Belgium). The prototype research was funded by StarTT 241 grant of the Industrial Research Fund, Ghent University.

Notes on contributors

Max Schoepen

Max Schoepen is a doctoral candidate at the Ghent University. His research focusses on the development of a patient support device for breast cancer radiotherapy.

Jan Detand

Jan Detand is associate professor at the department of Industrial Systems Engineering and Product Design of Ghent University. His research focusses on design through digital and bio-based processes, design for personalized, scalable manufacturing systems, and co-creation.

Liv Veldeman

Liv Veldeman, MD, is assistant professor at the department of Human Structure and Repair of Ghent University and Clinical Head at the department of Radiation Oncology. Her research focuses on toxicity-reducing techniques in breast cancer radiotherapy.

Hans Van Hulle

Hans Van Hulle is a doctoral candidate at the department of Human Structure and Repair of Ghent University. His research focusses on the (preoperative) accelerated irradiation of breast cancer.

Vincent Vakaet

Vincent Vakaet, MD, is a doctoral candidate at the Department of Human Structure and Repair of Ghent University. His research focusses on the development of technique to facilitate breath-holds for left-sided breast cancer radiotherapy treatments.

Wilfried De Neve

Wilfried De Neve, MD, is professor emeritus at the department of Human Structure and Repair of Ghent University. His research focusses on radiation treatment design and optimization, head & neck cancer radiotherapy, and breast cancer radiotherapy.