Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study
BackgroundA successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However,...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-07-01
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| Series: | JMIR Human Factors |
| Online Access: | https://humanfactors.jmir.org/2022/3/e31529 |
| _version_ | 1797734963616940032 |
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| author | Christel Schwartz-Lasfargues Camille Roux-Gendron Pim Edomskis Isabelle Marque Yves Bayon Johan F Lange Jean Luc Faucheron Bertrand Trilling |
| author_facet | Christel Schwartz-Lasfargues Camille Roux-Gendron Pim Edomskis Isabelle Marque Yves Bayon Johan F Lange Jean Luc Faucheron Bertrand Trilling |
| author_sort | Christel Schwartz-Lasfargues |
| collection | DOAJ |
| description |
BackgroundA successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development.
ObjectiveThe case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices.
MethodsUCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months.
ResultsFunctional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design.
ConclusionsThis paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case. |
| first_indexed | 2024-03-12T12:51:28Z |
| format | Article |
| id | doaj.art-fd1ece2bbc1946b58f3b85529ca9546c |
| institution | Directory Open Access Journal |
| issn | 2292-9495 |
| language | English |
| last_indexed | 2024-03-12T12:51:28Z |
| publishDate | 2022-07-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Human Factors |
| spelling | doaj.art-fd1ece2bbc1946b58f3b85529ca9546c2023-08-28T22:42:51ZengJMIR PublicationsJMIR Human Factors2292-94952022-07-0193e3152910.2196/31529Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case StudyChristel Schwartz-Lasfargueshttps://orcid.org/0000-0001-6146-0041Camille Roux-Gendronhttps://orcid.org/0000-0002-7450-8371Pim Edomskishttps://orcid.org/0000-0001-8995-4166Isabelle Marquehttps://orcid.org/0000-0002-0951-7298Yves Bayonhttps://orcid.org/0000-0002-0232-3079Johan F Langehttps://orcid.org/0000-0002-1987-3210Jean Luc Faucheronhttps://orcid.org/0000-0002-0837-2277Bertrand Trillinghttps://orcid.org/0000-0003-2403-462X BackgroundA successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. ObjectiveThe case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. MethodsUCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. ResultsFunctional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. ConclusionsThis paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case.https://humanfactors.jmir.org/2022/3/e31529 |
| spellingShingle | Christel Schwartz-Lasfargues Camille Roux-Gendron Pim Edomskis Isabelle Marque Yves Bayon Johan F Lange Jean Luc Faucheron Bertrand Trilling Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study JMIR Human Factors |
| title | Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study |
| title_full | Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study |
| title_fullStr | Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study |
| title_full_unstemmed | Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study |
| title_short | Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study |
| title_sort | development of a connected sensor system in colorectal surgery user centered design case study |
| url | https://humanfactors.jmir.org/2022/3/e31529 |
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