Medical device software development - A perspective from a lean manufacturing plant

Oisín Cawley; Ita Richardson; Xiaofeng Wang

doi:10.1007/978-3-642-21233-8_8

Medical device software development - A perspective from a lean manufacturing plant

Oisín Cawley
, Ita Richardson
, Xiaofeng Wang

University of Limerick

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

Abstract

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

Original language	English
Title of host publication	Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings
Publisher	Springer Verlag
Pages	84-96
Number of pages	13
ISBN (Print)	9783642212321
DOIs	https://doi.org/10.1007/978-3-642-21233-8_8
Publication status	Published - 2011

Publication series

Name	Communications in Computer and Information Science
Volume	155 CCIS
ISSN (Print)	1865-0929

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 9 Industry, Innovation, and Infrastructure

Keywords

Lean Software Development
Medical Device
Process Improvement
Regulated Environment
Software Development Process

Access to Document

10.1007/978-3-642-21233-8_8

Cite this

Cawley, O., Richardson, I., & Wang, X. (2011). Medical device software development - A perspective from a lean manufacturing plant. In Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings (pp. 84-96). (Communications in Computer and Information Science; Vol. 155 CCIS). Springer Verlag. https://doi.org/10.1007/978-3-642-21233-8_8

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Cawley, O, Richardson, I & Wang, X 2011, Medical device software development - A perspective from a lean manufacturing plant. in Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings. Communications in Computer and Information Science, vol. 155 CCIS, Springer Verlag, pp. 84-96. https://doi.org/10.1007/978-3-642-21233-8_8

Medical device software development - A perspective from a lean manufacturing plant. / Cawley, Oisín; Richardson, Ita; Wang, Xiaofeng.
Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings. Springer Verlag, 2011. p. 84-96 (Communications in Computer and Information Science; Vol. 155 CCIS).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

TY - GEN

T1 - Medical device software development - A perspective from a lean manufacturing plant

AU - Cawley, Oisín

AU - Richardson, Ita

AU - Wang, Xiaofeng

PY - 2011

Y1 - 2011

N2 - Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

AB - Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

KW - Lean Software Development

KW - Medical Device

KW - Process Improvement

KW - Regulated Environment

KW - Software Development Process

UR - https://www.scopus.com/pages/publications/79959432321

U2 - 10.1007/978-3-642-21233-8_8

DO - 10.1007/978-3-642-21233-8_8

M3 - Conference contribution

AN - SCOPUS:79959432321

SN - 9783642212321

T3 - Communications in Computer and Information Science

SP - 84

EP - 96

BT - Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings

PB - Springer Verlag

ER -

Medical device software development - A perspective from a lean manufacturing plant

Abstract

Publication series

UN SDGs

Keywords

Access to Document

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