Application of Lean-Agile Approach for Medical Wearable Device Development

Glazkova, Natalia; Fortin, Clément; Podladchikova, Tatiana

doi:10.1109/sysose.2019.8753825

Cited by 5 publications

(3 citation statements)

References 9 publications

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“…With the vast implementation of Agile development approaches across different industries, the medical device industry also found its benefits from adopting Agile (Shuren and Maizel, 2021;Gottlieb, 2019;FDA, 2021b;Pathfinder, 2013). Agile intends to review and iterate at earlier stages in a design, thus providing a much higher flexibility, variability and speed (Glazkova, 2019). These characteristics were revealed to be crucial for the medical product design and development during the COVID-19 pandemic.…”

Section: Alternative Product Development Frameworkmentioning

confidence: 99%

MedTech Product Development Framework for Post-Pandemic Era

Glazkova

Menshenin

Vasilev³

et al. 2022

Proc. Des. Soc.

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A case study during pandemic revealed the major drawbacks of the traditional product development process for MedTech industry. Disruption of conventional manufacturing, urgent need for accelerated design and production, faster regulatory approval have challenged the industry. In this paper the conventional medical product development process is explored based on the intramuscular injector case study. The study revealed core areas for improvement of the medical devices development process. The paper proposes the Lean-Agile methodology with the incorporated elements of Concurrent Engineering.

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Section: Alternative Product Development Frameworkmentioning

confidence: 99%

MedTech Product Development Framework for Post-Pandemic Era

Glazkova

Menshenin

Vasilev³

et al. 2022

Proc. Des. Soc.

View full text Add to dashboard Cite

show abstract

“…However, with the subversive changes in the medical field, the design speed, flexibility, and interconnection of wearable devices need to be further improved. A hybrid lean-agile method proposed in [33] is conducive to the development of wearable devices. In [34], the potential mechanism of human sweat leading to the separation of wearable devices is studied, which is helpful for the design of wearable devices applied to the skin, while the wearable large area touch sensor described in [35] can improve the adaptability and comfort of the wearer.…”

Section: Applications Of Iomtmentioning

confidence: 99%

Edge-Cloud Computing and Artificial Intelligence in Internet of Medical Things: Architecture, Technology and Application

et al. 2020

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With the booming development of medical informatization and the ubiquitous connections in the fifth generation mobile communication technology (5G) era, the heterogeneity and explosive growth of medical data have brought huge challenges to data access, security and privacy, as well as information processing in Internet of Medical Things (IoMT). This article provides a comprehensive review of how to realize the timely processing and analysis of medical big data and the sinking of high-quality medical resources under the constraints of the existing medical environment and medical-related equipment. We mainly focus on the advantages brought by the cloud computing, edge computing and artificial intelligence technologies to the IoMT. We also explore how to rationalize the use of medical resources and the security and privacy of medical data, so that high-quality medical services can be provided to patients. Finally, we discuss the current challenges and possible future research directions in the edge-cloud computing and artificial intelligence related IoMT. INDEX TERMS Internet of medical things (IoMT), deep learning, edge of computing, computation offloading.

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“…The study on the use of Lean tools and methodologies in the medical device sector has enormous potential for the improvement of both cost and lead times [26,27]. More recently Glazkova et al have discussed the combination of Lean and Agile in developing wearable device products [28]. However, the use of Lean in the NPI process in medical device organisations creates a gap in the literature.…”

Section: Introductionmentioning

confidence: 99%

A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

et al. 2022

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The purpose of this study is to review the Lean tool application and its utilisation in medical device design and the new product introduction process to establish the benefits and best practices for its integration with existing new product introduction processes. A review of the literature on the current state of medical device New Product Introduction (NPI) processes is completed along with a comprehensive review of the literature on the history and development of Lean NPI. The review indicates that Lean can be combined with the predominant NPI execution tools, Stage-Gate and Concurrent Engineering within the medical device industry to achieve a best-in-class continuous improvement methodology within the NPI process. This integration eliminates waste, focusses on customer value, and ultimately reduces cost and lead time to market. This review highlights for the first time the main challenges and issues with Lean in the medical device sector NPI processes, identifying possible future strands of research. Limitations of the current review are that despite the heavy emphasis placed on Lean manufacturing processes, comparatively little emphasis is placed on the use of Lean in the medical device NPI process. Future longitudinal case studies on case study application of Lean in medical device NPI processes would be useful. This study has implications for identifying best practices for Lean in NPI in the device industry, improving what is considered state-of-the-art for the introduction of devices into the public domain.

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Application of Lean-Agile Approach for Medical Wearable Device Development

Cited by 5 publications

References 9 publications

MedTech Product Development Framework for Post-Pandemic Era

MedTech Product Development Framework for Post-Pandemic Era

Edge-Cloud Computing and Artificial Intelligence in Internet of Medical Things: Architecture, Technology and Application

A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

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