Incorporating sustainability in decision-making for medical device development

Hede, Shantesh; Nunes, Manuel L.; Ferreira, Paula Varandas; Rocha, Licinio

doi:10.1016/j.techsoc.2013.09.003

Cited by 27 publications

(16 citation statements)

References 31 publications

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“…The study design is based on two main steps. The first step is to analyze and compare the available steps of the development of MD to set a basis for the phases of the medical device development that will be appraised later as part of the economic methods [41]. In addition, the model design and its verification will be performed.…”

Section: Methodsmentioning

confidence: 99%

Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

et al. 2020

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The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost–time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents’ responses, were conducted. The authors have proposed the complexity model MedDee—Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

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Section: Methodsmentioning

confidence: 99%

Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

et al. 2020

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“…In the medical device industry, the rapid development of new technologies incorporating complex entities has meant that, increasingly, cross-functional team collaborations are essential in their development (Hede, Nunes, Ferreira, & Rocha, 2013). Individuals heretofore not used to working together, find themselves expected to co-operate and collaborate.…”

Section: Organisationmentioning

confidence: 99%

“…Since the future of medical device innovation calls for increasing cross-functional collaborations (Hede et al, 2013), this issue needs further examination. After all, improving rates of regulatory approval will contribute to greater speed to market!…”

Section: Post-marketing Surveillancementioning

confidence: 99%

Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

O'Dwyer

Cormican

2017

Journal of Technology Management & Innovation

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This study explores new product development in a strict regulatory and historically secretive environment. Adopting a systems perspective and a mixed methods approach in our research, we examine medical device development in Ireland. Findings indicate that the possession of a regulatory strategy expedites the rate of commercialization, so too does the generation of clear product definitions and marketing claims in the earliest developmental phases. Moreover, results suggest that if the regulated industry strengthens its culture for regulation by prioritizing regulation over speed to market, by encouraging cross-functional team collaborations, and by taking a more proactive approach in post-marketing surveillance activities, it has the potential to improve customer satisfaction and enhance product innovation. This study provides unique empirical data enriched by the homogeneity of its sample. It also contributes guidance to practitioners of new product development within a regulatory context.

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“…Medical device decisions must be made considering the multi criteria. Hede et al (2013), used multi criteria hierarchical model, which is in fact an extensive revision of the AHP for the sustainability of medical devices. Cho and Kim (2003), used AHP for selecting medical devices and materials for development in Korea.…”

Section: Introductionmentioning

confidence: 99%

Selection of Electrocardiograph for Acardiology Department Using ANP

Bektur¹

2014

Proceedings of the International Symposium on the Analytic Hierarchy Process

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Selection of materials in health care systems is more critical than the other systems due to materials affect human life and the expenses of materials are met by the states. So, the most effective decisions to be made in the selection of materials. In this study, selection of electrocardiograph(ECG) for a cardiology deparment is discussed. ECG provides to record the occurred electrical activity of the heart. Many factors must be considered in the ECG selection. This situation requires the use of multi criteria decision making methods, ANP was used due to the take into account relationships between criteria. For determining the most suitable criteria, survey was applied to university staff and SPSS was used for reliability test. In conclusion the most suitable alternative was determined for the department.

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Incorporating sustainability in decision-making for medical device development

Cited by 27 publications

References 31 publications

Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

Selection of Electrocardiograph for Acardiology Department Using ANP

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