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REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES
REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES
Lopes, Karyn Martinelli; Zancul, Eduardo de Senzi
Poster:
The aim of the article is to present the requirements for a PDP reference model for medical devices. The methodological approach selected is a case study of six medical devices projects, carried out at the research group in which this article is inserted. The results of theoretical and empirical research show the initial requirements and the importance of regulatory issues. The projects analyzed employed the Biodesign approach. However, it is still necessary to improve the research about the requirements and medical devices development in Brazil. This article is part of a broader research that aims to develop a specific PDP reference model for the health sector.
The aim of the article is to present the requirements for a PDP reference model for medical devices. The methodological approach selected is a case study of six medical devices projects, carried out at the research group in which this article is inserted. The results of theoretical and empirical research show the initial requirements and the importance of regulatory issues. The projects analyzed employed the Biodesign approach. However, it is still necessary to improve the research about the requirements and medical devices development in Brazil. This article is part of a broader research that aims to develop a specific PDP reference model for the health sector.
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DOI: 10.5151/cbgdp2017-027
Referências bibliográficas
- [1] ANVISA. Resolução - RDC nº 185, de 22 de outubro de 2001, 2001. Available at: <http://www.anvisa.gov.br/anvisalegis/resol/2001/185_01rdc.htm>. Accessed on May 19, 2017.
- [2] ______. Manual para Regularização de Equipamentos Médicos, 2017. Available at: <http://portal.anvisa.gov.br/documents/33912/264673/Manual+para+regulariza%C3%A7%C3%A3o+de+equipamentos+m%C3%A9dicos+na+Anvisa/ad655639-303e-471d-ac47-a3cf36ef23f9 >. Accessed on May 18, 2017.
- [3] BECKER, J.; DELFMANN, P. Reference Modeling. Efficient Information Systems Design Through Reuse of Information Models. Heidelberg: Physica-Verlag, 2007. 147 p.
- [4] BIODESIGN. Biomedical Process Innovation, 2017. Available at: <http://engineering.case.edu/ebme/Research/cctrp/BioDesign>. Accessed on July 20, 2017.
- [5] EISENHARDT, K. M. Building Theories from Case Study Research. The Academy of Management Review, v. 14, n. 4, 1989, p. 532-550.
- [6] EL-HAIK, B. S.; MEKKI, K. S. A Medical Device Design for Six Sigma. Canada: John Wiley & Sons, 2008. 528 p.
- [7] FATUNDE, O.A.; BHATIA, S.K. Medical Devices and Biomaterials for the Developing World. Case Studies in Ghana and Nicaragua. New York: Springer, 2012. 112 p.
- [8] FRIES, R. Reliable Design of Medical Devices. Boca Raton: Taylor & Francis, 2006. 504 p.
- [9] ______. Reliable Design of Medical Devices. Boca Raton: Taylor & Francis, 2013. 501 p.
- [10] ITA. The International Trade Administration. Brazil - Medical Equipment. 2016. Available at: <https://www.export.gov/article?id=Brazil-Medical-Equipment>. Accessed on May 19, 2017.
- [11] PAIM, J. ET AL. The Brazilian health system: history, advances, and challenges. Lancet, v377, p. 1778–97, 2011.
- [12] RAMAKRISHNA, S. et al. Medical Devices. Regulations, Standards and Practices. Cambridge: Elsevier, 2015. 256 p.
- [13] ROZENFELD, H. et al. Gestão de Desenvolvimento de Produtos: uma referência para a melhoria do processo. São Paulo: Saraiva, 2006. 542 p.
- [14] RYBERG, A.B.; BÄCKRYD, R.D.; NILSSON, L. A meta-model based multidisciplinary design optimization process for automotive structures. Engineering with Computers, v31, p. 711-728, 2015.
- [15] SANTOS et al. Development of Medical Devices: Advantages of a Methodic Approach. In: Jobbágy Á. (eds) 5th European Conference of the International Federation for Medical and Biological Engineering. IFMBE Proceedings, v. 37, p. 1144-1147, 2011.
- [16] SHIRLEY, D. Project Management for Healthcare. Boca Raton: CRC Press, 2011. 240 p.
- [17] SILVA, G.C.; KAMINSKI, P.C. Proposal of framework to managing the automotive product development process. Cogent Engineering, v4, p. 1-25, 2017.
- [18] WHO. World Health Organization. Global atlas of medical devices. 2014. 2 p. Available at: <http://www.who.int/medical_devices/countries/bra.pdf?ua=1>. Accessed on May 22, 2017.
- [19] YOCK, P.G. et al. BIODESIGN. The Process of Innovating Medical Technologies. Cambridge: Cambridge University Press, 2015. 952 p.
- [20] ZAPIAIN, G. Top Markets Report Medical Devices. May 2016. Available at: <http://trade.gov/topmarkets/pdf/Medical_Devices_Top_Markets_Report.pdf>. Accessed on May 20, 2017.
Como citar:
Lopes, Karyn Martinelli; Zancul, Eduardo de Senzi; "REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES", p-262-270.
In: .
São Paulo: Blucher,
2017.
ISSN 23186968,
DOI 10.5151/cbgdp2017-027
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TY - CONF T1 - REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES JO - Blucher Design Proceedings VL - 3 IS - 12 SP - 262 EP - 270 PY - 2017 T2 - 11º Congresso Brasileiro de Inovação e Gestão de Desenvolvimento do Produto AU - , SN - 23186968 DO - http://dx.doi.org/10.5151/cbgdp2017-027 UR - www.proceedings.blucher.com.br/article-details/requirements-identification-for-a-pdp-reference-model-for-medical-devices-27490 KW - ER -
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@article{Lopes20144,
title="REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES",
journal="Blucher Design Proceedings",
volume="3",
number="12",
pages="262 - 270",
year="2017",
note="",
issn="23186968",
doi="http://dx.doi.org/10.5151/cbgdp2017-027",
url="www.proceedings.blucher.com.br/article-details/requirements-identification-for-a-pdp-reference-model-for-medical-devices-27490",
author="Karyn Martinelli Lopes", "Eduardo de Senzi Zancul",
keywords="",
}
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Karyn Martinelli Lopes, Eduardo de Senzi Zancul, REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES, Blucher Design Proceedings, Volume 3, 2017, Pages 262-270, ISSN 23186968, http://dx.doi.org/10.5151/cbgdp2017-027 (www.proceedings.blucher.com.br/article-details/requirements-identification-for-a-pdp-reference-model-for-medical-devices-27490) Palavras-chave:: ;