Abstract
This chapter contains a detailed description of a proposal for a structured methodology for developing medical devices. The intention is to simplify and promote the industrial expansion of biodevices, taking advantage of recent developments, whose special features can be applied for the enhanced development of biodevices with remarkable diagnostic or therapeutic capabilities. For this purpose, the use of systematic processes can be highly beneficial, as highlighted in several previous chapters.
This proposal is not only a result of the examination made at the beginning of the handbook, of the use of systematic methodologies for conventional product development and of the current state of technology related to the use of advanced design and manufacturing technologies, together with novel materials in medical devices, but also a result of the knowledge acquired during the specific developments covered in previous chapters.
Solutions are put forward for the different problems encountered that affect the development of any medical device together with an analysis of how the use of these novel technologies and materials has influenced the different stages of the systematic design methodologies already set out.
The promotion of teaching–learning activities linked to the development of medical devices and all kinds of biodevices, within programmes of Mechanical and Manufacturing Engineering, Bioengineering and even Medicine, is especially noteworthy for further scaling the effectiveness, capabilities and industrial impact of such devices. Collaboration between researchers of different fields is also necessary for continued improvements.
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Lantada, A.D. (2013). A Proposal for Structured Development Methodology for Biodevices. In: Lantada, A. (eds) Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6789-2_17
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DOI: https://doi.org/10.1007/978-1-4614-6789-2_17
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