A Proposal for Structured Development Methodology for Biodevices - Advanced Design and Manufacturing Technologies for Biomedical Devices - page 302

17.1 Introduction

This chapter contains a detailed description of a proposal for a structured
methodology for developing medical devices. The intention is to simplify and pro-
mote the industrial expansion of biodevices, taking advantage of recent develop-
ments, 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 benefi cial, 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 devel-
opment 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 consequence of the knowledge acquired during the specifi c 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 infl uenced the different stages of the system-
atic design methodologies already set out. Therefore, each step of the conventional
methodologies for systematic product development (including “arranging a team”,
“fi nding a need”, “defi ning specifi cations”, “conceptual design”, “basic engineer-
ing”, “detailed engineering” and “pre-production considerations”) is modifi ed to
incorporate the special characteristics of biomedical products.
The promotion of teaching-learning activities linked to the development of med-
ical devices and all kinds of biodevices, within programmes of Mechanical and
Manufacturing Engineering, Bioengineering and even Medicine, is especially note-
worthy for further scaling the effectiveness, capabilities and industrial impact of
such devices, as is covered in depth in Chap. 18 , including case studies linked to
project-based learning. Collaboration between researchers of different fi elds is also
necessary for continued improvements.

17.2 The Relevance of Multidisciplinary Teams

17.2.1 Multidisciplinary Teams: Advantages and Limitations

A typical medical device development team is usually made up of doctors, pharma-
cologists, engineers, computer experts, physicists, chemists and biologists, as well
as economists and law graduates, to provide fi nancial and legal advice, respectively.
Some of the main benefi ts of having multidisciplinary teams are as follows:

• Creativity is encouraged (see Chap. 16 ) .

• More varied responses to problems arise.