Increasingly, medical devices are being used by lay people outside the clinical
environment (FDA, 2010; Gardner-Bonneau, 2011). These are frequently called
home use medical devices (HUMD). A HUMD is defined as “a medical device
intended for users in a non-clinical or transitory environment, is managed
partly or wholly by the user, requires adequate labelling for the user, and may
require training for the user by a licensed health care provider in order to be
used safely and effectively” (FDA, 2010).
The process of designing a HUMD differs from consumer products, because
although these devices are used by lay people, they are medical devices which
are safety critical and subject to regulatory requirements (Gupta, 2007; FDA,
2012). On the other hand, as lay users differ significantly from professionals
in terms of their needs and capabilities, the design process of HUMD requires
a different approach than medical devices designed for professional use
(Wiklund & Wilcox, 2005). Despite many generic design process models (e.g.
Pugh, 1991; French, 1999; Stanton, 2004; Clarkson et al, 2007; Pahl et al, 2007)
and guidance and models for medical device (e.g. FDA, 1997; Alexander, et al.,
2001; Alexander & Clarkson, 2002), little information was identified regarding
the design process for HUMD.
In order to support designers, a new model was developed which involves five
stages, i.e. discovering the needs, task clarification, design, testing and final
validation. The model highlights the importance of understanding regulatory
requirements and lay user requirements, and also emphasises the validation
and verification activities. It is called the “Dual Verification Model for Designing
Home Use Medical Devices” (Figure 1).
This paper will discuss how the regulatory requirements and lay user requirments were captured, how the model was developed, and what potential
value it might have to designers.
D4H2013
environment (FDA, 2010; Gardner-Bonneau, 2011). These are frequently called
home use medical devices (HUMD). A HUMD is defined as “a medical device
intended for users in a non-clinical or transitory environment, is managed
partly or wholly by the user, requires adequate labelling for the user, and may
require training for the user by a licensed health care provider in order to be
used safely and effectively” (FDA, 2010).
The process of designing a HUMD differs from consumer products, because
although these devices are used by lay people, they are medical devices which
are safety critical and subject to regulatory requirements (Gupta, 2007; FDA,
2012). On the other hand, as lay users differ significantly from professionals
in terms of their needs and capabilities, the design process of HUMD requires
a different approach than medical devices designed for professional use
(Wiklund & Wilcox, 2005). Despite many generic design process models (e.g.
Pugh, 1991; French, 1999; Stanton, 2004; Clarkson et al, 2007; Pahl et al, 2007)
and guidance and models for medical device (e.g. FDA, 1997; Alexander, et al.,
2001; Alexander & Clarkson, 2002), little information was identified regarding
the design process for HUMD.
In order to support designers, a new model was developed which involves five
stages, i.e. discovering the needs, task clarification, design, testing and final
validation. The model highlights the importance of understanding regulatory
requirements and lay user requirements, and also emphasises the validation
and verification activities. It is called the “Dual Verification Model for Designing
Home Use Medical Devices” (Figure 1).
This paper will discuss how the regulatory requirements and lay user requirments were captured, how the model was developed, and what potential
value it might have to designers.
D4H2013
