Biomedical Engineering Reference
In-Depth Information
Information sources
Develop product
specification
File documentary evidence
in DHF
Need from Fig 4.1
Check
with
sources
Redraft
Pass for
approval
Figure 4.4
A typical product specification procedure.
the process, influencing the process but always just out of reach. It is the designer's task to
identify the elements that are influential and bring these into being. Some of the sources will
always have influence (standards for example); some will not (trade literature for example).
But none can be excluded without good reason. It is difficult to do anything but list all of the
sources you intend to use. A very important source for the specification will be an
initial risk
analysis
. This initial analysis will help you to understand the whole of the area in which you
will be designing. Understanding the risk is a large step towards understanding the reality of a
situation.
The ultimate aim of this procedure is to demonstrate the communication between the product
specification developer and the sources. This procedure must have built-in continuous
feedback to enable the primary sources, i.e., the end-users, patients, and customers, to have a
significant impact on the specification itself. This will enable you to develop a highly robust
specification. Note that each step produces a draft for comment, and each iteration does as
well. It is important that this is well documented and kept within your design history. Once
the team is happy with the product specification it can be passed on for final approval before
the next stage begins. Remember that the input is the statement of need and the data from the
sources; hence the product specification (the output) must meet the requirements of the need
and reflect the requirements of the sources.
Please also note that the specification should not only relate to the device itself, but also
any supporting documentation, etc. For example all devices will need labeling and the
Search WWH ::
Custom Search