Biomedical Engineering Reference
In-Depth Information
important. The technical design of a medical device must
comply with existing national and international standards
and regulations. Accepted design principles must be
used.
The involvement of external persons who are not fa-
miliar with the project is an important part of technology
assessment. Such individuals are valuable for conducting
tests and giving user feedback. Such an involvement
often results in major improvements in the design and
functionality of a device. Technology assessment of
a small number of devices (e.g., 5-10) in ''the real world''
of hospitals and clinics often will affect the final design of
the product in a decisive way.
Involvement of ''external'' persons in product assess-
ment must include some type of protection in terms of
a secrecy declaration or contract (nondisclosure or con-
fidentiality agreement) in which the involved person is
prohibited from revealing or utilizing the knowledge
obtained during their evaluation work.
The assessment of production technology problems is
important before mass production starts. The choice of
proper production technologies can strongly affect the
market price of a product. If new production equipment
must be set up, then large investments might be neces-
sary, and they would affect the economy of the whole
project. If a long production run of many devices is
contemplated, a production technology-oriented design
will result in large savings, particularly for an inventor in
a university or hospital environment, who usually does
not have extensive experience in industrial production
techniques. The initiation of close and early collaboration
between the inventor and the final (industrial) producer
of the device is strongly recommended. Such collabora-
tion often shortens the route to the market considerably
and can reduce production costs.
already. Concept testing is important for answering the
following questions:
Is the idea new?
Does the invention infringe on another patent upon
commercial exploitation?
Can the idea be patented?
What has been done in this area lately?
Concept testing can be carried out partly by screening
patents in areas in the proximity of the current invention.
A good conception of the ''state-of-the-art'' also can be
gained by searching databases of different types. Libraries
have large databases where correctly formulated questions
in the form of search profiles can give adequate guidance
on innovations in the current area of work. Published
scientific literature can provide interesting information on
the news value of an invention. The literature can suggest
the diagnostic value that is inherent in the utilization of the
invention. This, in turn, is an indicator of market size.
Prototype development
Prototype design is an important step of the innovation
process. Prototype development enables one to test the
strength of an idea from a technical and an economic
point of view, to evaluate the response of the market, and
to calculate the production cost. It is usually a long way
from the prototype stage to mass production, and often
it is practical to proceed in several steps:
Sketches: Show the idea from a functional and
technical point of view in terms of drawings or
technical diagrams.
Models: A three-dimensional presentation of the
product idea in wood, metal, or plaster, without
any functional demands. This form is especially good
for marketing purposes.
Functional model: A three-dimensional model, as
the one mentioned above, but one that also can
demonstrate how the idea will work.
Prototype: The prototype is an exact model of the
product as it will function and appear in mass
production.
O-series: A smaller series of the product, often used
for demonstration to prospective customers, or for
evaluation by experts
Mass-produced products: Products from the
production line
Economic assessment
According to its definition, an innovation must involve
financial success on the market. Thus, it is essential that
the project costs are monitored regularly and that, as
early as possible, an assessment be made of the feasibility
of the product being a technical and a commercial suc-
cess. At an early stage, only rough calculations can be
made. They should be based on the cost of product sales
and an estimate of the size of the product's market share
that is necessary to the product being a financial success.
Concept testing
Forms of exploitation
Before starting to exploit an idea technically and
commercially, an investigation should be launched to
ascertain whether it really is new. A patent search often
reveals that the same, or a similar, idea has been invented
Commercial exploitation of an invention can be accom-
plished in many different ways. The two most usual are
