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  • amd29 replied to the topic Design input sources in the forum Introduction to Design Controls 6 years, 7 months ago

    To understand the importance of an input source leading to the design of a medical device, it only suffices to recall Dr. Simon’s lecture Marketing – week 7. This lecture examines the volume of sales from the conception phase to obsolescence. It will be seen that the curve describing the sales trend is not a straight line. At one point – specifically toward the end – it enters a decline phase. What this means is that the value associated with the device essentially trends toward zero.

    Now, who would want this their product?

    Sales of their product is what keeps a company alive.

    What we really want for our device is to find that the sales trend does not move into some decline phase.

    Just to sight an example, the Stethoscope has been in the market since 1816 and instead of seeing a decline of its presence in the market we see more and more brands of the device spring into existence as time goes on.

    What this translates to is that the source of intel preceding the design of a medical device is crucial.

    Valuable discussion on this topic has already taken place. Sister Luisa Gutierres has, for example, delivered a brilliant discuss on the subject matter; but considering the importance of this subject, I believe we can use some more ideas from different perspectives on the subject.

    Let us not lose sight of the fact that companies may have reasons to exist; hence, such promulgations as MISSION STATEMENT. That this statement is important to a company is seen in the fact that a company is willing to spend to keep its need to live on going. So if a management of the company can be convinced that design of a device will place the company in an enviable position, the bosses will be more than willing to dish out as much financial resource towards the existence of the medical device as may be needed. What I am really saying is that financial resources are a valuable input towards the design of a medical device.

    In most lectures on Medical Device Development, Dr. Simon has essentially run out words with which to stress the value of getting inputs from potential the end user – the customer – of a medical device.

    With he help of a prototype, the most valuable (sincere) intel can be fished from the customer.

    Research on emerging technologies would be invaluable. Obviously there is competition out there; yet the customer fails to be satisfied. This emerging technological awareness integrated with a company’s device is likely to give the company a competitive edge if, in integrating this technology with a company’s medical device, consideration is focused on what makes similar devices fail to satisfy the existing customer.

    These are not all, but are among the sources of intel that may be considered for exploitation.