Biomedical Engineering Reference
In-Depth Information
wanted ones are those derived from customer input, e.g., it is easier to use, or it fits in the
palm of your hand. If you conducted the House of Quality analysis you will have compared
your device against your competitors and hence identified USPs.
The clinical evaluation report should have identified improvements on previous devices. Your
device may have shortened the procedure by 50%; it may have resulted in a device that is
50% more reliable. All are valuable marketing commodities.
14.6.2 Key Opinion Leaders (KOLs)
All medical devices are in fields of medicine where there is a key opinion leader. This is the
one (or more) person who everyone says “Has X got one?” and if you answer “yes” they
then reach for their wallet. While this is not guaranteed, without the answer “yes” everything
becomes more difficult.
You should seek out the KOL(s) in your area and introduce them to your device. Having them
in at the front of the process (i.e., in the focus group) will help tremendously.
Do not always assume that a KOL needs to be clinical. In the USA the KOL may be a
medical insurance company. In the UK it may be the National Institute for Health Clinical
Excellence (NICE). The definition of a KOL is very broad.
14.6.3 Independent Studies
Unfortunately it is a truism to say that any studies you have conducted will be tainted with
the grain of commercial bias. It is hard to prove that one has no bias towards one's own baby
so it is far better to get someone else to do this for you. All teaching hospitals have registrars
(interns) looking for research projects. Your key opinion leaders will also want to conduct
studies. The power of having a paper written by someone not associated with the product
cannot be underestimated: they are worth their weight in gold. Furthermore, when completed
they update your clinical evaluation report!
14.6.4 Health Economics
There is little doubt that your device will fall into one of two camps. It will either be
cheaper than the rest (hence it is a no-brainer sale); or it will be cost neutral or slightly more
expensive. In the latter case you will need to persuade the hospital that your device saves
them money in the long run. This could be due to lower running costs, or less medication
required. Either way the QALY analysis and clinical evaluation report, discussed previously,
will provide all the information you require.
14.6.5 Insurance
Do not forget insurance! The NHS, for example, demands £5 million cover as a minimum
just to get on their register. Before you sell anything you need to get adequate cover.
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