Will this be the answer for many
people, to accelerate medical devices to market, or just another
stepping-stone to slow the process? I hope for many people that the
first is true. Yes, the FDA has created a group – nonprofit,
public-private partnership. The object of this partnership is to
speed safe medical devices to market. The underlying aim is to
encourage competing manufacturers to pool their knowledge about
product testing. This last part may be the death of many medical
devices as some manufacturers do not want to share information and
may leave the market rather than be forced to share information.
Sounds great for patients if products
do make it to market sooner, but in telephone conversations with a
couple of manufacturers, there is little enthusiasm for the idea.
Many are concerned about the procedures and who will have control of
the testing. If the FDA is the only one doing the testing with only
people from the company's device present during testing, then maybe
this will work. If any company can be present during testing, it is
doubtful some companies will participate. Both agreed that it is
still too early in the process to know how this will work.
One spokesperson did say that this will
make acquiring some of the good ideas from cash strapped start-ups a
lot more difficult. He also said that the value added from FDA
approval will be great for the smaller companies, some will be able
to find the funds for manufacturing, and others will still sell the
product to larger manufacturers.
Both admitted that if this group,
called the Medical Device Innovation Consortium (MDIC), was actually
able to make it easier to bring products to FDA approval, then
everyone would gain, including the patients.
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