December 13, 2012

FDA Creates Group to Speed Medical Devices to Market

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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