FDA Creates Group to Speed Medical Devices to Market

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