As I indicated in my previous iBot update, the FDA held a hearing on December 12 to consider DEKA’s petition to change the iBot medical classification. As I wrote in that post:
“…The iBot needs a new manufacturer. But first, the regulatory environment must be improved. DEKA initiated an application to have the FDA modify the status of the iBot from a Class III medical device to Class II medical device. This would significantly reduce the regulatory burden on the product…On December 12 a team from DEKA will meet with the FDA Medical Devices Advisory Committee (it would have been sooner but for the government shutdown)…If (the application) is eventually approved, DEKA will be in a stronger position to recruit new manufacturing partners.”
Now we have this news from the Department of Health and Human Services meeting notes:
“…the panelists recommended a Class II designation for stair-climbing wheelchairs...”
There were two major regulatory impediments making it difficult for the iBot to be commercially viable. First, there was the Class III to Class II issue, which is apparently behind us. Second, there is the fact that Medicare will not reimburse patients for the iBot wheelchair. I don’t hold out much hope for changing the Medicare issue in the near future, but maybe I'm wrong.
By changing the iBot from a Class III device to Class II Device, a potential manufacturing partner could relatively easily improve the iBot in a number of ways, and make it more marketable to more users. Perhaps these improvements could eventually make it so that Medicare would reimburse patients.
I know that DEKA, with an assist from Huey 091, is recruiting potential manufacturing partners, and what happened on December 12 in Washington can only make the iBot a more appealing venture. Hopefully, this will be enough to lure in somebody. Maybe there was a group waiting in the wings and they will come forward soon because of this decision. It's more likely that DEKA still has a lot of work to do, but they now have a better case to make with these companies.
How big of a deal is this decision? That remains to be seen. Perhaps it was too little too late, or perhaps it was just what the doctor ordered. Only time will tell which of these two clichés will apply.
Here’s a video of Alan Brown’s public testimony before the panel. Alan is an iBot user and a member of the Board of Directors for the Christopher and Dana Reeve Foundation. He is a strong advocate for the iBot and for wheelchair users in general, and a gifted public speaker. Please watch and enjoy.