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And, their funders, their pets and everyone their funders know will be sued into poverty as soon as it's announced. I met a company that was going to make a po

And, their funders, their pets and everyone their funders know will be sued into poverty as soon as it's announced. I met a company that was going to make a powered wheelchair. At the moment your choice is a manual chair or a big heavy expensive and complex mobility scooter - like you see fat/lazy people using in Walmart. Their product was a smart power assist that gave you an automatic extra push on kerbs, ramps etc but could be cheaply bolted onto an existing manual chair. It had sensors that measured the force you were pushing with, the chair angle, speed etc, along with modern brushless DC motors and laptop batteries. Then they hit FDA. There is no FDA approval class for accelerometers - nobody has ever made a medical device using accelerometers so not only would they need their device tested and approved they would need to prove "equivalency" for a mems accelerometer. Apparently General Relativity and Mach's principle isn't enough for the FDA. They did propose simply opensourcing the design for anyone to build but were told that if anyone did build one they would be essentially in the same legal position as publishing instructions for making illegal drugs! In the FDA's eyes telling someone how to make an affordable electric wheelchair = running an meth lab.

WiseWeasel 14y ago
I could certainly see the FDA obstructing novel products without prohibitively expensive studies, but wouldn't it be significantly cheaper to demonstrate equivalence to existing devices?
- HeyLaughingBoy 14y ago
  Yes, it would. Problem is that "significantly cheaper" means it costs $1 million instead of $5 million.
  - WiseWeasel 14y ago
    $1M+ might be in the realm of the attainable for a Kickstarter project, assuming the device has a sufficiently wide usage. The estimated cost of approval would need to be included in the funding goal. [If the same studies might be used to seek approval in several countries at once, then it might make such an approach to funding medical devices more attainable for the size of their market. The missing piece of the puzzle seems to be an affordable method for conducting studies to get medical devices approved. It seems like the industry is highly vertical, with difficult access to financing and compliance infrastructure. This might be an opportunity for a service provider to come in, establish a selection process for clients, partner with universities around the world to conduct studies to the specifications of US FDA, and its EU, Canada, Japan, etc. equivalents' approval, and help store and file the needed paperwork in exchange for a cut of sales. Maybe it's also time for the UN to create a world body for standards of approval of medical technology which all these nations should recognize; or maybe ISO should take that role.]
jmj42 14y ago
This sounds like IntelliWheels, a UIUC startup. If it is, I don't think the FDA process has been that big of a obstacle. I was at another startup at UIUC's incubator when IntelliWheels spun up, and it looks like they are on track to meet their original projected release date (at least it's the only projection I've ever heard). That said, as pointed out elsewhere, there are some very good reasons for many of the regulations concerning DME. In many cases, it is about life and death. Understand, I'm not arguing for the status quo, here, but the FDA does provide, necessary, oversight. The DME industry and even the FDA are in dire need of an infusion of common sense, but this idea that no oversight or even disbanning the FDA (common talk among a certain political element in the states these days), is absolutely not what we need.

WiseWeasel 14y ago

I could certainly see the FDA obstructing novel products without prohibitively expensive studies, but wouldn't it be significantly cheaper to demonstrate equivalence to existing devices?

HeyLaughingBoy 14y ago
Yes, it would. Problem is that "significantly cheaper" means it costs $1 million instead of $5 million.
- WiseWeasel 14y ago
  $1M+ might be in the realm of the attainable for a Kickstarter project, assuming the device has a sufficiently wide usage. The estimated cost of approval would need to be included in the funding goal. [If the same studies might be used to seek approval in several countries at once, then it might make such an approach to funding medical devices more attainable for the size of their market. The missing piece of the puzzle seems to be an affordable method for conducting studies to get medical devices approved. It seems like the industry is highly vertical, with difficult access to financing and compliance infrastructure. This might be an opportunity for a service provider to come in, establish a selection process for clients, partner with universities around the world to conduct studies to the specifications of US FDA, and its EU, Canada, Japan, etc. equivalents' approval, and help store and file the needed paperwork in exchange for a cut of sales. Maybe it's also time for the UN to create a world body for standards of approval of medical technology which all these nations should recognize; or maybe ISO should take that role.]

jmj42 14y ago

This sounds like IntelliWheels, a UIUC startup. If it is, I don't think the FDA process has been that big of a obstacle. I was at another startup at UIUC's incubator when IntelliWheels spun up, and it looks like they are on track to meet their original projected release date (at least it's the only projection I've ever heard). That said, as pointed out elsewhere, there are some very good reasons for many of the regulations concerning DME. In many cases, it is about life and death. Understand, I'm not arguing for the status quo, here, but the FDA does provide, necessary, oversight. The DME industry and even the FDA are in dire need of an infusion of common sense, but this idea that no oversight or even disbanning the FDA (common talk among a certain political element in the states these days), is absolutely not what we need.