3rd party testing companies?

[Burgerman]

Wrong. It is in the US. Trying to comply, is the reason the iBot was delayed over 2 years costing millions of dollars. And the main reason for the eventual cost and failure in the market.

[wheelie junkie]

The developers of the ibot must have known that there would be safety standards and should of looked at them before designing it. With any device that is going into the medical market there is going to be regulation. This is where things like the EU standards come in, test for one standard and you can sell in 28 countries. You need to be able to have input if you want common sense to apply. ISO is a global version but does the same thing. The US market inevitably has its own rules, if you plan on a business with the majority of sales there you know that you will have to comply. It is driven by lawyers and insurers, stop liability claims and regulation will soon vanish. No-one wants to do it but have to because of potential claims.

[Burgerman]

They did. But the iBot (like my nitrous systems) went to a place where the regulatory bodies had never been before. They were all terrified that it would fall over and injure someone. But that stuff is all user and terrain dependent. For e.g. what does a balancing machine do, on a moving train. One thing they hadnt thought about until I suggested an interesting experiment. That was only one of 100s of scenarios. The answer was that they hadnt ever considered it. They were in at the deep end and the deep end kept getting bigger.

Of course the segway was the same electronic thing. By the same guy, dean kamen. Arguably far less safe with only a single computer and no polling results from 3 with independently written software. But not medical. He learned from the previous JJ and the Medical regulatory bodies, fiasco. So sold as - at your own risk basically for the able bodied. Well these are now sold and used as medical devices, but they dont call it a wheelchair. So as I said, they are still in business, selling the same thing, but instead of wasting 100 million or so, and 3 years, they just didnt bother... And THEY are all making money.

So I disagree with your opinions.

[ex-Gooserider]

The regulation game can also be a HUGE hassle when the regulators can't agree w/ each other.... A former employer was trying to get a power distribution box design approved - rack mount equipment, dual 48VDC supplies in, feeding a bunch of breakers supplying power to other gear in the rack....

We needed to get approval from at least three regulatory bodies - each had a DIFFERENT standard for how the 48V wires coming into the box from where they were tied to the rack at the point where they entered it were connected to the box innards... One wanted a crimped double screw lug. One wanted screw down clamps onto stripped wire, I forget what the third one wanted... All the methods were quite reasonable and safe, and used standard commercial hardware that was 'good practice' in other similar applications.... Most countries required at least two of the certifications, so it wasn't possible (even ignoring the impracticality) to make different versions of the box for different countries...

NONE of the bodies were willing to accept a method that one of the other bodies found acceptable instead of their own. It took the employer a huge amount of time, effort and expense to simply get representatives from all the bodies to sit down together and work out an agreement that all would accept...

I wasn't directly involved but the engineer in charge of the design said it was the sort of thing that really drove one to

I can say that the regulation thing is the biggest fear I have about doing the wheelie scale project...

ex-Gooserider