An artificial hand – at least one approved by the federal government -- costs as much as $50,000 or more. But among the millions of children around the world who need a hand, very few have parents who can afford to buy one. Fortunately, a research scientist has discovered that artificial hands created by 3-D printing can be produced for as little $50. And he has found a clever way to get around government regulations: He gives them away.
How did the government get in the business of telling us what kind of artificial limb we can buy in the first place? That’s a good question. The Federal Food and Drug Administration (FDA) was created for understandable reasons. It’s hard for ordinary citizens to tell whether the food they eat is going to poison them or whether the drugs they buy are safe and effective. But an artificial hand? It either fits or it doesn’t. It works well or it works poorly. It’s comfortable or it’s not. Why is the government involved?
Video: 3D Printed Prosthetic Hand
The answer: mission creep. Like many other federal bureaucracies, the FDA has gradually expanded its authority over the years. Here is why you should care. Estimates are that it takes $1.7 billion to get a new drug approved. Whenever the FDA gets involved, the cost of approval for any new invention or technology will be huge. The time it takes to get approval will be measured not in years but in decades. Hundreds of thousands of innovations that could have helped you and me will never come to market.
In the case of the low-cost artificial hand, the white knight of the moment is Jon Schull, a professor at Rochester Institute of Technology. (See this video interview with Bob Graboyes.) If he were to seek FDA approval, it would be very expensive and very time consuming. If his artificial limb contained any electronics, it would be even more expensive and more time consuming.
Currently, Schull heads an organization called E-Nable, which operates an online Google Plus community (E-nabling the Future) that puts together people who need hands with people who have access to 3-D printing and are willing to produce them. The technology is open source and as the makers discover improvements they share them with others. All the makers are volunteers.
Schull’s operation is small. Only 2,300 people are active participants at his web site, although the number is growing at a rate of about 10 percent a week. They are producing and delivering a few hands per week, although they have a goal of scaling up to 100. That would put only a small dent in the problem, however. Schull estimates that one in every 5,000 children born in the world is a potential beneficiary.
Imagine how much more could be done if only the federal bureaucracy did not prevent specialization and trade. If we handled artificial limbs the way we handle mosquito nets, a private, for-profit company would produce them; a charity (like the Gates foundation) would buy them; and perhaps another for-profit entity would distribute them.
Artificial limbs aren’t the only area in which the FDA stands between children and a healthier, happier life.
Take the case of Jason Adams, a business-development executive with a background in molecular biology. His 8-year-old daughter Ella has Type 1 diabetes and wears a glucose monitor that measures her blood sugar every five minutes and displays it on a nearby receiver. But it can't transmit the data to the Internet, which meant Adams couldn’t send Ella to sleepovers for fear she could slip into a coma during the night. As Kate Linebaugh reports in the Wall Street Journal:
“Then Mr. Adams found NightScout, a system cobbled together by a constellation of software engineers, many with diabetic children, who were frustrated by the limitations of current technology. The open-source system they developed essentially hacks the [monitor] and uploads its data to the Internet, which lets Mr. Adams see Ella's blood-sugar levels on his Pebble smartwatch wherever she is.”
Here’s the problem: the system Adams is using hasn’t been approved by the FDA. Further:
“Continuous glucose monitors such as the one Ella Adams uses are Class III medical devices, meaning they get the highest level of regulatory scrutiny, and even new support software must clear a battery of approvals.”
Moreover, getting approval is time-consuming: in general our FDA gets around to approving devices 3 or 4 years after they are approved in Europe. Meanwhile “medical do-it-yourselfers” all over the country are tinkering with monitoring systems and making improvements on their own:
“Users stay in touch with each other and the developers via a Facebook group set up by Mr. Adams. It now has more than 6,800 members. The developers are making fixes as bugs arise and adding functions such as text-message alarms and access controls via updates.”
Of course these are just a few of the ways the FDA makes life and death decisions that affect all of us. It prevents patients on death’s door step from getting access to experimental drugs. (See the movie Dallas Buyers Club) And more recently it stopped 23andMe from selling home genetic testing kits that can give patients 250 different test results.
The FDA: protecting us from ourselves.
