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| The Freehand System--Courtesy of MIT |
The demise of the company that made the Freehand System created a group of about 250 disbanded patients, and is a cautionary tale for patients, doctors and the industry about devices for rare medical conditions.
The Freehand System was approved by the FDA in 1987 and manufactured by NeuroControl of Cleveland, OH. The technology was developed in the 1970s to treat spinal injuries. It featured sensors and pacemaker-sized devices that were surgically implanted, as well as external wires, that stimulated nerves into working.
Unfortunately, the company had created a device for what is called an "Orphan Market", serving a relatively few number of people. The potential for making big money just wasn't there.
"The investors had expected that it would penetrate a much larger volume of the overall spinal-injury population," Geoff Thrope, NeuroControl's former director of business development, told MIT Technology Review. "We were able to make dozens of implant sales per year. You need to be in the hundreds, if not thousands, to have it make sense."
In 2001, NeuroControl said it was getting out of the Freehand business to focus on a potentially bigger market to help stroke victims, the publication reported. Soon after, NeuroControl went out of business having burned through about $26 million in investment.
NeuroControl's demise left the group of disbanded patients scrambling for information and scavenging for replacement parts as theirs began to wear out. Many, the publication reported, saw paralysis settle back into their limbs while about 65 continue to have use of their limbs.
When NeuroControl folded, nearly everything about it fell into a black hole. Not only did the company fail to arrange technical support for its customers, its website and phone numbers were disconnected, leaving both surgeons and patients in the dark.
Although the FDA has a pathway called the Humanitarian Device Exemption for devices that treat rare diseases that affects or is manifested in fewer than 4,000, there is nothing in place to protect patients if the company that manufactures those devices goes out of business.
"It was all legal," P. Hunter Peckham, the lead inventor of Freehand, told the publication. "Whether it was ethical or not is another question. Well, I guess it depends upon what your ethics are, right?"
Peckham resigned from NeuroControl's board following its decision to drop Freehand.
- read the MIT Technology Review story