"When I cut my fingers off, it was on a Saturday afternoon..."

A horrific moment. But the pain and sorrow of that day led to a medical innovation which is already making the lives of injured people more comfortable.

During 2011 when South African Richard van As lost four fingers on his right hand, the accident brought him to a moment of clarity. As he sat in the hospital waiting for treatment, van As was considering ways to address his loss, and a way to help others facing the same loss.

Following some research into the current state of prosthetic devices, van As was appalled at the lack of affordable solutions to replace his lost fingers. There was lots of experimentation, but the companies doing the work needed unworkable amounts of money for their products.

And so, in his garage, using parts brought home from many trips to the hardware store, van As set to work. After a year and through a long string of prototypes and iterations, van As began an internet collaboration with Ivan Owen in the United States.

Using two donated MakerBot Replicator 2 3D printers, the pair began to refine the prototypes of van As' early designs. It wasn't long before 'Robofinger' led to 'Robohand,' and the first finalized design was fitted for a 5-year-old boy in South Africa, Liam.

Their work led to a Rockefeller Next Century Innovators Award.

The Robohand project brings up some interesting points, such as how disruptive technologies like 3D printing and additive manufacturing might impact medical device innovation and testing going forward.

3D printing is making the headlines on a daily basis, and the technology, once considered a novelty and a tool for the future, has rapidly become a part of the present. Innovation in manufacturing via 3D printing is dramatically reducing the time required to design new products and get them out to the general public. It's that speed of innovation which will present a challenge to agencies like the Food and Drug Administration, the branch of government responsible for regulatory science.

The fact that using 3D printing allows the conversion of ideas from virtual computer model to physical object in what is essentially "real time" means such agencies will increasingly be called upon to react at lightning speed.

To that end, a pair of labs in the FDA's Office of Science and Engineering Laboratories are at this moment investigating ways such technology could affect the manufacturing of medical devices.

James Coburn of the FDA

"FDA built a Robohand with our 3D printer using plans published on the internet by the inventor," said James Coburn, a Mechanical Engineer with the Office of Science and Engineering Laboratories at FDA. "We concluded that the Robohand is very easy to download, print and construct, especially with the updated version."

Coburn, the FDA's 3D printing guru, added that he was stunned at how simple the process actually was.

"It was quite amazing how soon we were able to have a functional Robohand from the time they released version two," Coburn said. "The speed of development of the technology from v1 to v2 was also impressive, showing the force of the open source community. There are some ingenious designs in the open source community at large and we're happy to see more minds helping to make people's lives better."

Scientists at the Functional Performance and Device Use Laboratory say they're developing and adapting computer-modeling methods to aid them in determining the effect of design on the safety and performance of such devices. At the Laboratory for Solid Mechanics, the FDA is investigating how various printing techniques and processes affect the strength and durability of the materials used in medical devices.

"The review process for these devices will remain as it is for all medical devices at FDA – with safety and effectiveness of the device being paramount," said Susan Laine of the FDA's Office of Media Affairs. "By performing research in this field, it ensures that FDA understands the technological advantages and challenges of 3D printing. This enables the agency to provide the appropriate support to manufacturers as we review innovative products. We evaluate all devices, including any that utilize 3-D printing technology for safety and effectiveness and appropriate benefit and risk determination, regardless of the manufacturing technologies used. In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device."

Laine added that the FDA doesn't perform product testing for any submissions, and that manufacturers typically submit data to the agency to support their formal product application.

"While we can't comment on devices in review at FDA, we have approved several medical devices made using a 3D printing process that are on the market already," Laine said. "Several 3D-printed orthopedic implants are already cleared for marketing. Most take advantage of the printer's ability to make very intricately designed structures. All of the current 3D-printed orthopedic implants use it as a manufacturing technique to produce traditional, sized components. Some devices such as dental crowns or hearing aid ear plugs can be 3D printed to match patient imaging."

Laine said the FDA's Laboratory for Solid Mechanics is investigating how different printing techniques and processes affect the strength and durability of the materials used in medical devices. She said that research has already proved invaluable to the agency's reviews of devices down the road, and that much of the data will be used to develop standards and set parameters for scale, materials, and other critical aspects which contribute to product safety and innovation.

The Robohand, as an open source project, is available for download from Thingiverse.com, from their blog at www.robohand.blogspot.com , and you can get more information about the work on their Facebook page

To contribute to Robohand's ongoing fund-raising effort, please visit http://www.indiegogo.com/projects/sustaining-robohand.