Hands-off Healing
New medicine
ARANZ Medical hardware engineer Phil Barclay assembling one of the SilhouetteMobile devices.
ARANZ has been at the forefront of 3-D scanning and modelling technology development since 1995. The company was established to produce a handheld scanner used by Weta Workshop to digitise and animate Gollum in The Lord of the Rings trilogy.
Although SilhouetteMobile is similar to its predecessor, as a medical device it faced far greater regulatory hurdles before it could be successfully sold overseas.
Potential sales in the United States are significant, according to Chief Executive Bruce Davey. “There are chains of wound clinics in America where our device could be used, but we couldn’t sell them there without FDA approval.”
ARANZ decided that it would have to improve on its existing ISO 9001 certification and set about reorganising the way the company operated.
“It took us a year and a half to get the process in place. We had to completely overhaul the company’s quality system and at least one third of our staff was involved,” says Mr Davey.
Changes included introducing good practice into areas such as risk management, environmental controls, record retention, and regulatory and design controls. He believes the process was very beneficial for the company, which achieved ISO 13485 certification (relating to the design and manufacture of medical devices) in June 2007. SilhouetteMobile is the first medical device to gain the FDA’s 510(k) approval specifically for wound imaging, measurement and documentation.
