Design
“Our
design philosophy is focused on delivering the most innovative, cost
effective, creative, ergonomic and precisely engineered solutions for
our customers, both medical and industrial. Our design team strive to
add value to our products at all stages of the design process, from
generating new intellectual property during concept development, to the
design of the packaging used in production.
From a biro sketch on a napkin over lunch with a surgeon, to a
cardboard model of a mechanism the "Blue Peter" way, our designers
utilise a range of techniques on the journey to developing a new
medical device. Of course we are also running the latest 3D CAD/CAM
software and CNC machines to build fully functional prototypes in-house
for verification and validation testing activities.
Cutting edge CNC machines require the best people to program and
operate them - fortunately we have both, and the high tech side of our
product development team is also complimented by the instrument making
skills and genius brain of our founder.
On site, state of the art laparoscopic surgery simulators allow new
design prototypes to be quickly evaluated by our clinical advisory
board and design team. In fact, our designers are put through the same
core skills surgical training exercises as surgeons, allowing them to
truly immerse themselves in the role of the end user and understand how
prototypes can be improved and refined.
Detailed design procedures and controls ensure that we remain compliant
with the requirements of ISO 9001, ISO 13485 and FDA 21 CFR 820.30 Each
new product design journey starts with a sketch and finishes with an
approved Technical File that is maintained throughout the life of the
product”.