What’s taking so long?! The challenges facing medical device engineering

The medical devices industry demands products of the highest possible quality, indeed for
many companies, quality is their only focus. As a result, the Engineering behind their
production systems has to perform at the highest level - material specifications, design
tolerances, component forming and assembly, performance testing, are all required to be
optimal. Zero product defects is the aim in an industry where product failure could cost the
manufacturer a fortune in liability claims. Manufacturers therefore rely on intensive
engineering effort in the design, prototyping and pre-production stages.
For many products, the route to commercial success has also involved high volume
manufacture to achieve low product cost and marketing on a global scale. This has
restricted some product designs, that despite being innovative, could not justify being made
at a scale that would be economic.
However, recent developments in manufacturing technologies, originally seen as only
suitable for prototyping, may enable economic production of low volumes of product,
engineered for specific patients or patient groups.