Latvian 3D software company, WiDE, has received a CE mark for its software that helps users to quickly iterate 3D printed prosthesis in new sizes. The standards marking allows WiDE to distribute its software in the European Economic Area (EEA), Iceland, Liechtenstein, and Norway.
With this new assurance, WiDE hopes to stay in pursuit of its goal to make 3D printing in healthcare, simpler and easier for everyone.
WiDE prosthetic customization
WiDE software makes it easier for users to customize prosthesis and orthosis (support braces for joints) for 3D printing. By simplifying the user experience, the company wants to make 3D printing of prosthetics widely available, and create an environment where assistive device can be manufactured in a matter of hours.
To do this, WiDE software ‘wraps’ a digital template of prosthetic around the 3D scan of the patients arm or leg. This makes it easier for the user to make further adjustments to the model.
The complications of other CAD software is eradicated, as WiDE software offers a simple set of tools to customize a prosthetic in a digital environment. Furthermore, WiDE prepares the file for 3D printing, so there is no need for a separate slicer software.
Regulation and CE marking of medical 3D software
The application of 3D software in the medical industry is diverse. For example, Materialise’s Mimics innovation suite is used for 3D printing anatomical models for assistance in surgery. Furthermore, recently, it was reported that Adaptiiv Medical Technologies 3D software for 3D printed bolus will be used to treat cancer in veteran patients.
In the U.S medical software are categorized as medical devices and require certification, regulated by the FDA. Whereas, in Europe, a ‘CE Marking’ ensures that the medical device is fit to be sold in the European single market.
In order to obtain the CE Marking, a manufacturer must ensure that its product is in compliance with the requirements of European health, safety, and environmental protection guidelines, stated in the Product Directives and Harmonized Standards. These technical standards are set by European agencies such as the European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENLEC).
Once the product is tested for conformity to standards, and technical documents are drafted, the CE symbol is affixed to the device and the EU Declaration of Conformity is drawn up. The CE symbol certifies the product to be legally marketed in the EEA countries.
3D printed prosthetics
3D printed technology has also been effectively put to use for making 3D printed prosthetics. Earlier this year, the Northwell Health developed ‘The Fin’, a leg prosthetic which can be worn on land and water. More than this, global charities like e-NABLE, has provided low-cost 3D printed prosthetics to people in need.
It was also reported that Syria Relief sought funding for 3D printing prosthetics. The charity considered 3D printing to be the most efficient way to meet the demand of prosthetics in the war zone.
But, despite the availability of 3D printers, modeling and customization of prosthetics require technical skills. This puts a limitation on where and when 3D printed prosthetics can be produced.
WiDE software aims to bridge the gap between lack of skills and the need rapid modeling and customization of 3D prosthetics for 3D printing. Speaking in our guest article series WiDE founder Janis Jatnieks said of the Future of 3D Printing, “We will see patients feelings, and fears battled with the help of creative and involving designs that are smartly tailored to fit patients and that also adhere to their lifestyles and daily activities,”
“The future assistive devices will look stylish, they will catch an eye and make the wearer feel empowered to face the world and challenge their disability. It is likely that future assistive device users will have several units where one will be fitted to the dress worn to an Opera, but others made for school and even for doing household chores.”
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Featured image shows an example of 3D printed prosthetics. Image via WiDE
