When 50-year-old UK heart patient Julie Penoyer, a Jehovah’s Witness, needed surgery, she requested not to receive donated blood products. Fortunately for Penoyer, the medical industry now has a new device, developed with the aid of 3D printing, that captures, cleans and puts back lost blood lost during an operation. Penoyer was one of the first patients to benefit from the new Hemosep device.  The success of Hemosep’s use during Mrs. Penoyer’s operation presents new possibilities for patients across the globe, whose religious beliefs mean that receiving donated blood is not an option.

The Hemosep recovers blood spilled during open heart and major trauma surgery, concentrating the blood cells ready for transfusion back into the patient. This process, known as auto-transfusion, reduces the volume of donor blood required and the problems associated with transfusion reaction. The prototype device features a number of Stratasys 3D printed parts from the Dimension 1200es 3D Printer, including the main filtration and cooling systems, enabling the Brightwake team that developed the device to functionally test the system in its intended environment, before the final device is produced from metal.  The UK-based company was able to reduce prototyping costs by 96% using 3D printed parts. The device has been awarded the CE mark and is attracting global interest from distributors and healthcare providers.

“The Hemosep consists of a bag that uses chemical sponge technology and a mechanical agitator to concentrate blood sucked from a surgical site or drained from a heart-lung machine after surgery,” said Steve Cotton, Brightwake’s Director of Research and Development. “The cells are then returned to the patient via blood transfusion. In a climate of blood shortage, this recycling methodology has the potential to be a game-changer within the medical industry, saving the National Health Service millions.”

Successful clinical trials of over 100 open-heart surgery operations in Turkey confirmed the Hemosep’s ability to significantly reduce the need for blood transfusions, and further trials are now continuing in the UK.

Prototyping costs slashed by 96% and lead-times eliminated through in-house production

For Brightwake, with medical device production demanding extremely accurate parts, capable of enduring the stress of functional and safety tests, the company’s use of 3D printing presented significant cost- and time-saving benefits.

“Previously we had to outsource the production of these parts which took around three weeks per part,” said Cotton. “Now we’re 3D printing superior strength parts overnight, cutting our prototyping costs by 96% and saving more than £1,000 for each 3D printed model.

“3D printing has not only enabled us to cut our own costs, it has also been crucial in getting a functional device to clinical trials,” he added. “The ability to 3D print parts that look, feel and perform like the final product, on-the-fly, is the future of medical device manufacturing.”

Originating in Nottingham’s traditional textiles industry, Brightwake is a family-run creative development, engineering, production and research company specializing in innovative manufacturing solutions. With nearly 35 years’ experience, Brightwake has now extended its expertise into the medical field, starting with the production of wound dressing for the UK’s National Health Service (NHS). Armed with its Stratasys’ Dimension 1200es 3D Printer from UK reseller Stanford Marsh, the company now has the in-house capability to extend its medical device manufacturing program beyond the Hemosep.

“In the fast-paced, competitive medical device industry, we are seeing more and more of our customers use 3D printing to bring their products to market more efficiently and cost-effectively,” reported Andy Middleton, Senior Vice President and General Manager EMEA. “The ability to turn ideas into functional products quickly is something that in the long-term we believe will improve the quality of care, and in some cases, save lives.”

Stratasys Ltd.
www.stratasys.com