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Cambridge Consultants partners with HemoSonics on diagnostic instrument development for blood clotting disorders

Medical device company HemoSonics has chosen leading technology design and development firm Cambridge Consultants to finalize the development of its new diagnostic instrument. The device will provide critically needed data to guide the treatment of bleeding and blood clots in surgery, trauma and intensive care.

The Point-of-Care (POC) analyzer is being designed to test the four treatable systems that control clotting: platelets, coagulation factors, fibrinogen and fibrinolytic proteins. Disruption or imbalance of these systems causes life-threatening bleeding and blood clots, which can result in heart attack, stroke, pulmonary embolism and hemorrhage. These conditions are responsible for 30% of deaths in the developed world. The HemoSonics technology is intended to rapidly diagnose these disruptions for physicians to implement life-saving therapy.

“After a highly competitive search, we chose Cambridge Consultants due to its proven expertise and track record in the medical technology and surgical space,” said William Walker, President of HemoSonics. “We are excited to work collaboratively through the commercialization process to take this important product to market. Most people don’t realize that bleeding and blood clots are the main causes of death in the developed world. This diagnostic instrument is being designed to provide information rapidly to physicians to allow them to reduce complications for the patient, and, in turn, save lives and lower healthcare costs.”

Cambridge Consultants will use its expertise in diagnostic product development, electronics, industrial design, human factors, software engineering and microfluidics – as well as its development experience in highly regulated environments – to help HemoSonics navigate the stages of development to get the innovative instrument ready for large-scale clinical use.

The new device is being developed for its first application in open-heart surgery, where up to 25% of patients suffer from excessive bleeding. Today, doctors have two unattractive treatment options. First, they can send blood to a lab to perform an array of tests and wait for results in the operating room – a process that is unacceptably slow and is therefore rarely used. Alternatively, they can make a best guess, without hard data, to guide treatment. This process has been shown to waste blood products, increase costs, and worsen patient outcomes. The HemoSonics POC analyzer is being designed to-be-easy to use, and to rapidly provide straightforward data to physicians.

“Holding up an operating room while waiting for lab results is both expensive and risky,” said David Chastain, program manager in the Medical Technology division of Cambridge Consultants. “We are pleased to work with HemoSonics on this device that is being designed to deliver fast and accurate information that is critical in surgery – when the longer a patient is under anesthesia, the greater the risk. This project is particularly exciting as it will use so many areas of our expertise and we believe, once it is fully commercialized, it could become the standard blood coagulation diagnostic tool for hospitals around the world.”

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