MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, November/December 2015

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M e d i c a l P r o d u c t M a n u f a c t u r i n g n e w s q m e d . c o m / m p m n 2 2 n o v e M b e r / d e c e M b e r 2 0 1 5 sPecial feature: sensoRs W hile working at case western reserve university, Yoram rudy, Phd, had the idea for a game-changing cardiac monitoring device—a vest filled with more than 200 sensors that could detect the heart's electrical activity, providing a new method of studying problems such as heart arrhythmia. while standard 12-lead eKgs had become the gold standard for detecting many heart problems, eKgs still can miss cardiac problems because they only probe electrical potential at a limited number of points on the body. rudy's initial vision would evolve into a vest able to capture significantly more data than 12-lead eKgs. the data could be potentially integrated with ct data to provide a 3-d map of the electrical activity of the heart. the resulting maps would give electrophysiologists a new tool for studying cardiac rhythm disorders. unlike traditional catheter-based mapping methods, the imaging technique is noninvasive. in 2004, when rudy's technology was featured in the new York times, he had been working on refining the idea for 20 years. at that point, the technology was able to noninvasively detect sites of arrhythmic activity in the heart— an unprecedented breakthrough that would ultimately attract the attention of Medtronic roughly a decade later. rudy's students would ultimately continue refining the technology, and later founded the firm cardioinsight to commercialize it. Medtronic acquired the startup this year for $93 million. when cardioinsight was founded in 2006 by two case western reserve graduate students, charu ramanathan and Ping Jia, it had hopes of commercializing the new technology, known as electrocardiographic mapping, but the technology was still crude at that point. still, the firm was pleased with preliminary data it had gathered from animal trials. early human data was promising, too, which ultimately helped the company secure considerable funding. the startup planned on using some of the cash to create an advanced prototype. cardioinsight partnered with product development firm nottingham spirk (cleveland, oH) to transform a "frankenstein prototype" strewn with wires weighing about 15 pounds into a sleek device weighing roughly one pound, explains John nottingham, co-president and co-founder of nottingham spirk. the product would go on to obtain the ce Mark in 2011 and fda clearance in 2014. in 2012, the company orchestrated a limited launch of the product in europe. before that, the company managed to wow investors with the technology, raising $35.7 million worth of funding from institutional and industry supporters, vcs, angel investors, as well as government funding. to accomplish these advances, cardioinsight had to convince investors that its technology was gamechanging. accomplishing that objective was a matter of collaboration between the startup and the design firm nottingham spirk. "the teams remained in frequent contact with each other when issues and breakthroughs arose," says Jason tilk, product design specialist and nottingham spirk's lead industrial designer. "the collaboration was very organic and streamlined. cardioinsight was located down the hill from nottingham spirk, which enabled frequent face-to-face meetings. the ns–cardioinsight team would conduct weekly phone calls with vendors and manufactures, and after the calls the team would often sit in [cardioinsight founder and chief scientific officer] charu ramanathan's office and brainstorm questions that may have arisen during the call." the prototype that the design firm refined ultimately helped convince Medtronic that the startup was worth $93 million. (Medtronic announced the acquisition in July 2015; the product is now known as the Medtronic cardioinsight ecvue sensor array vest.) upon first seeing the prototype, Jeff taggart, program director, engineering team at the design firm, remembers thinking: "that's a mess!" He continues: "but, being from the technical field, i understood what the prototype was all about and that it did exactly what it needed to do. it just needed to be taken to the next level." while the idea behind the technology was promising—putting 252 eKg-type sensors on the body to gather electrical signals from the body and convert them into a graphic model of the heart— translating that idea into a sleek device was an immense challenge. "You can imagine having a patient and physically putting 252 sensors on them one by one," nottingham says. How a Frankenstein prototype ended Up Being Worth $93m Te CardioInsight ECVUE vest has sensors integrated through, probing the heart through a patient's chest and back. Te ECVUE vest can conform to a range of patient body types. John Nottingham decades ago, a case Western Reserve University professor had the idea for a sensor-based alternative to the eKG. The technology formed the basis for cardioInsight, a startup acquired by medtronic earlier in 2015. brian buntz Jason Tilk

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