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12 DESIGN007 MAGAZINE I NOVEMBER 2018 Are you working on any wear- ables, for instance? MacCallum: There is a growing desire to bring medical devices into the patient's home. This means that many devices no lon- ger interact primarily with doc- tors, nurses and technologists but with the patient, and with- out direct supervision. These devices often consist of multiple elements: those that are wear- able, portable and even implanted. Three years ago, there was a growing buzz around connectivity, "big data" and "the cloud." In the medical device industry, these terms collectively lumped into the term "digital health" and this in turn has morphed into the concept of "connected health." Since then, it's become clearer how to successfully leverage and implement these ideas in a practical and economical fashion. We're also learning how to address the associated regulatory hurdles, including the mandated attention to ensuring that identifiable patient data remains protected and secure. Notwithstanding the trends, the fundamen- tal focus on device safety and efficacy has not changed. In fact, if anything this primary goal of medical device design has strengthened. No matter how cool and progressive technol- ogy gets, if we can't ensure that we can con- trol the safety of the patient and operator or if we cannot demonstrate that the intended use is implemented in a reliably effective manner, then we have not succeeded. Shaughnessy: What are the big- gest technical challenges you and your team face today? MacCallum: Now, more than ever, our clients are expect- ing the same richness in user interfaces and connectivity with their medical device design as they see in the consumer prod- ucts that they interact with every day. This means not only harnessing the latest trends in technology and their implementation but also developing creative ways to adapt them to the nuances of the medical device market. For instance, although the margins tend to be higher in our industry, the quantities are often orders of magnitude smaller. Also, because of the regulatory hurdles of getting market clear- ance for just one product, leveraging develop- ment effort across suites of related products is rarely achieved. The challenge is to adopt all of these varied features and modalities in a cost- effective and efficient manner. Shaughnessy: Is IoT becoming fairly standard in the medical segment? MacCallum: The growth in IoT is certainly gen- erating plenty of interest in the medical device field. We see it creeping into our industry as medical devices become smaller and also as functionality that used to be limited to clinics and hospitals is made available for home use. Treatment and monitoring are increasingly done without direct physician supervision and in much less controlled environments. This means that technology must fill the gap to process and convey the data effectively, safely and securely to ensure the best clini- cal results. It used to be that connectivity was a desired add-on. Now, many devices that we are working on could not achieve their intended use without it. Fortunately, we are able to leverage many of the connec- tivity solutions springing out of the IoT trend. Similarly, the sensor technology that Kenneth MacCallum

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