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Medical Product Manufacturing News, September/October 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 6 s e P t e M b e r / o c t o b e r 2 0 1 5 need to KnoW How philips made App-based Ultrasound a Reality royal Philips is preparing to sell an fda- cleared ultrasound transducer called lumify that simply plugs into a tablet computer via its usb port. the interface runs off an app on the tablet. call it the birth of app-based ultrasound. Previous innovations, and collaboration with fda, helped Philips when it came to creating ultrasound that simply plugs into a smart device, says randy Hamlin, vice president and business segment leader of Philips ultra Mobile. Here's what Hamlin had to tell MPMN about lumify, and the design and regulatory challenges overcome to make it a reality: MPMN: which technological advances made app- based ultrasound possible? Hamlin: While I was [vice president of R&D at Philips Healthcare], we were looking at feasibility projects that were interesting, but didn't know whether they were technically possible. About 12-plus years ago, we created this technology where you put more of the electronics in a transducer. We were doing that because we were creating the world's first real-time 3-D ultrasound imaging transducer. In order for us to do that, we had to take more of the electronics that were in an ultrasound cart, and place them in the transducer so that you could use up-front processing. There was so much information being generated by thousands of little elements that were transmitting sound and receiving sound that we would have to have a huge cable that would go to this large processor. We had to invent what we called a funnel technique, funneling all this information to a more reasonable mount. It requires us to have this processor in the transducer. You go back about five years ago from today, there was a group of engineers in my office, and we were asking: "why don't we take this approach into the 2-d world?" there were some feasibility projects we started to adapt to that same concept. that was the birth of app-based ultrasound. it's really centered around the ability to put all the electronics in the transducer itself, in the device that couples to the patient. that frees you up to then have a cPu and display device at the other end of the wire. for us to achieve that, we needed highly capable electronics in a low-power format, so we just use the power from the smart devices. that is fundamentally a breakthrough. if you look at taking any off-the-shelf smart devices, it's really about being able to leverage miniaturization and low-powered electronics to then power your device from smart devices. that was really the breakthrough that allowed us to take app-based ultrasound to the next level. that's how the birth of it happen. MPMN: why is app-based ultrasound so beneficial? Hamlin: Your world opens up. You have all this amazing flexibility. that's where we see app- based ultrasound being so exciting for us. it fits on this very smart platform of smart devices. it allows us to constantly update content to our users in a very simple way. it's like accepting your app updates that you have on your smart device today. it eliminates the complexity and overhead of our customers have to wait a long time for software upgrades. there are some really amazing things that open up as a tool solution when you go to an app-based iteration. ultrasound that you can carry with you has been in the market a couple years now. what they struggle with is the image performance. the clinician really needs critical information at the bedside. we were able to overcome that through the Philips innovation migrating from real-time 3-d ultrasound to the 2-d world. we were able to deliver high image quality in an affordable solution. … it sits on the user's own smart device. they're highly connective, … solutions that are connected [to the electronic medical record] … in a very seamless way. they can put their own security services on that device to protect their own device. the whole security thing is being taken care of as well. ... it's a bring-your-own-device solution. … we fit into the existing paradigm of tools they already have today. MPMN: lumify is presently compatible with the android nexus 7-inch tablet, but the goal is to have it compatible with most android and apple devices in the future? Hamlin: our intent in the future is to be ubiquitous to the operating systems. … our first app is an imaging app that does a lot of ultrasound things. over time, we'll be adding additional capabilities, a lot of other applications that are simply downloaded by our customers, other transducer types, other tablet devices with other operating systems. we'll be delivering that through a web portal that is part of our solution. it's the innovation of the transducer coupled with the user's smart device. and then that's coupled to our web portal that enables them to access training materials, the latest app information. they can manage their devices through our cloud app dashboard that we have. and so if an institution has about 10 or 12 of these, they know where they're at in terms of who is using them and how much they are being used. … in the future, many institutions will have to track utilization and how many criticals they're doing, because they'll have to do accreditation. MPMN: why are you offering lumify under a subscription model? Hamlin: Many customers are interested in doing more ultrasound, but … they don't want to go through the process of acquiring a $30,000 ultrasound. … with our subscription model, there's no upfront fee to start, and there's no penalty for exiting at any time. we're doing this because, no. 1, it really breaks down another barrier of adoption, which is large capital expenditure. it gives our users flexibility where if the demand of patient care increases, they can add subscriptions very quickly. if they demand drops, they can drop some subscriptions. … it really matches access of ultrasound to the demand of healthcare. MPMN: How did you navigate regulatory hurdles related to potentially plugging into so many different smart device platforms? Hamlin: we're breaking a lot of new ground with lumify, so we've been collaborating a lot with the fda. … we have minimum specified requirements of the smart device displaying ultrasound. the fda has agreed to that minimum specification. they're very comfortable saying that anything that exceeds that minimum specification is underneath the 510(k). we have established where the bar is based on resolution and power of the smart device. and on apps that are developed, Philips takes responsibility that any app offered on our platform has 510(k). a 510(k) is required. … we're the gatekeepers of that. … we have found android devices that do not function consistently with others. so our website will include a qualified list of smart devices that we guarantee are compatible. and then we will have our minimum specification that will say these other devices [that surpass it] may work, but we will not guarantee them. Randy Hamlin Here's what the Lumify might look like in action.

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