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Proliferation of consumer platforms and devices into the Medtech Ecosystem, Part II: a panel of IT experts discusses regulatory issues, debates consumer technology's impact on the medical device space and medtech in the "cloud.".

This month's installment is the second in a series of articles that will examine the challenges as well as the possible successes of using consumer devices and platforms within the highly regulated medical device industry (the first part was published as a column in the November/December 2011 issue of Medical Product Outsourcing). The first article covered the changes in the healthcare ecosystem that are driving the need for consumer platforms and devices. This article will address recent U.S. Food and Drug Administration (FDA) regulatory guidance, current solutions on the market, and concerns of medical device companies with using consumer platforms in mission-critical applications. Donna Fedor, director of strategy at Jabil Circuit Inc., St. Petersburg, Fla., assembled three information technology professionals from diverse backgrounds to discuss the convergence of two dissimilar industries into a new ecosystem. Excerpts of the discussion she coordinated and moderated are below.

Participants include:

* Michael Huneycutt, chief technology advisor for the Federal, Commercial, and Healthcare business units of information technology company Dell Inc.;

* Simon Karger, associate director, Surgical, at Cambridge Consultants Ltd., a company that develops products, creates and licenses intellectual property, and provides technology consulting services in the areas of medical technology, industrial and consumer products, transport, energy, cleantech, and wireless communications; and

* Alan Portela, CEO of AirStrip Technologies Inc., a San Antonio, Texas, software company that is developing tools to send patient information directly from hospital monitoring systems, bedside devices and electronic health records to a clinician's mobile device such as an iPhone or BlackBerry.

Donna Fedor: What are your thoughts on the impact of the July 21, 2011, FDA guidance (Doc#263366) on mobile medical applications?

Alan Portela: I do have to say; I love the FDA. When AirStrip started, we realized in order to mobilize medical device data throughout the continuum--and what I mean by that is, the ambulance, the emergency department, the hospital, the home and even implanted devices will able to connect through the "cloud" to the patient and display their data on a mobile device--we knew that we needed to go for the highest level of approval required for our solution. The reality is that if you're going to use mobile technology as a display connected to a regulated device, we fully support the fact that the mobile device has to be regulated. The same thing applies if you start providing analytics or alerts.

In working with our consumer device partners, we had to go through several rounds of modification of their OS (operating system) to be able to support our solution. Not only were we the first with the FDA, but we were lucky that [we] were the first ones working with the mobile device OEMs. Today there is a backlog of companies that are trying to work with the big mobile phone guys.

Fedor: Michael, what is your take--as well as Dell's--on the regulatory environment for consumer platforms and devices entering the medical ecosystem?

Michael Huneycutt: There's a value because out of that has come much better discipline for Dell and the industry. From that perspective, Dell embraces the FDA. It also has impacted how we look at acquisitions since there most likely will be additional investment required from a regulatory certification standpoint that needs to be evaluated.

The idea of the mobile clinical computing platform is to allow physicians and people rendering care to move from device to device fairly easily without needing to store any data on the devices. Some of the FDA guidance might mean potential significant investment for companies like ours if the display itself becomes something that needs to be regulated.


We recognize that there needs to be that balance between fostering innovation and the possibility of crushing innovation through too much regulation. Small companies are generally very good at innovating but additional investments in the regulatory arena might be a challenge for them.

Portela: You are even going to see big vendors that were planning to get into medical mobility start to wonder if they really want to subject and expose themselves to regulations. Also, the pharma industry needs to differentiate itself from generic drugs. One way to do that is to start creating programs using mobile phones to provide support to patients and consumers about their medication interactions, compliance and adherence. In order to do that, even though you're just dealing with simple components like texting, the pharmas understand the importance of working with the FDA to minimize risk, even in text messaging. They are going to take it to the next level, they are going to secure it and they are going to ensure safety and minimize risk.

Fedor: Remote monitoring or mHealth has taken years and years to take off. But, finally, there's been a lot of momentum-a critical mass is really building. What do you see as the most recent drivers getting us over the implementation hump?

Simon Karger: There has been a real step up in activity in the last few years. The fundamental driver has been the economic need for us to reduce the overall cost of healthcare and the expense of specific chronic conditions. Combined with new worldwide social trends where people are interacting with technology, the acceptance of mobility has accelerated. Consumer and medical device technology supported by infrastructure technology have developed to the point where, from a product development point of view, we have confidence in our ability to get these things to work together. A few years ago, we didn't have that level of confidence.

As a society, we've become incredibly used to having instant access to information, instant control over everything from our bank accounts to our communications, and we're starting to demand that level of control, interaction and access to information in our clinical world as well. We may be doctors; we may be surgeons; we may be patients, but, ultimately, we are people who are used to our consumer devices on a day-to-day, hour-by-hour basis in other aspects of our lives.

But there are still a whole bundle of challenges. If you look at the complexities of bringing any medical device to market, it's about far more than just combining technology and being able to get the device to work. It's about being able to pull together the regulatory aspect, reimbursement models, business and service provision models with the physical hardware and with clinicians and patients to form a compelling whole so that all the stakeholders in the value chain and in the care pathway can see strong value proposition.

We're really only seeing the tip of the iceberg today in mHealth. The first very exciting applications are on the market and the regulatory pathway is starting to come clear. The industry is starting to pull the pieces together technically and commercially to incorporate mobility. We are thinking about going beyond data and information by using these consumer platforms as enabling interfaces to give us totally new ways of interacting with medical devices. We, as an industry, must come together to work out how we combine the various facets to make it happen.

Fedor: Alan, what are some of the successful use cases that you have from AirStrip's deployments?

Portela: Let's use cardiology [as an example]. When a person has a complete blockage, every minute saved results in less damage to heart muscle, which can save their life and provide a better quality of life. When the ambulance picks you up, they do an EKG (electrocardiogram--EKG or ECG--a test that checks for problems with the electrical activity of your heart), which was either faxed or sent [via email] as a PDF [file] to the emergency department where they have to find the on-call cardiologist and forward the EKG, who then would decide whether to activate the cath lab. Now, with remote technology, the EKG automatically goes to both the on-call cardiologist and emergency department directly from the ambulance. The cath lab can immediately be activated based on the EKG data on their tablet, PC or mobile phone. In a study we were able to do on some of our deployments, we were able to shorten the time from chest pain to balloon time (cath lab) from 45 minutes to about 15 to 20 minutes.

Remote technology can help you be more certain of the extent of blockages before you activate the cath lab. Every time you activate the cath lab, it's $10,000. False activations happen in 50 percent or more of the cases as emergency personal activate the cath lab in the ambulance when they believe it is a blockage. We also noticed that there is a shortening on the length of stay in the intensive-care unit (ICU) by almost one day. When you move to the step-down area, there are reimbursement rules around patient discharge. Cardiologists can perform remote reviews to discharge or orders to continue to hold patients using certified remote mobile devices. Re-admittance rates can also drop due to identification of possible issues more quickly at discharge and revenues can increase from better identification of patients that would benefit greatly from an implanted cardiac device.

If you look at the continuum of care for our cardiology example, a single hospital could save about $400,000 from the ambulance to the ICU. From ICU to the home, you could have new revenue generation of $1 million. Applying that in the United States, you can potentially have $10 billion in savings and revenue. Maybe the government needs to start looking at technology to be able to improve the quality of care but also prevent the loss of jobs.

And now, hospitals are asking us for exclusives to use our technology so they can market and tout their differentiation with social media and billboards to be able to gain competitive advantage over the other hospitals. I have never seen that in healthcare before.

Fedor: Let's discuss the device and where your solution fits into the FDA guidance. There are also concerns about device "ruggedization" and cleaning and disinfecting in the clinical environment.

Portela: In our case, when you use mobile technology to access data remotely, you're not replacing the caregivers that are at the bedside. You still have your resident and your nurses there. Before, however, you didn't have quick access to the specialist, especially in rural areas. As for infection control, it is not an issue because we are providing access for a specialist at a remote location. In the clinical environment, they're going to see the patient face to face or access the data on a desktop or see it in their office.

Fedor: Because it acts as a secondary mobile display when they are remote. It does not replace the primary display.

Portela: Exactly. As for "ruggedized" devices, I was just at NATO (North Atlantic Treaty Organization) about two weeks ago discussing mobility from the point of injury in the battlefield all the way to the inpatient site.

Huneycutt: In the battlefield, one of the big challenges with NATO is with soldiers from different countries. On the battlefield, you really don't need a full EMR (electronic medical record). I'm actually a former soldier. On the battlefield, it's not about trying to treat the patient; it's really about doing everything that's necessary to stabilize the patient to get them back to the MASH (mobile army surgical hospital) unit, which means you need to know about their allergies and things like that. We're working on electronic medical record dog tags, so that you could plug it into a device and be able to quickly see who they are, some basic allergies and characteristics that would keep you from putting them at risk.

As for ruggedizing in a hospital, you would think ... how much damage can you actually do to a laptop, but apparently you can do quite a bit of damage to a laptop--spills, drops, all kinds of stuff. We spent a lot of time ruggedizing our tablets, even to fit into a hospital environment.

Fedor: Many medical device companies still use proprietary controller devices. They're not using consumer platforms. And, many times, proprietary devices are still used for consumer-type applications outside a clinical environment, such as diabetes managers, cardiac communicators or neuro-modulation devices. What concerns do medical device companies have with using consumer platforms and when do you think that we could potentially get over those humps?

Karger: There are two elements here. One is around attitude to risk and control and the second is the lifecycle of medical products. Many medical device companies use proprietary devices because they can retain control of all of the elements of that medical device. The idea of bringing a piece of hardware and software into a heavily regulated environment over which you as a medical device manufacturer have no control is quite a scary prospect for most large medical device firms. From a liability point of view, most legal departments start throwing up their hands saying, "How can we assume liability here from a safety assurance and quality assurance point of view? "You now have a platform over which you have no control of what else might be put on that platform. The idea is that your medical device may be made unstable by a bad copy of another application that you have no idea that was even on that platform. That's not an acceptable risk to most medical device companies.

Medical device companies need to understand how to integrate those types of platforms into their devices which will result in a different approach to their device development and an altered way of looking at risk. From the point of view of the platform development organizations, companies like Apple and Dell and others need to understand how far down the road they need to go in providing a firewalled platform.

Fedor: What do you think is going to prompt the consumer mobile companies to start firewalling and partitioning their platform to allow for medical device companies to use consumer platforms as a primary display?

Karger: That's the million-dollar question of course. We'd need to see a level of guaranteed quality of service minimizing unwanted interaction between pieces of software providing assured levels of response time for applications within the underlying platform. Some level of guarantee coming from those companies would give medical device companies more confidence in using consumer platforms as a medical device. And, I don't mean necessarily just as a display option, but when we start getting to some of the really exciting opportunities of control, analytics, diagnosis and areas where these devices are becoming our primary interface into the medical functionality. It is happening to some degree. If you look at Apple and their JOS (Apple's mobile operating system), you have a very controlled, closed, kind of walled-garden-type app store there. Because of their degree of vertical integration, they have a lot of control over the hardware and software and a better ability to offer a higher level of guarantee, if not control, to device-app manufacturers. If you look at Android, you have a lot of the benefits from an open platform-something that's able to evolve quickly; something that the industry is able to drive in a much stronger way, but with far less control. We're starting to see the Android platform implement some of that control. How far will that go? How quickly will it happen across the various platforms? I don't think anyone can answer that right now.

Portela: As the FDA gets more involved in regulating the whole solution, they are going to recognize that they could bring a lot of value to the table if they work with those vendors to help them through the process. For example, with medical device connectivity, you have three ways of displaying the data. You can do a Citrix tunneling; you can do a Web-based application; or you can do a native application. Anybody can do Citrix. It's more complex to do the web, but the real complex process is the native; running natively on each OS. Native is what the FDA is now looking at as a possible standard because they cannot really keep the medical aspect ratio, especially on Citrix. (Citrix is a software vendor that allows users to route or "tunnel" information from a medical device, such as a patient monitor, through a sewer to view it real time on a remote display.) So what may happen is Apple and Google could start to realize that the more effort they put into supporting those vendors and going through the process of those regulations, they will be able to emphasize and differentiate on those benefits that they have over the other solutions.

Fedor: With so many people suffering from chronic disease, it is potentially a very large market for them. Another note is that startup companies will be challenged by having to support all of the different OS variants--BlackBerries and iPhones and Android phones ... with native applications for each one of them.

Portela: It's all down to the approach. At AirStrip, we created platforms and then we translated into each native OS. The real work is to do it in one platform, which can make the effort of con version simpler.

Fedor: Simon, you talked about lifecycle as well--medical versus consumer lifecycle.

Karger: That is the other critical piece here Mobile device lifecycles are incredibly fast compared with medical device lifecycles. That, inevitably, is going to lead to medical device manufacturers needing to think not only about multiple platforms, but of multiple versions of hardware and operating systems that are out on the market. In the future, manufacturers need to think about those things from day one. There is no getting away from the fact that Apple, Dell and other mobile consumer device manufacturers are currently releasing one or two new devices a year. That's probably not going to change. And even if it does, we certainly are not going to get to lifecycles measured in multiple years or even tens of years, which is how we tend to think about it in the medical device world.

My advice to medical device manufacturers who are looking to understand how to exploit these consumer platforms is that you have to be thinking about how you integrate that platform into your device from day one in the fundamental product of development, but you also have to have a life cycle plan that lets you recognize that there are going to be some new elements of the lifecycle and product churn that you haven't had to deal with before.

Huneycutt: iOS doesn't change much other than from platform to platform, although from Verizon to AT&T there are slight changes. Android, on the other hand, has tons of proliferations. I have at least three android devices tight now and all three android devices are controlled by different groups. Verizon's Motorola Droid has a different aspect and a different customization of the OS versus AT&T. There are thousands of Android variants.

Medical device manufacturers are going to have to take control to some degree of Android and make it their own. Android is an open platform. Apple says what goes into their OS, but with Android, its beauty is customization. But you have to also know what's being contributed into it during its lifetime.

Karger: That will present a great opportunity, because one of the things that I think the industry needs to see is some degree of standardization. With an open platform, there's an opportunity there to drive standardization from the medical device industry without necessarily having to drive it from the mobile carrier or the mobile hardware manufacturer. The flip side is that you need to make sure that you're maintaining those links and everything works together. But, we have to find a way to get some control over the platform if traditional medical device manufacturers are going to do use consumer platforms.

Huneycutt: At Dell, we are careful in releasing the next version of Android because we are trying to maintain control over the environment and only release it when it's stable. The challenge will be the balance of releasing the operating system and devices for consumers who want the latest and greatest thing every five minutes with ensuring our devices are stable for the medical sector.

Editor's note: Part three will focus on data security and data management within the cloud as well as the alterations needed to the hospital infrastructure, services and payment models to support physician and patient remote access and monitoring globally. Also in an upcoming edition, the future of the medical device will be discussed, if and when consumer platforms become a mainstream element in the medical ecosystem.

Donna Fedor * Contributing Writer

Donna Fedor has been the director of strategy for Jabil's Healthcare & Life Sciences sector since 2009. She is responsible for developing unique strategies to build deeper knowledge and expertise in the global healthcare industry, specific conditions and disease states, and medical products and technologies. Fedor holds a bachelor's degree in electrical engineering from Boston University.
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Title Annotation:FEATURE: IT Intelligence
Author:Fedor, Donna
Publication:Medical Product Outsourcing
Article Type:Discussion
Date:Mar 1, 2012
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