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Everything You Wanted to Know about Qualcomm's 2net App SDK

Everything You Wanted to Know about Qualcomm's 2net App SDK

The 2net App Software Development Kit (SDK) from Qualcomm Life is now available to developers on a variety of data-enabled platforms. Ten companies, including FitBit and Withings, have opened up their data streams to developers using the SDK. Instead of dealing with individual data streams, the service aggregates data streams and pulls it into the cloud. And now, with the APIs, the service allows data miners to come in and look at how they can create apps that will interpret and present that aggregated data.

In addition, Qualcomm has announced the 2net App Developer Challenge to choose the best 2net-enabled applications. The top three will be awarded cash prizes ranging from $5,000 to $20,000. Winners will be announced at the upcoming Wireless Health Conference held October 23 in San Diego. 

“We want to attract the best and most creative developers to the challenge,” says Kabir Kasargod, wireless health business development at Qualcomm Labs (San Diego). “[In addition to the cash prize], one of the key things that we are doing, which we have never done before, is invite the developers to be part of the Qualcomm pavilion and showcase their app,” he adds. “So in addition to the cash prize, one of the things that we are doing is immediately making them one of our key partners and introducing them to the right ecosystem players and making them a part of the ecosystem right away.”

To learn more about the SDK as well as the prize, Brian Buntz, editor-at-large for UBM’s medical device group and Bill Betten, medical technology director at UBM TechInsights sat down for an in-depth discussion with Kasargod. 

MD+DI: What do you think is the most important thing that you feel digital health companies should know about the 2net SDK?

Kabir Kasargod, Qualcomm Labs: For us, it is really important that developers now have an opportunity to have one consolidated data stream across multiple radio technologies—across apps. They can now have one way of unifying all of that content and visualizing the data inside of the applications so that they don’t have to use any of the siloed apps and services. Rather, they can have one consolidated platform to get all of that data.

MD+DI: Could you explain how the availability of the 2net SDK will ultimately help the end user?

Kabir Kasargod
 Kabir Kasargod

Kasargod: The key thing for us is that the end user should have multiple ways to access their own data. When you look at it from an end user’s perspective, today, they have to download multiple applications in order to see data across different devices, apps, and services.

What we wanted to provide is an easy mechanism so that any developer who is creating unique case studies has the ability to provide those visualizations back to the end user. I, the end user, can then completely take control of all of the different biometric information coming from my devices as well as have an easy way to share that with my physician, my caregiver, or the enterprise that is monitoring me. It is really intended to transition that data from disparate sources and bring that down very easily to the end users and ultimately enable that user to track their health in more than one way using the unique applications that these developers are creating.

MD+DI: I saw that ten companies, including FitBit and Withings, have opened up their data streams to encourage app development. How will biometric data from companies like these foster innovation?

Kasargod: They are very good partners. For us, it was really important that, if you already use a FitBit or a Withings, you can continue to use information from them. But if you also want to blend the FitBit or Withings information with data coming from other devices, then you have the option to have one aggregated stream that enables you to visualize that in a single dashboard. Depending on the specific use case for the user, you could essentially have just the app or service.

You could also have an aggregated view with a specific outcome that is being provided for you. For example, if you have a disease or sleep management application or if your caregiver wants to see whether you are taking your meds, or if you are moving around, we want to make sure that you have the option to have multiple data sources to give a much more holistic view of your health. 

If you are using just a FitBit or a Withings, those applications and services are excellent because they go deep into [the data generated from] those specific devices. But if you are looking for a consolidated view, we have provided a platform that enables an aggregated set of data coming through.

MD+DI: Can you provide an idea of what that aggregated platform might look like?

Kasargod: [Assuming] an end-user’s perspective, I would be able to go into my settings area inside my application and then link all of my accounts with whatever credentials that particular device requires. For example, if Withings requires my e-mail, address, password, and a three-letter nickname, if I enter that, then the application starts pulling the data in.

Similarly, from a provider’s perspective, if the user provided the right opt-ins, the provider can start pulling all of that data into an EMR or into an HIE. Depending on the specific visualization, that particular user would be able to see the data.

From a developer’s perspective, we have provided a website with Open RESTful APIs. Essentially, a developer goes in and we give them access to our service and we give them specific ways in which they can request data from each of the different sources. If I am a developer who has already developed an app or who is developing a brand new app, I can create a brand-new dashboard inside of my application that is visualizing the data coming from the data stream from the APIs.

A developer could be an application developer, it could be a website developer as well. We are platform agnostic because these are Open RESTful APIs. The plan is to have anyone who has the ability to create a visualization or a user experience to pull in data across a disparate set of sources and then blend that into their experience so they create the outcome specific to their solution.

MD+DI*: Can you comment in terms of how you are interacting with Continua Health Alliance and the relevance of that to the data aggregation?

Kasargod: To step back, there are four ways to collect data from various different devices, applications, and services. We call them gateways. We then aggregate that and provide that to our enterprise customers who provide visualizations to their customers. The first one is our 2net Hub, which plugs in the wall. It has multiple radios in it: Bluetooth, Bluetooth Low Energy, ANT+ local area radio protocols, and WiFi. Continua is one of the standards that we are supporting on the Hub. So that is the interoperability standard between the Hub and Bluetooth-enabled devices or sensors that are connecting to it. 

 The 2net ecosystem spans four gateways. 

We have three other ways to collect data. We use the smartphone itself as a biometric sensor using the accelerometer/gyroscope/GPS and any applications that leverage those components. We have the ability to connect with them and pull data from those applications as well.

The third is really more of a server play. Server-to-server, we have RunKeeper, MapMyFitness, as well as Withings and BodyMedia, which are back-end services. We connect with those as well.

The fourth one is our embedded gateway. When we incorporate our wireless chip to new biometric sensors, we enable them to have the ability to connect back to our platform as well.

MD+DI*: So the API specifically is going to be for people to be able to mine the cloud-based service and tap into that data stream?

Kasargod: I would think about it as the cloud-based exposure of our platform for all of our gateways. It is a device that is connected to the Hub that is transmitting the data to the Hub and then onwards, or if it is RunKeeper that is connecting to our cloud, it is an aggregated stream regardless of the gateway from which the data came. It is a cloud-based set of APIs that we are exposing to developers.

MD+DI: Regarding the 2net App Developer Challenge, how will Qualcomm determine which three winners?

Kasargod: For us, it is about doing what is right for the end user. We are going to look at it closely in terms of what is going to be the most useful application from an end user’s perspective. That is going to be one of the benchmarks, of course. Other factors include usability and whether it is a practical application from an overall mass-market appeal standpoint.

The underlying premise is: is it trying to solve a problem of the two pillars that Qualcomm Life is founded upon, which are: reducing healthcare costs and improving connectivity. If the application is really able to address those two issues in a meaningful and usable way, that application will be one of the ones we will pick as a winner. 

MD+DI*: Are you really focusing on the home environment or how do you see you penetration into a hospital environment?

Kasargod: The 2net offering is a B2B environment for our enterprise customers. The specific use cases that they are looking at run the gamut. One could be chronic disease management where you have just transitioned from the hospital and you have gone home and now the hospital continues to want to monitor your health or they have provided an extension of their service home so you can continue to have your vitals measured. You also could measure the home monitoring service that enables a caregiver to see your data. It also could be simply a remote monitoring service where there is a physician available. Depending on the specific use case, the dashboard and the related connectivity is done by that particular enterprise who is creating that solution.

MD+DI*: Can you say a little more about how the data will be de-identified?

Kasargod: Simply put, we don’t know the human being behind the readings. We don’t know who exactly is the one who is providing us the readings. We just use identifiers to correlate a particular human’s readings across multiple devices. We cannot reverse engineer back to that specific individual who has provided the readings.

The way it works is on the enterprise side, whoever is actually providing that consumer experience, they have a look-up table to know which identifier corresponds with which human. That look-up table is abstracted from us. We will only be communicating with them in the context of unique identifiers. 

MD+DI: Do you have an idea of how many enterprise customers are using the 2net platform?

Kasargod: We are at various stages of development. Some of the ecosystem partners will be actually announcing on our website very soon. So far, we had announced more than 40 partners active in mHealth and that number has now gone up considerably. 

MD+DI: What can you tell me about the plan for 2net—other than what you have already touched on?

“Our plan is, from an industry perspective, to have that open ecosystem so that any developer, and device manufacturer is able to plug into our platform.”

Kasargod: Our plan is, from an industry perspective, to have that open ecosystem so that any developer, and device manufacturer is able to plug into our platform. When you look at the trend in devices, you are starting to see lots of different kinds of devices. On the one side, you are seeing specialty devices and specific sensors that use the phone as a dashboard. On the flipside, you are seeing the phone itself being very powerful and having multiple applications using the sensors on the phone itself. In the middle ground, you are seeing some accessory sensors—things that connect to the phone and then convert the phone into a biometric sensor as well.

For us, it is really important to continuously evolve. We keep the ecosystem open so that regardless of which of these segments ultimately becomes the most dominant one, they have a place in the ecosystem. And from an enterprise perspective as well as from an end-user perspective, they don’t have to worry about which ecosystem that particular device belongs to.

Now it is more of a service play but I definitely anticipate multiple platforms leveraging our Hub capability. 

MD+DI: What prompted Qualcomm to step in and provide this 2net service?

Kasargod: If there is one thing we do right at Qualcomm it’s wireless. For us, it was really important that the main problem we solve is the fragmentation of the radio technologies and how multiple devices were coming out with their own standards. I think Continua does a good job at trying to standardize part of that. But we just wanted to make sure that our years of experience in wireless could be applied in the context of healthcare and provide one consolidated stream.

Because we are an open ecosystem, other aggregators are absolutely welcome to plug into our system as well. The key thing for us is that the end user has one place to have all of this information. With the evolution of wireless technology in general, it is not just a cell phone any more that has wireless. Everything is going to have some kind of wireless capability. We feel that it becomes all the more important that we solve the connectivity issues.

*The questions marked with an asterisk where posed by Bill Betten, medical technology director at UBM TechInsights. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Big Corporations Set to Outshine Startups in 'Fourth Era of Innovation'

Pioneering startups have often been credited with pushing the boundaries of medtech innovation for the past several decades. And while medical device powerhouses such as Medtronic and Boston Scientific have also been instrumental in developing progressive technologies, they often look to the little guys for both inspiration and acquisition potential. But a paradigm shift could be on the horizon as major corporations--not VC-backed startups--usher in an impending 'fourth era of innovation' that could impact a plethora of industries, including the medical device industry, according to a recent piece in the Harvard Business Review.

In "The New Corporate Garage," author Scott D. Anthony argues that, with the exception of Apple, many major corporations have historically been too constrained by their size and bureaucratic nature to be at the forefront of innovation. Instead, nimble and creative entrepreneurs have blazed the trails for exciting, influential new technologies. However, the changing climate may be ripe for a role reversal, Anthony suggests. He speculates that we're on the cusp of the 'fourth era of innovation,' characterized by the vision of entrepreneurs within major companies that leverage available resources, scale, and agility to develop revolutionary solutions to global challenges.

"Three trends are behind this shift," Anthony states. "First, the increasing ease and decreasing cost of innovation mean that startups now face the same short-term pressures that have constrained innovation at large companies; as soon as a young company gets a whiff of success, it has to race against dozens of copycats. Second, large companies, taking a page from startup strategy, are embracing open innovation and less hierarchical management and are integrating entrepreneurial behaviors with their existing capabilities. And third, although innovation has historically been product- and service-oriented, it increasingly involves creating business models that tap big companies' unique strengths."

To illustrate the shifting business and innovation climate, Anthony highlights several examples, including the Healthy Heart for All initiative from Medtronic. Launched with the intent to bring low-cost pacemaker technology to underserved patients in India, the program entailed setting up camps to screen patients, communicating data to remote doctors, and partnering with a local company to produce India's first financing plan for medical devices, according to Anthony.

Although the program's success has been modest to date, it has been deemed promising and plans exist to scale up and expand efforts. Perhaps the most noteworthy aspect of the program, however, is that it exemplifies the use of business model innovation to tap into new markets and opportunities rather than technological innovation. This methodology, including the fact that the program was spearheaded by entrepreneurial-spirited 'corporate catalyst' Keyne Monson who launched the initiative without a direct report, is representative of fourth-era innovation, Anthony says.

"Medtronic mixed the entrepreneurial approach of a third-era VC-backed startup with the unique capabilities once housed in second-era corporate labs," he writes. "It's easy to bemoan the stifling bureaucracies that characterize some large companies. But giants like Medtronic have hard-to-replicate advantages over startups."

"[A startup] could mimic pieces of Medtronic's approach, such as the diagnostic camps and a financing plan," Anthony further opines. "But it would have to either build a new pacemaker and seek regulatory approval, which would take years, if not decades, or partner with an established pacemaker manufacturer. It would struggle to get meetings with local doctors with whom Medtronic already has deep relationships. And, of course, it would have to learn how to operate in India, a notoriously complex market. Medtronic simply has capabilities, experience, relationships, expertise, and resources that entrepreneurs don't."

And while not all corporate environments are conducive to such entrepreneurial mindsets and innovation, the ones that do offer a depth of resources that are simply unattainable to startups. Anthony identifies these key advantages of large corporations compared with startups:

  • Global infrastructure
  • Strong brand reputation
  • Partner relationships
  • Scientific knowledge
  • Experience with regulators
  • Process excellence

Anthony's article is a good read and brings up some significant food for thought. His proposed fourth era of innovation is certainly a principle that seems feasible for the medical device industry, especially in light of increasing globalization and emerging challenges. Medtech startups, after all, have struggled in recent years as risk-averse venture capital firms have shied away from early-stage funding and perceived challenges within the stringent regulatory environment. In addition, the impending medical device tax potentially further threatens startups' and small companies' livelihoods. The debate rages on, after all, that the current climate is stifling medical device innovation, so it seems reasonable that innovation could change in definition and shift back to the stables of the major medical device manufacturers, granted they provide a supportive environment in which innovation of all kinds can thrive.

But that's a big if, according to Anthony. "For catalysts to flourish, companies need to embrace open innovation, approach innovation systematically, simplify and decentralize decision-making mechanisms, and be learning-focused and failure-tolerant. Beyond that, they need to make the pursuit of transformative innovation a purpose-driven activity."

Who do you think will be at the helm of medtech innovation in coming years? Let us know in the poll below. --Shana Leonard

Retinal Implant Could Crack the Code to Restoring Sight in the Blind

The three blind mice immortalized in nursery rhyme could have had entirely different fates today, thanks to a breakthrough in retinal implants that has restored sight in blind mice. Researchers at Weill Cornell Medical College have cracked the code for both a mouse and a monkey retina's neural code, which has enabled them to develop a working artificial retina for mice that they hope will pave the way for a similar device that will restore sight in humans.

When caused by diseases of the retina, blindness results when photoreceptors on the surface of the retina and the retinal circuitry that processes the signals from the photoreceptors and converts them into a code of neural impulses are damaged or destroyed. Current prosthetics are designed to stimulate ganglion cells in the damaged tissue, which are often spared during the course of the disease, by applying current. However, this approach yields only rough visual fields, according to the researchers.

To improve prosthetics and the image quality they produce, researchers are exploring the effects of increasing stimulators as well as the use of light-sensitive proteins, introduced by gene therapy, as an alternate method of cell stimulation. But these efforts may be overlooking one important piece of the puzzle, according to lead researcher Sheila Nirenberg, a computational neuroscientist at Weill Cornell. "Not only is it necessary to stimulate large numbers of cells, but they also have to be stimulated with the right code--the code the retina normally uses to communicate with the brain."

Putting this theory to the test, the researchers developed a retinal prosthetic consisting of an encoder and a mini projector. Using a set of mathematical equations, the encoder converts images that enter the eye into electrical impulses, which, in turn, are converted into light impulses by the mini projector. In response to these light impulses, light-sensitive proteins that have been introduced into the ganglion cells subsequently communicate the code to the brain.

"The reason this system works is two-fold," Nirenberg explains. "The encoder is able to mimic retinal transformations for a broad range of stimuli, including natural scenes, and thus produce normal patterns of electrical pulses, and the stimulator is able to send those pulses on up to the brain."

This approach, according to the researchers, is so effective that it enables the user to discern facial features and allows animals to track moving images; the prosthetic provides normal or near-normal vision. Building on this success with restoring vision in animals, the researchers plan to advance their sight-restoration technology and model it for human use. 

Novel Wrist-Worn Device May Mitigate mHealth Security Risks

Wearable technologies are on track to be a $6-billion industry by 2016. But despite the potential mHealth, wearable sensing, and telemedicine applications hold, such wireless medical technologies also pose significant vulnerabilities to patients in terms of security and privacy. Aiming to prevent hacking and privacy breaches, a team of researchers from Dartmouth College (Hanover NH) and Myongji University (South Korea) have proposed the development of a wrist-worn platform dubbed the Amulet that provides continuous sensing and actuation with minimal reliance on wireless gateways for connectivity.

The cornerstones of optimal, patient-centric mHealth products are that they ensure data confidentiality, data integrity, data authenticity, data availability, and command authenticity and integrity, according to the scientists' research paper, "An Amulet for Trustworthy Wearable mHealth." They should, the paper notes, also protect patient anonymity to nonclinicians or emergency personnel, and support interoperability, modularity, and ease of use. These comprehensive specifications and essential needs, however, are unmet by current designs, the researchers state.

"To reach their full potential in transforming healthcare, wearable networks of sensors and actuators must be able to operate continuously and securely without relying on mobile phones and other nonwearable personal computing devices. We need a personal device that is with the user at all times, can authenticate its wearer, can be secured independently of other apps on the mobile phone or home computer, can provide a trustworthy interface to the user, and support mHealth devices with computation and a network link to the mobile phone or other Internet gateway," the researchers state in the paper.

Intended to meet these criteria, the Amulet mHealth architecture is designed as a bracelet-type device worn by the patient that is synced up to wireless devices or apps and mediates communication while minimizing security risks. Although critical factors such as usability, interoperability, and emergency access are addressed with the system, security features are among the Amulet's primary advantages.

"The Amulet provides complete (physical) isolation between general-purpose applications, running on the mobile phone, and critical applications, running on the Amulet," according to the researchers. "With appropriate hardware support, the Amulet could provide strong isolation between individual apps. In contrast, today's phones are complex multipurpose computing platforms that host a variety of applications provided by different sources, some of whom the patient may not trust. This makes them susceptible to malware and other software-based attacks."

Although a number of design and development challenges must be overcome before the Amulet is effectively realized, the researchers are optimistic about the device's potential. Read more about the proposed device in the associated research paper.

Northern Indiana Pursues Development of Medical Packaging Cluster

Home to Warsaw, IN--also known as the "Orthopedic Capital of the World"--Northeast Indiana boasts $12 billion in total regional orthopedic device industry revenues in addition to nearly 100 life sciences, orthopedic, and medical device companies. Looking to leverage and support these local thriving orthopedics and life sciences sectors, Northeast Indiana's Whitley County Economic Development Corp. is now launching an initiative to cultivate a medical device and disposables packaging cluster.

Boasting the presence of such top orthopedics companies as Zimmer, Biomet, and DePuy Synthes, the region is ripe for the development of a medical packaging cluster, according to an industry report, "Securing a Strategic Advantage: Developing Medical Device Packaging Capabilities in Northeast Indiana." Despite the area's solid infrastructure and proximity to a large concentration of medical device companies, however, these opportunities are simply not being capitalized on and the need for local service providers is evident.

"Indiana and other Midwest companies are currently sending their products hundreds, even thousands, of miles away to Tennessee, Ohio, Illinois, even California, to be packaged, sterilized, and shipped," says Brian Emerick, president and CEO of local company Micropulse in a press release. "Both local and regional medical device companies could save considerable time and money by engaging with a Northeast Indiana-based packaging operation."

And the timing couldn't be better for a medical device packaging hub to materialize, according to the research. It found that the impending medical device excise tax has medical device manufacturers focusing on cost-cutting measures, including the outsourcing of 'non-core' elements of manufacturing, such as packaging and sterilization. Consequently, local packaging companies could reap the benefits of such outsourcing decisions while manufacturers cut costs and keep operations local.

In order to go the outsourcing route, however, medical device manufacturers must be convinced that "the financial gains offset internal concerns about quality, traceability, and loss of control," the report found. It further identified a critical concern as: "My packaging engineers want to look out on our shop floor and see product moving efficiently, safely, and meeting quality standards firsthand. What are you going to do to make up for that if we outsource?"

Thus, packaging companies would need to address these key concerns and offer the capabilities OEMs require. Local medical device manufacturers specifically identified the following needs from packaging providers, according to the report:

  • Precision die-cutting, multilayer laminating, and slitting to tight tolerances
  • Cleanroom capabilities
  • Access to medical-grade adhesives
  • Testing and validation capabilities
  • QA capabilities and processes that minimize the possibility of Class 1 product recalls attributed to compromised or defective packaging

The potential uptick in local outsourcing opportunities and the concentration of potential clients are key angles for attracting medical packaging companies to Northeast Indiana. Furthermore, the region offers a highly skilled workforce with a depth of expertise in the medical device industry, regulatory affairs, and even packaging. The local talent pool may also expand in the coming months and years in the face of a struggling economy and the controversial device tax to which many layoffs are being attributed. "Potential or real layoffs within orthopedic OEMs, including outsourcing of packaging operations, creates new workforce asset/availability," the report states.

For more information on Indiana's medical device industry, check out a regional focus feature on the region from MPMN's archives titled, "Indiana's Medical Device Mecca Has Good Bones." --Shana Leonard

Weekly Vitals: Ossur Shines at Olympics, 'Smart' Devices Give Patients Power, and More

Among the most-talked-about stories at this year's London Olympics was that of South African Sprinter Oscar Pistorius. A double amputee, Pistorius simultaneously won over crowds and fellow athletes alike and generated debate as to whether his artificial limbs, made by Ossur, gave him any sort of unfair advantage. Plus, the Wall Street Journal examined smart prostheses and other medical devices. Read about these and more of the top stories from the past week in our roundup below.

Venture Capital Funding For Life Science Declines Fourth Straight Quarter; Funding for Medical Devices Up Over Last Quarter

Venture capitalists turned a cold shoulder to life science companies in the second quarter of 2012, bringing the sector’s share of venture capital (VC) funding to its lowest level since 2002.

This past quarter marked the fourth straight quarter of decline in VC funding for life sciences, which include biotechnology and medical devices. The $1.4 billion the sector earned in 174 deals was down 39% in dollar value and 22% in the number of deals from the same period in 2011, according to a recent MoneyTree report from PricewaterhouseCoopers (PwC) and the National Venture Capital Association. VC funding in the sector was also down from Q1 2012, losing 9% in dollar value and 6% in deal volume.

“The long time horizon often required for a liquidity event, regulatory challenges, and large amount of capital often needed to fund life science companies likely contributed to this sector’s investment decline during the past four quarters,” Tracy T. Lefteroff, global managing partner of the venture capital practice at PwC US, said in a statement.

The $700 million in 84 deals that went to medical device companies represented a 17% drop in dollars and an 11% decrease in the number of deals year over year. Deal volume rose 11% over the previous quarter, although the dollar amount was flat.

Funding for medical and health products more than doubled over the same quarter last year, but the other two segments of the medical device industry, diagnostics and therapeutics, saw funding decline by close to half and more than a quarter respectively.

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Remote-Monitoring Device Debuts for Patients with Cardiac Devices

In May, the Brookings Institute published a piece titled “How Mobile Devices are Transforming Healthcare.” The document mentions a number of examples that illustrate how mobile tech is affecting healthcare. For instance, Portsmouth Regional Hospital was able to cut the ER waiting times using mobile technology.

In a similar vein, Medtronic has just launched a service to improve the treatment of patients with cardiac devices awaiting treatment in the ER or OR. The industry-first service, known as CareLink Express, allows healthcare facilities to work with device technical experts remotely.

In the past, a patient with such a cardiac device had to be checked by a qualified expert. The process could take hours. Wait times are especially long in rural areas, where the expert must travel lengthy distances to the facility in question. 

"Hospitals are being increasingly measured on patient satisfaction scores and waiting in the emergency room for a patient can be a real source of angst," says Elizabeth Hoff, vice president and general manager of Cardiac Connected Care at Medtronic. "Let’s say I am a patient having left shoulder pain, my chest just doesn’t feel right, or maybe I have palpitations," she says. "If I go into the emergency room and they find I have an implantable device: a pacemaker, a defibrillator or a heart failure device, they will not act on the treatment until they make sure that the device is acting as it should," she explains. "The device, 95% of the time, is absolutely fine. But until it is checked, they are not able to move forward with the treatment of my shoulder pain or chest pains or whatever." In the current scenario, hospital workers determine which kind of device a patient has and who makes it. "If it is a Medtronic device, they would call a rep from Medtronic. The average time for one of our people to come to the emergency room to check the patient’s device is 84 minutes," she says.

Medtronic launched the CareLink Express system with the goal of speeding clinical decision-making as it enables hospital administrators to assess a patient’s cardiac health and device status without needing to wait for the arrival of device technical experts. The system also has the ability of sending a real-time report to the patient’s primary physician using an EHR system. 

This technology is unprecedented, Hoff says. "For 99% of patients in North America, if they walked into an ER and had a Medtronic device, this universal system could read it. That is what is industry first about this device," she says.   

The efficacy of the system was tested in a recent 50-site pilot program over five months. They study reported that hospitals using the CareLink Express were able to cut patient wait times from the average 84-minute wait time to less than 15 minutes.

The reduced time translates to reduced costs. For instance, the Forsyth Medical Center (Greensboro, NC) reported that it saved almost $130,000 in two and a half months using the system.

Accessing cardiac devices in less than 15 minutes.

 Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Achieving Success at User Interface Validation

Achieving Success at User Interface Validation

Today, manufacturers routinely conduct summative (i.e., validation) usability tests to determine if their medical devices are safe to use “as is,” or if they require user interface design modification(s) to ensure safe use. Tests that go smoothly usually reflect a development team’s application of good human factors engineering. Conversely, tests that go poorly usually reflect at least a degree of neglect in terms of applying human factors engineering fully, particularly conducting formative usability tests ahead of the higher stakes, summative usability test.

Product testing is being conducted in a mirrored room. Photo courtesy of Wiklund Research & Design Inc.
Many manufacturers respond to poor summative usability test results by making superficial changes to their devices, comparable to applying a bandage to a wound that really needs sutures. For example, to reduce the chance that a device user will commit a safety-related use error, a developer might insert a warning into the device’s instructions for use (IFU), hoping the low-cost risk control measure works and eliminates the need for a more substantial and costly user interface design change.
 
Alternatively, or in addition to making IFU changes, a manufacturer might state in a given device’s IFU that all users should be trained properly before using the device. However, relying on training to serve as the primary risk control measure is a precarious strategy. First and foremost, stipulating that all users receive effective training might not accurately reflect reality. Consider, for example, the temporary nurse agency that sends a junior nurse into an understaffed hospital unit, resulting in the nurse doing his or her best to operate an unfamiliar device (e.g., infusion pump, hospital bed, glucose meter). In this scenario, the nurse will focus on helping an otherwise short-handed care unit, not spending his or her time learning more than basic device operations, perhaps with time-constrained support from an experienced colleague. Second, people are prone to forget at least some of what they might have learned in training.
 
Implementing superficial mitigations against user-interaction problems— use errors being the most troubling—often signals a manufacturer's underlying reluctance to make meaningful design changes that might eliminate the user-interaction problems altogether. Late-stage design changes, such as those that require revising and revalidating software code or changing hardware tooling, can be time consuming and costly, threatening development budgets and launch schedules. Moreover, late-stage changes can be an anathema to project managers, engineers, and designers who worked long and hard to develop the regrettably underperforming device. Therefore, a “make it pass” attitude can develop, creating an obstacle to changing the user interface of what the development team assumed to be a production-equivalent device.
 
And so, kudos to development teams that view poor usability test results as an important signal to revisit their design; to make their device safer by implementing meaningful user interface changes rather than reaching for bandages and perhaps running an arguably easy-to-pass, overly lenient usability test. Such teams accept that it is better to eliminate a design shortcoming as soon as they discover it— to recognize the “inconvenient truth” of it—rather than press forward with a compromised (i.e., flawed) device. The good news for them is that they probably have chosen the most reliable path toward a successful design validation, device approval, and commercial launch.
 
Manufacturers that have not yet adopted the product development strategy of fixing rather than patching fundamental user interface design shortcomings should consider it. In fact, the change in strategy just might be essential to commercial success in a new era. The 2010s are a time when regulatory bodies routinely reject (or withhold approval) of devices, particularly those intended for home use, which appear vulnerable to potentially hazardous usability problems or if the device’s use safety is indeterminate.

Lessons Learned

As discussed in regulatory guidance and standards, and texts (see the sidebar “Recommended Reading”), manufacturers should establish human factors engineering programs and procedures to ensure that intended users will operate a medical device safely and effectively. Therefore, this article focuses instead on lessons that manufacturers have learned (usually the hard way) about how to succeed at user interface validation. For simplicity, the lessons are based on manufacturers’ experiences in the United States and dealing with FDA. However, the same lessons should apply to user interface validation efforts and regulatory processes in many other countries.
 
Test a Production-equivalent Device. Summative usability testing should involve a production-equivalent device, or at least the version that the manufacturer intends to use on humans after receiving regulatory approval to do so.1 Methodologically speaking, testing anything less than a production-equivalent device carries the risk that subsequent changes to the device will introduce usability problems that could reduce the device’s safety and effectiveness. For example, changing a symbol’s color from blue to green, reducing a button’s height and width by a quarter inch,  or rewording an on-screen prompt could change how users perform tasks, perhaps inducing a potentially harmful use error. This is not hyperbole. Small user interface design changes can dramatically influence user interactions with a device, sometimes improving them, but sometimes degrading them substantially.
 
Involve Representatives of All Distinct User Groups. Good luck to the manufacturer that conducts a summative usability test that excludes, either by intent or neglect, what FDA terms a “distinct user group.” FDA will almost surely call for additional testing to complete the picture of how well the intended users—all significant types—fare when using the device. For example, a manufacturer that only includes adult participants in a test of a home-use device might be directed by FDA to conduct additional testing with adolescents and children if they are identified as intended users. Or, the agency might ask the manufacturer to perform a supplemental test involving a layperson (e.g., an individual who helps a child, friend, or spouse use a device), and healthcare providers. The agency might even ask for a supplemental test involving device installers and maintainers if such workers perform safety-critical tasks with the given device. A third possibility is that FDA calls for further user group differentiation, such as a test that involves nurses that have different training and responsibilities, such as critical care nurses trained in advanced cardiac life support versus licensed practical nurses who deliver care to lower acuity patients living in their homes. Notably, the agency generally expects summative testing to involve at least 15 representatives of each distinct user group.2
 
Link User Tasks to Use-related Risk Analysis. Logically, a summative usability test focused on use-safety should require users to perform safety-related tasks. Extending the logic, the best way to develop a complete list of safety-related tasks is to consult the use-related risk analysis (e.g., failure modes and effects analysis). Therein, one should find a list of potential use errors and their associated risk ratings; the raw material from which human factors specialists can build a comprehensive set of realistic tasks for users to perform in a summative usability test. Subsequently, task performance during a usability test will assess whether the manufacturer has effectively controlled use-related risks. Lacking such a link between the risk analysis and user tasks, regulators would have no reliable basis for concluding that the test had focused on the tasks of greatest concern from a safety standpoint.
 
Determine Root Causes of Interaction Problems. It is imperative to determine, with reasonable certainty, the root cause of all use errors and other significant interaction problems that occur during a usability test. Accordingly, usability testing specialists should conduct the necessary observations and question test participants afterward to understand their perspective on what might have led them to err while performing tasks (e.g., press the wrong button, enter the wrong parameter value, connect a tube to the wrong port, forget to set an alarm limit, allow a fluid reservoir to run dry, and commit any other type of use error). Determining the root cause of interaction problems (e.g., an undersized button, small data input field, lack of connector color-coding, missing prompt, or hidden fluid reservoir and lack of fill-level display) is the first step toward fixing it.
 
Give Test Participants Representative Training. FDA expects that summative usability test participants will receive training if the intended device users, or at least some of them, will receive training before using a given medical device. For instance, they recognize that a perfusionist might be trained to use a new heart-lung machine; that a surgeon might be trained to use a surgical robot; and that a layperson might be trained to use an insulin pump. In fact, one FDA staffer unofficially equated withholding training from certain users who use certain types of devices as equivalent to asking a pilot to fly a new aircraft without prior orientation.
 
Therefore, a summative usability test of certain devices might include only trained test participants, or perhaps some trained and some untrained participants if training is common but not assured. In either case, it is important to deliver representative training rather than improvising something at the last minute, perhaps because training development has lagged device development. Hearing that a company is ready to perform a summative usability test, but has not yet developed the accompanying training is a red flag indicating that such testing is premature. Poor training can induce user-device interaction problems just as well as a user interface design flaws during a usability test, thereby sinking an otherwise well-designed device. That said, a manufacturer should provide representative training—training that is no more extensive and no better than they expect actual users to receive. The underlying lesson is not only to provide test participants good training, but also to make sure that real users receive good training. Of course, some devices are meant for use without prior training and, therefore, training test participants would be inappropriate.
 
Give Test Participants Good Learning Tools. Just as it is important to give users good training, it is also important to give them effective learning tools (e.g., quick reference card, user manual, online help), rather than ones quickly put together just prior to the test. Firstly, learning tools are technically part of a device design, and so one should be testing the best and final set, which ideally has been evaluated in prior formative usability tests. Secondly, poor learning tools are just as capable of spoiling a usability test as poor training. For example, unclear wording in a procedural guide could lead a test participant to perform steps in the wrong and potentially hazardous order.
 
Do Not Assist Test Participants. What’s the quickest way to cause a medical device to fail its summative usability test? Give test participants assistance with a task. FDA requires human factors specialists to declare an assisted task as a failure, and this posture is logical. A test participant that needs assistance is experiencing difficulty performing a task and could commit a potentially harmful use error. FDA does not want even well-intentioned, empathetic test administrators interfering with the test participant as he or she performs a task because the test administrator would not be available to offer assistance in an actual use scenario.
 
Write an Excellent Test Report. Suppose a manufacturer has performed a perfect test that produced sterling results. The manufacturer still faces the challenge of reporting the test approach and results coherently and succinctly. Lacking a good report, FDA and other regulators would struggle to find and interpret the test results. Keys to a good report include fully and clearly describing the basis for choosing the test participants and tasks, and describing the test participants’ task performance and safety-related impressions of the device with a strong emphasis on interaction problems and their root causes. One more key is to refrain from claiming that significant use errors pose an acceptable risk because other products on the market (e.g., the predicate device cited in a 510(k) application) have the same, unmitigated vulnerability. FDA is likely to reject such a claim, because a claim that a device is no less dangerous than other products already in use is not a safety claim but actually a danger claim.
 
Perform a Residual Risk Analysis. This lesson steps away from the subject of usability testing for a moment. It focuses on what a manufacturer needs to do with the test results, namely treat them as an input to a follow-up, use-related risk analysis. Indeed, FDA expects that manufacturers will perform a follow-up risk analysis of every use error as well as patterns of interaction difficulties, including close calls — cases when a test participant almost makes a mistake. This is not to say that FDA has a zero-tolerance policy regarding use errors. The agency seems to accept that users will make mistakes.3 However, they expect a manufacturer to analyze all mistakes and patterns of interaction difficulties to determine if further risk control measures are necessary. Importantly, do not discount a use error-inducing problem simply because it only happened once or a few times during a test. FDA has made it clear that claims such as “95% of the test participants performed the task correctly” are unacceptable. Ideally, manufacturers will identify and mitigate all critical user interaction problems during formative usability testing, making the summative usability test a successful exercise [It’s not fail safe.]. This is why FDA seems to strongly encourage manufacturers to conduct at least one and preferably several formative usability tests ahead of a summative usability test.
 
Do Not Force Users to Pay Attention to Learning Tools. FDA is critical of manufacturers that direct users to read an IFU before or during tasks performed during a usability test. The agency considers forced attention to learning tools to be artificial, distorting how users interact with a given medial device. Accordingly, it is best to make learning tools available to test participants in the same manner that they would be available in a real use environment and scenario.
 
Really Fix the User Interface. The last lesson learned is probably the most important one. That is, manufacturers should fix user interface shortcomings rather than put bandages on them, as discussed earlier. A bandage approach, such as adding warnings to an IFU or reformatting the IFU, rarely prevents use errors effectively. Sure, it is good to optimize an IFU and ensure it includes all appropriate warnings. But, there is no assurance that users will read it.
Recommended Reading
ANSI/AAMI HE75:2009, “Human Factors Engineering—Design of Medical Devices,” (Arlington, VA: Association for the Advancement of Medical Instrumentation. 2009).
 
 
IEC 62366:2007, “Medical Devices—Application of Usability Engineering to Medical Devices,” (Geneva, Switzerland: International Electrotechnical Commission, 2007).
 
M Wiklund, J Kendler, and A Strochlic, Usability Testing of Medical Devices, (Boca Raton, FL: CRC Press, 2011).

Conclusion

Since FDA changed the quality systems regulation in 1996 to address user needs, usability testing of medical devices has been transformed from an uncommon, value-add activity into a necessary and mission critical one.4 Accordingly, when a medical device fails a summative usability test, CEOs get very concerned, and for good reason. A failed test can substantially delay a device's regulatory approval and commercial launch because of the need to revise and retest the device. In some cases, a failed summative usability test has contributed to a company's ultimate demise. Therefore, medical device manufacturers have to bring their “A” game to conducting usability tests.
 
This means building a strong, in-house, human factors engineering capability or at least retaining human factors consultants to run usability tests. Taking either approach, manufacturers should consider the lessons learned by others, dispensing with the flawed impression that past is prologue when it comes to regulatory approval of devices that require safety-critical user interactions. Just because a regulatory authority such as FDA approved a manufacturer’s current generation pump, monitor, or injection device without a supporting validation usability test does not mean it will happen again. It is best to assume that it will never happen again and invest accordingly, fixing the given device rather than putting patches on user interface design problems that arise during a preliminary evaluation (optimally a lower-stakes, formative usability test). And to personalize the matter, would you like a clinician to operate on you or a loved one with a life-preserving device that is "patched," perhaps by including an important, safety-related guidance in its IFU? Or, would you like the device to have safety engineered directly into it? Yes, that is a rhetorical question, as most people would prefer the latter.

References

1.     FDA draft guidance “Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Section 10: Human Factors Validation Testing” (Silver Spring, MD: FDA, 2011).
2.     FDA, draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Section 10.1.2: Test Participants (Subjects)” (Silver Spring, MD: FDA, 2011).
3.     MF Story, “Identifying and Mitigating Potential Use Errors” (presented at MD&M East, New York City, June 7, 2011), Slide 30.
 
Michael Wiklund is founder and president of Wiklund Research & Design Inc. (Concord, MA), a consulting firm offering user interface research, design, prototyping, and usability testing services. He has made substantial contributions to sections of AAMI HE75-200X addressing software user interface design, workstation design, and mobility. He has devoted his career to making a variety of devices more user-friendly, including heart monitors, dialysis machines, defibrillators, blood glucose meters, and wheelchairs. Wiklund is a member of MD+DI's Editorial Advisory Board. Contact him at [email protected] 
 

Phthisis Diagnostics' President on Translating Research into Diagnostic Products

Charlottesville, VA–based startup Phthisis Diagnostics began operations in 2006 with a mission to bridge the translational gap between infectious disease research and diagnostic products that help patients. The company now has its first product on the international marketplace and it is making progress in expanding its distribution channels. Only recently, Phthisis has announced distribution agreements for its products in Latin America, Asia, and the United Kingdom. In July, the company received a second round of angel funding.

MD+DI recently had the opportunity to speak with the company’s president and chief science officer, Crystal Icenhour, PhD, who was the recent recipient of the Kauffman Outstanding Postdoctoral Entrepreneur award and our very own “40 Under 40” feature. In this Q&A, Icenhour provides an overview of her plans for the company and how she became an entrepreneur.

MD+DI: Could you explain how the different distribution agreements Phthisis Diagnostics has signed recently are helping you to tap into the global diagnostics market?

Icenhour: Our first product is a tool that clinical laboratories use for doing the downstream diagnostic but it is not a diagnostic itself. Our second product, for which we are getting ready to start clinical trials, is a clinical diagnostic. Our strategy is to get all of our international distributors in place now so that once we get [regulatory approval for] the first diagnostic, we will be able to very quickly and efficiently push that out into [a number of markets]. Actually, before we get it cleared by FDA, we will be able to introduce it into a lot of the international markets because we are able to do the CE Marking more efficiently than going through the FDA clearance process.

MD+DI: I’ve heard a lot about how the CE Mark process is generally more efficient than going through the U.S. system. I’d be interested to hear your thoughts on this.

Icenhour: For us, the CE Mark has been much more efficient than the FDA 510(k) clearance. It allows us to begin sales in Europe before we technically get our FDA clearance here in the United States. From a cash flow standpoint, that is ideal because we can begin bringing in revenue for the products. We can also begin collecting a lot more data about the product before it ever hits the U.S.-based market. There are a couple of different reasons why it has been beneficial to do that, but, right now, everybody is facing the same economic crunch. Getting revenues rolling in on each individual product as efficiently as we can is really important.

MD+DI: When you say “economic crunch,” are you referring to the global efforts to cut costs in healthcare?

Icenhour: More basic than that: we are an early stage company and we only have a certain amount of funds to carry us through. Our last round of funding was specifically invested to get us through clinical trials. If we expend those funds before we are able to make it all the way through our clinical trials without bringing in some sales revenues, that would be an issue because we don’t have unlimited resources to fund the company.

MD+DI: Another thing I was interested in relates to MD+DI’s selection of you for our “40 Under 40” features. Can you give me some background on how you became a healthcare entrepreneur at a young age?

Icenhour: To be honest, I didn’t really even think about it. I grew up in a family-run business and that was simply the way that my world existed. You see a problem, you create a solution for it and you run a company. In my case, it has been a much different industry. My family owns a truck repair shop. So I am definitely not in the same industry but the idea of working for yourself and of being able to step into a business setting wasn’t a foreign idea to me.

MD+DI: The mission of Phthisis Diagnostics is to bridge "the translational gap between infectious disease research and the patient." Could you provide some more context on how it does that?

Icenhour: A lot of my earlier days as a researcher were spent investigating things such as sugar transport pathways. Although it was very interesting, as a researcher I didn’t feel very fulfilled by that because it didn’t have an immediate or even a sometime-in-the-future impact on an actual patient who was suffering from the infectious diseases. Certainly, those questions are incredibly important and worth finding the answers to, but for me, I really wanted to be able to apply my scientific knowledge to problems and come up with some more tangible solutions to things and to actually measure the benefits that you are able to create.

Some of the technology that has been explored more thoroughly is real time PCR. It is a fairly well understood technology from the science realm but from the clinical diagnostic perspective, it is newer. I want to be able to take that basic biology understanding and be able to develop products that will solve a need, which is to diagnose patients who have different infectious diseases. That is something I have a passion for and something I think I am good at. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.