certainty Choosing the Right Mobile OS For YOUR Medical Device MPR Product Development March 2013 MPR Product Development Outsourced Innovation, Design, Engineering & Vision
The Smartphone Revolution (Viva La Smartphone) The smartphone as a device is revolutionary. It has brought together a convergence of communications, computing and consumer electronics. Even more astonishing than its capabilities is the astonishing rate of its adoption. More than half of all mobile phones being sold in the United States are now smartphones. About 37 percent of Americans ages 12 to 17 tap the Internet using a smartphone. Seventy eight percent of teens have a cell phone and 47 percent of those have a smartphone. Over 80% of US doctors own a smartphone. While the meteoric rise of the smartphone is impressive - there is still a huge up potential of this device. There are over seven billion people on the planet and only 1 billion have smartphones. 80% of US physicians carry smartphones. There are 1.3 billion smartphones in the world. More smartphones were sold last year than the number of babies born. 55% of US mobile users own a smartphone. Smartphones are revolutionizing many industries. The healthcare and medical device market is one of them. The huge growth of smartphones and tablets is on a collision course with the 120 billion-dollar/year medical device market. From a smartphone based blood pressure monitor to a FDA approved smartphone based Electro Cardio Gram (ECG) to an iphone based blood glucose meter - the potential of medical devices based around the smartphone/tablet is enormous. The integration of smartphone technology into medical devices is a natural fit. Smartphones provide a rich and intuitive user experience that customers are not only getting accustomed to, but in fact demand from the devices they use. Things like smooth scrolling, multi gesture controls and pinch and zoom are getting to be as common as mouse clicks. Smartphones offer connectivity via cell phone network WiFi and Bluetooth. They have GPS location awareness and best off all they are a device that most people carry with them on a daily basis. Building medical devices around smartphones empowers the patients, as they are in charge of their health. Routine medical visits with a healthcare provider or a lab can now be done by the patient. Data collected can then be uploaded to the cloud. Mobile disease management allows the healthcare provider to collect and analyze patient data. The underprivileged population of the world can tremendously benefit from the integration of smartphone technology into healthcare. A low cost otoscope or stethoscope that can attach to a smartphone may represent the future of saving millions of children in third world countries. A low cost smartphone based ultrasound can bring twenty-first century medical imaging to third world nations. Smartphones and medical devices Medical device manufacturers face the challenge of which mobile Operating System (OS) and platform to use for their medical device. The mobile market is fragmented with new players frequently emerging and leaving the market. The pie charts of who is leading the mobile smartphone / tablet market is constantly changing. The two constant contenders in this market are Google s Android and Apple s ios. According to Gartner s 2012 Q4 poll, Android and ios combine for over 90% of smartphone sales. 2
Apple vs Android This fragmentation of the mobile market presents a challenge to the medical device maker as there are multiple architectures and design patterns to choose from, and one solution does not fit all. Apple s ios has a curated ecosystem in which Apple controls the hardware, the software and the apps that run on Apple devices. Apple also controls how external accessories like medical devices communicate and integrate with Apple hardware and software. Google s Android ecosystem on the other hand is more open. Multiple hardware makers such as Samsung, HTC and Motorola provide the hardware platform and Google provides the software framework. Apple for tablets has the advantage of being the first to penetrate the medical space. Because of this, Apple s ipad has gained a strong footing compared to Android tablets in Healthcare IT (HIT). Android tablets are made by multiple manufacturers as compared to Apple who makes it s own hardware. Hardware variation in the Android marketplace, coupled with the fragmentation of Android OS is a double whammy for Android in the medical device market. The too restrictive attitude of Apple claimed by the naysayers is extremely beneficial for the medical device market, healthcare and HIPAA. There is a built in quality system in the Apple model which Android lacks. ios Curated Ecosystem First mover advantage in medical market Restricitive attitude is beneficial for medical apps and devices Tighter security model ios vs Android Key Characteristics Open Architecture Plug and Play Android No Certification required Vitera Healthcare Solutions conducted a survey study that found the most common mobile device used among healthcare professionals was the iphone (60%) followed by the ipad (45%) and an Android phone (38%). Android tablets were used by only 3% of respondents. Bulletin Healthcare conducted a similar study in which they tracked which device 550,000 healthcare providers used to read their daily email briefi ngs from June 2010 to Feb, 2011. By the end of the study (Feb, 2011), according to the authors, more than 90% of these briefi ngs were being read on an ios device (iphone and ipad) compared to 6% on Android. 3
The four categories of smartphone based medical devices Designing a smartphone based medical device falls into multiple categories. First, it s important to have clarity on what is considered a medical device. The answer might seem obvious, but did you know that a simple smartphone App can be classified as a medical device by the FDA? Smartphone medical devices can fall into multiple categories - from a simple medical App running on a smartphone/tablet to a medical device that is fully controlled via a smartphone. Each of these medical devices requires a different architecture and a different design approach which has an implication on the choice of the mobile OS used. Lets look at these 4 categories of medical devices in more detail below. Approach Example Product Recommended Development Path ASmartphonerunning anapponly MedicalcalculatorApp Chroniccondition ManagementApps Developformultiple platforms. UseCrossDevelopment tools&technology ASmartphoneasaData Conduit Medicalimager Smartphoneconnectstoa medicaldeviceand augmentsitsfunctionality GoforApple Securitybenefits Curatedecosystem ASmartphoneisUsedfor RemoteMeasurement& ControlofaMedicalDevice. PatientUsebaseddevices ECGheartmonitor PulseOximeter BloodpressureMonitor GoforApple MFiprogram ASmartphoneistheMedical Device PointofCarebasedmedicaldevices Ex:ControlpanelforaMRImachine GoforEmbeddedAndroid LinuxbasedOScanrunon proprietaryhardware Featurerichsoftwarestack 1. A Smartphone running an App only In this category your App is the medical device. Examples of such Apps include Apps for Chronic condition management or for vital sign monitoring. App only medical devices can fall into the several categories including consumer health, reference App (Drug Interaction) / fitness and medical calculators to name a few. When designing an App only solution that does not interface to any hardware - you are free to make the app available on as many platforms as possible from the start. App development can be native or cross platform. Native apps only run on the platform they are written for whereas cross platform apps utilize the write once and deploy on many multiple platforms paradigm. 4
What is Cross Platform Development? An App can be native or Cross Platform. Native Apps only run on the platform that they are written for. Cross Platform Apps are written once and can run on many different platforms (Android, ios, Blackberry etc). Cross platform Apps are a good choice for content only apps. 2. A Smartphone as a Data Conduit Cross platform technology has matured to the point where many successful Apps have been written and deployed using this approach. Cordovo (formerly PhoneGap) and Titanium are two major players in the cross platform tool market and offer solutions for the ios, Android, Windows8 and Blackberry platforms. In the past many developers avoided cross platform tools as the App did not have a native look and feel this is no longer the case. If implemented correctly, cross platform Apps can have the look and feel of native apps and in fact it is hard to distinguish whether a App is native or cross platform. Cross platform Apps are ideal candidates where your App is content only or where the content is a big part of the App. One solution to consider carefully in this category is HTML5. HTML5 is the latest standard that allows feature-rich Web based applications. As long as your mobile device s browser is HTML5 compliant - you can write web pages that look like Apps and have the benefit that once written they will work on any device as long as the browser is HTML5 compliant. Another advantage of an HTML5 based App is that since the App is being served to the smartphone client from the web server - it is always current and does not require an update. One downside is that HTML5 Apps do have some limitations. HTML5 adoption and implementation is far from uniform. HTML5 Apps also suffer when there is sporadic or no connectivity. Some medical devices provide an interface to smartphones or tablets to enable increased functionality by providing the user with the ability to trend medical device data. As an example, consider a device that provides therapy to the patient and collects data on the amount and time of the therapy provided. The medical device is a standalone device but can connect to a tablet and display the therapy data in a graphical format. The large screen and the rich user interface of the tablet can be used for displaying graphs and tables of the collected data. The Bluetooth interface between the tablet and the smartphone can be used to collect data. The GPS on the tablet can be used to stamp where the therapy was provided. The Wi-Fi connection on the tablet can be used to then push the therapy data to the cloud and to the healthcare infrastructure. In this category the tablet is simply collecting the data from the medical device and presenting the data to the user. The integrity and security of the data exchanged between the medical device and the tablet is extremely important and should not be vulnerable to attacks. Not only is the security of the data transmission between the medical device and the tablet important - it is extremely important that the patient data residing on the smartphone is secure as well. Apple s App architecture has an advantage in this regard. Apple prevents other rogue Apps from accessing the data of your App. This architecture is much looser and more vulnerable in the Android OS. 5
3. The Smartphone is Used for Remote Measurement and Control of a Medical Device. Another category of medical devices is the concept of transforming a smartphone/tablet into a regulated medical device by using attachments, sensors or other devices. In this scenario the smartphone/tablet is an accessory to the medical device. All of the science and measurement is done in the medical device and the smartphone is the only way to control the device. Therefore, the medical device can not operate on its own without a smartphone. As an example consider a blood glucose meter or a pulse oximeter that attaches to an iphone via the 30 pin connector or the newer lightning connector. The smartphone provides the user interface, connectivity and control. In addition the smartphone offers GPS / Wi-Fi / Bluetooth / 3G/4G - Connection to the Cloud- M2M. Your Medical Device can leverage the connectivity, GPS, Camera and other features offered byt the smartphone, For medical device makers in this category, the Apple platform again has an advantage. In order to connect a medical device to an Apple iphone or ipad - the device manufacturer has to be Apple approved via Apple s MFi program. Apple s MFi is a licensing and certification program for electronic accessories that connect to Apple s devices. Apple pays close attention to what your device does and how it interfaces to the Apple products. While the process of getting MFi certified by Apple may seem daunting and difficult at first - the reward is that your device gets approved by Apple to display Made For ipad/iphone logo. Such a program does not yet exist for the Android marketplace. 4. The Smartphone is the Medical Device There exists yet another category of medical devices that requires the User Experience of a smartphone/tablet but the hardware form factor of a medical device. The hardware required to accomplish the functionality may not be available in the Commercial Off the Shelf (COTS) device. You may need a 14 inch display which is not available on any tablet or there may be obsolescence issues. For example, the medical device has a life expectancy of 20 years whereas most COTS devices have a life expectancy of less than two years. In this scenario the medical device can benefit from a rich user experience offered by a mobile OS but the hardware platform needs to be custom. Android OS has an advantage here, as Google s Embedded Android can be customized to run on a proprietary hardware platform whereas such an option is not available for Apple ios. Apple ios only runs on proprietary Apple hardware. Embedded Android offers a rich stack of software services such as the Kernel, File System, User Interface, connectivity etc. Embedded Android is considered by FDA to be Software Of Unknown Provenance (SOUP). 6
Where possible it is a good idea to keep the science of the medical device outside the SOUP boundary. Use a separate microprocessor with dedicated firmware for critical functionality that is easily verifiable (make it non SOUP). Embedded Android acts as the User Interface and Data conduit to the cloud. Key Takeaways The smartphone revolution is upon us and is changing the landscape of medical device design. Integrating a smartphone or tablet into your next medical device can augment the functionality of your device and also help accelerate the product development cycle by leveraging the rich set of features already available on your mobile device. The mobile platform is fragmented and there are multiple architectures to choose from. MPR Associates has the knowledge and expertise to help you navigate the mobile OS technology platform and bring your next smartphone based medical device concept to reality. 7
About The Team Rajeev Bhalla is the manager of mhealth initiatives at MPR Associates. He has over 20 years of software development experience in diverse industries ranging from Aviation, Defense, Product development and Medical instrumentation. Recent project work includes designing communication gear for war fighters to high throughput drug screening machines for the biotech industry to avionics collision detection for fighter jets. He holds advanced degrees in Computer Engineering and Electrical Engineering. Rajeev has a strong passion for all things software. Adam Caccavale joined MPR in 2011. He has worked on a variety of projects ranging from app development to bioabsorbable implants. His most recent app development project transformed an iphone into a data acquisition tool (with complementing hardware). Other past work includes a next generation actuating bed frame and a negative pressure wound therapy device. Craig Mauch joined MPR in 1990 and serves as the Director of Design. He has worked in the areas of embedded systems, software development, product development, machine design, machine automation, and control theory About MPR MPR Associates, Inc. is a global design and engineering firm, specializing in translational innovation and expeditious solutions to difficult life sciences and medical technology problems. Although many companies claim to deliver services from idea-to-product, MPR is unique in spanning the full spectrum of product design, from initial concept and technological innovation to detailed design for manufacturing, and provides unmatched engineering and design services. During every step of the design and innovation process, MPR s team stays focused on client needs considering technical requirements, the business goals of the client, the voice-of-thecustomer, and the involvement of manufacturers early in the process to ensure a smooth transition from concept to product. MPR s unique First Principles Development Process is the foundation of its ability to consistently deliver innovative solutions quickly and efficiently. Engineers rigorously apply MPR s proven First Principles Process to every challenge, ensuring that solutions are based on tested technologies that reduce risk and cost and accelerate time to delivery. Rigorously applying the process ensures that all designs are based on proven technologies, reliably reducing risk and cost, optimizing technical designs, and maximizing opportunities for creativity and innovation. Using MPR s First Principles approach, customers experience real cost savings now and in the future. In the short term, First Principles eliminates risk early in the process by solving critical problems first and allowing devices to reach the market faster often in as little as twelve months. For More Information Contact: rbhalla@mpr.com 703-519-0584 703-519-0200 MPR Associates, Inc 320 King Street, Suite 400 Alexandria, VA 22314 8