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1 medical devices begin to drift into cloud melisa bockrath

2 Medical Devices Begin to Drift into the Cloud Since the invention of the first medical device more than a century ago, the design, complexity, and sheer volume of medical devices has grown into a $250 billion industry. Today medical devices serve not only a diverse community of medical practitioners, but also a global marketplace of patients. Advances in technology have propelled the industry to the point where medical devices are integrated into all aspects of healthcare. According to industry analysts, nearly 75% of physicians use a smartphone, and more than 10,000 mobile health applications are already in use. Handheld devices make it easier for physicians to access information in patient records or research data on drugs and treatments. Specialized implants and prosthetics extend and improve the quality of life for millions of people. And consumers use personal medical devices remotely without direct physician supervision such as blood pressure monitors, digital thermometers, and blood glucose meters. An industry that depends so heavily on technology would seemingly be eager to embrace business solutions that enable more efficient collaboration and faster communication, but the healthcare sector in general has been a laggard in the rush to adopt cloud computing, primarily due to security and privacy concerns. However, the benefits of moving to the cloud are fast becoming evident across all industries, and the medical devices industry is beginning to sit up and take notice. 2

3 The Challenge: Saving Time and Money The creation of an essential medical device is an increasingly complicated process that requires more than just an innovative idea. The cost and complexity of clinical trials design decisions as early as possible However, current information technology parties managing data, sponsors of clinical can be staggering. If a medical device costs $25,000 and each clinical trial participant must be given a device, the clinical trial for that device can cost a manufacturer up to $10 million. More complex or implantable devices can be even more expensive to test. With so much money riding on the development of a device, today s most successful medical device companies are challenged by pressures to increase efficiency and reduce costs. As with other technologies, medical device during clinical trials, and those decisions depend on fast access to data. During the clinical trial process, a wide range of images must be collected from multiple sources in different locations. Cost-effective image management solutions are needed in order to control these images and ensure the quality and integrity of the data from receipt to final transfer. They must be flexible to enable collaboration, and must offer scalability to grow along with the organization as its solutions enterprise archival systems, imaging core labs, electronic data capture systems, and individual customized solutions are becoming increasingly overloaded. Legacy infrastructures are impractical for managing vast amounts of data, and they slow down the transfer of information and increase the expense and inefficiency of labor-intensive processes. Standalone solutions don t always integrate well with other systems, hindering the collaboration essential for trials may not be able to make timely course corrections that could limit risk and contain costs. Other challenges faced by the medical devices industry include strict regulations, rising costs for device service and support, and issues related to internet security and privacy. Adding to the woes of manufacturers is a flood of device recalls, an aging population that needs more specialized care, and the upcoming U.S. healthcare reform bill that will levy an additional tax of 2.7% on manufacturers must be able to make clinical trials increase. development. And with various external every device sold. 3

4 The Solution: Convenience and Collaboration For an industry that s always in motion, cloud computing seems like the ideal solution to connect a diverse pool of users with many needs to manage and share data. From device manufacturers to clinical trial sponsors, health providers, and patients, the only thing users need is a computer with an internet connection to access the softwareas-a-service (SaaS) approach offered by cloud computing. There is no need to install and configure software on individual systems and the system can be accessed at any time from any location. The flexibility afforded by cloud computing gives medical device manufacturers the ability to design devices that deliver specific services to patients, process the data collected, and deliver it to healthcare providers in real time. This nimble approach to data sharing couldn t be coming along at a better time. Industry trends indicate that by 2020, at least 160 million patients in the U.S. will be monitored and treated remotely for at least one chronic condition. Cloud computing is already integrated into the design of some innovative new diagnostic procedures. With earlydetection health monitoring, ambulatory life recorders can detect health changes in monitored patients before clinical symptoms of an illness appear and alert physicians to those changes, enabling early medical intervention. Patients can be given devices such as digital thermometers and peakflow meters that collect health data, which patients can then enter into a website so their physicians can access the data. Wireless medical devices such as defibrillators and infusion pumps can continually monitor a patient and automatically adjust treatments, and then send results directly to a recordkeeping system at a physician s office. 4

5 Outcomes and Advantages Perhaps the biggest advantage to cloud computing is that it provides easy scalability to meet the growing demands of manufacturers and healthcare providers. There is a vast and growing number of highly detailed and interactive software applications geared toward the professional medical community, particularly in the areas of imaging, monitoring, and research. With a cloud computing solution, software applications can be installed, configured, and upgraded at a central location so each user can access the most current version of the software. Clinical trials of medical devices can begin rapidly because the necessary software applications are available via the internet and there is no need to get multiple sites up and running. Data collection can begin within just a few weeks, even if many contributors are operating from multiple locations. By having real-time access to data throughout the trial, sponsors can bring part or all of the trial in house. And the more involved a sponsor can be in the development of a device, the greater impact they will have on the design, manufacture, and outcome. Sponsors can have complete transparency throughout the clinical trial, and the flexibility of the cloud model makes it easy to outsource specific components of the trial as needed. For medical device sales reps, cloud computing is a dream come true. A single source for data makes it easy to manage sales across multiple channels, products, and geographies. Key metrics such as aggregate physician spend can be accessed in real time. Reps can easily track, navigate, and influence relationships among physicians, facilities, and purchasing organizations. After a sale is made, the convenience of an SaaS model simplifies customer service, technical support, and medical device service and repair. 5

6 Benefits for Clinical Trials Cardiovascular stents are a good example of how cloud computing can streamline the image management solutions used by medical device manufacturers. A typical clinical trial process begins with a clinical research organization (CRO) receiving images from multiple sites. Some images are saved on electronic media and sent by mail, others are sent by FTP, and some are sent on original films. The electronic data may be in standard DICOM (Digital Imaging and Communications in Medicine) format, or it may be in a vendor-proprietary format. When the CRO receives images, they are scanned into digital format, proprietary formats are converted to DICOM, and private tags and patient identifying information is removed. After all the images are standardized, they are loaded into a SaaS-based clinical trial image management system. These loaded images can then be shared with management, project team members, development teams, and any external collaborators. As other digital scans are done periodically to evaluate the stent and how well it is working, those images are added to the image management system. Throughout the entire trial process, images can be reviewed or analyzed as necessary by key opinion leaders and scientific experts anywhere in the world without having to move physical images and risk the integrity of the data. And the entire cloud-based process can be done quickly in a secure, regulatory-compliant environment. A cloud computing solution provides all the important functionality of an imaging core lab. A solution specifically built for clinical trials will obviously be more useful and efficient than a solution that must be reverse engineered for clinical trials, and a robust cloud computing solution offers just that type of efficiency. The ability to customize workflows and establish standards to be used for each clinical trial helps to increase productivity and lessen the potential for errors. 6

7 Weighing the Risks The flexibility, scalability, and numerous advantages of cloud computing make it a no-brainer for many industries. But for medical device manufacturers, those benefits must be carefully weighed against understandable concerns about meeting the rigorous data security and protection requirements of the healthcare industry. Most modern privacy and data protection laws govern principles related to the subject matter of data, the technology used to process it, how it is managed, and the lifespan of the information. With a cloud computing model, data transfer between local clients and remote servers is not always secure, despite advances in encoding and encryption technologies. Manufacturers and providers must comply with the requirements of of the Health Insurance Portability and Accountability Act (HIPAA) and other government regulations. Additionally, many countries have their own proprietary compliance policies about record keeping, even in regard to the physical storage location of medical data. These concerns are part of the driving force behind the creation of the Medical Device Innovation, Safety and Security Consortium (MDISS), a nonprofit professional organization committed to advancing quality health care with a focus on the safety and security of medical devices. The organization s goals include helping to advance IT risk management practices to ensure innovative and safe medical devices, improving the safety and security of networks they are associated with, providing information about how risks can be mitigated, and driving regulatory and technology efforts to support long-term solutions. Organizations such as MDISS can help medical device manufacturers understand how to take full advantage of the benefits of cloud computing while keeping a close watch on data security and regulatory compliance. 7

8 the future in the cloud In today s fast and furious business world, the twin challenges of globalization and increasing competition have fueled the development of new technologies for communication and collaboration. Companies have begun to realize that outdated computing systems are inhibitors to growth and success, but instead of upgrading PCs and software, they are upgrading their overall communication solution. SaaS and other cloud-based models have become the solution of choice for most industries, and the medical device industry is warming to the idea. Challenges exist, as with any new technology. But if these obstacles can be overcome, cloud computing solutions can offer tremendous benefits to the medical device industry while helping to improve patient care and reduce healthcare costs. With a well-defined plan, organizations can make it a smooth transition and be ready to take advantage of the next generation of innovations that are sure to come. 8

9 References Thangaraj, Ven. Clinical Trials in the Cloud. Radiant Sage Belmont, September 2, medicaldesign.com/engineering-prototyping/regulatory/clinical-trials-cloud-0902 Dutta, Arindam. Is Cloud the tomorrow of Medical Devices Industry? Engineering Out of the Box / ERS Blogs, January 3rd, Improve Your Organization s Health with Cloud Computing. Salesforce.com com/industries/healthcare Wireless Medical Devices: Security Issues, Market Opportunities and Growth Trends, The Nerac Strategists, Winter Healthcare Cloud Computing: Fueling Medical Device Industry Gains. Field Service Medical Conference by Worldwide Business Research healthcare-cloud-computing.aspx 9

10 About the Author Melisa Bockrath is Vice President, IT Centers of Excellence, Kelly Services, a leader in providing workforce solutions. She holds a Bachelor of Arts in Marketing Communication from Michigan State University in East Lansing, Michigan. About Kelly Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly offers a comprehensive array of outsourcing and consulting services as well as worldclass staffing on a temporary, temporary-to-hire and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 550,000 employees annually. Revenue in 2011 was $5.6 billion. Visit and connect with us on Facebook, LinkedIn, & Twitter. Download The Talent Project, a free ipad app by Kelly Services. Our IT specialty places professionals across a comprehensive scope of services, including application development and integration, data warehousing and business intelligence, software quality assurance and testing, enterprise maintenance and support, data storage, infrastructure support, disaster recovery and business continuity, and network engineering. Kelly Global Workforce Index EXIT

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