|By Business Wire||
|November 5, 2012 09:00 AM EST||
Crimson Life Sciences, a division of TransPerfect and the only ISO 13485 and ISO 14971 certified translation provider, has introduced an advanced XML labeling solution to help manufacturers cope with the effects of changing regulatory requirements such as French Decree No 2012-743 of May 9, 2012 and China’s medical device Regulation Number 276 (unofficial translation and analysis available upon request from [email protected]). The regulatory changes, prompted in part by healthcare scandals such as the PIP breast implant recall, require device companies to make substantial content updates. Crimson’s XML-based publishing solution enables manufacturers to automate labeling updates, eliminate formatting costs, and realize savings up to 40% over traditional methods.
Changing Regulations Drive Labeling Costs
A raft of new and revised medical device regulations, including France’s Decree No 2012-743 of May 9, 2012 and China’s updated Regulation Number 276, will create significant compliance challenges for many manufacturers in 2013. That’s the prediction of Marc Miller, President of Crimson Life Sciences: “Labeling mistakes are the number one cause of product recalls and these new regulations will affect tens of thousands of IFUs and marketing pieces industry-wide.”
In fact, recent research from Crimson indicates that the “Total Cost of Content” for device makers, including updates imposed by changing regulations, amounts to $1 billion per year (research memo available upon request from [email protected]). According to Miller, “Most manufacturers operate with a document-based system for their labeling and marketing materials – working in applications like Word, InDesign, or Illustrator. In order to make updates, each individual document must be opened and modified. For large manufacturers with hundreds or even thousands of products, each small change can take weeks or even months to implement and comes with enormous cost and error risk.”
A Cure for the $1 Billion Industry Headache
As labeling updates become more frequent due to changing regulatory requirements and corporate rebranding, manufacturers are exploring new ways to achieve cost and time savings. Crimson’s solution is based on industry-standard DITA XML publishing strategies and proven, mature technologies to help manufacturers safely reduce labeling costs by as much as 40%. Explains Miller, “Not only does XML publishing make sense for manufacturers who want to reduce the cost of labeling, it also opens up a whole range of opportunities for content reuse in other channels, such as the web and tablet-based multimedia apps.”
Through the development of a custom “Information Model,” Crimson works with manufacturers to convert their content to XML format for storage and automated retrieval in the same Component Content Management system used by device makers industry-wide (and developed by sister company, Astoria Software). Publishing is then automated through the use of document templates. Any content changes made by the user are automatically propagated to all documents where the designated change occurs. Says Miller, “Thanks to the many cost-cutting efforts underway in the device industry, XML publishing based on the DITA standard is quickly becoming the labeling strategy of choice for global, multi-product manufacturers. We are pleased that we could develop this solution in partnership with Astoria Software—the recognized leader in DITA-based XML publishing systems.”
About Crimson Life Sciences
Crimson Life Sciences is a division of TransPerfect Translations International, Inc. and is the only translation practice exclusively devoted to the medical device industry. Crimson is the world’s first translation firm certified to both ISO 13485 and ISO 9001 and the only translation firm certified to ISO 14971. Crimson’s ISO 14971-certified risk management system is the basis for the world’s only translation risk management patent (U. S. Patent No. 8,140,322 B2). TransPerfect, certified to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with more than 80 offices worldwide. For more information, visit www.crimsonlanguage.com.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Nov. 28, 2014 03:00 PM EST Reads: 1,180
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water, are pursuing SmartGrid initiatives that represent one of the more mature examples of SAE. We have s...
Nov. 27, 2014 04:00 PM EST Reads: 1,307
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, and physical persons. In the IoT vision, every new "thing" - sensor, actuator, data source, data con...
Nov. 27, 2014 04:00 PM EST Reads: 1,642
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series data. By focusing on enterprise applications and the data center, he will use OpenTSDB as an example t...
Nov. 27, 2014 03:00 PM EST Reads: 1,478
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happens, where data lives and where the interface lies. For instance, it's a mix of architectural styles ...
Nov. 27, 2014 03:00 PM EST Reads: 1,311
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and assessments, including a decade of leading incident response and digital forensics. He is co-author of t...
Nov. 27, 2014 01:00 PM EST Reads: 1,674
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
Nov. 27, 2014 11:00 AM EST Reads: 1,285
The Internet of Things will put IT to its ultimate test by creating infinite new opportunities to digitize products and services, generate and analyze new data to improve customer satisfaction, and discover new ways to gain a competitive advantage across nearly every industry. In order to help corporate business units to capitalize on the rapidly evolving IoT opportunities, IT must stand up to a new set of challenges. In his session at @ThingsExpo, Jeff Kaplan, Managing Director of THINKstrategies, will examine why IT must finally fulfill its role in support of its SBUs or face a new round of...
Nov. 27, 2014 10:00 AM EST Reads: 1,235
One of the biggest challenges when developing connected devices is identifying user value and delivering it through successful user experiences. In his session at Internet of @ThingsExpo, Mike Kuniavsky, Principal Scientist, Innovation Services at PARC, described an IoT-specific approach to user experience design that combines approaches from interaction design, industrial design and service design to create experiences that go beyond simple connected gadgets to create lasting, multi-device experiences grounded in people's real needs and desires.
Nov. 27, 2014 08:00 AM EST Reads: 1,244
Enthusiasm for the Internet of Things has reached an all-time high. In 2013 alone, venture capitalists spent more than $1 billion dollars investing in the IoT space. With "smart" appliances and devices, IoT covers wearable smart devices, cloud services to hardware companies. Nest, a Google company, detects temperatures inside homes and automatically adjusts it by tracking its user's habit. These technologies are quickly developing and with it come challenges such as bridging infrastructure gaps, abiding by privacy concerns and making the concept a reality. These challenges can't be addressed w...
Nov. 27, 2014 07:45 AM EST Reads: 1,528
The Domain Name Service (DNS) is one of the most important components in networking infrastructure, enabling users and services to access applications by translating URLs (names) into IP addresses (numbers). Because every icon and URL and all embedded content on a website requires a DNS lookup loading complex sites necessitates hundreds of DNS queries. In addition, as more internet-enabled ‘Things' get connected, people will rely on DNS to name and find their fridges, toasters and toilets. According to a recent IDG Research Services Survey this rate of traffic will only grow. What's driving t...
Nov. 27, 2014 07:00 AM EST Reads: 1,503
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective storage designed to handle the massive surge in back-end data in a world where timely analytics is e...
Nov. 27, 2014 06:45 AM EST Reads: 1,332
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using the URL as a basic building block, we open this up and get the same resilience that the web enjoys.
Nov. 27, 2014 06:45 AM EST Reads: 1,399
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will want to use their existing identities, but these will have credentials already that are (hopefully) i...
Nov. 27, 2014 04:00 AM EST Reads: 1,245
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 27, 2014 04:00 AM EST Reads: 1,194
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect at Hookflash, will walk through the shifting landscape of traditional telephone and voice services ...
Nov. 26, 2014 02:00 PM EST Reads: 1,629
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Architect for the Internet of Things and Intelligent Systems at Red Hat, described how to revolutioniz...
Nov. 24, 2014 07:00 PM EST Reads: 1,723
Bit6 today issued a challenge to the technology community implementing Web Real Time Communication (WebRTC). To leap beyond WebRTC’s significant limitations and fully leverage its underlying value to accelerate innovation, application developers need to consider the entire communications ecosystem.
Nov. 24, 2014 12:00 PM EST Reads: 1,626
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from hardware to software, or as we like to say, it’s an Internet of many different things. The difference ...
Nov. 24, 2014 11:00 AM EST Reads: 1,753
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world.
Nov. 24, 2014 09:00 AM EST Reads: 1,787