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The $400 Million Prize: XML Cost Savings In The Medical Device Industry
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The $400 Million Prize: XML Cost Savings In The Medical Device Industry


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Most manufacturers have document-based content systems and use applications like Word or InDesign to produce their labeling and marketing materials. This severely hampers their ability to standardize …

Most manufacturers have document-based content systems and use applications like Word or InDesign to produce their labeling and marketing materials. This severely hampers their ability to standardize and reuse content. It also increases process cost and error risk.

Here's why:

1) Document-based systems require manual operations to create or update labeling, both in the English source and all translated versions. Research indicates that manual formatting processes are a significant contributor to the device industry’s $1 billion per year “Total Cost of Content”

2) Document-based systems are also responsible for 50% of labeling errors, the number-one cause of costly product recalls.

Increasing regulatory and economic pressures have prompted manufacturers to tackle the rising cost and risk of document-based labeling and content systems. The most effective approach uses the DITA/XML authoring standard in combination with component content management and process automation software. Device makers who successfully implement XML publishing processes are seeing 40% reductions in total translation costs and up to 70% reductions in turnaround times. Industry-wide, this amounts to an estimated $400 million in potential savings.

In addition to reducing cost, risk, and turnaround, XML publishing also enables content reuse on other platforms, such as web or tablet-based apps. Not surprisingly, an estimated 70% of large device manufacturers have some form of XML initiative underway in the form of research or internal discussion, a pilot project, or an operating implementation.

This presentation shows how XML-based publishing drives down these costs and reduces the risks facing today’s global medical device manufacturers. It includes implementation lessons learned, a real-world-savings case-study, and resources that attendees can use to evaluate the transition to XML-based publishing.

Published in: Healthcare, Business, Technology

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  • JoAnn – speak to definition.First, important to clearly state what we’re talking about…Based on an informal survey of large manufacturers, we know that 70% have active content management initiatives, including…But DITA/XML and component content systems have been around for quite some time, so why the sudden interest and attention from the medical device industry?
  • Through a combination of structured content and process automation technology.
  • Same magnitude of improvement from scriptorium to printing press as from doc-based processes to XML-based systems
  • A big part of the reason we can do that (cut costs by 40%), is because it cut translation budgets by up to 50%
  • Startup, Mature, Enterprise…Now, another thing that increased visibility has provided is a perspective on the content challenges facing the device industry, for instance:Silos, Ad-hoc fixes, failed automation implementations.
  • The key *driver* for medical device content is easier, because there’s really only one – and that is complexity…Alone, each of type of complexity is manageable – but taken together, they can create a real challenge for device makersAnd that’s because complexity is not as benign as it might seem.
  • In fact, unmanaged complexity can be a real killer…Atul Gawande, who was a keynote speaker at the RAPS annual conference a couple of years back, and is a neighbor of mine here in Newton MA, recently wrote a best-seller about the effects of unmanaged complexity titled “The Checklist Manifesto” it describes how… Not surprisingly, the risks of unmanaged complexity also show up in medical device content
  • Discuss the set of processes in more detail
  • As you consider source quality, it’s important to remember that there are really 2 components to your “single source of truth” and that’s the English original and your translated, or derivative, source. For labeling implementations this is especially important because your translated labeling serves the same risk management function in overseas markets as your EN source does domestically…and errors in the translation can jeopardize compliance in your overseas markets. Also, since labeling translation errors need to be considered in your post-market risk management activities, the importance of quality matters even more.
  • Transcript

    • 2. CRIMSON LIFE SCIENCES • Founded in 1992, only translation service exclusively dedicated to medical device • Only translation service certified to ISO 9001; ISO 13485; ISO 14971; Notified Body-endorsed, patented labeling risk management • Division of TransPerfect Translations since 2005 • World‟s largest private language services provider • 80 worldwide offices, over 2,500 employees, growing “Family of Companies”
    • 3. Nearly 70% of large device manufacturers currently have active content management initiatives: • Discussing (internal/external) • Planning (researching/estimating) • Piloting (clinical/non-clinical) • Executing (initial/remediation) DEVICE MAKERS SEEK THE (SINGLE SOURCE OF) TRUTH Content Management defined: 1: A structured method, typically involving XML-tagged content combined with specialized system software and programmed templates, to automate publishing and enable content reuse across multiple output channels (e.g. print, web, tablet apps, mobile phone, etc.) 2: Any similar approach used to achieve goals of publishing automation and content reuse, aka. Single Source of Truth (Single Source), Component Content Management (CCMS), XML Publishing, DITA Publishing, Dynamic Publishing, Database Publishing, etc.
    • 4. • Increasing margin pressure in device Industry due to: • Reimbursement changes • Increased regulation (metal hips, PIP implants) • Worldwide healthcare austerity • Medical Device Tax INDUSTRY MARGINS BETWEEN A ROCK… Greece Fails to Pay Medical Bills The Greek government has fallen sharply behind on payments to healthcare companies, raising doubts about patient safety while revealing the looming cash-flow crisis faced by the state - Financial Times
    • 5. AND A HARD PLACE The Bad News: Total Cost of Content Over $1 Billion Annually The Good News: 40% ($400 Million) Can Be Eliminated
    • 6. For medical device manufacturers, “total cost of content” is all internal and external costs required to: TOTAL COST OF CONTENT DEFINED • Create • Verify/Validate • Approve • Update • Manage • Translate • Format • QA/Review • Clinical • Regulatory • Marketing • CorpComm
    • 7. • $400 million potential savings applies to you if… • Employ document-based publishing processes • Use document-based applications like Word, InDesign, FrameMaker • Use document-based repository systems like Documentum, Artesia, Windchill, OpenText • Have silo‟d groups creating content (e.g. labeling and software) DOCUMENTING EXCESS COSTS
    • 8. • Same authoring processes since the Middle Ages • Revolutionary savings with structured authoring in DITA/XML THE (R)EVOLUTION OF PUBLISHING 900’s 1400’s 2014
    • 9. • Class III labeling process • Analysis/Strategy: Resources/Processes • Linguistic • Non-linguistic (formatting) TRANSLATION PROCESS COST, TIME & RISK 50% 50% 50% 70% • Formatting Processes: • 50% of “serious error” risk • Up to 50% of cost • Up to 70% of turnaround
    • 10. CONTENT CHALLENGE: ROOT CAUSES • Content challenges, opportunities stem from: • Industry structure • Industry drivers • DITA/XML addresses issues at both levels
    • 11. Content Lifecycle Model types of device makers types of content
    • 12.  Mature content:  Increased volume and complexity  Targeted Technology  Enterprise content:  Enterprise automation  Global support  Startup (Core) content:  making, registering, selling  Common content issues:  Silo‟d division/departments  Ad-hoc fixes lead to system inefficiencies  Increased risk and “Cost of Content”
    • 13. • Increasing product/technology complexity • Increasing organizational complexity • Increasing market complexity • Increasing regulatory complexity CONTENT DRIVER: INCREASING COMPLEXITY
    • 14. COMPLEXITY KILLS Unmanaged complexity creates unacceptable risks • Increasing surgical complexity leads to patient mortality • 50% of 150,000 U.S. surgical fatalities due to increased complexity • Patient risk: 35% of “Serious Errors” in translated labeling due to complex processes • Business risk: Labeling errors #1 cause of costly recalls
    • 15. “Simplify, simplify, simplify!” - Thoreau “Don‟t you think one „simplify‟ is enough?” - Emerson THE ANTIDOTE TO COMPLEXITY • Simplify content complexities with Single Source content management (XML/DITA)
    • 16. • Document-based = distributed risk THE RISK OF SIMPLICITY <map title = “X-Knife User Guide”> <topicref href = “QuickGuide.dita”> topicmeta> <author> Jennifer </author> <topicmeta> <topicref> </map> </topicref> <topicref href = “AboutX-Knife.dita” Navtitle = “About X-Knife” format = “dita” > “GettingStarted.dita” Navtitle> • Single Source = single point failure risk • Leveraged = propagated failure risk
    • 17. Percentage of savings from increased system efficiencies invested in: Quality at the Source English Source Derivative Source (translation) QUALITY AT THE SOURCE: “PUT YOUR RIGOR WHERE YOUR RISK IS”
    • 18. • Content authoring • The Global English Style Guide, John R. Kohl • Minimalism • Terminology management • Guided authoring • Legacy analysis and conversion • e.g. ABREVE analysis QUALITY AT THE SOURCE CONTENT
    • 19. • 2 equivalent sources in CCMS: English Source and Derivative Source (translation) • Translated labeling serves same risk management function as English language labeling SINGLE SOURCE = TWO SOURCES “Inaccurate translation of device labeling may jeopardize ISO 14971 compliance in overseas markets.” - Oliver Christ, CEO, PROSYSTEMS (RAPS) “…failures of labeling translation comprise post-market information that the original device manufacturer needs to assess as part of its risk management process.” “… it is impossible to predict a priori the probability of an error in translation causing a harm, so, like software, trying to estimate a probability is to be discouraged. The company is entirely outcome driven in controlling risks.” - Dr. Harvey Rudolph, FDA, UL, co-author ISO 14971 <title> Composants auxiliaires de l‟endoprothèse vasculaire</title> <conbody><p>Les extensions de corps principal aortique peuvent être utilisées pour augmenter la longueur de la partie proximale de l‟endoprothèse vasculaire.</p></conbody> <title>Endovascular Graft Ancillary Components </title> <conbody><p>The aortic main body extensions can be used to provide additional length to the proximal portion of the endovascular graft. </p></conbody>
    • 20. XML/DITA: PLAYS WELL WITH OTHERS <map title = “X-Knife User Guide”> <topicref href = “QuickGuide.dita”> topicmeta> <author> Jennifer </author> <topicmeta> <topicref> </map> </topicref> <topicref href = “AboutX-Knife.dita” Navtitle = “About X-Knife” format = “dita” > “GettingStarted.dita” Navtitle> <map title = “X-Knife User Guide”> <topicref href = QuickGuide.dita”> <map title = “X-Knife • DITA-structured, XML tagged content in CCMS system • $300 million (75%) savings • DITA/XML automation-friendly for translation/GMS systems • $100 million (25%) savings • Translation metrics & audit • Conversion supports upstream/downstream integration • Authoring • Labeling
    • 21. • Conversion can be “heavy lifting” – across all industries, 25% initially fail • Importance of “getting it right” the first (or second) time • Requires planned, controlled approach • pilot, scale-up, budget for expert support • Not only technology change, but behavior change • Budget time for retraining to topic- based authoring LESSONS LEARNED FROM PRACTICE
    • 22. • “We reduced our translation budget 30% by eliminating DTP” • 20% time-to-market improvement • “50% reduction in formatting costs” • “We process 10x the work with the same headcount” • Without XML publishing, companies will drown in work and cost FROM PRACTICE: BENEFITS NOW
    • 23. • “XML publishing and metadata allow you to „future-proof‟ your content” • XML will help us implement prepare for SPL • “Automating output is key – without XML publishing, there‟s no way to get there” • Supports our eLabeling initiatives • We don‟t know how information will be delivered in 10-15 years, but we know it won‟t be flat files with writers working in silos. FROM PRACTICE: BENEFITS THEN
    • 24. Marc H. Miller, President Crimson Life Sciences RESOURCES Thank You! Questions? - Memo: FDA perspective on topic-based approvals - Gartner case study - GE update memo - Astoria ROI calculator