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CONTENT AUTOMATION FOR MEDICAL DEVICE MANUFACTURERS

Information Development World2015/10/2

BY THE NUMBERS

BEYOND TRANSLATION

“WELL…HOW DID WE GET HERE?”

PERSONAL PERSPECTIVE, BY THE NUMBERS

• 24 years translation• 23 years medical device• 13 years founder/owner• 10 years Division President• 8 years patient

FINANCIAL CRISIS, MARGIN CRISIS

• Since 2009, increasing margin pressure due to– Reimbursement changes– Increased regulation (metal hips, PIP implants)– Worldwide healthcare austerity– Medical device tax

Greece Fails to Pay Medical BillsThe 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

TARGETING COSTS, PROTECTING MARGINS

• Worldwide “cost of content” estimated at $3 Billion (1% of sales)

QUALITY JENGA• Stagnant, declining tech pubs

budgets• Procurement-led selection

– Focus on rates• Supplier response

– Resources (ex. qualification)– Processes (ex. RM and MT)

• Net result: increased risk; economic adulteration

COMPLEXITY CREATES RISK• Surgical complexity leads to

patient mortality• 50% of 150,000 U.S. surgical

fatalities• Patient risk: 35% of “Serious

Errors” due to complex labeling processes

• Business risk: labeling errors #1 cause of recall

CONTENT COMPLEXITY KILLS• Organizational• Regulatory• Product/Technology/Use

…the issue was not mechanical failure, but user confusion over proper use of the device--not that surprising given the complexities of walking around with a life-supporting wire under your shirt [2 deaths, 1 serious injury]…

- Fierce Medical Devices, Sept 2015

CONTENT COMPLEXITY DRIVES COSTS

Lifecycle •Create, Verify, Approve (EN)•Translate, Format, QA (6 > 28 languages) •Update, Manage, Control

Type•Clinical (e-clinical trial)•Regulatory (filings, labeling, field notices, e-learning, rebranding, QMS )•Marketing (print, websites, video, e-learning, rebranding)•CorpComm, HR (contracts, PR, employee info)

Cost •Total Cost of Content• $3 Billion Worldwide

OVERCOMING “IMPOSSIBLE”

• Faster-Better-Cheaper with systemic change

• The best way to predict the future is to create it

– Dragon Star

PLUS ÇA CHANGE, PLUS C'EST LA MÊME CHOSE

900’s 1400’s 1985-2015

DOWNSTREAM COSTS, VALUELESS RISK• Class III labeling

– Analysis/Strategy– Linguistic – Formatting50%

50%50% 70%

• Formatting– No value-add for labeling– Serious Error risk– Cost– Turnaround

THE ANTIDOTE TO COMPLEXITY

“Simplify, simplify, simplify”- Thoreau

“Don’t you think one ‘simplify’ is enough?”

- Emerson

“IMPOSSIBLE WITHOUT SINGLE SOURCE”

• Stryker: 50% reduction in formatting costs, 20% TAT improvement

• Medtronic: “10x the work with the same headcount”

• Cook Medical: “XML helps us prepare for SPL”

XML: PLAYS WELL WITH OTHERS• Supports upstream/downstream

systems integrations– authoring, labeling

• Structured, XML content in CCMS– $900 million savings (75% of total)

• Integrated with GMS/TMS system– $300 million savings (25% of total)– METRICS (!)

THE RISKS OF SIMPLICITY

IFU

IFU

IFU

• Document = distributed risk• CCMS = single point risk• CCMS + TMS/GMS = single

point, propagated risk

“PUT YOUR RIGOR WHERE YOUR RISK IS”

• Invest % of savings in:– CCMS technology– English source– Translated (derivative)

sourceQuality at the Source

POINTS FROM PRACTICE• Conversion can be ‘heavy lifting’

– Across all industries, 25% initially fail

• Controlled approach– Pilot, scale-up, expert support

• Tech AND behavior change– Retraining to topic-based authoring

TICK THE BOXES

• Does it work (validate-able)? • Does it handle multilingual content?• Is it in use with device clients?• Has it been integrated, does it have

open API’s?

#1 IMPLEMENTATION ISSUE: “WET-WARE”

• Consider the team– Supplier-side changes

easier than client-side• Implementation leads are

key:– Client-side– Technology, Services– Translation

STYLE SHEETS: DEVIL IN THE DETAILS• Document complexity• Document variability• Client-supplied branding

guidelines, official logos• Multilingual• Required fonts• Nested Lists• Tables in list items• SVG vs. jpeg, eps, etc.• Source/Target in same file

<XML>

XML: IT’S NOT A DECK• “Long Game” project management

– Staff turnover– Global teams– “Contractor” organizations

• Who’s on first: XML or TMS?• Content analysis, Information Model• Focused, customized training, pilot• Tracking files, project collateral

ENCOMPASS SYSTEM: WE KNOW HOW

ENCOMPASS SYSTEM: WE KNOW HOW

RESOURCES• www.transperfect.com/meddev

– XML at Medtronic (recorded webinar)– Coming soon: conversation with Steve Huffman, former

Manager of Labeling Services at Medtronic (podcast)• FDA perspectives on topic-based approvals• The Global English Style Guide, John R. Kohl• ABREVE analysis• XML ROI calculator

THANK YOU! QUESTIONS?

Marc H. MillerDivision President

TransPerfect Medical Device Solutionsmmiller@transperfect.com

www.transperfect.com/meddev