addressing the increasing challenges facing medical device content with ann rockley

@arockley | #infodevworld | www.rockley.com

Addressing the Increasing Challenges of

Medical Device Content

Ann Rockley – CEO, The Rockley Group


The Rockley Group •  More than 15 years’ experience in

Healthcare •  Clinical •  Labeling •  Promotional •  Industry experts •  Structured content strategy •  Content reuse •  Structured content management

systems •  Content globalization strategy •  Multichannel delivery


Ann Rockley @arockley •  CEO and Founder, The Rockley Group •  Creator of the concept of intelligent content •  Founder, Intelligent Content Conference •  Known as the "mother of content strategy" •  Forefront of intelligent content strategy, reuse,

structured content management, multichannel delivery (Web, eBook, mobile, print)

•  Passionately committed to defining and sharing industry best practices

•  Master of Information Science •  Fellow of the Society for Technical

Communication


The challenges •  Increasing regulatory requirements •  Translation •  Timelines • Usability


INCREASING REGULATORY REQUIREMENTS


Frequent new requirements • New requirements are coming down the line all the

time •  Long timelines on labeling means implementing the

changes as early as possible even when the change is not yet fully understood • Regulatory needs to interpret the change and

determine a direction •  Labeling needs to determine the impact and

implement the change


Impacts numerous documents •  Some regulatory changes impact content on a go-

forward basis • Others impact all your content, massive changes

(e.g., UDI) •  Labeling must identify all occurrences of the change

and determine how to rapidly but effectively make all the changes


US vs Global •  Some regulatory changes are US based while others

are global •  Labeling needs to identify the change and the

variations of the changes in labeling depending upon the region


Changing interpretation of requirement • Not only does regulatory change or refine the

decisions on how to interpret the new requirements, questions to the regulatory body result in further changes


UDI


Universal Device Identifier (UDI) • Uniquely identifies every device to: •  Track a device through distribution and use •  Facilitate recalls •  Incorporate adverse event reporting and device

registries to facilitate better reporting and analysis •  Integrate device information with Electronic Health

Records •  Provide an easily accessible source of device

information for patients and clinicians


What does UDI have to do with labeling? •  This is an example of how UDI requirements were

interpreted in a sample labeling team •  Impacts only the filing information for the device,

no impact on labeling •  Then, impacts the package label but not the

labeling (operations guide, user guide, patient guide, quick guide/reference, etc.) and a separate team handles the package label, so no impact on me

•  Then, I have to attend a 3 day workshop on UDI, why, what does it have to do with us?


UDI is all about data. Data is content. Content is labeling.


Get structured


Add metadata


Match your metadata to UDI metadata


Share data (content) with UDI database


TRANSLATION


Translation issues •  Translation takes too long •  Translation costs too much •  Translation is more than just language • We don’t understand the language, how do we

validate it? •  The quality of the translation is poor


Case study •  Large medical device company • Diabetes division • Meters, lancets • User guides, posters, quick start cards, lancet and

control solution inserts, packaging and package labels


Current situation

•  English master created in Word/Excel • All content in

tabular form to enable differentiation of regional differences


Country matrix


Review/Publishing • Reviewed in Word •  English copied and pasted into InDesign by an

Agency and 300% proofread • Reviewed English Word file provided to translation

agency for translation • Returned as translated Word files •  Language versions manually copied and pasted into

InDesign • Agency expected to determine correct information

for each region/country


Publishing issues •  Copy paste errors • Multiple language versions of content • Agency expected to know/pick correct information in

a language they can’t read and paste it into InDesign •  300% proofing but done by non-language speaking

proofreaders •  CAPA: Wrong language pasted into existing InDesign

content (took 4 years to clear this CAPA)


Package label • Multi-language • Produced on the manufacturing floor just-in-time • Manufacturing in four global sites

•  Issue •  100’s of templates •  Modified by Marketing, not standardized •  Content changes not changed across labels •  Database, but not really used


Go modular


Develop structured content


Develop a reuse strategy


Go format-free


Case study: Models


Reuse

•  UDI attributes •  Between products •  Tasks •  Concepts (e.g., hypoglycemia) •  Images •  Intended use •  Indications •  Contraindications •  Precautions •  Warnings •  Symbol statements •  Warranty •  Etc.


Use conditional reuse •  Include all variants of content in the module •  Tag the content with metadata to identify what the

content is applicable to •  Create a version of the content with the correct

content included in English for translation


With conditions


Develop rules • Brazil •  Portuguese •  mg/dL •  C •  Comma •  dd/mm/yy •  24 hr


Metadata


Empty structured label template


Automatically filled label


Print: Empty structured InDesign template IFU


Automatically filled IFU


TIMELINES


Challenges •  Takes forever to get things done! • We never have enough time to get things done!


Go Agile!


What is Agile? •  The methodology associated with Agile was

developed for the software industry to speed up the development of software • Prior to Agile, the most common software

development process was the Waterfall process (sequential through the lifecycle) • Rather than waiting until everything is finished Agile

creates iterative interim deliverables that are assessed and rapidly updated • Agile results in faster turn-arounds


Agile in reality •  Create content in modules designed for reuse • Review in modules (in context) •  Translate modules (in context) •  Iterate modules • When all modules are approved, automatically

publish


USABILITY


Challenges •  “Nobody” reads the labeling • People “lose” the accompanying information • We have to meet “regulatory” guidelines which aren’t

consumer friendly • Regulatory insists on X number of pages of warning

and precautions before the content • Our customers/consumers look for information

online, but we can’t provide content online, paper is required


Some suggestions •  Clear instructions for use •  Lots of pictures • Access to customer-support phone number • Make a copy available online • KISS •  Create consistent complete instructions


Usability test with patients/caregivers/HCP in creation of labeling


The FDA is listening and want your input

http://www.regulations.gov


A work in progress, but there is hope


Questions?

[email protected]

addressing the increasing challenges facing medical device content with ann rockley

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