“Writing documents and putting them into binders does not sound like rocket science.” Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into a both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements. This presentation highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences and potential remedies with the intent to make the medical device documentation process more efficient.

1. “Where have all the hours gone?”
Medical Device Development - Death by documentation?
May 2015

2. Aligned AG
About Aligned AG
 Provider or Aligned Elements -
a Medical Device ALM
 Founded in 2006 in Zürich, Switzerland
 Team highly experienced in Medical
Device Development
 Experts in Medical Device
Documentation Management

3. Aligned AG
Medical Devices and Documentation
 Up to 30% of development effort
 The documents are interdependent
 Constant change in content
 Changing regulatory landscape
 Difficult to detect gaps and errors
 Large potential penalties

4. Aligned AG
Trends and Observations
 Curbs innovation velocity
 “Everyone” is documenting
 Continuously growing burden
 People get bored and leave the company

5. Aligned AG
Not all documents are alike
 Documentation is here to stay
 A competitive dimension
 Can we make it efficient?
 Note: A document ALWAYS incur a cost!
 Total Cost of Document
 What are the drivers for increased
documentation costs?

6. Aligned AG
Where is the work? Example I
4%
32%
19%
45%
Requirements
Specifications
Risk Analysis
V &V

7. Aligned AG
Where is the work? Example II
21%
25%
54%
Other
Design Output
V &V

8. Aligned AG
Where is the work? Example III
Type RQ Risk Spec Test Case Test Report
Avg. # Changes 1.8 3.6 6.3 8.5 2.4
Total # Items 251 992 1652 2370 2045

9. Aligned AG
What causes work? Example I
 Q manager 1: „Do not leave table cells empty, use dashes“
 Q manager 2: “Do not use dashes in table cells, use N/A”
 Q manager 3: “All N/A in table cells must be explicitly qualified”

10. Aligned AG
What causes work? Example II
References
Ref. # Document name Version
1 397884 Guideline test case template V1.1
2 01440_97555 Software tool validation plan trace matrix generator V1.3
3 01440_97556 TraceMatrixGenerator Specification Document V1.0

11. Aligned AG
Reasons
 Reality changes
 Templates/Process/People changes
Many vs. Few modifications
What can we do?
 Understand the true cost of template/process changes
 Reduce the risk for committing formal errors
 Reduce / outsource dependencies between documents
 Use automated tools to detect and correct inconsistencies
 Correcting “formal” errors
 Document interdependencies

12. Aligned AG
The more the merrier
Write
Dry run
Peer
review
Q review
Tester
Releases
Update
TC
Overview
Dry run
by other
Tester
Update
TC
overview
Ready
for real
test run

13. Aligned AG
Three is a crowd
 Signatures per Test Case: 3
 Total Number of signatures: 18000
 Avg. time to collect a signature: 0.5h
 Total time: 5 man-years

14. Aligned AG
Reasons
 Interdisciplinary documents
 Many stakeholders
Involves many vs. few people
What can we do?
 Ask yourself: “Does this make the product safer and better?”
 Reduce number of people involved
 Trim down Review – Release – Sign-off procedures
 Assign deputy rights
 “Enforce” responsibility
 Extensive workflows

15. Aligned AG
The extensive master template

16. Aligned AG
“One size fits all”- template

17. Aligned AG
Reasons
 Fear of non-compliance (“better safe than sorry”)
 Extensive master templates
 “One size fits all” - templates
Content vs. Overhead in Document
What can we do?
 Challenge template growth
 Identify and eliminate overhead sections and actions
 Allow for variation in the template
 Increase the content/overhead ratio by aggregation

18. Aligned AG
Rigid Workflows
 “I can’t sign this document before the author has signed it.”
 “The review cannot start until the draft is official.”
 “She can’t write the test case because she only has testing
authorization, not test case writing authorization.”
 “This test iteration does not start until all bugs have been
assigned to a tester.”
 „We cannot start until Q-manager has signed off the reqs.“

19. Aligned AG
Changing specifications
 Common knowledge says: “Start with testing early”
 The specifications are going to change
 Changing specifications =>
Test changes + Additional test cycles
 What shall we do? Write tests early or wait until the end?

20. Aligned AG
Reasons
 Reality changes
 Complex collaborations
Long time vs. Short time to completion
What can we do?
 Wait for stabilization, “Document late” / J.I.T when you need them
 Prepare for writing – set the table
 Separate stable data from unstable data
 Allow for variations in workflows
 Allow parallel workflows
 Data has not stabilized
 Rigid, sequential workflows

21. Aligned AG
Repetitive tasks I
21%
25%
54%
Other
Design Output
V &V

22. Aligned AG
Repetitive tasks II
 Monday morning:
Hi Bob,
The milestone is
coming up Friday.
Here is the 240
page document to
review!

23. Aligned AG
Reasons
 Reoccurring tasks (e.g. reviews)
 Design control item (e.g. Test Cases)
 Unwarranted division of content
Many instance vs. few instances
What can we do?
 Analyze the creation and modification process
 Relentlessly eliminate unnecessary process steps
 Use minimalistic templates
 Focus Reviews on changes
 Aggregate content where applicable

24. Aligned AG
The “ideal” document
 Easy to write
 Fast to complete
 High content vs. overhead ratio
 Involves few people
 Does not get sent around
 Few modifications
 Few dependencies

25. Aligned AG
 Administrative overhead in creation and modification of documents
 Template Designers  Documentation Executer
 Extensive Templates (capture all info needed for any situation)
 Templates that do not fit the task (“one size fits all”)
 Workflows involving lots of people (tends to create bottlenecks)
 Workflows with rigid order (“this can’t start until that is finished”)
 “Good intentions” can have unexpected effects
Common Culprits

26. Aligned AG
 Optimize process and templates for reoccurring doc types
 Trim down the master templates
 Allow for variations in templates
 Allow for variation in workflows
 Trim down the review-release-sign-off process
 Keep interdependencies in separate documents
 Use automated tools for version, change and trace management
Proposed solutions

27. Aligned AG
Aligned Elements – a medical device ALM
 Manages the Technical Documentation
 Version Control + Traceability + Documents
 Integrated Risk Management
 Integrated DHF Index
 Reviews + Workflows + E-signatures
 Automatically finds formal gaps and errors
 Ensures completeness and consistency

28. Thank You!Aligned AG
Binzmühlstrasse 210
CH-8050 Zürich
Switzerland
t +41 (0)44 312 50 20
f +41 (0)44 312 50 20
m info@aligned.ch
w www.aligned.ch