Aidan Petrie, Chief Innovation Officer and Co-Founder Ximedica

1. Standard Operating Procedures
Fit for Human Use

2. Agenda:
The background behind Ximedica’s decision
The process of re-designing
The results and benefits

3. Applying usability to
Standard Operating Procedures
for improved compliancefor improved compliance.
3

4. The value of re-designing SOPs:
Defined methods
I d t i iImproved training
Ensuring alignment with
FDA requirements + ISO
Able to evolve with theAble to evolve with the
organization
P idi it ti lProviding situational
awareness
4

5. Ximedica is a medical and healthcare firmXimedica is a medical and healthcare firm
focused on helping our clients bring
innovative products to market.
RESEARCH DETAILED IMPLEMENTATIONRESEARCH
+ INNOVATION
DETAILED
DEVELOPMENT
IMPLEMENTATION
+ LAUNCH
5

6. RESEARCH DETAILED IMPLEMENTATIONRESEARCH
+ INNOVATION
DETAILED
DEVELOPMENT
IMPLEMENTATION
+ LAUNCH
Product/platform strategy Designing and developing
new product offerings
Pilot manufacturing
2nd gen product refinement
User research + concept
testing
U b ti d h
new product offerings
Regulatory strategy +
submission
Tech. feasibility assessments
Supply chain strategy
Global sourcing
User observation and human
factors studies Formative studies
6

7. RESEARCH DETAILED IMPLEMENTATION
140+ personnel with diverse
backgrounds and roles
RESEARCH
+ INNOVATION
DETAILED
DEVELOPMENT
IMPLEMENTATION
+ LAUNCH
Product/platform strategy Designing and developing
new product offerings
Pilot manufacturing
2nd gen product refinement
User research + concept
testing
U b ti d h
new product offerings
Regulatory strategy +
submission
Tech. feasibility assessments
Supply chain strategy
Global sourcing
User observation and human
factors studies Formative studies
7

8. Before:
Written for/by Content Experts
Difficult to maintain and update
Not reflective of current processesNot reflective of current processes
Siloed awareness across different
f tifunctions
Very long, lots of duplicate information
Diverse format styles
8

9. Ease of seR hit t d f - Ease of use
- Accuracy
Re-architected for:
y
- Simplicity
Team: Time to completion:Team:
Information Architects
Human Factors Engineers
C t t E t
Time to completion:
1.5 years
Content Experts
Regulatory
Executive Sponsorsp
9

10. P
1. Deconstructed into elements
Purpose Scope
Definitions
Responsibilities
R f D tReference Documents
Record Retention
Procedure Process
Record Retention
A l M th d
Revision History
Approval Methods
Appendix10

11. 2. Re-architected
11

12. Definitions
3. Removed redundancy
D fi iti D fi iti D fi iti D fi itiDefinitions Definitions Definitions Definitions Definitio
Definitions Definitions Definitions Definitions Definitions Defin
Definitions Definitions Definitions Definitions Definitions Defin
Definitions Definitions Definitions Definitions Definitions Defin
Reference DocumentsDocuments Document
Documents Documents Documents Documents Documents Do
Definitions Definitions Definitions Definitions Definitions Defin
Stakeholders
Documents Documents Documents Documents Documents Do
Stakeholders Stakeholders Stakeholde
Documents Documents Documents Documents Documents Do
StakeholdersStakeholders Stakeholders Stakeholde
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Details Details Details Details Deta
Details Details Details Details Details Details Details Details De
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Process Details
Details Details Details Details Details Details Details Details De
Details Details Details Details Details Details Details Details De
12

13. 1 5P
4. Created a repeatable framework
1
2
5
6
Purpose
Scope
Process Flow
Procedure
3
4
7Definitions
Stakeholders
Reference Documents,
Attachments, Appendices
13

14. 5. Emphasized front page
All the high level information
was included on the coverwas included on the cover.
Information hierarchy; top of page
guides your eye
Company process serves as iconic
graphic
Predominant headerPredominant header
Location in process gives user context
Footer reinforces title gives mostFooter reinforces title, gives most
current revision and page number
14

15. 6. Using images/charts whenever
possiblepossible
15

16. 7. Re-wrote concisely, in common
language when possiblelanguage when possible
““Ximedica’s Product Development
Process consists of 6 phases. It is a
flexible process allowing for specific
activities to occur as needed.
“
16

17. 8. Referenced the process
17

18. The results:
- Reduced time spent reading- Reduced time spent reading
- Easier to understand
- Easier to train on
- Decreased frustrations
- Easier to update
Shared view across process- Shared view across process
- Additional perceived informational value
18

19. Project team and phase activities
Ph O Ph TPhase One Phase Two
Team:
All department VPs
Team:
Information Architect - All department VPs
- Selected staff members
- COO + CIO as advisory board
- Content Experts
- Information Architect
- All department VPs
- COO + CIO as advisory board
Activities:
- Deconstructed existing structure and
Activities:
- VPs and select staff assigned to
d l t t f ifi SOPcontent
- Removed redundant content
- Optimized format and content
develop content for specific SOPs
- Reformat and move content into
template
- Refined clarity of content and alignment
- Created a standard SOP template
- Created detailed visual diagram of
Ximedica’s development process
y g
with corporate goals
- Test against process
- Advisory board approved content
Final approval and signoff- Final approval and signoff
- Company-wide training on new SOPs
19

20. Before After
Benefits
Number of
Before After
pages to read
per SOP:
12 - 27
pages
6 - 18 pages
Time spent
to read: 30-45 minutes 10-15 minutes
Audience:
Targeted for FDA, Auditors Inclusive for all potential
audiences; FDA, Auditors,
current and new hires
Technical
specifications:
Specs locked in
li d fil ith
Accessible to all
t i i t
current and new hires
specifications: licensed files with
limited access
users to view, print,
and transfer efficiently
20

21. Th l d i d SOP b ttThe newly designed SOPs are better
organized, more concise, and easier
t f ll th t d I ito follow than most procedures I review.
The process flow shows what the procedure is
doing and what phase of the process it isdoing and what phase of the process it is
linked to. The details at the end provide an
appropriate level of instruction andappropriate level of instruction and
information to be useful for readers.
R t A dit- Recent Auditor
21

22. Thank you.
Aidan Petrie
apetrie@ximedica.com
www.ximedica.com
Chief Innovation Officer, Co‐Founder
Thank you.
22