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 compliance.
3

4.
The value of re-designing SOPs:
Defined methods
Improved training
Ensuring alignment with
FDA requirements + ISO
Able to evolve with the
organization
Providing situational
awareness
4

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

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

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

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

9.
Re-architected for: - Ease of use
- Accuracy
- Simplicity
Team: Time to completion:
Information Architects 1.5 years
Human Factors Engineers
Content Experts
Regulatory
Executive Sponsors
9

10.
1. Deconstructed into elements
Purpose Scope
Definitions
Responsibilities
Reference Documents
Record Retention
Procedure Process
Revision History
Approval Methods
Appendix 10

11.
2. Re-architected
11

12.
3. Removed redundancy
Definitions 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
Documents Documents Documents Documents Documents Do
Documents Documents Documents Documents Documents Do
StakeholdersStakeholders Stakeholders Stakeholde
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Process DetailsDetails Details Details Details Deta
Details Details Details Details Details Details Details Details De
Details Details Details Details Details Details Details Details De
Details Details Details Details Details Details Details Details De
12

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

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

15.
6. Using images/charts whenever
possible
15

16.
7. Re-wrote concisely, in common
language 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
- Easier to understand
- Easier to train on
- Decreased frustrations
- Easier to update
- Shared view across process
- Additional perceived informational value
18

19.
Project team and phase activities
Phase One Phase Two
Team: Team:
- Information Architect - All department VPs
- All department VPs - Selected staff members
- COO + CIO as advisory board - COO + CIO as advisory board
- Content Experts
Activities:
- Deconstructed existing structure and ctivities:
content
- Removed redundant content VPs and select staff assigned to
develop content for specific SOPs
- Optimized format and content
- Created a standard SOP template Reformat and move content into
- Created detailed visual diagram of template
Ximedica’s development process
Refined clarity of content and
alignment with corporate goals
19
Test against process

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

21.
The newly designed SOPs are better
organized, more concise, and easier
to follow than most procedures I review.
The process flow shows what the procedure is
doing and what phase of the process it is
linked to. The details at the end provide an
appropriate level of instruction and
information to be useful for readers.
- Recent Auditor
21

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