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Process Deviation Testing of Skin-Barrier Contact for Ostomy Bags (engage…
Process Deviation Testing of Skin-Barrier Contact for Ostomy Bags
engage diverse stakeholders
Company X
End-Users
Manufacturers
Supply Companies
Doctors/Nurses/Medical Professionals who recommend products
identify where outside expertise is needed
Company X
Knowledge of barrier mix process
Ostomants
Desired outcomes
understanding the bigger system within which your problem exists
History of ostomy bags
How to apply an ostomy bag
Reasons for stoma surgery
taking a long-term perspective on how the problem came to exist and what it means for the future
Purpose of 3 lines...were their ever more or less
Current Testing done and results
current Barrier mixing process/regulations
No way to detect deviation in the data
explicity address political/cultural contexts
Political
Code of Federal Regulations
WOC Nurse regulations/non-compete
Cultural
Ostomy Bags in 3rd World Countries
Lifestyle of a patient
How do ostamants choose their bags?
Consider scientific, technological, economic, social, and political merits of possible solutions
Scientific Merits
Sound research on what is happening
Technological Merits
Economic Merits
Save patients $$$
Save company $$
Social Merits
increased confidence for patients
better patient outcomes: more consistent product performance or greater comfort
Political Merits
Adherence to the Code of Federal Regulations
Data for the FDA
employ sound science in your study
credible sources
company procedures
IRB training
Recognize how your work fits in with the bigger picture
PATIENT HAPPINESS
Evaluate system-wide impacts of possible solutions
How much money would be saved?
Benefits for end-users?