Table 1 Barriers to the development and implementation of improved AST systemsa

From: Developmental roadmap for antimicrobial susceptibility testing systems

BarriersEffect on patientEffect on userEffect on manufacturerEffect on policy maker
Competence of laboratory personnel x  
Distance between clinicians and diagnosticians x  
High cost of test x  
Continuous availability in the laboratory x  
Lack of clinical outcome studies x  
Costs of clinical studies  x 
Costs of development  x 
Data management and poor electronic medical records  x 
Finding partners (clinicians, laboratory directors, researchers, etc.) for clinical studies  x 
Intellectual property challenges associated with multiple innovation  x 
Laboratory decentralization and unlinked stewardship teams  x 
Lack of appropriate marketing  x 
Lack of pre-market commitment  x 
Quality and availability of primary materials  x 
Policy makers not understanding the development process   x
Issues concerning sample takingxx  
Specimen accessibilityxx  
Knowledge gaps of physicians or clinicians in the relevance of antimicrobial resistance xx 
Lack of funding xx 
Storage, transport and stability of the test xx 
Sample transport and other logistical issues xx 
Supply chain failure xx 
Limited exchange between diagnostic and pharmaceutical companies  xx
Lack of speedxxx 
Test availabilityxxx 
FDA validation and European certification (CE) including differences between countries xxx
Biological hazard xxx
Ethical aspects xxx
Insufficient exchange between the public and private sector xxx
Environmental aspectsxxxx
Health practice behaviourxxxx
Communication (or lack thereof)xxxx
Lack of support programmesxxxx
  1. aThe table is partially based on a prior key paper in this field81.