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

From: Developmental roadmap for antimicrobial susceptibility testing systems

Barriers Effect on patient Effect on user Effect on manufacturer Effect 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 taking x x   
Specimen accessibility x x   
Knowledge gaps of physicians or clinicians in the relevance of antimicrobial resistance   x x  
Lack of funding   x x  
Storage, transport and stability of the test   x x  
Sample transport and other logistical issues   x x  
Supply chain failure   x x  
Limited exchange between diagnostic and pharmaceutical companies    x x
Lack of speed x x x  
Test availability x x x  
FDA validation and European certification (CE) including differences between countries   x x x
Biological hazard   x x x
Ethical aspects   x x x
Insufficient exchange between the public and private sector   x x x
Environmental aspects x x x x
Health practice behaviour x x x x
Communication (or lack thereof) x x x x
Lack of support programmes x x x x