Strategies to improve the medical device life cycle in Mexico.
OBJECTIVE
To analyze the role of stakeholders to three alternative strategies to improve processes and practices regarding the regulation, assessment, and management of orthopaedic medical devices in Mexico.


MATERIALS AND METHODS
The study was based on document analysis and 17 structured interviews with multiple key actors within the Mexican health system to inform a stakeholder analysis aiming at assessing the political feasibility of these strategies.


RESULTS
Central level government agencies, those with a relation to quality of care, were identified as most relevant stakeholders to influence the adaption and application of the strategies. Major barriers identified are financial and human resources, and organisational culture towards reform.


CONCLUSIONS
Discussed strategies are political feasible. However, solving identified barriers is crucial to achieve changes directed to improve outputs and outcomes of medical device life cycle and positively influence the quality of health care and the health system's performance.
['Lingg|Myriam|M|', 'Dreser|Anahi|A|', 'Durán-Arenas|Luis|L|', 'Wyss|Kaspar|K|']
D005240:Feasibility Studies D005260:Female D006077:Government Agencies D006801:Humans D008297:Male D008800:Mexico D009983:Orthopedic Equipment D011640:Public Policy D000073597:Stakeholder Participation D011795:Surveys and Questionnaires
regulation assessment management health technology medical device.