The regulation, assessment, and management of orthopaedic medical devices in Mexico : crucial aspects, problems, and steps to improve it

Introduction:
In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement or technology assessments. Well-tailored policies for health technologies such as medical devices are essential and contribute to improved quality of health care. The regulation, assessment, and management represent important functions of the Medical Device Life-Cycle (MDLC). Insufficiently developed interactions between these functions impact the quality of health care and health system’s effectiveness. To date studies lack to analyse these functions in a broad way even though they are increasingly of interest to policy makers and health system experts in Mexico.
Objective:
This Ph.D. research was designed and carried out so get a better understanding on policies and practices of the MDLC areas for orthopaedic medical devices in Mexico. The research encompasses four objectives spanning from (i) defining which areas of procurement are crucial for clinical practice and outcomes of orthopaedic medical devices, (ii) assessing attitudes of stakeholders regarding outcomes of the MDLC areas and analysing knowledge-related factors that influence these areas, (iii) analysing challenges of and discussing possible ways forward in fostering the regulation, assessment, and management of orthopaedic medical devices in Mexico, and (iv) analysing interests, positions, and power of stakeholders to three alternative strategies to improve processes and practices with regard to the regulation, assessment, and management of orthopaedic medical devices in Mexico to assess the political feasibility of these strategies.
Methods:
We used a mainly qualitative research approach through overall 166 interviews (four sub-studies) and 187 survey participants (one sub-study) as well as a literature review (one sub-study) based on an overall framework that considers the MDLC relevant areas and the different levels by which the delivery of health care is being shaped.
First, we determined and analysed themes that were relevant to the different interest groups of the MDLC by using ‘procurement’ as starting point. We used in-depth interviews and interviewed 58 persons representing different stakeholders from four countries to define which areas of procurement are crucial for clinical practice and outcomes of orthopaedic HRMDs.
Second, we generated initial conclusions that served to further provide more specific insights on the most relevant themes. To do so we conducted two sub-studies: (i) we conducted a study using semi-structured interviews to assess opinions from 48 stakeholders from Mexico, and (ii) we conducted a survey to assess attitudes of 187 orthopaedic specialists from Mexico.
Third, we discussed ideas for possible ways forward in fostering the MDLC. To do so we conducted two sub-studies: (i) we interviewed 42 persons representing different stakeholders from Mexico to analyse challenges of and discuss possible ways forward in fostering the regulation, assessment, and management of orthopaedic medical devices in Mexico, and (ii) we used a literature review to discuss the contribution of survival rate benchmarks as decision-making rule.
Fourth, we analysed interests, positions, and power of stakeholders to specific strategies with regard to changes of processes and practices of the MDLC relevant areas. We used a stakeholder analysis method and included 17 persons representing multiple interest groups to analyse interests, positions, and power of stakeholders to three alternative strategies to improve processes and practices with regard to the regulation, assessment, and management of orthopaedic medical devices in Mexico to assess the political feasibility of these strategies.
Results:
The MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices, and this results in a situation that the quality of services delivered to patients is sub-optimal. First, the management of data and information is a critical aspect of the performance of the MDLC. Our research provided insights into problems related to data and information, and how this might have an influence on outputs and outcomes of the MDLC.
The focus on knowledge-related factors (second sub-study) allowed us to better explain the relation of MDLC function such as ‘management’ and clinical procedures for orthopaedic medical devices in Mexico. Second, technovigilance receives relatively high attention by policy makers in Mexico but that stakeholders of the MDLC underestimate its contribution regarding improving MDLC outcomes. Our research showed that the information flow between the micro level (observations from clinical practice) and macro level is relatively weak.
Third, in Mexico, HTA adds little value to decision-making and HTA at the level of hospitals has not received a lot of attention yet even though it may provide important benefits to the quality of health care and to the health system’s effectiveness. Fourth, stakeholders of the MDLC function ‘management’ in Mexico underestimate the role played by procurement regarding purchasing of orthopaedic HRMDs. Our research showed that decisions are either based on simple decision criteria or impacted by lowest-price offers. Quality attributes such as clinical long-term performance and intra-operative handling performance is rarely influencing into decision-making.
Conclusion:
Only some of the findings that our research has produced have been discussed in the literature before. This research is novel in terms of its specific focus on key MDLC functions and on orthopaedic medical devices. Further, it was timely because some of the presented themes are currently undergoing policy discussion in Mexico. The MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices.
The fragmentation of responsibilities of the MDLC areas, which is underpinned by the health system structure, has recently received more attention from different stakeholders and is subject to the current policy discussion. The suggested changes of current processes and practices of the regulation, assessment, and management can improve outputs and outcomes of these functions and positively influence the quality of health care and health system’s effectiveness. We have the following recommendations to the Mexican policy makers and other stakeholders related to the MDLC: (i) A government agency is needed to broadly oversee, monitor and report on quality-related issues within the health system; (ii) Decision-makers should apply an integrative approach of selecting medical devices to better prevent an economic and health burden due to disconnected processes and practices of the MDLC functions; (iii) Specific policies and organizational practice targeting orthopaedic medical devices are necessary; (iv) Technovigilance needs to be strengthened to improve the understanding of potential health risks associated with sub-standard HRMDs; (v) Data, information, and knowledge need to be managed appropriately across the sub-systems of health care provision; (vi) Technologies should be assessed during the purchasing process by applying strategies such as risk assessment, the adequate involvement of end-users, and basing decisions on multiple criteria including clinical impact in the short-term and long-term; (vii) The methodology applied to technology assessments for evaluating HRMDs needs to be adapted to the gold standard and HTAs at the level of hospitals should be introduced; (viii) Decision-making needs to distinguish between different risk classes of medical devices because decisions on complex medical devices are based on simple decision criteria; and (ix) ‘Procurement’ needs more attention so that actors involved in procurement or impacted by procurement decisions are less confronted by problems.