Abstract

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.

Conclusion

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.

Keywords
health technology; regulation; assessment; management; medical device

Resumen

Objetivo

Analizar el papel de actores clave ante tres estrategias para mejorar los procesos y prácticas relacionados con la regulación, evaluación y gestión de dispositivos médicos ortopédicos en México.

Material y métodos

Análisis de grupos de interés (stakeholder analysis) basado en un análisis documental y 17 entrevistas estructuradas con actores clave, dirigido a evaluar la viabilidad política de las estrategias.

Resultados

El papel de las agencias federales de gobierno, principalmente las relacionadas con calidad de atención, fue identificado como central y con mayor poder para influenciar la adaptación y aplicación de las estrategias. Como barreras se identificaron los recursos financieros y humanos, y reorientar la cultura organizacional hacia la reforma.

Conclusión

Las estrategias discutidas son políticamente viables. Resolver las barreras es importante para lograr cambios que optimicen el ciclo de vida de los dispositivos médicos e influyan positivamente en la calidad de atención y el desempeño del sistema de salud.

Palabras clave
tecnololgía biomédica; regulación; evaluación; gestión; dispositivos médicos

Introduction

Medical devices, together with drugs and other health technologies, comprise one of the six components considered as essential for good health system performance.¹1. World Health Organization. Systems thinking for health systems strengthening. Alliance for Health Policy and Systems Research [Internet]. Geneva: WHO, 2009 [cited 2016 Aug 4]. Available from:http://www.who.int/alliance-hpsr/resources/9789241563895/en/
http://www.who.int/alliance-hpsr/resourc... Accordingly, the regulation, assessment, and management of medical devices receive increasing attention by policy makers and health system experts involved in efforts to attain universal coverage of safe, equitable and high-quality health services.²2. Duke-Margolis Center for Health Policy. Better evidence on medical devices. A Coordinating Center for a 21st Century National Medical Device Evaluation System [report in internet]. Durham: Duke University, 2016 [cited 2016 Jun 4]. Available from:https://healthpolicy.duke.edu/better-evidence-medical-devices
https://healthpolicy.duke.edu/better-evi... ^,33. Bundesministerium der Justiz und für Verbraucherschutz. Das Fünfte Buch Sozialgesetzbuch-Gesetzliche Krankenversicherung. [Statute in internet]. Germany: Bundesministerium der Justiz und für Verbraucherschutz, 1988 &391;cited 2017 Dec 5]. Available from: https://www.gesetze-im-internet.de/sgb_5/BJNR024820988.htm
https://www.gesetze-im-internet.de/sgb_5... ^,44. World Health Organization. Medical devices: Managing the Mismatch: An outcome of the Priority Medical Devices project [report in internet]. Geneva: WHO , 2010 [cited 2016 Aug 4]. Available from:http://apps.who.int/iris/bitstream/10665/44407/1/9789241564045_eng.pdf
http://apps.who.int/iris/bitstream/10665... ^,55. International Society for Pharmaeconomics and Outcome Research [Internet]. Medical devices and diagnostics special interest groups [cited 2017 Jan 28]. ISPOR, 2017. Available from:https://www.ispor.org/sigs/MedDevicesDiagnostics.aspx
https://www.ispor.org/sigs/MedDevicesDia... At the centre of the discussion is the improvement of outputs and outcomes of the medical device life cycle (MDLC).⁶6. World Health Organization. Development of medical device policies, WHO Medical device technical series. Geneva: WHO, 2011 [cited 2016 Aug 2]. Available from: http://www.who.int/medical_devices/policies/en/
http://www.who.int/medical_devices/polic... A cohesive medical devices policy, well planned, supported and coordinated among all areas represented by the MDLC stakeholders (i.e. those involved in regulation, assessment, and management) is necessary to meet the population needs and to ensure the quality of health care.⁶6. World Health Organization. Development of medical device policies, WHO Medical device technical series. Geneva: WHO, 2011 [cited 2016 Aug 2]. Available from: http://www.who.int/medical_devices/policies/en/
http://www.who.int/medical_devices/polic...

The Mexican health system is composed by a complex structure that includes various ‘sub-systems’ in charge of health service regulation, financing and provision. Most important ‘sub-systems’ are the public social security institutes (Mexican Institute of Social Security, IMSS and Institute of Social Security and Services for State Workers, ISSSTE) and the state-level health care services (SESA), which function along a large number of private health care providers.⁷7. Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems. Paris: OECD Publishing, 2016. https://doi.org/10.1787/9789264230491-en
https://doi.org/10.1787/9789264230491-en... ^,88. Gómez-Dantés O, Sesma S, Becerril V, Knaul FM, Arreola H, Frenk J. The health system of Mexico. Salud Publica Mex. 2011;53(Suppl2):s220-32. The Ministry of Health (MOH) and its departments enact regulations and recommendations at the federal level for the public and private sector, but the ‘sub-systems’ (such as social security institutes) comply with these in different ways due to their specific legal regulations and embedment.⁹9. Organización Panamericana de la Salud. Perfil del sistema de servicios de salud México. Washington: OPS, 2002 [cited 2016 Oct 21]. Available from: http://www1.paho.org/hq/dmdocuments/2010/Perfil_Sistema_Salud-Mexico_2002.pdf
http://www1.paho.org/hq/dmdocuments/2010... ^,1010. Frenk J, Gonzalez-Pier E, Gómez-Dantés O, Lezana Mç, Knaul FM. Comprehensive reform to improve health system performance in Mexico. Salud Publica Mex. 2007;49(Suppl 1):s23-36. The health system is characterized by a distribution of roles across a substantial number of actors resulting in a fragmentation of responsibilities.

This fragmentation of roles and responsibilities is well illustrated with regard to medical devices. The General Health Council (CSG), an independent governmental organisation is responsible for overseeing the Inter-institutional Commission of the Standard List for Health Supplies; the Federal Commission for the Protection against Sanitary Risks (Cofepris), an autonomous MOH agency, is responsible for the quality and safety of new medical drugs, medical devices and other health inputs; while the National Centre for Health Technology Excellence (Cenetec), a central MOH office, is responsible for health technology assessments, supervision of medical equipment, and clinical guidelines.¹¹11. Knaul FM, Gonzalez-Pier E, Gómez-Dantés O, García-Junco D, Arreola-Ornelas H, Barraza-Llorens M, et al. The quest for universal health coverage: achieving social protection for all in Mexico. Lancet. 2012;380(9849):1259-79. https://doi.org/10.1016/S0140-6736(12)61068-X
https://doi.org/10.1016/S0140-6736(12)61... Notwithstanding their important achievements, it has been stressed that the functioning of these agencies has room for improvement; specially, with regard with their linkage with guidelines for the quality of care and with assuring value for money across all ‘sub-systems’.⁷7. Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems. Paris: OECD Publishing, 2016. https://doi.org/10.1787/9789264230491-en
https://doi.org/10.1787/9789264230491-en... The Mexican Congress is discussing the creation of the Federal Commission for the Regulation and Surveillance of Health Care Services and Facilities,¹²12. Cámara de diputados. Anexo XXVI. Gaceta Parlamentaria [statute in internet]. México: Cámara de diputados, 2016 [cited 26 Sep 2016]. Available from:http://sil.gobernacion.gob.mx/Archivos/Documentos/2016/04/asun_3377525_20160428_1461890047.pdf
http://sil.gobernacion.gob.mx/Archivos/D... which could generate momentum for the uptake of a broad spectrum of aspects concerning quality in health care and this may support outcomes of the MDLC areas; therefore, the stakeholder analysis presented here comes in a timely manner.

In a series of previous studies we analysed critical aspects between and within key MDLC functions and discussed ideas about desired changes to overcome identified challenges (table I).¹³13. Lingg M, Wyss K, Duran-Arenas L. How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico? BMC Med Inform Decis Mak. 2016;16:85 https://doi.org/10.1186/s12911-016-0324-1
https://doi.org/10.1186/s12911-016-0324-... ^,1414. Lingg M, Wyss K, Duran-Arenas L. Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries. BMC Health Serv Res. 2016;16:362 https://doi.org/10.1186/s12913-016-1610-4
https://doi.org/10.1186/s12913-016-1610-... ^,1515. Lingg M, Merida-Herrera E, Wyss K, Duran-Arenas L. Attitudes of orthopaedic specialists towards effects of medical device purchasing. Int J Technol Assess Health Care. 2017;33(1):46-53. https://doi.org/10.1017/S0266462317000101
https://doi.org/10.1017/S026646231700010... ^,1616. Lingg M, Dreser A, Duran-Arenas L, Wyss K. The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare? Safety in Health. 2017;3(1):4 https://doi.org/10.1186/s40886-017-0055-8
https://doi.org/10.1186/s40886-017-0055-... The findings highlighted that the overall MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices (OMDs), resulting in sub-optimal quality of services delivered to patients. This finding resonates with concerns raised by other authors regarding the regulation, assessment, and management of health services in Mexico at different levels of health care delivery.⁷7. Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems. Paris: OECD Publishing, 2016. https://doi.org/10.1787/9789264230491-en
https://doi.org/10.1787/9789264230491-en... ^,99. Organización Panamericana de la Salud. Perfil del sistema de servicios de salud México. Washington: OPS, 2002 [cited 2016 Oct 21]. Available from: http://www1.paho.org/hq/dmdocuments/2010/Perfil_Sistema_Salud-Mexico_2002.pdf
http://www1.paho.org/hq/dmdocuments/2010... ^,1717. Gómez-Dantés O, Frenk J. Health technology assessment in Mexico. Int J Technol Assess Health Care. 2009;25(Suppl 1):270-5. https://doi.org/10.1017/S0266462309090746
https://doi.org/10.1017/S026646230909074... ^,1818. World Health Organization. Country data - Global atlas of medical devices. [cited 2016 Aug 15]. Available from: http://www.who.int/medical_devices/countries
http://www.who.int/medical_devices/count... ^,1919. Ruelas E, Gómez-Dantés O, Leatherman S, Fortune T, Gay-Molina JG. Strengthening the quality agenda in health care in low- and middle-income countries: questions to consider. Int J Qual Health Care. 2012;24(6):553-7. https://doi.org/10.1093/intqhc/mzs061
https://doi.org/10.1093/intqhc/mzs061...

The aim of the present study is to review three alternative strategies to improve the regulation, assessment, and management of orthopaedic medical devices in Mexico with regard to their political feasibility.

Materials and methods

The strategies under review (table I) stem from our previous study,¹⁶16. Lingg M, Dreser A, Duran-Arenas L, Wyss K. The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare? Safety in Health. 2017;3(1):4 https://doi.org/10.1186/s40886-017-0055-8
https://doi.org/10.1186/s40886-017-0055-... which discusses alternatives to improve the outcomes of the MDLC. In the present study, we reviewed three strategies regarding their political feasibility based on a structured stakeholder analysis to identify key stakeholders, and their potential stake, interest, position and power.²⁰20. Schmeer K. Guidelines for conducting a stakeholder analysis. Bethesda, MD: Partnerships for Health Reform, Abt Associates Inc, 1999 [cited 2017 Jan 28]. Available from: http://www.who.int/entity/management/partnerships/overall/GuidelinesConductingStakeholderAnalysis.pdf
http://www.who.int/entity/management/par... ^,2121. Hyder A, Syed S, Puvanachandra P, Bloom G, Sundaram S, Mahmood S, et al. Stakeholder analysis for health research: Case studies from low- and middle-income countries. Public Health. 2010;124(3):159-66. https://doi.org/10.1016/j.puhe.2009.12.006
https://doi.org/10.1016/j.puhe.2009.12.0... ^,2222. Buse K, Dickinson C, Gilson L, Murray SF. How can the analysis of power and process in policy-making improve health outcomes? World Hosp Health Serv. 2009;45(1):4-8.^,2323. Reich MR. The politics of reforming health policies. Promot Educ. 2002;9(4):138-42. Available from: https://cdn1.sph.harvard.edu/wp-content/uploads/sites/480/2012/10/Politics_of_reform.pdf
https://cdn1.sph.harvard.edu/wp-content/...

Identifying stakeholders

To identify the most relevant stakeholders we did a general search in Portal de Obligaciones de Transparencia, which lists all government units or institutes and their departments and facilitates the access to government information. Further, we complemented the retrieved data by stakeholder information as provided by our previous study findings and documental analysis of information on the identified stakeholders such as recent advancements, or future projects related to the key functions of medical devices. Based on the obtained data we developed a list of most relevant stakeholders regarding medical device regulation, assessment, and management. We classified stakeholders according to four levels: macro level (normative and policy mechanism), meso level (service provision), micro level (specialists and orthopaedic associations), and supplier level (medical device suppliers and medical device industry associations). Further, we described their relative importance regarding the regulation, assessment, and management of medical devices.

Data collection

We contacted prospective participants between November 2016 and January 2017 by email and presented our study rationale and research. We used a maximum variation sampling to recruit stakeholders to achieve a balanced variety of stakeholders and diversity of data. Data collection was based on 17 structured interviews to collect data from the interviewees on themselves but also their opinions on other stakeholders (table II). For the interviews we used a questionnaire^**Supplementary file [dataset in internet]. Harvard Dataverse. 2017. https://doi.org/10.7910/DVN/8fatyz with mainly closed-ended questions using a 5-point Likert scale. The questionnaire was previously tested among three Mexican stakeholders. We used a file-naming system and anonymised interviewees by generating a list of archival numbers.

Data analysis

We analysed the retrieved data and information on stakeholders based on four characteristics and regarding each of the three strategies (organized as sub-sections): (i) ‘Potential stake’ to distinguish between stakeholders potentially important to carrying the discussed strategy forward, considered being moderately valuing with the strategy, or not important to carrying the discussed strategy forward; (ii) ‘Interest’ to display the stakeholder’s opinion in the strategies based on advantages or disadvantages that these may bring to the stakeholder; (iii) ‘Position’ to present whether the stakeholder supports, opposes, or is neutral about the strategy; and (iv) ‘Power’ to differentiate between high to low influence regarding the realization of the strategy. Based on the stakeholder information, we discussed for each strategy its political feasibility.

Ethics

The committee for research and ethics, research division of the medical faculty of the National Autonomous University of Mexico, approved this project (Date of approval: November 4, 2014; oficio no. FMED/CI/SPLR/188/2014; dictamen proyecto: 143-2014). No formal ethical approval was needed from the ethical committee from Northwest and Central Switzerland (Switzerland), which exempted it from ethical review under Swiss law (June 24, 2014). All interviewees provided informed consent before the interview.

Results

Most relevant stakeholders

Table III displays the most relevant stakeholders. Their relative importance regarding the three strategies is decreasing from the macro to the micro levels at least for ‘regulation’ and ‘assessment’ of medical devices. Stakeholders with a relative high importance for regulation is Cofepris, for assessment are Cenetec and CSG, and for management are the ‘sub-systems’.

Analysis of stakeholders regarding strategies under review

Table IV displays the most relevant stakeholders regarding each of the three strategies under review (‘potential stake’). Further, it summarizes their ‘Interest’ and indicates their ‘Position’ and ‘Power’ towards these strategies.

Findings regarding strategy for improving ‘Regulation’

The analysis identifies Cofepris as a stakeholder with high potential stake to carrying technovigilance strengthening forward. Its ‘interest’ is relatively focused on the following advantages that this strategy would imply for their own organisation: improving report quality of e.g. incidents; achieving stakeholder support; improving quality of health services; preventing sub-standard products. Its ‘position’ was categorized as supporter of this strategy. The ‘power’ of Cofepris is being considered by different stakeholders as high, because technovigilance is one of its responsibilities.

Cofepris is a critical organization within the Mexican health system and holds the overall responsibility for technovigilance. Other relevant stakeholders considered being moderately supporting the strategy but to be involved in one way are: MOH (in general, but particularly DGCES and Cenetec); the ‘sub-systems’ (different actors in charge of health service regulation, financing and provision); orthopaedic community; and medical device community. Their ‘interest’ is relatively focused on ‘access to data’ such as data quality and availability; stakeholder support; enhancing knowledge. Their ‘position’ was categorized between supporter and moderate supporter, and the level of their potential influence ranged from moderate to low.

Few stakeholders mentioned that the requirement catalogue for hospital certification, which is not compulsory, should include as well technovigilance as a component. In Mexico, hospital certification is aligned to the Joint Commission requirements and overseen by CSG.²⁴24. The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, 2012 [cited 07 Abr 2016]. Available from:https://www.jointcommission.org/assets/1/18/TJC-ImprovingPatientAndWorkerSafety-Monograph.pdf
https://www.jointcommission.org/assets/1...

Findings regarding strategy for improving ‘Assessment’

The analysis identifies DGCES, CSG, and Cenetec as stakeholders with high potential stake to carrying forward quality attributes of medical device assessments. Their ‘interest’ is focused on the following advantages that this strategy would imply for their own organizations: relating decision-making to quality attributes of medical devices; guiding decisions on eligibility of medical devices; improving quality of health services; generating transparency on decisions; introducing technology assessment at hospital level; controlling expenditures; being in line with current quality efforts; improving data bases; creating regulations for determining quality of medical devices; assuring safe use of products; strengthening decisions about medical device eligibility. Their ‘position’ was categorized as supporter of this strategy. The ‘power’ of these three stakeholders was being considered as moderate, because clinical long-term aspects of medical devices as dynamic quality attribute haven’t been in the focus of any of these stakeholders so far.

Other relevant stakeholders considered being moderately supporting the strategy but to be involved in one way are Cofepris, National Academy of Health (ANM), ‘sub-systems’, and orthopaedic community (e.g. orthopaedic specialists and orthopaedic associations). Their ‘interest’ is focused on the following advantages that this strategy would imply for their own organisations: promoting transparency and evidence-based decisions. Their ‘position’ was categorized between supporter and moderate supporter of stronger quality attributes of assessments, and the level of their potential influence low to high. Overall, this would positively influence the decision-making process regarding decision-making attributes.

Few stakeholders mentioned that such strategy requires an increase in human resources but that recent budget cuts may currently not allow allocation of required financial resources to pursue such strategy.

Findings regarding strategy for improving ‘Management’

The analysis identifies DGCES and ‘sub-systems’ stakeholders with high potential stake to carrying forward an orthopaedic specific purchasing strategy. The ‘interest’ of these two actors is focused on the following advantages that this strategy would imply for their own organisations: achieving similar level of quality of health services across ‘sub-systems’; improving the management of financial resources; achieving cost-benefit; improving quality of health services; improving quality of procurement outcomes; enhancing human resource skills; preventing problems during clinical practice; developing procurement specialists based on medical speciality for high-risk class medical devices; satisfying outcomes; updating profile requirements of procurement agents.

Their ‘position’ was categorized as supporter of this strategy. The ‘power’ of DGCES is being considered as moderate and that of social security institutes (‘sub-systems’) as high.

Other relevant stakeholders considered being moderately supporting the strategy, but to be involved in one way are Cenetec and the orthopaedic community. Their ‘interest’ was focused on the following advantages that this strategy would imply: cross sharing expertise between involved stakeholders, and prevention of sub-standard outcomes. Their ‘position’ was categorized as supporter, and the level of their potential influence low to high. Overall, this would positively influence the decision-making process regarding procurement outcomes.

Few stakeholders mentioned that the role played by DGCES should be strengthened to enhance the competencies of procurement agents and to realize subsequent effects of improved outcomes of purchasing strategies such as Servicio Integral, which encompasses a range of disposable and non-disposable medical products used for surgery and merges them into one supplier service.

Discussion

The discussed strategies to improve the MDLC were largely perceived to be within the competence of central government (CSG) and MOH agencies: Cofepris, DGCES, and Cenetec. These are the different interest groups that have started looking deeper into needs that this study focuses on; however, in Mexico as in other countries the discussion about challenges or weaknesses regarding the MDLC areas develops slowly.⁷7. Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems. Paris: OECD Publishing, 2016. https://doi.org/10.1787/9789264230491-en
https://doi.org/10.1787/9789264230491-en... ^,1212. Cámara de diputados. Anexo XXVI. Gaceta Parlamentaria [statute in internet]. México: Cámara de diputados, 2016 [cited 26 Sep 2016]. Available from:http://sil.gobernacion.gob.mx/Archivos/Documentos/2016/04/asun_3377525_20160428_1461890047.pdf
http://sil.gobernacion.gob.mx/Archivos/D... ^,2525. Coronel MR. Viene fuerte desregulación en tecnología médica. El Economista [internet] 2017 [cited 2017 Feb 12]. Available from: Available from: http://eleconomista.com.mx/columnas/salud-negocios/2017/02/08/viene-fuerte-desregulacion-tecnologia-medica
http://eleconomista.com.mx/columnas/salu... For instance, at the government level the MOH is developing a new policy that aims to strengthen technovigilance across all ‘sub-systems’ of the health-system. One aspect of this policy is to integrate technovigilance into the requirement catalogue for hospital accreditation. Further, the participation of the private sector (industrial-commercial sector) in the policy-making increases and will contribute to enrich policy discussion by their interests. At the same time the participation of the public and professional associations in decision-making remains limited.¹³13. Lingg M, Wyss K, Duran-Arenas L. How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico? BMC Med Inform Decis Mak. 2016;16:85 https://doi.org/10.1186/s12911-016-0324-1
https://doi.org/10.1186/s12911-016-0324-... ^,1414. Lingg M, Wyss K, Duran-Arenas L. Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries. BMC Health Serv Res. 2016;16:362 https://doi.org/10.1186/s12913-016-1610-4
https://doi.org/10.1186/s12913-016-1610-... ^,1515. Lingg M, Merida-Herrera E, Wyss K, Duran-Arenas L. Attitudes of orthopaedic specialists towards effects of medical device purchasing. Int J Technol Assess Health Care. 2017;33(1):46-53. https://doi.org/10.1017/S0266462317000101
https://doi.org/10.1017/S026646231700010... These findings coincide largely with the literature that portrays public policy-making in Mexico as a governmental-centred process, largely impermeable to civil society participants, but increasingly influenced by the private sector.²⁶26. Camp RA. The Oxford Handbook of Mexican Politics. USA: Oxford University Press, 2012.^,2727. Cabrero-Mendoza E. Usos y costumbres en la hechura de las políticas públicas en México. Límites de las policy sciences en contextos cultural y políticamente diferentes. Gestión y Política Pública. 2000;9(2):189-229 [cited 2017 Feb 12]. Available from:http://www.gestionypoliticapublica.cide.edu/num_anteriores/Vol.IX_No.II_2dosem/CME_Vol.9_No.II_2sem.pdf
http://www.gestionypoliticapublica.cide.... We found that ANM can act as visionary for at least orthopaedic associations and therefore play an important role to change this situation in the future.

During this study we only identified significant differences regarding the power of the multiple actors to potentially influence policy (in favour). Central level government agencies were perceived as those with greater power to influence policies. In this sense, we found that the policy environment is in favour of developing such strategies and no one strategy seems to be preferred over the other. This leads to the impression that they are all politically feasible. However, organisational culture towards reform and leadership is a barrier. This came up in some of the interviews and was referred to the relation of national government offices and social security institutions regarding reforms or guidelines, for example, and how the different social security institutions adapt them. For instance, the ‘sub-systems’ tend to adapt the national standard list to their needs. Further, any strategy that intends to change processes or practices of the MDLC functions requires being included into the political agenda at federal level.

The discussed strategies are a matter of multiple actors and interviewees emphasized the role played by the social security institutions regarding the successful realization of any changes to processes and practices in order to improve outputs and outcomes of the MDLC areas.

Overall, we found that improving the MDLC is politically feasible, and may positively influence the health system performance regarding two central aspects. First, it may increase quality of care e.g. at the level of health care professionals because their clinical practice will be less affected by sub-standard medical devices and patients will benefit from orthopaedic medical devices that create less burden of revision. Second, it may support the health system’s efficiency by post-market surveillance activities that effectively identify medical devices of sub-standard clinical long-term performance, and improve decision-making through improved technology assessments.

OECD recommended specifically in its 2016 Mexico’s health systems report to improve technology assessment and regulation of medical devices, and strengthening the role of Cenetec.⁷7. Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems. Paris: OECD Publishing, 2016. https://doi.org/10.1787/9789264230491-en
https://doi.org/10.1787/9789264230491-en... We found that good progress has been made in the authorisation and safety of new technologies through Cofepris. Still, however, not enough is known about the quality and outcomes achieved by the multiple social security institutes. A national and comprehensive approach to collect data of the quality of care remains lacking.

At the level of medical device assessment, Cenetec has the potential to be strengthened in its role and take on more extensive responsibilities in e.g. producing Health Technology Assessments (HTAs). Analyses should not just be applied to new treatments but to existing ones as well, to encourage value for money across the system. Rather than just focussing on services for the uninsured provided by the MOH health services, Cenetec’s remit should expand to cover the social security institutes as well. The expansion of Cenetec’s role will require increased investment, and modification of its legal status may also be necessary. Currently, it operates as a subsidiary unit within the MOH and is limited in its ability to contract with external bodies. Re-establishing CENETEC as an independent and decentralized office would solve this issue.

Limitations

This study has several limitations. We used the stakeholder analysis as foresight, which deals with uncertainty but helps as well to probe system boundaries. Additionally, the way in which we conducted and interpreted the analysis is not value free and potentially may have resulted in some bias. The stakeholder analysis did not reveal any group that presented itself as opposed to any of the three strategies. In-depth analysis of each strategy is necessary to assess direct or indirect improvements of cost-benefit aspects of health technologies, patient safety, workforce, quality of health care and performance of organisational processes that aim at discussing them in greater detail in the context of financial and human resources of the identified ‘main stakeholders’ for each strategy.

Conclusions

This study used a stakeholder analysis as foresight to better understand positions of different groups and institutions to changes to current processes and practices of the MDLC for medical devices. 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. To date, policy makers have endeavoured to advance the regulation, assessment, and management of medical devices. However, needs for improvement are rarely analysed in a broad way, even though these functions contribute importantly to the successful implementation of health technology policies.

The coordination of changes among stakeholders is complex in Mexico due to the longstanding distribution of roles and responsibilities across multiple organisations. 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.

Furthermore, within the ‘sub-systems’ a similar fragmentation of the responsibilities of the MDLC is replicated. For example, within IMSS there have their own offices that deal with MDLC responsibilities independently from the MHO agencies.

In Mexico, discussion and proposals by interest groups are slowly gaining momentum on how to improve the regulation, assessment, and management of medical devices. We have the following recommendations to the Mexican policy makers and other stakeholders related to the MDLC: (i) initiating a working group at national level that aims at refining the discussed strategies, (ii) enhancing the communication between different interest groups as identified in this analysis at the meso and macro level, (iii) fostering the role played by ANM and its relation to professional associations.

References

Publication Dates

History