The Role of Gender, Academic Affiliation, and Subspecialty in Relation to Industry Payments to Orthopaedic Surgeons.

BACKGROUND: The Physician-Payments-Sunshine-Act (PPSA) was introduced in 2010 to provide transparency regarding physician-industry payments by making these payments publicly available. Given potential ethical implications, it is important to understand how these payments are being distributed, particularly as the women orthopaedic workforce increases. The purpose of this study was thus to determine the role of gender and academic affiliation in relation to industry payments within the orthopaedic subspecialties. METHODS: The PPSA website was used to abstract industry payments to Orthopaedic surgeons. The internet was then queried to identify each surgeon's professional listing and gender. Mann-Whitney U, Chi-square tests, and multivariable regression were used to explore the relationships. Significance was set at a value of P < 0.05. RESULTS: In total, 22,352 orthopaedic surgeons were included in the study. Payments were compared between 21,053 men and 1299 women, 2756 academic and 19,596 community surgeons, and across orthopaedic subspecialties. Women surgeons received smaller research and non-research payments than men (both, P < 0.001). There was a larger percentage of women in academics than men (15.9% vs 12.1%, P < 0.001). Subspecialties with a higher percentage of women (Foot & Ankle, Hand, and Pediatrics) were also the subspecialties with the lowest mean industry payments (all P < 0.001). Academic surgeons on average, received larger research and non-research industry payments, than community surgeons (both, P < 0.001). Multivariable linear regression demonstrated that male gender (P = 0.006, P = 0.029), adult reconstruction (both, P < 0.001) and spine (P = 0.008, P < 0.001) subspecialties, and academic rank (both, P < 0.001) were independent predictors of larger industry research and non-research payments. CONCLUSIONS: A large proportion of the US orthopaedic surgeon workforce received industry payments in 2014. Academic surgeons received larger payments than community surgeons. Despite having a larger percentage of surgeons in academia, women surgeons received lower payments than their male counterparts. Women also had a larger representation in the subspecialties with the lowest payments.

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.

Strategies to improve the medical device life cycle in Mexico / Estrategias para mejorar el ciclo de vida de dispositivos médicos en México

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.

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.

Assistive technology provision: towards an international framework for assuring availability and accessibility of affordable high-quality assistive technology.

PURPOSE: This is a position paper describing the elements of an international framework for assistive technology provision that could guide the development of policies, systems and service delivery procedures across the world. It describes general requirements, quality criteria and possible approaches that may help to enhance the accessibility of affordable and high quality assistive technology solutions. MATERIALS AND METHODS: The paper is based on the experience of the authors, an analysis of the existing literature and the inputs from many colleagues in the field of assistive technology provision. It includes the results of discussions of an earlier version of the paper during an international conference on the topic in August 2017. RESULTS AND CONCLUSION: The paper ends with the recommendation to develop an international standard for assistive technology provision. Such a standard can have a major impact on the accessibility of AT for people with disabilities. The paper outlines some the key elements to be included in a standard. Implications for Rehabilitation Assistive technology is a key element in rehabilitation, but many people have no access to affordable AT solutions. The recommendations in the paper aim to inform policies, systems and service delivery procedures on how to improve access to AT across the world.

The natural history of new orthopaedic devices.

Each year, hundreds of new devices and implants are introduced for orthopaedic surgeons. However, the proportion of new devices which ultimately will be successful is unknown. We investigated the natural history of new devices introduced to the orthopaedic market. From a list of all devices approved for use by the Food & Drug Administration 5 and 10 years before, a cohort of 100 devices was randomly selected using a random number list. Companies were contacted regarding the safety record and current availability of these devices. The company response rate was 93%. Forty-seven percent of devices approved 10 years ago and 25% of devices approved 5 years ago no longer were on the market. Of the 55 companies studied, 18 (33%) were out of business and their devices no longer were available. Devices approved 10 years ago were more likely to be unavailable than devices approved 5 years ago. Devices introduced by smaller companies were more likely to be unavailable. The majority of unavailable devices were discontinued not for clinical problems, but for poor market performance. Only 2% of devices studied had safety problems. Approximately 50% of devices approved for introduction to the orthopaedic marketplace no longer are available 10 years later. However, major device-related problems seem uncommon.