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.

"Red-Yellow-Green": Effect of an Initiative to Guide Surgeon Choice of Orthopaedic Implants.

BACKGROUND: Orthopaedic procedures are expensive, and devices account for a large proportion of the overall costs. Hospitals have employed a variety of strategies to decrease implant costs, but many center on restricting surgeon choice. At our institution, we developed an implant selection tool that guides surgeons toward more cost-effective implants, while minimally restricting choice. The purpose of this study was to assess the effect of this tool on preferred implant usage rates, vendor attitudes toward pricing structure, and hospital implant expenditures. METHODS: For 6 commonly used orthopaedic trauma devices, similar constructs were created for the 4 vendors used at our hospital, and the costs were determined. On the basis of these costs, the available options for each device type were categorized as "green" (preferred vendor), "yellow" (midrange), or "red" (used for patient-specific requirements). The "Red-Yellow-Green" chart was posted on the wall of each orthopaedic trauma operating room. To assess the effect of the tool, we compared implant usage patterns before and after implementation of the implant selection tool. We also assessed changes in vendor contract prices, as well as overall savings to our institution. RESULTS: Implant usage changed significantly from 30% "red," 56% "yellow," and 14% "green" prior to the intervention, to 9% "red," 21% "yellow," and 70% "green" after the intervention (p < 0.0001). As a result of price renegotiation with vendors following implementation, we observed average price decreases that ranged from 1.1% to 22.4%. Average expenditures on these 6 implants decreased 20% during the study period, which represented a savings of $216,495 per year. CONCLUSIONS: At our institution, we designed and implemented "Red-Yellow-Green," a simple tool that guides surgeons toward the selection of lower-cost implants without violating vendor confidentiality clauses, limiting the implants from which surgeons can choose, or requiring surgeons to discern the prices of complex constructs. Following implementation, hospital implant expenditures decreased as a result of a combination of increased preferred vendor usage by surgeons, as well as increased competition among vendors, which resulted in lower overall prices.

Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices.

BACKGROUND CONTEXT: Recently, there has been increased public awareness of regulatory actions by the United States Food and Drug Administration (FDA) on spinal devices. There has also been increased scrutiny of the pivotal clinical trials of these devices. PURPOSE: To investigate the premarket approval (PMA) of class III spinal devices in the United States since the turn of the century. To explore clinically relevant issues that affect the interpretation of investigational device exemption trials. STUDY DESIGN: Literature review. METHODS: From 2000 to 2015, data on PMA applications for spinal devices were obtained from two sources. First, meetings of FDA's Orthopaedic and Rehabilitation Devices Panel were identified from the Federal Register. Second, the FDA database of approved PMA applications was queried. For each device, two authors reviewed all archival data. There was no external source of funding. RESULTS: Twenty-one devices met the study criteria. There were 76.2% that received approval and 47.6% that went to panel. Arthroplasty devices were most common (52.4%), least likely to go to panel (3 of 11), and most likely to be approved after panel (3 of 3). Biologic devices were most likely to go to panel (3 of 3) and least likely to be approved after panel (1 of 3). Before and after 2009, there was no decrease in the number of spinal devices approved. All 21 devices were studied in a pivotal clinical trial. All trials except one were randomized controlled trials, and all trials except one were two-arm noninferiority designs. CONCLUSIONS: There has been no decrease in the number of new FDA-approved class III spinal devices since the turn of the century. The majority of devices have been for cervical arthroplasty. By contrast, biologic devices were most likely to go to panel and least likely to be approved after panel. The pivotal trials for nearly all devices were randomized, two-arm, noninferiority trials.

Surgeon Attitudes Regarding the Use of Generic Implants: An OTA Survey Study.

OBJECTIVES: To determine the role of generic orthopaedic trauma implants in the current orthopaedic trauma market, as perceived by OTA members, and investigate potential hurdles to the use of generic implants and other cost-containment measures. DESIGN: Survey study. SETTING: Not applicable. PARTICIPANTS: All active OTA members with valid e-mail addresses were invited to participate. INTERVENTION: Participants completed a brief online survey with questions regarding participation in cost-containment and incentive programs, industry relationships, generic implant use, and the role of surgeons in cost containment. MAIN OUTCOME MEASURES: Survey data. RESULTS: Participation in cost-containment programs (comanagement agreements, bundled payment for care improvement, and gainsharing) was found to be very low among participants (17%, 36.5%, 17%, respectively). Industry sales representatives were present in a majority of participants' cases (76.9%) the majority of time, but relatively a few surgeons (21.2%) felt their presence was necessary. Most surgeons were aware of the availability of generic implants (72.6%), but a few had adopted the use of such implants (25.5%), despite 50/52 (96.2%) prescribing generic drugs and 45/52 (86.5%) using generic products in their own households. CONCLUSIONS: Most participants agreed that generic orthopaedic implants have a role in cost containment, but a few have adopted these implants. The presence of sales representatives does not seem to be necessary for most surgeons, and minimizing or eliminating their presence may result in substantial savings for health care institutions. Increased education and the use of financial incentive programs may encourage improved surgeon participation in cost containment and adoption of generic implants and may help reduce health care spending. LEVEL OF EVIDENCE: Level 4. See Instructions for Authors for a complete description of levels of evidence.

Financial Impact of Dual Vendor, Matrix Pricing, and Sole-Source Contracting on Implant Costs.

Implant costs comprise the largest proportion of operating room supply costs for orthopedic trauma care. Over the years, hospitals have devised several methods of controlling these costs with the help of physicians. With increasing economic pressure, these negotiations have a tremendous ability to decrease the cost of trauma care. In the past, physicians have taken no responsibility for implant pricing which has made cost control difficult. The reasons have been multifactorial. However, industry surgeon consulting fees, research support, and surgeon comfort with certain implant systems have played a large role in slowing adoption of cost-control measures. With the advent of physician gainsharing and comanagement agreements, physicians now have impetus to change. At our facility, we have used 3 methods for cost containment since 2009: dual vendor, matrix pricing, and sole-source contracting. Each has been increasingly successful, resulting in massive savings for the institution. This article describes the process and benefits of each model.

Taking a Concept to Commercialization: Designing Relevant Tests to Address Safety.

Taking a product from concept to commercialization requires careful navigation of the regulatory pathway through a series of steps: (A) moving the idea through proof of concept and beyond; (B) evaluating new technologies that may provide added value to the idea; (C) designing appropriate test strategies and protocols; and (D) evaluating and mitigating risks. Moving an idea from the napkin stage of development to the final product requires a team effort. When finished, the product rarely resembles the original design, but careful steps throughout the product life cycle ensure that the product meets the vision.

Person factors and work environments of workers who use mobility devices.

BACKGROUND: Nearly 25% of people with mobility impairments and limitations who are of working age are employed, yet few studies have examined their perspectives on their jobs or work environments required to complete job tasks. OBJECTIVE: The purpose of this study was to describe the factors that contribute to successful employment for those who use mobility devices. PARTICIPANTS: A convenience sample of 132 workers who use power wheelchairs, manual wheelchairs, canes, crutches or walkers. METHOD: Participants completed an online version of the Mobility Device User Work Survey (MWS). A multivariate analysis and a two-step multiple linear regression analysis were used. RESULTS: Study participants had few secondary health conditions that influenced their work. Employee satisfactoriness to their employers was high. Accessibility of worksites was high. Assistive technologies were inexpensive, and personal assistance was used infrequently and usually was unpaid. Co-worker communications were very positive. Flexible work rules and supportive managers were highly valued. Job satisfaction positively correlated with accessibility, work tasks, co-worker communication and work support. CONCLUSION: The description of work environments of successfully employed mobility device users can provide some useful guidance to employers, vocational rehabilitation (VR) counselors and unemployed mobility device users to balance employee abilities and preferences with the needs of employers.

iPad apps for orthopedic surgeons.

The development and distribution of mobile applications, or apps, designed for medical professionals and patients is quickly expanding, and within this group are apps designed specifically for orthopedic use. Currently, the most popular mobile apps are sponsored by private companies and focus on delivering device-specific information. If this trend toward the use of privately funded educational materials continues, regulations may need to be established to ensure that the information provided is accurate, honest, and supported by peer-reviewed literature. It will likely be the responsibility of the orthopedic community to ensure that the development and use of these apps has appropriate oversight and validation as they are incorporated into clinical practice and training.

Orthopaedic surgeons in the pocket of the industry.

The development of new orthopaedic products depends on a close cooperation between orthopaedic surgeons and the industry. However, in recent years a number of cases of financial collusion between the industry and parts of the professional orthopaedic environment in the US have been exposed. This has highlighted the question of the extent to which orthopaedic-related research and development may have been influenced by inappropriate financial incentives.

Financial payments by orthopedic device makers to orthopedic surgeons.

BACKGROUND: There is ongoing concern over potential conflict of interest inherent in physician relationships with industry. However, there are limited empirical data detailing the prevalence and magnitude of these relationships. Our objective was to use data made available by a US Department of Justice (DOJ) lawsuit to describe the extent of orthopedic surgeons' financial relationships with implant manufacturers. METHODS: We used data made available by the 2007 DOJ settlement with 5 major joint implant manufacturers to detail the number of orthopedic surgeons receiving payments, the size of these payments, the aggregate dollar amount, and the proportion going to academically affiliated orthopedic surgeons between 2007 and 2010. RESULTS: In 2007, 1041 payments totaling in excess of $198 million were made to 939 orthopedic surgeons. In 2008, following the DOJ settlement, the implant makers made 568 payments totaling more than $228 million to 526 orthopedic surgeons (which included $109 million in one-time royalty buyouts by a single firm). The proportion of surgeons receiving payments who had academic affiliations rose from 39.4% in 2007 to 44.9% in 2008. Similar patterns were observed in 2009 and 2010 for 3 firms that continued to disclose by choice. We also noted substantial variation across firms in the details provided in the disclosed data. CONCLUSIONS: The impact of the DOJ settlement in the short term appears complex, with an increase in payments, a decline in the number of consultants, and an increase in the proportion of consultants drawn from academia. There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed.