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Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.

Introduction: Implant wastage is an under-reported issue in orthopaedics, yet it has been shown to have a significant cost burden on healthcare budgets. In a background of a perilous financial climate in the UK health service, our aim was to define the frequency and costs of implant wastage in orthopaedic trauma., Materials and Methods: The trauma theatre's implant logbook was retrospectively analysed between April 2017 and April 2018. Wasted implants were identified by the study authors independently. Patient demographics, implant details and costs were among the data collected. Product codes of wasted implants were used to identify implant costs through the manufacturer., Results: Implant wastage occurred in 25.1% of trauma procedures during the study period. Most wasted implants (91%) were screws. The total cost of implant wastage was £8,377.25 during the 12-month period, accounting for 2% of the total implant budget. Wasted intramedullary nails accounted for almost 50% of the total cost. More than 51% of affected procedures involved a trainee as the primary operator., Discussion: We report the first study of implant wastage in orthopaedics from the UK. Total implant wastage was higher than reported in most of the published literature, although it represented a small portion of the budget. Implant wastage is attributable to surgeons or operating theatre staff in most cases and is compounded by surgeons' limited understanding of implant costs. Initiatives to reduce implant wastage should include raising awareness of costs and departmental wastage to surgeons and operating theatre staff as well as employing preoperative planning techniques.

Importance: Significant cost savings can be achieved from consolidating purchases of spinal implants with a single vendor. However, it is currently unknown whether sole-source contracting or vendor rationalization more broadly affects patient care., Objectives: To describe the single-vendor procurement of spinal implants, characterize the economic benefits of sole-source contracting, and gauge whether vendor rationalization is associated with a diminished quality of care., Design, Setting, and Participants: This retrospective cohort study assessed adult patients receiving single-level lumbar interbody fusions at a single institution from January 1, 2009, to July 31, 2017. Exclusion criteria included multilevel fusions and prior spinal fusions., Exposures: Patients were analyzed based on the number of vendors available to surgeons at the time of the patient's surgery. January 1, 2009, to December 31, 2010, was defined as the multivendor period (10 vendors); January 1, 2011, to December 31, 2014, was defined as the dual-vendor period; and January 1, 2015, to July 31, 2017, was defined as the single-vendor period., Main Outcomes and Measures: Rates of 12-month revision surgery, complications, 30-day readmissions, and postoperative patient-reported outcomes, as measured by 5-dimension European Quality of Life (EQ-5D) and Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) utilities. Propensity score weighting was performed to control for confounding. The Holm method was used to correct for multiple testing. Annual cost savings associated with the dual-vendor and single-vendor periods were also reported., Results: A total of 1373 patients (mean [SD] age, 59.2 [12.6] years; 763 [55.6%] female; 1161 [84.6%] white) were analyzed. Rates of revisions after adjusting for confounding were 3.2% (95% CI, 1.5%-6.7%) for the multivendor period, 4.5% (95% CI, 3.1%-6.5%) for the dual-vendor period, and 3.0% (95% CI, 1.7%-5.0%) for the single-vendor period. Complication rates were 5.3% (95% CI, 2.7%-10.1%) for the multivendor period, 7.2% (95% CI, 5.4%-9.6%) for the dual-vendor period, and 6.4% (95% CI, 4.6%-8.8%) for the single-vendor period. Readmission rates were 14.2% (95% CI, 9.7%-20.2%) for the multivendor period, 12.6% (95% CI, 10.1%-15.5%) for the dual-vendor period, and 9.7% (95% CI, 7.4%-12.7%) for the single-vendor period. Revisions, complications, and patient-reported outcomes were statistically equivalent across all periods. Readmissions were not statistically equivalent but not statistically different. The savings attributable to vendor rationalization were 24% for the dual-vendor and 21% for the single-vendor periods., Conclusions and Relevance: The single-vendor procurement of spinal implants was associated with significant cost savings without evidence of an associated decline in the quality of care. Large hospital systems may consider sole-source purchasing as a viable cost reduction strategy.

Objective: Health care costs are increasing in medicine and in orthopedics. Device choice in orthopedic cases can impact the cost of the procedure and thus result in cost savings. This study aims to determine whether orthopedic attendings and residents accurately estimate device costs they are implanting in trauma cases and whether costs would influence their surgical device selection., Design: Using nationally published average cost data for 13 implants, a survey was distributed at 6 US academic centers. Respondents were asked to select the correct cost from cost ranges. They also answered yes/no questions about their choices regarding published research outcomes for specific fractures. Residents' answers were compared with faculty answers using t tests for each cost estimate question, and chi-square tests for yes/no questions and frequencies., Results: A total of 51 faculty members and 76 residents responded. Attending estimates were closer to the actual cost for most devices. The average total error in cost estimate for all 13 implants was $11,288.36 for residents (35.6% difference) and $10,208.33 for faculty members (32.2% difference). Significantly more faculty members estimated costs within 10% versus residents. When asked if the literature showed differences in outcome when using different implants to treat 4 common fractures, most answered these questions correctly. Further, 71.1% of residents said their choice of implant would change if costs affected physician reimbursements versus 58% for faculty members., Conclusions: Our data indicate orthopedic physicians are not aware of true implant costs and nearly half of attendings would not consider cost as a factor in deciding between equivalent implants, even if this affected their reimbursement. Most notably, participants showed a poor ability to closely estimate the cost of more expensive implants (actual device cost greater than $2000). Our results suggest that medical cost containment should be stressed to the next generation of surgeons., (Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare the yearly cost involved per patient in the use of magnetically controlled growing rod (MCGR) and traditional growing rods (TGRs) in the treatment of early onset scoliosis (EOS) and to assess the overall cost burden of MCGR with reference to patient and health-care infrastructure., Methods: For a hypothetical case of a 5-year-old girl with a diagnosis of EOS, a decision-tree model using TreeAge Software was developed to simulate annual health state transitions and compare the 8-year accumulative direct, indirect, and total cost among the four groups: (1) dual MCGRs with exchange every 2 years, (2) dual MCGRs with exchange every 3 years, (3) TGR with surgical distraction every year, and (4) TGR with surgical distraction every 6 months. Base-case values and ranges of clinical parameters reflecting complication rate after each type of surgical distraction were determined from a review of literature and expert opinion. Government gazette and expert opinion provided cost estimation of growing rods, surgeries, surgical complications, and routine follow-up. Microsimulation of 1000 individuals was conducted to test the variation in total direct costs (in 2016 Hong Kong dollars (HKD)) between individuals, and estimated the standard deviations of total direct costs for each group., Results: Over the projected treatment period, indirect costs incurred by patients and family were higher for the MCGR as compared to the TGR. However, the total costs incurred by MCGR groups (group 1: HKD164k; group 2: HKD138k) were lower than those incurred by TGR groups (group 3: HKD191k; group 4: HKD290k). Although the accumulative costs of three groups (TGR with distraction every year and MCGR replacing every 2 and 3 years) were approaching each other in the first 2 years after initial implantation, at year 3 the accumulative cost of MCGR exchange every 2 years was HKD36k more than the yearly TGR surgery due to the cost of implant exchange. The cost incurred by both the MCGR groups was less than that incurred by the TGR groups from year 4 to skeletal maturity., Conclusions: The use of dual MCGRs, regardless of its 2- or 3-year exchange, was only cost saving and less expensive than the dual TGRs for EOS treatment from the fourth year of continuous treatment. Despite higher patient-related costs during MCGR treatment, it is important to consider the reduced risks and mental burden suffered by these children during repeat surgeries. With improved knowledge of the costs associated with long-term MCGR use, better constructed cost-effectiveness studies can be performed in the future.

Financial relationships between physicians and industry are vital to biomedical innovation yet create the potential for conflicts of interest in medical practice. I consider an inducement model of the role of financial relationships in health care markets, where consulting payments induce physicians to use more devices of the firms that sponsor them. To test the model, I exploit a policy shock, whereby government monitoring of payments to joint replacement surgeons resulted in declines of over 60% in both total payments and in the number of physicians receiving payments from 2007 to 2008. Using hospital discharge data from three states, I find that the loss of payments leads physicians to switch 7 percentage points of their device utilization from their sponsoring firms' devices to other firms' devices, an effect which is concentrated among surgeons with low switching costs. These results offer support for the inducement model. I also find evidence of an increase in medical productivity following the policy intervention, which suggests conditions under which regulation of financial relationships would be socially beneficial. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

Purpose: To evaluate the cost differences between a conventional growth rod system (CGRS) and magnetic controlled growth rods (MCGR) in treating early onset scoliosis (EOS) over a projected 5 year period. We hypothesise that the high initial outlay for MCGR would be recouped from fewer admissions and surgical procedures over the lifetime of the implant., Methods: The costs of all aspects of treatment for 14 patients undergoing conversion from CGRS to MGRS were collected over a 3 year period. The costs of all aspects of each treatment including clinic visits, hospital stay, theatre and complications were calculated and projected over the lifetime of each device., Results: The initial outlay for insertion for MCGR was £12,913 more than the CGRS. There were significant cost savings for each lengthening which projected over the 5 year lifetime amounted to a cost saving of over £8,000 per patient., Conclusions: Magnetic controlled growth rods reduce the need for multiple invasive procedures in the management of EOS. The implant has a significant projected cost saving in comparison to CGRS.

Study Design: Randomized clinical trial with 2-year follow-up., Objective: To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis., Summary of Background Data: Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment., Methods: We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio., Results: The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700., Conclusion: The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate., Level of Evidence: 2.

Orthopedic procedures represent a large expense to the Medicare program, and costs of implantable medical devices account for a large proportion of those procedures' costs. Physicians have been encouraged to consider cost in the selection of devices, but several factors make acquiring cost information difficult. To assess physicians' levels of knowledge about costs, we asked orthopedic attending physicians and residents at seven academic medical centers to estimate the costs of thirteen commonly used orthopedic devices between December 2012 and March 2013. The actual cost of each device was determined at each institution; estimates within 20 percent of the actual cost were considered correct. Among the 503 physicians who completed our survey, attending physicians correctly estimated the cost of the device 21 percent of the time, and residents did so 17 percent of the time. Thirty-six percent of physicians and 75 percent of residents rated their knowledge of device costs "below average" or "poor." However, more than 80 percent of all respondents indicated that cost should be "moderately," "very," or "extremely" important in the device selection process. Surgeons need increased access to information on the relative prices of devices and should be incentivized to participate in cost containment efforts.

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.

Study Design: Prospective observational study., Objective: This study aims to quantify the incidence of intraoperative waste in spine surgery and to examine the efficacy of an educational program directed at surgeons to induce a reduction in the intraoperative waste., Summary of Background Data: Spine procedures are associated with high costs. Implants are a main contributor of these costs. Intraoperative waste further exacerbates the high cost of surgery., Methods: Data were collected during a 25-month period from one academic medical center (15-month observational period, 10-month post-awareness program). The total number of spine procedures and the incidence of intraoperative waste were recorded prospectively. Other variables recorded included the type of product wasted, cost associated with the product or implant wasted, and reason for the waste., Results: Intraoperative waste occurred in 20.2% of the procedures prior to the educational program and in 10.3% of the procedures after the implementation of the program (P < 0.0001). Monthly costs associated with surgical waste were, on average, $17680 prior to the awareness intervention and $5876 afterwards (P = 0.0006). Prior to the intervention, surgical waste represented 4.3% of total operative spine budget. After the awareness program this proportion decrease to an average of 1.2% (P = 0.003)., Conclusion: Intraoperative waste in spine surgery exacerbates the already costly procedures. Extrapolation of this data to the national level leads to an annual estimate of $126,722,000 attributable to intraoperative spine waste. A simple educational program proved to be and continues to be effective in making surgeons aware of the import of their choices and the costs related to surgical waste.

Background: As the cost of medical care has steady risen, patients, insurance companies, and the government, have all appropriately questioned the benefit of the care provided versus the cost. Expensive treatments such as surgery for spinal deformity have been especially scrutinized. This article reviews the history of spinal implant usage in deformity surgery, including the benefits of these implants to the patient and also the associated costs. The paper was presented at the One Day Course during the 2009 Pediatric Orthopaedic Society of North America annual meeting in Boston., Methods: A review was conducted regarding the benefits and costs of the care provided to patients as spinal implants became more clinically effective., Results: Compared with postoperative casting, spinal implants provide better deformity correction and better stability of the fusion mass with resulting lower rates of secondary surgery, mostly because of fewer pseudarthoses. Many of these advantages were achieved with the less-expensive second and third-generation implants. Unfortunately, patient outcomes when the latest, most expensive implants are used are not significantly different from outcomes when older, less-expensive implants are used., Conclusions: Although the cost of spinal deformity surgery has risen the benefit to the patient from modern spinal implants has also increased. Nevertheless, patient outcomes have not improved in proportion to the increase in costs. Outcomes from the newest, all pedicle screw constructs are not significantly better than outcomes from the older, less-expensive hybrid constructs. Rising expenses and dramatic variation in the cost of the same implant have led payors, hospitals, and the government to question the value added to the care of the patient. Some implant costs should fall as hospitals use competitive bidding. Surgeons should help their hospitals in the competitive bidding process and declare a willingness to switch to an equivalent system if price differences are excessive., Levels of Evidence: Level IV Economic Analysis.

Replacement of the anterior cruciate ligament (ACL) is presently routinely carried out with autologous transplantation of the ligamentum patellae (LP), semintendinosus-gracilis (SGS) or quadriceps (QS) tendons. The anatomical positioning of the drilling canals, transplant fixation, complication rate, revision aspects as well as economic aspects are still under discussion. Fixation of the transplant can be carried out mechanically with various anchoring systems or using biological implant-free healing (free of cost). The compulsory and private health insurance companies as well as staff medical insurance associations guarantee a constant remuneration according to the EBM (uniform evaluation standard), GOA (scale of fees for physicians) or UV-GOA (accident insurance scale of fees for physicians). At present all health insurances accept the costs for implantations in outpatient areas (minus 25 Euro own contribution for compulsory health insurance). For inpatient treatment remuneration is according to the flat-rate scale (diagnosis-related groups). Costs for implants, which are increasing over the years, diminish the economic result in this case. The technique of implant-free replacement of ACLs is cheaper, with fewer complications and achieves functional results for fixation of the transplant which are comparable to techniques with implants. This also applies to the double bundle technique. Implant-free replacement of ACLs with the patellar tendon is a suitable, uncomplicated operation technique with comparably low costs and belongs to the state of the art according to Hertel, Petersen and other authors. This method already has a valuable place in surgery of the ACL.