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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.

Background: A poor understanding of cost among healthcare providers may contribute to high healthcare expenditures. Currently, it is unclear whether and how much surgeons know about the costs of implantable medical devices (IMDs)., Questions/purposes: We (1) determined the level of comfort with orthopaedic IMD costs among orthopaedic residents and attending surgeons, (2) quantified how accurately surgeons understand the costs of orthopaedic IMDs, and (3) identified which constructs yield the most accurate cost estimations among residents and attending surgeons., Methods: A questionnaire was presented to 60 residents and 37 attending orthopaedic surgeons from two large academic medical centers. Respondents estimated the cost of 13 commonly used orthopaedic devices. Fifty-one surgeons participated (36 residents, 15 attending surgeons), for an overall response rate of 53%. Cost estimates were compared against the actual material costs, and we recorded the percentage error for each estimate., Results: More than ½ of the respondents rated their knowledge of IMD cost as poor. The mean percentage error in estimation for all respondents was 69% (range, 29%-289%). Overall, 67% of responses were underestimations and 33% were overestimations. Residents demonstrated a mean percentage error of 73% (range, 29%-289%) while attending surgeons had a mean percentage error of 59% (range, 49%-79%). Residents and attending surgeons demonstrated differences in accuracy within groups and between groups based on the IMD being estimated., Conclusions: We found the knowledge of orthopaedic IMD costs among the orthopaedic residents and attending surgeons surveyed was poor. Further investigation of how physicians conceptualize material costs will be important to healthcare cost control.

Background: Growing prostheses accommodate skeletally immature patients with bone tumors undergoing limb-preserving surgery. Early devices required surgical procedures for lengthening; recent devices lengthen without surgery. Expenses for newer expandable devices that lengthen without surgery are more than for their predecessors but overall reimbursement amounts are not known., Questions/purposes: We sought to determine reimbursement amounts associated with lengthening of growing prostheses requiring surgical and nonsurgical lengthening., Methods: We retrospectively reviewed 17 patients with growing prostheses requiring surgical expansion and eight patients with prostheses capable of nonsurgical expansion. Insurance documents were reviewed to determine the reimbursement for implantation, lengthening, and complications. Growth data were obtained from the literature., Results: Mean reimbursement amounts of surgical and nonsurgical lengthenings were $9950 and $272, respectively. Estimated reimbursements associated with implantation of a growing prosthesis varied depending on age, sex, and location. The largest difference was found for 4-year-old boys with distal femoral replacement where reimbursement for expansion to maturity for surgical and nonsurgical lengthening prostheses would be $379,000 and $208,000, respectively. For children requiring more than one surgical expansion, net reimbursements were lower when a noninvasive lengthening device was used. Annual per-prosthesis maintenance reimbursements to address complications for surgical and nonsurgical lengthening prostheses were $3386 and $1856, respectively., Conclusions: This study showed that reimbursements for lengthening of growing endoprostheses capable of nonsurgical expansion may be less expensive in younger patients, particularly male patients undergoing distal femur replacement, than endoprostheses requiring surgical lengthening. Longer outcomes studies are required to see if reimbursements for complications differ between devices., Level of Evidence: Level III, economic and decision analysis. See the Guidelines for Authors for a complete description of levels of evidence.

This report summarizes the results from 1132 ISO-10328 standard tests performed on 21 different prosthetic foot models commonly utilized in the developing world. None of the tested feet passed the strictest ISO testing protocol. All but one failed at the initial Static Proof test, which simulates a single momentary overload, due to permanent forefoot deformation. In addition, all tested feet had significant internal failures that were visible when sectioned longitudinally. Static Proof testing revealed average permanent deformation of the forefoot of all feet that exceeded the optional 5 mm ISO requirement. Forefoot deformation for non-Jaipur rubber feet came closest to meeting the standard at 8.3+/-3.4 mm; deformation of the various types of rubber Jaipur feet was the greatest at 22.5+/-5.4 mm. Forefoot deformation for polyurethane (PU) feet was 13.6+/-5.5 mm. Forefoot deformation of the ethyl-vinyl-acetate (EVA) feet was slightly greater than the Jaipur feet at 22.8+/-5.7 mm. After the Static Strength test, which simulates a higher momentary overload, permanent deformation of the feet increased. The average maximum deformation for rubber SACH forefeet varied from 17 - 30 mm, and 11 - 26 mm for the heel; Jaipur forefeet 47 - 60 mm and heels 13 - 19 mm; PU forefeet 20 - 44 mm and heels 20 - 33 mm; and EVA forefeet 33 - 50 mm and heels 16 - 31 mm. After completion of the Cyclic Test the prosthetic feet were sawn in half and closely examined visually. All feet revealed internal derangements: (i) Deformation of rubber or PU foam under the keel of forefoot and/or heel: HCMC, VI, EB1, BAVI, HI Cambodia, Myanmar, Angola, TATCOT, Kingsley and CR; (ii) Delamination from the keel: Mozambique, PHN, and Pro-cirugia; and (iii) Delamination between foam layers: BMVSS, NISHA, MUKTI, and OM. The influence of the two environmental factors tested was minimal for rubber feet with respect to deformation and inconsistent for the polymer feet; in particular for the forefeet. Creep increased with humidity exposure in some feet of natural rubber. However, creep decreased with ultraviolet (UV) exposure for these natural rubber feet, as was also the case for EVA feet, whereas the creep increased for two PU feet. Comparison of the effect of humidity and UV exposure generally showed less creep with UV exposure. In conclusion, ISO-10328 testing prior to release of a new foot construction for amputee use appears to be useful in the developing countries as well as in the developed world, even though it does not simulate the wear on the plantar surface that is seen clinically in barefoot walking. Inspection of the internal structures after the laboratory testing has been shown to reveal occult failure mechanisms in all tested feet.

Total joint arthroplasty is a successful surgical treatment for painful, arthritic hips and knees. The prevalence of total joint arthroplasty is increasing, and it is consuming an increasing proportion of health care dollars. Payers, especially Centers for Medicare and Medicaid Services, have targeted total joint arthroplasty for cost control, and joint implants, the greatest expense in total joint arthroplasty, have been identified as an opportunity for cost control. Hospitals seek to control the cost of joint implants because the rate of increase in the price of implants is rising faster than the rate of increase in hospital payment for total joint arthroplasty. As joint implants consume more of the hospital payment for total joint arthroplasty, hospitals are encouraging surgeons to use less expensive implants. Several methods for controlling the cost of implants have been described, but no method has succeeded without the cooperation and involvement of surgeons. Gainsharing programs may help align the incentives of hospitals and surgeons relative to the selection and cost of implants. We have implemented a Single-price/Case-price Purchasing program with considerable savings on the cost of implants without adversely affecting the patient outcome of total joint arthroplasty.

Purpose: We determined therapeutic and operative cost efficacy of endoscopic collagen injection for vesicoureteral reflux., Materials and Methods: We performed a multicenter study of 10 male and 23 female sequential patients (45 renal units) with vesicoureteral reflux and a surgical indication. Patients were skin tested with collagen and when negative, they underwent endoscopic injection. Renal ultrasound/cystography was done 3 months after treatment. Cost analysis was performed at 1 institution., Results: Reflux was grade I in 2 renal units, II in 18, III in 15 and IV in 10. The majority of cases were single systems with primary reflux. We performed 1 treatment in 32 renal units, 2 in 6, 3 in 6 and 4 in 1. Cure was evident in 31 of 38 renal units (81.6%) and 21 of 27 patients (78%) 3 months after the last injection. Patient morbidity was minimal. Operative cost per renal unit was $1,599.68 for collagen injection and $9,144.47 for reimplantation., Conclusions: Endoscopic injection of collagen is effective treatment for vesicoureteral reflux. Furthermore, it causes minimal morbidity and may effect cost savings in health care management.

During the 1980s, the hospital cost for total hip arthroplasty was controlled, but the implant cost for total hip arthroplasty was not controlled. With the introduction and acceptance of case price payment systems, hip implant cost consumed a greater portion of the hospital payment each year during the 1980s. Cost control for total hip arthroplasty during the 1990s will require control of implant costs. One objective method for controlling implant costs in total hip arthroplasty is implant standardization.

To help balance the operating budget of The Hospital for Special Surgery, which was encountering an annual major deficit of $4 million in 1989, a program of cost awareness leading to cost containment was instituted in 1990. Costs of supplies, implants, and equipment were identified and reviewed by the hospital staff, including orthopaedic surgeons, orthopaedic residents, health care personnel, and administration, for cost effectiveness. Methods to accomplish the goals included structuring committees for information; workshops organized by different services to affect change; feedback to health care professionals through posters and newsletters; and statistical identification for continued education. Major cost savings resulted from recycling wasted implants, reduction of costly implants, and reduction of unnecessary supplies. As a result, vendors had been challenged, leading to more competitive prices. This program has opened new avenues of cost reduction without sacrificing quality of medical care and has contributed to a breakdown of barriers between medical staff, administration, and finance, leading to a strong hospital-team commitment. The price of health care in the United States in 1993 exceeded $900 billion. Health care expenditures now account for approximately 14% of the gross domestic product. Health care costs have been rising faster than the inflation rate for more than a decade. The result is the current national focus on containment of health care expenditures.

The cost of health care in the United States has been rising steadily during the past 10 years. Total joint arthroplasty, a commonly performed orthopaedic procedure, accounts for approximately $10 billion dollars per year. The objective of this study was to perform a clinician-oriented cost analysis of primary and revision hip and knee arthroplasty. Twenty-five consecutive cases each of total knee arthroplasty, total hip arthroplasty, revision total knee arthroplasty, and revision total hip arthroplasty were analyzed. The length of stay and number of minutes spent in the operating room were significantly higher for the patients with revision hip surgery than for the other groups. The total charges for the prosthesis in the 4 groups exceeded 40% of the total charges for the procedure. Primary hip and knee surgery had similar billed costs, and work for revision hip surgery has a significantly higher billed cost than physician's work. The implant selection process by an orthopaedic surgeon performing arthroplasty of the hip and knee needs to include economic aspects.

To decrease implant costs for total hip arthroplasty, a number of different options are available, including the use of remaindered implants, older designs, discounted stock, or specifically designed implants manufactured and sold at low cost. To determine the prevalence of these practices, 80 questionnaires were mailed to members of the Hip Society; 55 (79%) were completed and returned. In addition, 32 questionnaires were mailed to a representative group of orthopaedic surgeons in Canada; 29 (90%) were completed and returned. Analysis of these returns revealed that 73% of the respondents used a low-cost prosthesis for certain indications in total hip arthroplasty. No uniform policy with regard to cost containment or to the definition of low cost was apparent. In a parallel study, the results of a clinical trial with a generic hip implant in 150 patients observed for 2 years or longer revealed the general improvement in hip scores and the rate of complication to be compatible with those of other, more-expensive hip prostheses. Control of prosthetic costs as a means of influencing the cost of arthroplasty appears to be a wide-spread practice.