The economics of artificial organs.

Spurred by devoted research and institutional financing, organ replacement therapies have progressed monumentally over the last century. Concomitantly, there has been an escalation in healthcare costs. In an aging society where organ replacement therapy utilization is expected to continue to rise, will society need to rethink the economics of end-stage organ dysfunction management?

Manufacture of patient-specific vascular replicas for endovascular simulation using fast, low-cost method.

Patient-specific vascular replicas are essential to the simulation of endovascular treatment or for vascular research. The inside of silicone replica is required to be smooth for manipulating interventional devices without resistance. In this report, we demonstrate the fabrication of patient-specific silicone vessels with a low-cost desktop 3D printer. We show that the surface of an acrylonitrile butadiene styrene (ABS) model printed by the 3D printer can be smoothed by a single dipping in ABS solvent in a time-dependent manner, where a short dip has less effect on the shape of the model. The vascular mold is coated with transparent silicone and then the ABS mold is dissolved after the silicone is cured. Interventional devices can pass through the inside of the smoothed silicone vessel with lower pushing force compared to the vessel without smoothing. The material cost and time required to fabricate the silicone vessel is about USD $2 and 24 h, which is much lower than the current fabrication methods. This fast and low-cost method offers the possibility of testing strategies before attempting particularly difficult cases, while improving the training of endovascular therapy, enabling the trialing of new devices, and broadening the scope of vascular research.

Evaluation of a low-cost design keratoprosthesis in end-stage corneal disease: a preliminary study.

PURPOSE: To evaluate the indications, outcomes and complications of Auro keratoprosthesis (a low-cost design based on type I Boston Keratoprosthesis) in the end-stage corneal disease in a preliminary study. METHODS: In this prospective interventional study, 10 eyes of 10 patients with an end-stage corneal disease underwent implantation of Auro keratoprosthesis with the mean follow-up of 14.5±2.1 months. The indications included multiple failed grafts (n=7), aphakic bullous keratopathy (n=2) and chemical injury (n=1). The additional intraoperative procedures performed were synechiolysis (n=9), cataractous lens extraction (n=2), Ahmed glaucoma valve implantation (n=1) and vitreoretinal surgery (n=1). Antibiotic prophylaxis was administered postoperatively, and patients were followed up at 1 week, 2 weeks, 1 month and thereafter at monthly intervals. The main outcome measures were best corrected visual acuity (BCVA), retention of prosthesis, complications and need for secondary surgical interventions. RESULTS: The most common indication for keratoprosthesis implantation was graft failure (7/10, 70%). The postoperative BCVA improved to ≥20/200 in six patients. Nine out of 10 patients had retained keratoprosthesis. The complications seen were inflammatory debris behind keratoprosthesis (n=4), retroprosthetic membrane (n=2), glaucoma (n=4), small (<2 mm) sterile stromal necrosis or erosions at the graft edge (n=3) and microbial keratitis (n=1). Explantation of the keratoprosthesis was performed in one eye due to fungal keratitis. CONCLUSIONS: Auro keratoprosthesis, a low-cost keratoprosthesis, is a viable option in the end-stage corneal disease in this preliminary study. Multicentre studies with long-term follow-up are required to conclusively prove its safety and efficacy.

Comparative effectiveness and cost-effectiveness of the implantable miniature telescope.

OBJECTIVE: To assess the preference-based comparative effectiveness (human value gain) and the cost-utility (cost-effectiveness) of a telescope prosthesis (implantable miniature telescope) for the treatment of end-stage, age-related macular degeneration (AMD). DESIGN: A value-based medicine, second-eye model, cost-utility analysis was performed to quantify the comparative effectiveness and cost-effectiveness of therapy with the telescope prosthesis. PARTICIPANTS: Published, evidence-based data from the IMT002 Study Group clinical trial. Ophthalmic utilities were obtained from a validated cohort of >1000 patients with ocular diseases. METHODS: Comparative effectiveness data were converted from visual acuity to utility (value-based) format. The incremental costs (Medicare) of therapy versus no therapy were integrated with the value gain conferred by the telescope prosthesis to assess its average cost-utility. The incremental value gains and incremental costs of therapy referent to (1) a fellow eye cohort and (2) a fellow eye cohort of those who underwent intra-study cataract surgery were integrated in incremental cost-utility analyses. All value outcomes and costs were discounted at a 3% annual rate, as per the Panel on Cost-Effectiveness in Health and Medicine. MAIN OUTCOME MEASURES: Comparative effectiveness was quantified using the (1) quality-adjusted life-year (QALY) gain and (2) percent human value gain (improvement in quality of life). The QALY gain was integrated with incremental costs into the cost-utility ratio ($/QALY, or US dollars expended per QALY gained). RESULTS: The mean, discounted QALY gain associated with use of the telescope prosthesis over 12 years was 0.7577. When the QALY loss of 0.0004 attributable to the adverse events was factored into the model, the final QALY gain was 0.7573. This resulted in a 12.5% quality of life gain for the average patient during the 12 years of the model. The average cost-utility versus no therapy for use of the telescope prosthesis was $14389/QALY. The incremental cost-utility referent to control fellow eyes was $14063/QALY, whereas the incremental cost-utility referent to fellow eyes that underwent intra-study cataract surgery was $11805/QALY. CONCLUSIONS: Therapy with the telescope prosthesis considerably improves quality of life and at the same time is cost-effective by conventional standards.

Interview. The story of Advanced BioHealing: commercializing bioengineered tissue products. Mr Tozer speaks to Emily Culme-Seymour, Assistant Commissioning Editor.

Dean Tozer is Senior Vice President at Advanced BioHealing, Inc. (ABH), overseeing marketing, corporate development, government affairs, product development, various regulatory functions and international expansion. After completing his Bachelor of Commerce from Saint Mary's University in Halifax, Canada, Mr Tozer spent 10 years in the global pharmaceutical industry, primarily with G.D. Searle (a division of Monsanto) where he had a wide variety of roles in Global Marketing, Sales, Business Redesign, and Accounting and Finance. Mr Tozer then worked as a consultant to the biopharmaceutical industry, assisting start-up organizations in developing commercial strategies for both pharmaceutical products and biomedical devices, prior to joining ABH in March 2006 as Vice President of Marketing & Corporate Development. In addition to his leadership role at ABH, Mr Tozer currently serves as an officer and board member for the Alliance for Regenerative Medicine, a Washington DC-based organization formed to advance regenerative medicine by representing and supporting the community of companies, academic research institutions, patient advocacy groups, foundations, and other organizations before the Congress, federal agencies and the general public.

Cost-effectiveness of the Boston keratoprosthesis.

PURPOSE: To conduct a cost-utility analysis and determine the cost-effectiveness of the Boston Keratoprosthesis (Boston Kpro). DESIGN: Retrospective cohort study. METHODS: setting: The Massachusetts Eye and Ear Infirmary corneal service. patients: Inclusion required a minimum 2-year follow-up. Patients with autoimmune diseases and chemical burns were excluded. Eighty-two patients were included with various indications for surgery. intervention: The keratoprosthesis is a collar button-shaped polymethylmethacrylate (PMMA) device consisting of 2 curved plates sandwiched around a corneal donor (allo)graft. The device is assembled intraoperatively and sutured to a patient's eye after removing the diseased cornea. MAIN OUTCOME MEASURES: Average cost-effectiveness of the keratoprosthesis was determined by cost-utility analysis, using expected-value calculations and time-tradeoff utilities. The comparative effectiveness, or gain in quality-adjusted life years (QALYs), was also sought. Cost-effectiveness was compared to recently published data on penetrating keratoplasty (PK). RESULTS: A total discounted incremental QALY gain for the Boston Kpro of 0.763 correlated with a conferred QALY gain of 20.3% for the average patient. The average cost-effectiveness of the keratoprosthesis was $16 140 per QALY. CONCLUSIONS: Comparable to corneal transplantation, with a cost-effectiveness between $12 000 and $16 000 per QALY, the keratoprosthesis can be considered highly cost-effective.

Synthetic human tissue models can reduce the cost of device development.

Synthetic human tissues and body parts that closely resemble the live human environment have been developed for use in medical device verification and validation tests. This article discusses how they can save time and money while improving quality and accuracy.

The growth of tissue engineering.

This report draws upon data from a variety of sources to estimate the size, scope, and growth rate of the contemporary tissue engineering enterprise. At the beginning of 2001, tissue engineering research and development was being pursued by 3,300 scientists and support staff in more than 70 startup companies or business units with a combined annual expenditure of over $600 million. Spending by tissue engineering firms has been growing at a compound annual rate of 16%, and the aggregate investment since 1990 now exceeds $3.5 billion. At the beginning of 2001, the net capital value of the 16 publicly traded tissue engineering startups had reached $2.6 billion. Firms focusing on structural applications (skin, cartilage, bone, cardiac prosthesis, and the like) comprise the fastest growing segment. In contrast, efforts in biohybrid organs and other metabolic applications have contracted over the past few years. The number of companies involved in stem cells and regenerative medicine is rapidly increasing, and this area represents the most likely nidus of future growth for tissue engineering. A notable recent trend has been the emergence of a strong commercial activity in tissue engineering outside the United States, with at least 16 European or Australian companies (22% of total) now active.

Artificial organs and vanishing boundaries.

With the first clinical use of the artificial kidney over 5 decades ago, we entered into a new era of medicine-that of substitutive and replacement therapy. Yet it took nearly another 15 years until chronic treatment was possible and nearly another 15 years until widespread treatment was possible due to government support. The history of development and clinical use of other artificial organ technologies such as the artificial heart and heart valves, the artificial lung, artificial blood, joint replacements, the artificial liver, the artificial pancreas, immunologic, metabolic, and neurologic support, neurocontrol, and tissue substitutes have followed similar long development paths. Despite their relatively long time to be put into clinical use, the contributions of artificial organ technologies to the betterment of mankind have been unquestionably a major success. For example, modern day surgery would not be possible without heart-lung support, and the technologies for heart support have led to the development of various minimally invasive technologies. The powerful impact that artificial organ technologies presently has on our lives is seen through the statistic that in the U.S.A. nearly 1 in 10 persons is living with an implanted medical device. With the aging of our population and the improvements in technologies, these numbers will only increase.

An economic survey of the emerging tissue engineering industry.

The contemporary scope of worldwide tissue engineering research and development was estimated by totaling the relevant annual spending and other economic parameters of firms involved the field. Operating expenses allocated to tissue engineering in 1997 exceed $450 million and fund the activities of nearly 2,500 scientists and support personnel. Growth rate is 22.5% per annum. Most activity is centered in the United States. Government spending in this field represents <10% of the total. The aggregate capital value of start-ups that have gone public was approximately $1.7 billion as of January 1, 1998; total capital value of all firms and business units in the field was estimated to be roughly $3.5 billion. The level of investment and valuation represents a remarkable act of faith in the future of a technology yet to produce its first significant revenue-generating product.

Ethics of the allocation of highly advanced medical technologies.

The disproportionate distribution of financial, educational, social, and medical resources between some rich countries of the northern hemisphere and less fortunate societies creates a moral challenge of global dimension. The development of new forms of highly advanced medical technologies, including neoorgans and xenografts, as well as the promotion of health literacy and predictive and preventive medical services might reduce some problems in allocational justice. Most governments and the World Health Organization (WHO) reject financial and other rewards for living organ donors thus indirectly contributing to the development of black markets. A societal gratuity model supporting and safeguarding a highly regulated market between providers and recipients of organs might provide for better protection of those who provide organs not solely based on altruistic reasons. The moral assessment of global issues in allocation and justice in the distribution of medical technologies must be increased and will have to be based on the principles of self determination and responsibility, solidarity and subsidiarity, and respect for individual values and cultural traditions.