Bringing Your Idea to the Market: A Primer for Plastic Surgeons.

SUMMARY: The progress of biotechnology, medical instruments, and applied sciences contributes to a rapidly expanding space for the advancement of the medical field. Surgeons experience first-hand the limitations of current medical devices and thus have unique insight into problems that could be solved with new products. The process of turning an idea into a product capable of success in the marketplace, however, is often unfamiliar to surgeons. The authors seek to illuminate this process and provide an ordered list of tasks that can make bringing ideas to market more achievable for surgeons. The first step in this process is the generation and protection of a new idea. Next, the process of making an idea into a product is outlined. This phase involves team assembly, business planning, and product development. Market research and valuation are key to understanding how a product can be applied in the market, and meticulous research during this phase allows for informed decision-making that will help secure funding down the road. Finally, various options for financing are discussed and compared to help surgeon-entrepreneurs find an option that best fits their project, and steps to maximize leverage are described. The development of new products can be a complicated process for surgeons. Organized into four phases, with ordered instructional steps to advance through each phase, the process of bringing an idea to the market is clarified. Facilitating this process will possibly contribute to the continual improvement of medical and surgical abilities through the introduction of new devices and technologies.

The Cost of Innovation and Evidence in Cardiac Surgery.

This review summarizes a systematic analysis of 216 randomized trials of cardiovascular interventions performed during 2008-2019, according to the source of trial funding. The systematic analysis showed that on average the results of each trial would change significance if only 5 patients experienced different outcomes. Industry-sponsored trials were more likely to use composite endpoints, noninferiority designs, and twice as likely as nonindustry trials to report results favoring the device arm. Over 80% of industry trials used reporting strategies or "spin" suggesting the device arm was advantageous versus fewer than half of non-industry trials. The review discusses the implications of these findings.

Innovation, Royalties, and Introduction of the Patent Hirsch Index within U.S. Academic Neurosurgery.

BACKGROUND: Historically, practicing neurosurgeons have been key drivers of neurosurgical innovation. We sought to describe the patents held by U.S. academic neurosurgeons and to explore the relationship between patents and royalties received. METHODS: The Centers for Medicare and Medicaid CMS Open Payments Data was used to identify academic neurosurgeons who had received royalties and royalty amounts during a 5-year period (2013-2017). Online patent databases were used to gather patent details. Patent citations and 5-year individual and departmental patent Hirsch (h)-indexes were calculated. Royalties were correlated with the number of patents, patent citations, and patent h-index. RESULTS: We found that 119 academic neurosurgeons (7.8%) from 57 U.S. teaching programs (48.3%) had received royalty payments; 72 (60.5%) had published 648 patents. All surgeons were men, with approximately one half in the "late" stages of their career (45.3%) and subspecializing in spinal surgery (50.4%). The patented products or devices were most commonly used for spinal surgery (72.1%), with 2010-2019 the most productive period (n = 455; 70.2%). The median number of citations per patent was 32 (range, 0-620), with 33% having ≥100 citations. The highest individual and institutional patent h-index was 95; 25 (34.7%) neurosurgeons had a patent h-index of ≥5. The median total royalty payment per individual neurosurgeon was $111,011 (range, $58.05-$76,715,750.34). Royalties were correlated with the number of patents (Spearman r = 0.37; P ≤ 0.001), citations (Spearman r, 0.38; P ≤ 0.001), and inventor h-index (Spearman r = 0.38; P ≤ 0.001). CONCLUSIONS: Few U.S. academic neurosurgeons (7.8%) receive royalties and hold patents (4.7%), with an even smaller select group having a patent h-index of ≥5 (1.6%).

Patient willingness to contribute to the cost of novel implants in total joint arthroplasty: the Canadian experience

Background: In Canada, health care is covered by provincial health insurance programs; patients do not directly participate in paying for their acute care expenses. The aim of this study is to assess the willingness of Canadian patients to contribute to the costs of novel total joint arthroplasty implants. Methods: We administered a questionnaire to patients attending an outpatient arthroplasty clinic in Ontario. In the questionnaire, the longevity and risk of complications of a "standard" implant were described. We asked if participants would be willing to contribute to the cost of 3 novel implants that had differing longevities and risks of complications compared with the standard implant. Results: One hundred and fifteen patients completed our questionnaire. Up to 62% of patients were willing to contribute a copayment to get an implant with greater longevity. Willingness to pay decreased to 40% for an implant with greater longevity but an increased risk of complications. Forty percent of participants were willing to pay for an implant with the same longevity as the standard implant but a decreased risk of complications. Participants with a higher income were more willing than other participants to contribute to the cost of a novel implant with greater longevity or lower complication rates. Conclusion: This study demonstrated that up to 62% of our sample of patients in Ontario were willing to share the costs of a novel total joint replacement implant. Willingness to pay was associated with the proposed benefits of the implant and certain patient characteristics. Our study shows that a high proportion of Canadian patients may be willing to copay to have access to new technologies.

Contexte: Au Canada, les soins de santé sont assurés par les régimes provinciaux d'assurance maladie; les patients ne participent pas directement au paiement des soins de santé actifs. Le but de cette étude était de vérifier si les patients canadiens sont prêts à contribuer au paiement de prothèses d'un type nouveau pour les arthroplasties totales. Méthodes: Nous avons administré un questionnaire à des patients d'une clinique externe d'arthroplastie en Ontario. Dans le questionnaire, on décrivait la durée de vie et les risques de complications associés à une prothèse « standard ¼. Nous avons demandé aux participants s'ils étaient ouverts à l'idée de contribuer au paiement de 3 prothèses d'un nouveau type, comportant une durée de vie et des risques de complications différents de ceux de la prothèse standard. Résultats: Cent quinze patients ont répondu à notre questionnaire. Jusqu'à 62 % des patients se sont dits prêts à contribuer à une forme de copaiement pour obtenir une prothèse plus durable. La volonté de payer diminuait à 40 % pour une prothèse plus durable mais comportant plus de risques de complications. Quarante pour cent des participants se sont dits prêts à payer pour une prothèse de même durée de vie que la prothèse standard, mais comportant moins de risques de complications. Les participants ayant un revenu plus élevé étaient davantage disposés à contribuer au paiement d'une prothèse d'un nouveau type plus durable et comportant moins de risques de complications comparativement aux autres participants. Conclusion: Cette étude a démontré que jusqu'à 62 % de notre échantillon de patients ontariens étaient prêts à partager les coûts d'une nouvelle prothèse pour arthroplastie totale. La volonté de payer était associée aux avantages présumés de la prothèse et à certaines caractéristiques des patients. Notre étude montre qu'une forte proportion de patients canadiens seraient prêts à s'engager dans un copaiement pour avoir accès à de nouvelles technologies.

Incentives and challenges related to technological research and innovation within the Unified Health System in the Federal District of Brazil. / Incentivos e desafios relacionados à condução da pesquisa científica, tecnológica e de inovação no âmbito do Sistema Único de Saúde no Distrito Federal, Brasil.

This article analyzes the profile of research conducted in the Federal District of Brazil funded through public calls for proposals issued by the Research for the SUS Program: shared health management/Federal District (PPSUS/DF) and a research support program run by the Superior School of Health Sciences, maintained by the Health Sciences Teaching and Research Foundation (ESCS/FEPECS, acronym in Portuguese). A document analysis was undertaken of all research funded by the PPSUS/DF and ESCS/FEPECS's Research Support Program between 2008 and 2017 using the following variables: year, title, research themes of the National Agenda for Health Research Priorities (ANPPS, acronym in Portuguese), implementing organization, area of application of research, and amount of funding. PPSUS/DF funded 73 projects with a total investment of approximately R$8 million, while ESCS/FEPECS funded 85 projects with a total investment of R$2.3 million. This study provides a critical analysis of the research themes supported by ESCS/FEPECS and PPSUS/DF between 2008 and 2017. It is recommended that future calls for proposals should prioritize the three leading causes of death in the Federal District and the organization and evaluation of healthcare services.

O objetivo deste trabalho foi analisar o perfil das pesquisas científicas financiadas no Distrito Federal provenientes das chamadas públicas do Programa Pesquisa para o SUS: Gestão Compartilhada em Saúde (PPSUS/DF) e Programa de Fomento a Pesquisa Científica da ESCS/FEPECS, no período de 2008 a 2017. O estudo é analítico e documental, abrangendo o universo das pesquisas financiadas nesses dois Programas. As variáveis foram: ano, título, tema de pesquisa da Agenda Nacional de Prioridades de Pesquisas em Saúde (ANPPS), setor de aplicação, instituição e valor financiado. No período de 2008 a 2017, 73 projetos foram financiados pelos cinco editais do PPSUS/DF. O valor total foi de aproximadamente oito milhões de reais. Em relação à ESCS/FEPECS, entre 2008 a 2017, foram financiados 85 projetos pelos dez editais lançados. O valor total foi de 2,3 milhões de reais. Concluiu-se que o perfil das pesquisas científicas permitiu uma análise crítica das temáticas dos projetos. Recomenda-se que os próximos editais adotem como prioridade de pesquisa as três principais causas de óbitos, o processo de organização e avaliação de linhas de cuidados, serviços de saúde e redes de atenção.

Incentivos e desafios relacionados à condução da pesquisa científica, tecnológica e de inovação no âmbito do Sistema Único de Saúde no Distrito Federal, Brasil / Incentives and challenges related to technological research and innovation within the Unified Health System in the Federal District of Brazil

Resumo O objetivo deste trabalho foi analisar o perfil das pesquisas científicas financiadas no Distrito Federal provenientes das chamadas públicas do Programa Pesquisa para o SUS: Gestão Compartilhada em Saúde (PPSUS/DF) e Programa de Fomento a Pesquisa Científica da ESCS/FEPECS, no período de 2008 a 2017. O estudo é analítico e documental, abrangendo o universo das pesquisas financiadas nesses dois Programas. As variáveis foram: ano, título, tema de pesquisa da Agenda Nacional de Prioridades de Pesquisas em Saúde (ANPPS), setor de aplicação, instituição e valor financiado. No período de 2008 a 2017, 73 projetos foram financiados pelos cinco editais do PPSUS/DF. O valor total foi de aproximadamente oito milhões de reais. Em relação à ESCS/FEPECS, entre 2008 a 2017, foram financiados 85 projetos pelos dez editais lançados. O valor total foi de 2,3 milhões de reais. Concluiu-se que o perfil das pesquisas científicas permitiu uma análise crítica das temáticas dos projetos. Recomenda-se que os próximos editais adotem como prioridade de pesquisa as três principais causas de óbitos, o processo de organização e avaliação de linhas de cuidados, serviços de saúde e redes de atenção.

Abstract This article analyzes the profile of research conducted in the Federal District of Brazil funded through public calls for proposals issued by the Research for the SUS Program: shared health management/Federal District (PPSUS/DF) and a research support program run by the Superior School of Health Sciences, maintained by the Health Sciences Teaching and Research Foundation (ESCS/FEPECS, acronym in Portuguese). A document analysis was undertaken of all research funded by the PPSUS/DF and ESCS/FEPECS's Research Support Program between 2008 and 2017 using the following variables: year, title, research themes of the National Agenda for Health Research Priorities (ANPPS, acronym in Portuguese), implementing organization, area of application of research, and amount of funding. PPSUS/DF funded 73 projects with a total investment of approximately R$8 million, while ESCS/FEPECS funded 85 projects with a total investment of R$2.3 million. This study provides a critical analysis of the research themes supported by ESCS/FEPECS and PPSUS/DF between 2008 and 2017. It is recommended that future calls for proposals should prioritize the three leading causes of death in the Federal District and the organization and evaluation of healthcare services.

Assessing Cost-Effectiveness of New Technologies in Stone Management.

Diagnosis, treatment, and follow-up are all influential in determining the overall cost to the health care system for kidney stones. New innovations in the field of nephrolithiasis have been abundant, including disposable ureteroscopes, ultrasound-guided approaches to percutaneous nephrolithotomy, and advanced laser lithotripters. Identifying cost-effective treatment strategies encourages practitioners to be thoughtful about providing value-based high-quality care and remains on important principle in the treatment of urinary stone disease.

Decreasing the Toxicity of Radiation Therapy: Radioprotectors and Radiomitigators Being Developed by the National Cancer Institute Through Small Business Innovation Research Contracts.

PURPOSE: The use of radioprotectors and radiomitigators could improve the therapeutic index of radiation therapy. With the intention of accelerating translation of radiation-effect modulators (radioprotectors and mitigators), the Radiation Research Program and SBIR (Small Business Innovation Research) Development Center within the National Cancer Institute issued 4 Requests for Proposals (RFPs) from 2010 to 2013. Twelve SBIR contract awards in total were made in response to the 4 RFPs from September 2011 through September 2014. Here, we provide an update on the status of SBIR contract projects for the development of radiation-effect modulators. METHODS AND MATERIALS: To assess the status of research and development efforts under the 4 RFPs on radiation-effect modulators, we searched PubMed for research articles, google.com for published abstracts, clinicaltrials.gov for ongoing or completed clinical trials, and company websites for press releases and other news. All information obtained and reported here is publicly available and thus protects the intellectual property of the investigators and companies. RESULTS: Of the 12 SBIR projects funded, 5 (42%) transitioned successfully from phase 1 to phase 2 SBIR funding, and among the Fast-Track contracts, this rate was 100% (3 of 3). The Internet search identified 3 abstracts and 6 publications related to the aims of the SBIR contracts. One-third of the companies (4 of 12) have successfully launched a total of 8 clinical trials to demonstrate the safety and efficacy of their investigational agents. Two drugs are in clinical trials for their indication as a radioprotector, and 2 drugs are under evaluation for their anticancer properties (an immunomodulator and a small molecule inhibitor). CONCLUSIONS: The National Cancer Institute's SBIR has provided pivotal funding to small businesses for the development of radioprotectors and radiomitigators, which resulted in multiple early-phase clinical trials. Longer follow-up is needed to determine the full impact of these novel therapeutics that enter clinical practice.

Valuing innovative endoscopic techniques: per-oral endoscopic myotomy for the management of achalasia.

BACKGROUND AND AIMS: Unclear reimbursement for new and innovative endoscopic procedures can limit adoption in clinical practice despite effectiveness in clinical trials. The aim of this study was to determine maximum cost-effective reimbursement for per-oral endoscopic myotomy (POEM) in treating achalasia. METHODS: We constructed a decision-analytic model assessing POEM versus laparoscopic Heller myotomy with Dor fundoplication (LHM) in managing achalasia from a payer perspective over a 1-year time horizon. Reimbursement data were derived from 2017 Medicare data. Responder rates were based on clinically meaningful improvement in validated Eckardt scores. Validated health utility values were assigned to terminal health states based on data previously derived with a standard gamble technique. Contemporary willingness-to-pay (WTP) levels per quality-adjusted life year (QALY) were used to estimate maximum reimbursement for POEM using threshold analysis. RESULTS: Effectiveness of POEM and LHM was similar at 1 year of follow-up (0.91 QALY). Maximum cost-effective reimbursement for POEM was $8033.37 to $8223.14, including all professional and facility fees. This compares favorably with contemporary total reimbursement of 10 to 15 total relative value units for advanced endoscopic procedures. Rates of postprocedural GERD did not affect the preference for POEM compared with LHM, assuming at least 10% cost savings with POEM compared with LHM in cost-minimization analysis, or at least 44% cost savings in cost-effectiveness analysis (WTP = $100,000/QALY). LHM was only preferred over POEM if both procedures were reimbursed similarly, and these findings were primarily driven by lower rates of postprocedural GERD. The rate of conversion to open laparotomy due to perforation or bleeding was infrequent in published clinical practice experience, thus did not significantly affect reimbursement. DISCUSSION: POEM is an example of an innovative and potentially disruptive endoscopic technique offering greater cost-effective value and similar outcomes to the established surgical standard at contemporary reimbursement levels.

The Effect of Medical Technology Innovations on Patient Outcomes, 1990-2015: Results of a Physician Survey.

BACKGROUND: Developments in diagnostics, medical devices, procedures, and prescription drugs have increased life expectancy and quality of life after diagnosis for many diseases. Previous research has shown that, overall, increased investment in medical technology has led to increased health outcomes. In addition, the value of investment in specific innovations, particularly in new pharmaceuticals or biopharmaceuticals, has frequently been shown through an evaluation of the associated health outcomes and costs. Value assessments for all medical technologies and interventions are an important consideration in current debates on access and affordability of health care in the United States. OBJECTIVE: To identify practicing physician impressions of the historical effect of postdiagnosis innovations in medical technology on patient outcomes within the 8 health conditions that have the largest effect on health in the United States. METHODS: National statistics were used to identify the 8 conditions responsible for the most mortality and morbidity within the United States between 1990 and 2014. A physician survey was developed for each major condition to obtain physician opinion on the extent to which pharmaceuticals and biopharmaceuticals, medical devices, diagnostics, and surgical procedures contributed to improvements in postdiagnosis mortality and morbidity outcomes over the evaluated period. Respondents were provided with a fifth category, "cannot allocate," to account for postdiagnosis outcome gains resulting from other factors such as public health interventions. RESULTS: The conditions identified as having the greatest effect on morbidity and mortality since 1990 were breast cancer, ischemic heart disease, human immunodeficiency virus infection, diabetes, unipolar depression, chronic obstructive pulmonary disease, cerebrovascular disease, and lung cancer. After excluding other factors, physicians specializing in these conditions, with a mean of 21.4 years in practice, considered pharmaceuticals and biopharmaceuticals as having the greatest postdiagnosis effect across all 8 conditions, with 56% of outcome gains attributed to this innovation category. Diagnostics was the second biggest contributor at 20%. CONCLUSIONS: Physician perceptions indicated that attention should be paid to value assessments of innovative diagnostics, devices, and surgical procedures, as well as to pharmaceuticals and biopharmaceuticals, before goals for allocating health care expenditures among the different innovations are determined. DISCLOSURES: Funding for this study was provided by the National Pharmaceutical Council, a health policy research group that receives its funding from biopharmaceutical manufacturers. Wamble is employed by RTI Health Solutions, which received funding from the National Pharmaceutical Council to conduct this research. Ciarametaro and Dubois are employed by the National Pharmaceutical Council.

Innovation and Entrepreneurship: Perspectives From Orthopedic Surgery.

Orthopedic surgeons are tasked with treating complex patients while employing critical surgical skills, clinical knowledge, and new technologies. The constant inundation of information, coupled with hours in the hospital setting, provides unique perspectives on various aspects of how health care is delivered, thereby creating a milieu ripe for innovation. The rigors of an orthopedic career make it challenging for physicians to translate an idea into a great product. Through the authors' experiences at a tertiary orthopedic practice, they review the process of taking an idea from concept to fruition. [Orthopedics. 2018; 41(3):135-140.].

Surgical Outcomes of a New Low-Cost Nonvalved Glaucoma Drainage Device in Refractory Glaucoma: Results at 1 Year.

PURPOSE: The purpose of this study was to report the early outcomes in terms of efficacy and safety of a new, indigenously manufactured, low-cost nonvalved drainage device [AADI (Aurolab Aqueous Drainage Implant)] in the management of refractory glaucoma in the Indian population. METHODS: Retrospective review of consecutive patients older than 12 years, who underwent glaucoma drainage device surgery (GDD) using AADI, by a single fellowship-trained surgeon, between January 2014 and December 2016, who had at least 3 months of documented post-op follow-up. OUTCOME MEASURES: Primary-intraocular pressure (IOP).Secondary-number of antiglaucoma medication (AGM), LogMAR best corrected visual acuity (BCVA), and complications.Complete success was defined as IOP ≥5 mm Hg and ≤21 mm Hg or reduction of IOP by ≥20% from baseline without AGM; qualified success with use of AGM. Failure was defined as inability to meet IOP criteria, loss of perception of light, explantation or any additional glaucoma surgery. RESULTS: A total of 54 eyes of 51 patients were included. Mean follow up was 12.1±6.3 months. The IOP and number of AGM required was significantly lower at every visit postoperatively (P<0.001). Median LogMAR BCVA remained unchanged (P=0.5). Complications occurred in 22 patients (40.7%). Complete success was seen in 66.6%; overall success was 92.6%. CONCLUSIONS: New nonvalved GDD (AADI) surgery is effective in reducing IOP and need for AGM with a safety profile similar to published reports of prevailing GDDs. It thus has the ability to breach the cost barrier in low-to-middle income countries; further follow-up is required to determine sustainability over time.

Conceptual Considerations for Payment Bundling in Breast Reconstruction.

Rising health care costs and quality demands have driven both the Centers for Medicare and Medicaid Services and the private sector to seek innovations in health system design by placing institutions at financial risk. Novel care models, such as bundled reimbursement, aim to boost value though quality improvement and cost reduction. The Center for Medicare and Medicaid Innovation is leading the charge in this area with multiple pilots and mandates, including Comprehensive Care for Joint Replacement. Other high-cost and high-volume procedures could be considered for bundling in the future, including breast reconstruction. In this article, conceptual considerations surrounding bundling of breast reconstruction are discussed.

Innovation, productivity, and pricing: Capturing value from precision medicine technology in Canada.

For new technology and innovation such as precision medicine to become part of the solution for the fiscal sustainability of Canadian Medicare, decision-makers need to change how services are priced rather than trying to restrain emerging technologies like precision medicine for short-term cost savings. If provincial public payers shift their thinking to be public purchasers, value considerations would direct reform of the reimbursement system to have prices that adjust with technologically driven productivity gains. This strategic shift in thinking is necessary if Canadians are to benefit from the promised benefits of innovations like precision medicine.

Enhancing surgical innovation through a specialized medical school pathway of excellence in innovation and entrepreneurship: Lessons learned and opportunities for the future.

The mission of an academic medical center and academic departments of surgery focuses on teaching, scholarship/research, and expertise of clinical care. The standard 4-year medical school curriculum and general surgery residency training are well balanced to expose trainees to these missions in varying degrees, yet the advancement of medicine as a field is predicated on the creation, development, and successful implementation of medical innovations. Surgeons, by virtue of their clinical training, are immersed in medical technology and are continually required to use this technology effectively in combination with their own technical skills and judgment to provide optimal patient care. As such, they routinely face the challenges of current technology and the need for innovation and improvement, leading many to become natural inventors. Having a good idea or innovation to improve patient care, however, is just the starting point of the complex process of implementing that idea in the clinic. Unfortunately, the vast majority of surgeons and medical students have no formal educational training on the innovation process regarding how good ideas can be developed successfully for clinical and commercial implementation. Added to this lack of formal education are the limited resources and time constraints that surgeons, residents, and medical students face in acquiring the educational skill set to adeptly navigate this innovation and entrepreneurial landscape. To address these challenges, the University of Michigan recently created the first pathway of excellence for medical students to focus their passions and interests in medical innovation and entrepreneurship. This program has been transformative for building a new culture of young, motivated medical innovators, many of whom have dedicated their talents already to addressing several key problems in surgical patient care.