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.

Examining Associations Between Licensed and Unlicensed Outlet Density and Cannabis Outcomes From Preopening to Postopening of Recreational Cannabis Outlets.

BACKGROUND AND OBJECTIVES: To expand on epidemiologic studies examining associations between the legalization of recreational cannabis and use among young adults, we examined the associations between licensed and unlicensed cannabis outlet density and cannabis outcomes. METHODS: A total of 1097 young adults aged 21 and older living in Los Angeles County were surveyed before licensed recreational cannabis outlets opened (Time 1: July to December 2017) and after (Time 2: July 2018 to June 2019). Using a database of open licensed and unlicensed cannabis retailers to calculate individual-level cannabis outlet density measures, we examined associations between outlet density within a 4-mile radius of participants' residences with Time 2 outcomes of any past-month use, daily use, intentions to use, quantity used, consequences, and cannabis use disorder (CUD) symptoms. RESULTS: After controlling for demographic factors and cannabis outcomes at a time point prior to their opening (Time 1), licensed cannabis outlets were associated with young adults' cannabis use, heavy use, and intentions, and unlicensed outlets were associated with young adults' heavy cannabis use and CUD symptoms. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: This study expands beyond studies of outlet prevalence to find that, after controlling for outcomes 1 year prior, licensed and unlicensed outlets were associated with young adults' cannabis outcomes. The current study is among the first to find associations between cannabis use outcomes and density of cannabis outlets among young adults using data from two time points: preopening and postopening of recreational cannabis retailers. Findings can inform policies around the density and placement of cannabis outlets. (Am J Addict 2020;00:00-00).

Diagnostic Power of DNA Methylation Classifiers for Early Detection of Cancer.

DNA methylation-based epigenetic signatures have become valuable cancer biomarkers. We highlight the advantages of liquid biopsy based DNA-methylation profiling for noninvasive diagnosis of early stage cancers and discuss the advanced analytical approaches developed by commercial and academic partnerships.

Trabalho, subjetividade e gestão gerencialista: um estudo com trabalhadores do comércio / Work, subjectivity and management techniques: a study with commerce workers

O presente estudo teve como objetivo caracterizar e problematizar as técnicas de gestão gerencialistas utilizadas no contexto de trabalho do comércio varejista. Essa análise teve como eixos teóricos os estudos de Vincent de Gaulejac a respeito das técnicas de gestão da subjetividade e os estudos da Psicodinâmica do Trabalho. Realizou-se uma pesquisa qualitativa, por meio de entrevistas semiestruturadas com cinco comerciários da cidade de Porto Alegre. As entrevistas foram submetidas à análise de conteúdo, a partir da qual foram identificadas quatro categorias temáticas. Destacou-se primazia da gestão do desempenho e da excelência, pautada por técnicas que visam à homogeneização de comportamentos e à mobilização subjetiva dos trabalhadores. Os resultados dão luz a particularidades e precarizações no setor do comércio, assim como às implicações dessas técnicas de gestão para a subjetividade dos trabalhadores.

This study aims to characterize and discuss management techniques applied in the retail business. The analysis was based on the studies of Vincent de Gaulejac on techniques for managing subjectivity and on Psychodynamic of Work. We conducted five semi-structured interviews with retailers from Porto Alegre, Brazil, which were analyzed using qualitative methods. The results showed four categories. It was highlighted the primacy of performance management and excellence, ruled by techniques that aim to homogenize behavior management. The results also shed light on particularities and precariousness in the commercial sector, as well as the implications of management techniques on the subjectivity of the workers.

A multidisciplinary review of the policy, intellectual property rights, and international trade environment for access and affordability to essential cancer medications.

In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children's EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.

Merchant Attitudes Toward a Healthy Food Retailer Incentive Program in a Low-Income San Francisco Neighborhood.

In low-income urban communities across the United States and globally, small stores frequently offer processed foods, sodas, alcohol, and tobacco but little access to healthy products. To help address this problem, the city of San Francisco created a healthy food retailer incentive program. Its success depends, in part, on retailers' willingness to participate. Through in-person interviews, we explored attitudes toward the program among store owners or managers of 17 nonparticipating stores. Eleven merchants were uninterested in the program due to negative past experiences trying to sell healthier products, perceived lack of customer demand, and fears that meeting program requirements could hurt profits. Six merchants expressed interest, seeing demand for or opportunity in healthy foods, foreseeing few difficulties in meeting program requirements, and regarding the assistance offered as appealing. Other municipalities considering such interventions should consider merchants' perspectives, and how best to challenge or capitalize on retailers' previous experiences with selling healthy foods.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

Competitive Advantage of MBA for Physician Executives: A Systematic Literature Review.

In response to systemic challenges facing the US healthcare system, many medical students, residents and practicing physicians are pursuing a Master in Business Administration (MBA) degree. The value of such proposition remains poorly defined. The aim of this review is to analyze current literature pertaining to the added value of MBA training for physician executives (PEs). We hypothesized that physicians who supplement their clinical expertise with business education gain a significant competitive advantage. A detailed literature search of four electronic databases (PubMed, SCOPUS, Embase and ERIC) was performed. Included were studies published between Jan 2000 and June 2017, focusing specifically on PEs. Among 1580 non-duplicative titles, we identified 23 relevant articles. Attributes which were found to add value to one's competitiveness as PE were recorded. A quality index score was assigned to each article in order to minimize bias. Results were tabulated by attributes and by publication. We found that competitive domains deemed to be most important for PEs in the context of MBA training were leadership (n = 17), career advancement opportunities (n = 12), understanding of financial aspects of medicine (n = 9) and team-building skills (n = 10). Among other prominent factors associated with the desire to engage in an MBA were higher compensation, awareness of public health issues/strategy, increased negotiation skills and enhanced work-life balance. Of interest, the learning of strategies for reducing malpractice litigation was less important than the other drivers. This comprehensive systemic review supports our hypothesis that a business degree confers a competitive advantage for PEs. Physician executives equipped with an MBA degree appear to be better equipped to face the challenge of the dynamically evolving healthcare landscape. This information may be beneficial to medical schools designing or implementing combined dual-degree curricula.

Energy Management in Industry: An Enterprise Engineering Approach

ABSTRACT Companies have needs and experience new opportunities to build their structure and align organizational process to achieve energy management with higher priority facing economic and environmental issues. The objective of this paper is to present the design and modeling of the Energy Management System (EnMS) in energy-intensive industries in an enterprise engineering approach, according to the management discipline called Business Process Management (BPM). The design of the process is based on the ISO 50001 standard and in good practices cited in the scientific literature. The methodology is characterized as basic, experimental, qualitative, and oriented according to the BPM development cycle. The process design created in the "should be" format presents a framework based on the Plan, Do, Check and Act (PDCA) cycle. The process is described in a necessary and sufficient way, arranging activities, actors and roles to establish an energy management process. The key process model of the energy review was developed in the Business Process Model and Notation (BPMN). The design and modeling allows to: analyze the EnMS as a process for understanding the activities; assist decision making; automate processes; enable collaboration; allow alignment of the process with the strategy; support the change and assisting with the evaluation of the organizational potential to implement the EnMS.

Disentangling regional trade agreements, trade flows and tobacco affordability in sub-Saharan Africa.

BACKGROUND: In principle, trade and investment agreements are meant to boost economic growth. However, the removal of trade barriers and the provision of investment incentives to attract foreign direct investments may facilitate increased trade in and/or more efficient production of commodities considered harmful to health such as tobacco. We analyze existing evidence on trade and investment liberalization and its relationship to tobacco trade in Sub-Saharan African countries. METHODS: We compare tobacco trading patterns to foreign direct investments made by tobacco companies. We estimate and compare changes in the Konjunkturforschungsstelle (KOF) Economic Globalization measure, relative price measure and cigarette prices. RESULTS: Preferential regional trade agreements appear to have encouraged the consolidation of cigarette production, which has shaped trading patterns of tobacco leaf. Since 2002, British American Tobacco has invested in tobacco manufacturing facilities in Nigeria, Kenya and South Africa strategically located to serve different regions in Africa. Following this, British America Tobacco closed factories in Ghana, Rwanda, Uganda, Mauritius and Angola. At the same time, Malawi and Tanzania exported a large percentage of tobacco leaf to European countries. After 2010, there was an increase in tobacco exports from Malawi and Zambia to China, which may be a result of preferential trade agreements the EU and China have with these countries. Economic liberalization has been accompanied by greater cigarette affordability for the countries included in our analysis. However, only excise taxes and income have an effect on cigarette prices within the region. CONCLUSIONS: These results suggest that the changing economic structures of international trade and investment are likely heightening the efficiency and effectiveness of the tobacco industry. As tobacco control advocates consider supply-side tobacco control interventions, they must consider carefully the effects of these economic agreements and whether there are ways to mitigate them.

How does an inventor find an investor or partner? Raising funds to start a company.

Rudy Mazzocchi has over 25 years of senior executive management, technology and intellectual property development, and financing experience in the medical-technology/biotechnology industries. He serves currently as cofounder/chief executive officer of ELENZA, Inc, an ophthalmology company that has developed an electro-active, autofocusing, implantable lens; executive chairman of Establishment Labs; executive chairman of LAFORGE Optical; and executive chairman of OptiSTENT, Inc. He served previously as managing director of Accuitive Medical Ventures and The Innovation Factory; cofounder/chief executive officer of Image-Guided NEUROLOGICS, acquired by Medtronic in 2005; and founding chief executive officer of MICROVENA Corporation, which became "eV3," acquired by Covidien. He was formerly cofounder/director of Vascular Science, acquired by St Jude Medical in 1996, and cofounder/chairman of CytoGenesis, one of the first United States stem cell companies that was merged with BresaGen and listed on the Australian public exchange. He is the recipient of the Technology Leadership Award, the Businessman of the Year Award, the Ernst & Young Entrepreneur of the Year Award in Healthcare, and Global Entrepreneur of the Year Award. He has also authored more than 70 patents; 2 published, award-winning novels (medical thrillers); and a top-selling business book on entrepreneurism.

My most valuable learning experience: Starting a business.

Alexander is a preliminary medicine resident at State University of New York Upstate Medical University and a recent graduate of Harvard Medical School. While in medical school, he cofounded Wizdy Games, a company developing mobile games that teach children to manage various health conditions, and PreMed Insiders, an advisory service for those considering or applying to medical school.

Os primeiros 24 meses de uma empresa: um estudo de caso de uma distribuidora de chocolates / The First 24 Months a Business a Case Study of a Chocolate

A abertura de uma nova empresa é um grande desafio. Diversos fatores influenciam no sucesso ou no fracasso de um novo empreendimento. Aspectos internos (finanças internas, recursos humanos, produtos, etc.) e externos (políticos, econômicos, tendências de mercado, novas oportunidades, etc.) são fundamentais no desenvolvimento de um novo negócio. Alguns são mais controláveis e previsíveis enquanto outros necessitam de uma análise mais detalhada, para isso o planejamento é essencial. Esta pesquisa tem como objetivo descrever os primeiros 24 meses de uma empresa e fazer um comparativo com as indicações sugeridas pelo Sebrae. A metodologia utilizada é um estudo de caso de uma empresa de distribuição de chocolates localizada na cidade de São Paulo, durante o período de 24 meses, compreendido entre janeiro de 2015 até dezembro de 2016. Como resultado dessa pesquisa, pretende-se identificar pontos convergentes e divergentes entre as ações tomadas pelo empreendedor e as instruções do Sebrae e seus respectivos impactos no negócio

Opening a new business is a big challenge. Several factors influence the success or failure of a new venture. Internal aspects (internal finance, human resources, products, etc.) and external (political, economic, market trends, new opportunities, etc.) are fundamental in the development of a new business. Some are more controllable and predictable while others require more detailed analysis, so planning is essential. This research aims to describe the first 24 months of a company and make a comparison with the indications suggested by Sebrae. The methodology used is a case study of a chocolate distribution company located in the city of São Paulo, during the period of 24 months, between January 2015 and December 2016. As a result of this research, it is intended to identify convergent points And divergent between the actions taken by the entrepreneur and the instructions of Sebrae and their respective impacts on the business

Cannabis cultivation in Spain: A profile of plantations, growers and production systems.

BACKGROUND: The European market for cannabis derivatives is being transformed. The cultivation of cannabis within the EU and the shift of demand from hashish to domestic marihuana are key aspects of this transformation. Spain, formerly central to the trade of Moroccan hashish, is becoming a marihuana-producing country. The emergence of "import-substitution" has been researched in other EU countries, but thus far the Spanish case remains undocumented. METHODS: This paper is based on analysis of data of 748 cannabis plantations seized by Spanish police in 2013. The sample comprises reports of seizures identified through a survey of online news and police reports. "Event-analysis" methods were applied to these sources. RESULTS: The analysis offers a typology of plantations, a profile of participants and the different production systems, and a model of regional distribution. Half of the plantations were small (less than 42 plants) and half contained between 100 and 1000 plants, with an average size of 261 plants. About three-quarters of plants were cultivated indoors using stolen electricity. 86% of all plants seized were from large-scale plantations (more than 220 plants). Most plantations were located along the Mediterranean coast, where population and tourism are concentrated. Over three-quarters of those indicted by police were Spanish (85%). Among the foreign owners of big plantations, Dutch nationals predominated. The number of seized plants by province was directly associated with the number of grow shops (ß=0.962, p<0.001). CONCLUSION: The rise of large-scale cannabis plantations in the Spanish Mediterranean coast is increasingly replacing import of Moroccan hashish. Indoor cultivation supported by grow shops, that provide the technology and know-how, seem to be the dominant form of organization in this emerging industry. Large-scale plantations may have met most of the demand for marihuana in 2013.