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Mastering innovation in highly regulated markets might require companies to overcome significant barriers. Rules, laws and limitations on social, economic and institutional dimensions can hinder the ability of a company to transfer knowledge within and across organizational boundaries. However, as recent research in innovation management increasingly advocates user involvement and early understanding of user needs as best practices, the inability to freely interact with customers due to highly regulated market restrictions can hinder the company’s capability to innovate. Hence, this paper aims to shed light on how an emerging managerial approach, such as Design Sprint, can support companies operating in highly regulated markets to overcome user involvement limitations and boost human-centered innovation.

This paper sheds light on how to boost innovation in a highly regulated market by leveraging an in-depth case study. The study investigates the use of the Design Sprint approach adopted by the pharmaceutical multinational Johnson & Johnson to revise the way its R&D department orchestrates the new product development process, overcoming the user involvement challenges of highly regulated markets.

In analyzing six different projects undertaken in the past two years, the findings illustrate three microfoundational dimensions of the Design Sprint approach in highly regulated markets, the so-called 3T model: team, time and tools. Indeed, deploying the Design Sprint in a highly regulated market has proven that being able to experiment in the early stages, building rough prototypes in real-time and openly collaborating with partners is crucial to boost innovation and anticipate constraints.

The paper sheds light on the Design Sprint approach by initially grounding an emerging managerial approach on organizational and management theory, leveraging the lens of microfoundations. In doing so, this study suggests how Design Sprint is based on the pillars of experimentation, knowledge transfer and co-creation usually neglected in highly regulated markets where user involvement is challenging. Finally, this study discloses the importance of using a design-based methodology in fostering innovation in highly regulated markets.

In industrial markets, different players concur to diffuse the new products and services. However, in high-regulated industries, firms might find substantial limitations to their usual strategies. This paper aims to analyze the strategic marketing approaches adopted by firms to overcome these limitations.

The authors used a case study approach to explore the strategies adopted by two multinational health-care companies to promote their new products in the Italian health-care market.

The two firms adopted three specific strategic marketing approaches: educational activities for all the different players of the market with the involvement of highly reputed partners (e.g. opinion makers, scientific societies and patients’ associations); simulation of the innovation’s impact on the entire system realized; and creation of an ad hoc organizational unit, called market access unit, to deal with the specific issues of this highly regulated market.

The study contributes to the literature on marketing strategies aimed at promoting the diffusion of new products in highly regulated industrial markets by illustrating the strategic approaches that innovative firms can adopt to both achieve regulatory compliance and promote the diffusion of their new products.

The internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.

The research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulatory capabilities.

To manage regulatory requirements firms need knowledge related to plant approval and product registration. Firms have to submit dossiers to the respective country's regulatory authority to get plant approval and product registration. They can simultaneously apply for both to save time to enter the target market. The requirements for each market are unique in terms of format and contents for dossier preparation. Dossier preparation needs data from various departments which calls for good coordination among various functional areas, i.e. production, QA and QC, R&D, purchasing, etc. If the firm has operations in multiple markets and offers multiple products in a single market the regulatory function is separately organized for less regulated, semi‐regulated and regulated markets.

Pharmaceutical firms targeting international markets can get insight into the regulatory requirements and the process to be adopted to build regulatory requirements.

The paper shows that firms use a systematic process to build capabilities for managing regulations. The paper also offers a process model for firms to build regulatory capabilities for internationalization.

Corporate scandals at Enron, Tyco, and MCI highlight the issue of opportunistic management behavior. The US Congress responded to these scandals by passing the Sarbanes‐Oxley Act of 2002 (SOX). SOX imposes additional management responsibilities and corporate operating costs on companies trading under SEC regulations. This paper examines three options for US corporations responding to SOX: compliance with SOX, taking a company private, or moving to a non‐ SEC‐regulated exchange, such as an international exchange. The paper then examines potential corporate governance options using Transaction Cost Economics (TCE; Williamson 1985) to develop propositions regarding which options firms may select.

Internationally public utilities, sometimes referred to as network industries, are being privatised and dedicated regulatory structures to protect the public interest are being introduced. This study looks at the related issues of post‐privatisation performance, regulatory risk and management strategies in privatised public utilities, drawing on evidence from the UK. The main findings are, first, that in assessing the impact of privatisation on economic performance it is difficult to separate out the effects of ownership, competition, regulation and technological change. Second, that in terms of the distribution of the efficiency gains, initially investors were the main beneficiaries in the UK, but consumers gained as competition developed and regulation tightened. Third, regulated enterprises are subject to regulatory risk as well as commercial risk with implications for types of management strategies adopted. Following privatisation the dynamics of regulation involve both the regulator and management learning about regulation and the optimal strategies to adopt. The UK's experiences are educational for those countries now contemplating or in the process of introducing privatisation programmes.

The purpose of this paper is to analyse the role of switching costs (SwCs) on established firm cost behaviour towards a competitive entry in the Spanish domestic airline market, taking into account the entrant profile and airport capacity restrictions.

The dynamic model is based on information of 193 Spanish domestic routes in which incumbents react to entrants (quarterly data during 10 years, 620 reactions are analysed). The balanced panel used is constructed by setting up a multiple-source database based on accounting and industrial engineering procedures.

Results show that both entrant profile and regulatory constraints conditions incumbent cost reaction (CR) to entry at the route-level. Regression models show that the relationship between SwCs and incumbent reaction is moderated by the entrant profile and the regulatory conditions of the market.

This study reveals the importance of policy measures aimed at reducing firm market power and increasing consumer protection in the airline industry, in which SwCs are artificially created at the company’s discretion and where operating costs at the route-level need to be evaluated together with the various service elements.

This study complements current literature related to incumbent CR to entry in the airline industry since it analyses the specific reaction performed by a carrier at the route-level. Moreover, it analyses the whole set of routes in the Spanish domestic market rather than a selection of it. It also explicitly includes three alternative measures of SwCs that can influence such incumbent reaction.

Esta investigación analiza el papel de los costes de cambio en el comportamiento en costes de las empresas establecidas ante las entradas competitivas en el mercado aéreo nacional español, teniendo en cuenta el perfil de los entrantes y las restricciones de capacidad de los aeropuertos.

El modelo dinámico propuesto se basa en la información de 193 rutas nacionales españolas en las que los implicados reaccionan ante los nuevos entrantes (datos trimestrales durante 10 años, se analizan 620 reacciones). El panel equilibrado utilizado se construye configurando una base de datos de múltiples fuentes basada en procedimientos de contabilidad de costes e ingeniería industrial.

Los resultados muestran que tanto el perfil del entrante como las restricciones a la entrada condicionan la reacción en costes del implicado ante la entrada a nivel de ruta. Los resultados de las regresiones muestran que la relación entre los costes de cambio y la reacción del implicado está moderada tanto por el perfil del entrante como por las condiciones regulatorias del mercado.

Este estudio revela la importancia de las medidas de política destinadas a reducir el poder de mercado de las empresa y a aumentar la protección del consumidor en el sector de las aerolíneas, en las que los costes de cambio se crean artificialmente a discreción de la compañía y donde los costes operativos a nivel de ruta deben evaluarse juntos con diversos elementos de servicio.

Este estudio complementa la literatura actual relacionada con la reacción del implicado ante la entrada en el sector de las aerolíneas, ya que analiza la reacción específica realizada por las compañías a nivel de ruta. Además, analiza de forma exhaustiva el conjunto de rutas en el mercado nacional español en lugar de una muestra de ellas. También, incluye explícitamente tres medidas alternativas de costes de cambio que pueden influir en dicha reacción predominante.

The objective of the paper is to analyse the economic justification of introducing deregulation to Israel's regulated electricity market and infer whether such a policy change makes sense for the country.

The paper employs an analytical model of electricity market equilibrium under regulation and deregulation. It considers two technologies – coal‐fired generators and combined cycle gas turbines, and two time‐of‐day prices – peak and off‐peak. It analyzes pricing, revenues, profits and consumer surplus both for the regulated industry and the deregulated industry where firms compete, during the peak and off‐peak periods, according to the Cournot conjecture. The model is then applied to the Israeli case.

The analysis shows that a workably competitive electricity market with financially viable firms does not improve net benefits to Israeli society. A deregulated market is likely to yield smaller net benefits than a regulated market, and certainly a smaller consumer surplus. This happens since efficiency improvements in generation costs under deregulation will not be sufficient to compensate for the reduction in consumer surplus due to higher electricity prices under deregulation.

The simplifications used in the analytical model for ease of analysis and presentation could have influenced some results.

The findings of the paper would have significant relevance for electricity sector deregulation in Israel and other regions that currently have a regulated electricity sector (e.g. Hong Kong, Africa, and many parts of North America).

The value of the paper lies in its ability to demonstrate the inherent weaknesses of the deregulation policy through an analytical model.

The purpose of this paper is to explain and analyze recent US Congressional, Obama Administration, and financial services industry initiatives to reform and regulate the market for OTC derivatives.

The paper outlines Congressional committee bills, other Obama Administration initiatives, and industry self‐regulatory initiatives and discusses underlying current issues such as which derivatives would and would not have to be cleared through central counterparties (CCPs); how standardized and customized derivatives would be distinguished from each other; potential margin, business conduct, reporting, and recordkeeping standards for OTC derivatives dealers; how fraud, market manipulation, and other market abuses would be policed; possible limitations on the types of parties that may participate in unregulated derivatives; possible resolution of the sometimes confusing and overlapping authority of the SEC and CFTC over OTC derivatives; how and by which federal or state authority credit default swaps (CDS) might be regulated; the potential for regulatory arbitrage; and the danger that stringent regulation in the USA will drive OTC derivatives business offshore.

Unlike markets for other financial instruments, derivatives market participants, largely through ISDA, have for some time cooperated closely with the New York Fed and engaged in a myriad self‐policing activities. Time will tell whether this existing framework, combined with the redoubled self‐policing efforts of market participants, will cause policymakers to seek appropriate legislation that will not threaten the preservation of the OTC derivatives market in the USA.

The paper presents a clear and detailed guide and explanation of recent regulatory initiatives and underlying issues.

The purpose of this article is to present the results of empirical research concerning the identification of the impact of the transfer of companies from the alternative market to the regulated market of the Warsaw Stock Exchange on their operating and net performance.

The study was conducted based on the empirical data of the companies that changed the listing place on the Warsaw Stock Exchange. Data regarding the years before the transfer were collected from the prospectuses of companies prepared mandatorily in connection with the transition to the regulated market. Data regarding the years of the event and subsequent years were obtained from companies' annual reports. As in other studies in the analysis, the operational metrics were used (operating return on sale, operating return on assets, total asset turnover), which was further extended to net profitability ratios (net return on ale, net return on asset, net return on equity). The significance analysis was based on the Student's t-test and Wilcoxon’s test.

The results show that before the transfer from the alternative market to the regulated market, companies improved financial performance. As a result of the change of listing venues, the results already collapsed in the year of the event. The downward trend continued in the following two years, with a noticeable improvement in the third year after the transfer.

The literature lacks such studies based on the Polish market. To the best knowledge of the author, this is one of the first studies in Poland showing the changes in operating and net performance of companies changing the stock listing venues. The research is based on a large group including all companies that have changed listing venues since the beginning of the alternative market in Poland. The article presents an original empirical result that can be used both by managers and investors in their decisions.

This study explores the interrelationship between regulatory risks and strategic controls within the financial supervision architecture of an emergent global financial centre of China that embraces innovation as part of its strategic objectives.

This paper employs a longitudinal case study approach to examine the institutional dynamics of the key financial regulators in connection with the regulated financial institutions in Hong Kong before and after the financial tsunami of 2008.

First, this study reveals an organic development of a specialised financial regulatory architecture that resists transforming itself structurally despite the significant impact of externalities. Second, in this post-financial crisis analysis, regulated financial institutions swiftly respond by strengthening their risk controls through compliance with the guidelines imposed by the regulator. Institutional dynamics in influencing the implementation of risk controls through a top-down interactive mechanism are observed. Such dynamic and pertinent rapid responses induce the pursuit of optimal risk management within a regulatory framework.

This paper provides a longitudinal case study to reveal regulatory risks and strategic controls of the global financial centre of China. It unveils mitigating risk control measures in the aftermath of the global financial crisis. The study demonstrates how regulatory institutions strive to take precautionary, coercive measures such that the regulated institutions mimic and implement prudent mechanisms.