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Medical device industry in India is a niche sector with few key players but it possesses huge potential for both domestic and international trade. In recent years, a number of regulatory relaxations have been provided to medical device manufacturers in India to enhance production and further trade especially exports. Though the industry is highly dependent on imports, the purpose of this paper is to identify key medical devices using the revealed comparative advantage, which can be exported from India by identifying new markets.

For the selected medical devices, India’s exports to the world and the newly identified markets are forecasted using the autoregressive integrated moving average model of regression.

It is seen that three major medical devices emerge to be the ones where India has the capacity and potential to manufacture and export. These medical devices are electro-cardiographs, magnetic resonance imaging apparatus and oscilloscopes and oscillographs being exported to the USA, Australia; China and the USA, respectively, which is rising in recent years.

As the forecasted values indicate that there is an increasing potential in exports from India to the world of the selected medical devices, there is an urgent need to develop this industry and enhance exports from India. Very few studies have been carried out to examine and forecast exports from specific sectors or industries which is the need of the hour now.

The paper also provides suggestions to exporters and policymakers on leveraging the future export potential of selected medical devices.

The purpose of this paper is to examine a unique marketing and legal problem that manufacturers of prescription drugs and medical devices face in the USA, under the theory of “overpromotion” and the Learned Intermediary Doctrine (the LID), and suggests a solution to the problem.

The study uses a critical review of the literature and decided legal cases to analyze the problem of direct-to-consumer advertising of prescription drugs and medical devices under the LID and “overpromotion” doctrines.

The study suggests a different approach to advertising drugs that divides the audiences into primary and secondary targets to immunize drug and medical device manufacturers against liability.

Because the laws guiding advertising are different in different countries, the findings of this study are relevant only to the US market.

The paper gives practical guidance on an alternative communication strategy that could immunize drugs and medical device manufacturers against liability.

The study uses knowledge of law and marketing to tackle an issue that, even though is useful and relevant, is rarely discussed in the marketing literature.

The learning outcomes of this paper is as follows: to analyse the drivers, mediators and threats of commoditisation. To critically evaluate the merits of different marketing options that may be employed to avoid commoditisation. To critically assess the branding-focussed or customer-focussed strategies that could be used. To develop appropriate strategies for Biotronik SA to counter commoditisation in the future.

The case begins with the protagonist and managing director of Biotronik SA, Robbie Nel, brewing over a new industry development. One of the leading private hospital groups has sent an open invitation to medical device suppliers to tender, where the lowest-priced products will win shelf space in their cathlabs. Robbie has to decide whether to sacrifice Biotronik SA’s profit margins to win the tender or risk not being stocked in their cathlabs. Or, he must find an alternative non-price-based strategy to pursue. The medical device industry is facing increasing price pressures from various stakeholders in the device-purchasing process. The decision to purchase is no longer the responsibility of specialist physicians alone. International and local market trends indicate that the medical device industry is threatened by commoditisation. Robbie has to make a decision on changing the Biotronik SA business model and strategy in response to these macro trends.

This teaching case is aimed at postgraduate students, particularly those pursuing MBA, EMBA and Postgraduate Diploma programmes, as well as specialist masters and executive education. The students should have some work experience to comprehend and assess the case from a practical perspective.

Teaching notes are available for educators only. Please contact your library to gain login details or email support@emeraldinsight.com to request teaching notes.

CSS 8: Marketing.

The area of focus is on internationalization strategies, specifically on developing suitable strategies to support an internationalization initiative of a new medical device company.

This case is designed for final year undergraduate and MBA students. It is suitable for courses of organizational management, organization theory and design, strategic management, and international business as well as international marketing.

GranuLab, a medical device company that produced the synthetic bone graft substitute GranuMaS, aspired to be a high-growth company. To achieve this aspiration the company had made plans for internationalization, which include penetrating the ASEAN, Middle East, Latin American, and African markets within the next five years. By December 2010, GranuLab had completed the construction of its new manufacturing facility in Shah Alam, about 30km from Malaysia's capital city of Kuala Lumpur. This manufacturing facility had the capability to produce high volumes to support the company's high growth plan. However, the company's internationalization processes had taken longer than expected and this has led to a low business volume. By mid-2012, the company was forced to make a quick decision as it had suffered a year and a half of operations losses. GranuLab had to formulate a strategy as to how to position GranuMaS and penetrate the targeted markets. Failure to internationalize would incur even greater losses and might hinder the achievement of its high growth aspiration by 2015.

This case is designed to stimulate case analysts' thinking into providing recommendations for the appropriate internationalization strategies to be adopted by the management team to ensure that the company could succeed in achieving its goals. The case will expose students to the concepts and theories of strategic management, international business, international entrepreneurship; and facilitate the development of students' abilities to apply those concepts in managerial situations.

Teaching notes are available for educators only. Please contact your library to gain login details or email support@emeraldinsight.com to request teaching notes.

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices.

The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals.

The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals.

This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.

When a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.

Establishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.

This is an original paper written for the Third Canadian Quality Congress.

The purpose of this study is to explore knowledge absorptive capacity (ACAP) (both potential and realized) and new product development (NPD) in bipolar entrepreneurial small- and medium-sized enterprises (SMEs).

In response to recent calls for research on knowledge ACAP and NPD in entrepreneurial SMEs, particularly in different contexts, this research aims to answer a specific question: What are the characteristics of ACAP (both potential and realized) and the salient issues concerning working complementarily between both types of ACAP to foster NPD in bipolar entrepreneurial SMEs (in this case, three new low-tech and three established high-tech cases)? The authors conduct case study research based on cross-case and within case analyses to answer the question.

The findings show that, in the established high-tech cases, realized ACAP plays an outsized role in developing new products and prior-related knowledge acts as a precondition for capturing useful knowledge from external sources (potential ACAP). On the contrary, in the new low-tech cases, potential ACAP is the key driver of NPD, so external knowledge from network ties becomes a crucial source of acquiring new knowledge, along with entrepreneurs’ level of skill at applying useful knowledge (realized ACAP) to achieve NPD.

On the basis of the bipolar entrepreneurial SMEs (i.e. established high-tech and new low-tech ventures), the characteristics of entrepreneurial SMEs (i.e. firm’s age, size and level of technology) affect the different roles of realized and potential ACAP in driving NPD successes. Realized ACAP plays a critical role for NPD in established high-tech SMEs, whereas potential ACAP is the main driver of NPD in new low-tech SMEs. This research has some limitations that future research should conduct quantitative research in other industries’ context as well as in other countries.

For new ventures, they should be aware that to strengthen their network ties with customers and suppliers can be an important tool for not only overcoming their limitations of existing knowledge but also acquiring tacit knowledge from the external sources. For established high-tech ventures, they should focus not only on the short-term NPD (the achievement of current NPD) but also the long-term NPD (e.g. series of new products and new strategic alliances) that can help avoid a not-invented-here syndrome situation.

The government should customize the policy to suit each targeted SME. Policymakers should play a crucial role of a linking pin among key external sources (e.g. R&D national and international institutions, SME banks and marketing agents) in different stages of the business cycle.

This research contributes to the literature of knowledge ACAP in SMEs to the understanding of the distinction roles of potential and realized ACAP as a mechanism in the different natures of entrepreneurial SMEs.

The singularity of being the first Chinese manufacturer of drug-eluting stents to arrive in Brazil and the country being selected as the company's first experience outside its home country motivated the interest in the study of this case, vis-à-vis with the characteristic of internationalization medical device companies according to the Uppsala model. Considering this context, the following research question was outlined: “How did Microport internationalize before the distribution of its stents product in Brazil?” The aim of the study is to investigate Microport's internationalization process for the distribution of its drug-eluting stents in Brazil.

Exploratory research under the qualitative method was adopted. It chose the single case study as a procedure for data collection, as it is a revealing, exemplary subject that offers opportunities for access to unusual research. The company MicroPort was chosen because in the period when Chinese medical device companies were focused on gaining market share in China, MicroPort began its international expansion, choosing Brazil as the first country to have its own subsidiary. It consists in the case of the internationalization of a high-tech EMNE in an emerging country that has institutional and cultural differences.

Taking advantage of new technology in highly internationalized environments favors its insertion; the internationalization of medical technology can expand according to the Uppsala Model, which does not explain internationalization, but rather its evolution. Cultural and behavioral issues reinforce that the development of the market for medical devices depends on local perspectives and values. The formation of an ecosystem in the local market for internationalization is observed. One implication of the study is that MicroPort's experience and the application of the Uppsala model for international expansion can serve as an important learning experience for Brazilian multinational companies.

Empirical analysis carried out in the context of a single company. Although the results can be used as lessons learned from the application of the Uppsala model for international expansion of EMNE in an emerging market, caution should be exercised when generalizing its findings. Future studies could carry out comparative cases considering other emerging multinational companies, from the same sector or even from different industries, investing in other emerging markets. There is a limitation of the fact that the case studied does not explore the concepts of the later stages of the Uppsala model.

High-tech EMNEs internationalizing in other markets need to adopt aggressive strategies. The need to adopt different strategies for supply chain operations according to the specificities of the markets in which they operate. Important contributions to the Uppsala model, with regard to the process of passing stages, learning and networking. The findings of this study have similarities to the process described as a sequence of distinct phases of activities.

A local top management team is essential to deal with institutional issues of government agencies when EMNE is internationalized in a culturally distant market. When there are major institutional differences between the country of origin and the host country, the autonomy in the management of the foreign subsidiary positively influences the acceleration of the internationalization process of companies in the high-tech sector. When there are major institutional differences between the country of origin and the country of destination, the use of local social networks positively influences the acceleration of the internationalization process of companies in the high-technology sector.

Regardless of these limitations, the study provided an exciting case of internationalization of a Chinese company in Brazil operating in a high-tech medical sector. The challenges for the internationalization of EMNEs continue, which makes it opportune for future studies to include more research in this area. The propositions suggested in the study may be the first step.

This paper focuses on medical device university spin-offs (USOs), taking into account the peculiarities of financial and nonfinancial support and intellectual property rights (IPRs). The authors declare that these parameters play a significant role in business development at the early stages.

This empirical data consist of individual and group interviews in Finland and Sweden, which are later inductively analyzed.

The results show that public financial support contributes to the formation and start of sales stages in small countries and local markets. However, at the validation stage, approaches for supporting entrepreneurship in the field of medical devices may differ. The ownership of IPRs assists in the development of entrepreneurship in the region due to the transfer of research results and researchers to the industry and increases the number of spin-offs and the cooperation of universities with business.

This contribution is in the identification of the key parameters for the formation, support and development of the USOs from the point of view of the availability of financial resources and the ownership of IPRs.

Focuses on a simple question: should Zimmer develop a gender-specific artificial knee? The decision is complicated because while the idea seems to make sense, there is little clinical evidence that a gender-specific knee produces superior patient outcomes, and orthopedic surgeons are likely to be skeptical of the innovation.

To teach new product strategy and growth strategy, and introduce students to the medical device industry.