A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company

This article focuses on the importance of intellectual property (IP) in startup companies to attract investment. Various examples of startup companies dealing with medical devices were also discussed. Much of a medical device startup’s assets, however, lie in ideas or concepts it hopes to develop into a commercial product. Patent protection often is considered a critical component of corporate transactions involving medical technologies because it can protect the significant upfront investments required for R'D and regulatory activities. Investors evaluating the IP of a target medical device company are attracted to a demonstrated awareness of IP and to a clean house as it relates to administrative issues potentially affecting the company’s intellectual property. A target company also may make investment more attractive by minimizing or eliminating contractual restrictions on the transfer of its IP. A startup company seeking its portion of investment dollars must pay attention to its IP: it must ensure that its technology is freely marketable without infringing third-party rights and that its IP portfolio is free of encumbrances and has the necessary protection.

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Regulatory hurdles in bringing an in vitro diagnostic device to market

Clinical Chemistry ◽

10.1093/clinchem/42.9.1556 ◽

1996 ◽

Vol 42 (9) ◽

pp. 1556-1557 ◽

Cited By ~ 3

Author(s):

K M Smith ◽

J A Kates

Keyword(s):

Medical Device ◽

Drug Administration ◽

New Products ◽

New Product ◽

Diagnostic Device ◽

Regulatory Strategy ◽

The Us ◽

In Vitro Diagnostic ◽

Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

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GranuLab (C): internationalizing GranuMaS

Emerald Emerging Markets Case Studies ◽

10.1108/20450621211320524 ◽

2012 ◽

Vol 2 (8) ◽

pp. 1-15 ◽

Cited By ~ 1

Author(s):

Khairul Akmaliah Adham ◽

Mohd Fuaad Said ◽

Nur Sa'adah Muhamad ◽

Saida Farhanah Sarkam ◽

Zizah Che Senik ◽

...

Keyword(s):

Strategic Management ◽

Medical Device ◽

International Business ◽

Latin American ◽

High Growth ◽

Capital City ◽

Content Type ◽

Manufacturing Facility ◽

Internationalization Strategies ◽

Medical Device Company

Subject area The area of focus is on internationalization strategies, specifically on developing suitable strategies to support an internationalization initiative of a new medical device company. Study level/applicability 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. Case overview 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. Expected learning outcomes 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. Supplementary materials Teaching notes are available for educators only. Please contact your library to gain login details or email [email protected] to request teaching notes.

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