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March 2000
Case

Aspect Medical Systems

By: Richard M.J. Bohmer and Naomi Atkins

Entrepreneur Nassib Chamoun has created an innovative anesthesiology device that monitors patients' consciousness levels during surgery. This case tracks how Chamoun and his executive team built the infrastructure of the company and actively managed the adoption... View Details

Keywords: Decision Choices and Conditions; Entrepreneurship; Independent Innovation and Invention; Infrastructure; Product Design; Product Development; Problems and Challenges; Adoption; Competitive Strategy; Technology Industry

November 2018 (Revised January 2019)
Case

Investor Relations Practices at Edwards Lifesciences

By: C. Fritz Foley and F. Katelynn Boland

In January 2017, the senior leadership team at Edwards Lifesciences were preparing for the quarterly earnings call that would cover the fourth quarter of 2016. They faced questions about what types of information they should disclose on the call, as well as during... View Details

Keywords: Investor Relations; Medical Devices; Corporate Disclosure; Decisions; Business and Shareholder Relations; Medical Devices and Supplies Industry; United States

June 2004
Case

Medical Technology Industry and Japan (A), The

In a five-year effort, the Health Industry Manufacturers Association (HIMA) tried to influence government health policy in Japan. In 1993, HIMA mobilized in response to fears the Japanese government was planning to target the U.S. medical devices industry. The case... View Details

Keywords: Health Care and Treatment; Policy; Globalized Markets and Industries; Government and Politics; Medical Devices and Supplies Industry; Japan; United States

March 2013 (Revised May 2013)
Case

Omar Ishrak: Building Medtronic Globally

By: Bill George and Natalie Kindred

Omar Ishrak, Medtronic's first non-American CEO, aims to reinvigorate the medical device maker's growth by focusing on emerging markets, therapy innovation, and creative business models. In 2012, budget constraints in mature economies, the lack of new medical therapies... View Details

Keywords: Healthcare; Medical Devices; Medtronic; Globalization; Innovation; Reverse Innovation; Leadership; Multinational Firms and Management; Globalized Markets and Industries; Management Teams; Business Model; Emerging Markets; Global Strategy; Health Care and Treatment; Acquisition; Innovation and Invention; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; China

Article

Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring

By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern

In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern... View Details

Keywords: Wearables; Regulatory Changes; Medical Technology; Medical Devices; Market Access; Market Entry and Exit; Information Technology; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States; Germany; Belgium

2022
Working Paper

Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

By: Alexander O. Everhart and Ariel D. Stern

Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so... View Details

Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry

January 2002 (Revised October 2005)
Case

General Electric Medical Systems 2002

By: Tarun Khanna and James Weber

Discusses one of General Electric's flagship divisions--the world's leading provider of medical diagnostic imaging equipment. Provides an opportunity to examine a multinational confronting massive technological and demographic changes around the world. Genomics has... View Details

Keywords: Information Technology; Business Model; Change Management; Multinational Firms and Management; Genetics; Customer Value and Value Chain; Age; Medical Devices and Supplies Industry; China; United States

January 2017
Article

Innovation Under Regulatory Uncertainty: Evidence from Medical Technology

By: Ariel Dora Stern

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details

Keywords: Technological Innovation; Medical Devices and Supplies Industry

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December 1993 (Revised March 1995)
Case

Medical Products Co.

By: Robert H. Hayes

In early 1990, the company is contemplating changes in its European plant network for producing hypodermic products, including the total production capacity to be provided, the number and location of plants over which to spread this capacity, and which products should... View Details

Keywords: Factories, Labs, and Plants; Decision Making; Forecasting and Prediction; Cost; Production; Performance Capacity; Performance Effectiveness; Strategic Planning; Competitive Strategy; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe

June 2011
Teaching Note

Novasys Medical (TN)

By: Richard G. Hamermesh

Teaching Note for 810027. View Details

Keywords: Product Development; Health Care and Treatment; Policy; Medical Devices and Supplies Industry

September 2014
Case

Radiometer, 2013

By: John R. Wells and Galen Danskin

In 2013, Radiometer continued to lead the world in blood gas analysis equipment and accessories, selling direct and through distributors to hospital central laboratories, point-of-care locations, and non-hospital medical locations. Founded in 1935 and based in Denmark,... View Details

Keywords: Medical Devices; Medical Equipment ＆ Devices; Mergers ＆ Acquisitions; Strategic Analysis; Strategic Change; Family Business; Strategy; Mergers and Acquisitions; Medical Devices and Supplies Industry; Denmark; United States

April 1978 (Revised January 1985)
Case

Searle Medical Instruments Group (Abridged)

By: Steven C. Wheelwright

SMIG, a division of G.D. Searle, was a fast growing high market-share company in the field of nuclear medical instruments. It manufactured two basically different product lines, one very successful and the other less so. Although marketing was separate for these... View Details

Keywords: Change; Brands and Branding; Market Participation; Production; Success; Performance Capacity; Expansion; Medical Devices and Supplies Industry

June 2003 (Revised November 2003)
Case

Siemens Medical Solutions: Strategic Turnaround

By: D. Quinn Mills and Julian Kurz

Describes how Siemens Medical Solutions (MED) accomplished a remarkable turnaround from a money-losing operation to one of Siemens' most profitable divisions. By late 1996, a challenging market environment in the health care industry as well as inefficiencies in the... View Details

Keywords: Opportunities; Globalized Firms and Management; Health Care and Treatment; Transformation; Problems and Challenges; Medical Devices and Supplies Industry

2024
Chapter

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details

September 2014
Case

Radiometer, 2003

By: John R. Wells and Galen Danskin

In 2003, Radiometer was the world's leading supplier of blood gas analysis equipment and accessories for critical care patients. Based in Denmark, Radiometer sold through a combination of sales subsidiaries and distributors around the world, and generated sales of over... View Details

Keywords: Medical Devices; Medical Equipment ＆ Devices; Mergers ＆ Acquisitions; Strategic Analysis; Strategic Change; Family Business; Strategy; Medical Devices and Supplies Industry; Denmark; United States

December 2005 (Revised October 2013)
Case

Fred Khosravi and AccessClosure (A)

By: Richard Hamermesh and Liz Kind

Fred Khosravi is a serial medical device entrepreneur. In his latest venture, he must decide whether to sell now or continue to develop his current product and whether to market it, sell the company, or IPO. View Details

Keywords: Negotiation; Medical Devices; Venture Capital; Life Sciences; Health Care Industry; Healthcare Technology; Healthcare Ventures; Business Startups; Decision Choices and Conditions; Entrepreneurship; Growth and Development Strategy; Medical Devices and Supplies Industry; United States

September 2017 (Revised February 2018)
Case

Becton Dickinson: Global Health Strategy

By: Mark R. Kramer and Sarah Mehta

Becton, Dickinson and Company (BD) was a medical technology firm headquartered in Franklin Lakes, New Jersey, with 43,000 employees and 2016 revenues of $12.5 billion. For several years, the company had pursued developing products that created shared value, defined as... View Details

Keywords: Shared Value; Creating Shared Value; Odon Device; Medical Technology; Value Creation; Values and Beliefs; Philanthropy and Charitable Giving; Health; Health Care and Treatment; Health Testing and Trials; Emerging Markets; Social Issues; Competitive Strategy; Medical Devices and Supplies Industry; Africa; Asia; Middle East

2022
Working Paper

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details

Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry

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November 2022
Case

Ajax Health: A New Model for Medical Technology Innovation

By: Regina E. Herzlinger and Ben Creo

This case teaches key success factors for both startup and established MedTech firms. It examines how to structure a firm to maximize innovation and financial returns with organizational structures that better align the incentives for the different skill sets... View Details

Keywords: Business Startups; Success; Innovation Strategy; Mergers and Acquisitions; Market Entry and Exit; Financial Strategy; Business Model; Partners and Partnerships; Entrepreneurship; Private Equity; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

29 Jun 2015
HBS Case

Consumer-centered Health Care Depends on Accessible Medical Records

health, the process is a bit like throwing a lasso around a tsunami. That's why integrated medical data has now become a major goal of health care reform. Integrating patient records, such as physicians' notes, diagnoses, View Details

Keywords: by Dina Gerdeman; Health; Technology

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