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  • 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
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Watkins, Michael D., and Terri Zavada. "Medical Technology Industry and Japan (A), The." Harvard Business School Case 904-018, June 2004.
  • October 2013 (Revised January 2014)
  • Supplement

Fred Khosravi and AccessClosure (B)

By: Richard G. Hamermesh and Lauren Barley
It was January 2013, and Fred Khosravi, chairman of the board of AccessClosure Inc., wondered what the new year had in store for him and AccessClosure, the company he founded in late 2002. Khosravi was cautiously optimistic—the Mountain View, California-based medical... View Details
Keywords: Medical Devices; Vascular Closure Device; Patent Litigation; Patenting; Biomedical Research; Biotechnology; Biotech; Technological Innovation; Patents; Health Care and Treatment; Biotechnology Industry; United States; California
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Hamermesh, Richard G., and Lauren Barley. "Fred Khosravi and AccessClosure (B)." Harvard Business School Supplement 814-038, October 2013. (Revised January 2014.)
  • 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
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Foley, C. Fritz, and F. Katelynn Boland. "Investor Relations Practices at Edwards Lifesciences." Harvard Business School Case 219-058, November 2018. (Revised January 2019.)
  • 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
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George, Bill, and Natalie Kindred. "Omar Ishrak: Building Medtronic Globally." Harvard Business School Case 413-065, March 2013. (Revised May 2013.)
  • 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
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Hayes, Robert H. "Medical Products Co." Harvard Business School Case 694-065, December 1993. (Revised March 1995.)
  • 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
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Wells, John R., and Galen Danskin. "Radiometer, 2013." Harvard Business School Case 715-410, September 2014.
  • 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
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Wheelwright, Steven C. "Searle Medical Instruments Group (Abridged)." Harvard Business School Case 678-189, April 1978. (Revised January 1985.)
  • 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
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Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
  • 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
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Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
  • 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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Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
  • 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
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Khanna, Tarun, and James Weber. "General Electric Medical Systems 2002." Harvard Business School Case 702-428, January 2002. (Revised October 2005.)
  • 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
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Hamermesh, Richard G. "Novasys Medical (TN)." Harvard Business School Teaching Note 811-084, June 2011.
  • 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
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Kramer, Mark R., and Sarah Mehta. "Becton Dickinson: Global Health Strategy." Harvard Business School Case 718-406, September 2017. (Revised February 2018.)
  • 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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Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
  • August 1995
  • Teaching Note

Medical Products Company TN

By: Robert H. Hayes
Teaching Note for (9-694-065). View Details
Keywords: Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe
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Hayes, Robert H. "Medical Products Company TN." Harvard Business School Teaching Note 696-010, August 1995.
  • 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
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Mills, D. Quinn, and Julian Kurz. "Siemens Medical Solutions: Strategic Turnaround." Harvard Business School Case 703-494, June 2003. (Revised November 2003.)
  • 02 Jul 2019
  • Working Paper Summaries

Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices

Keywords: by Alberto Galasso and Hong Luo; Medical Devices & Supplies
  • 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
Citation
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Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay Agrawal, Joshua Gans, Avi Goldfarb, and Catherine E. Tucker, 107–138. Chicago and London: University of Chicago Press, 2024.
  • 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
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Hamermesh, Richard, and Liz Kind. "Fred Khosravi and AccessClosure (A)." Harvard Business School Case 806-044, December 2005. (Revised October 2013.)
  • November 2001
  • Teaching Note

Catalyst Medical Solutions (TN)

By: Richard M.J. Bohmer, Amy C. Edmondson and Laura Feldman
Teaching Note for (9-601-014). View Details
Keywords: Medical Devices and Supplies Industry
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Bohmer, Richard M.J., Amy C. Edmondson, and Laura Feldman. "Catalyst Medical Solutions (TN)." Harvard Business School Teaching Note 602-032, November 2001.
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