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- All HBS Web
(855)
- People (1)
- News (195)
- Research (499)
- Events (4)
- Multimedia (11)
- Faculty Publications (345)
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- 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
Khanna, Tarun, and James Weber. "General Electric Medical Systems 2002." Harvard Business School Case 702-428, January 2002. (Revised October 2005.)
- 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
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.
- August 1995
- Teaching Note
Medical Products Company TN
By: Robert H. Hayes
Teaching Note for (9-694-065). View Details
- November 2007 (Revised August 2014)
- Case
D2Hawkeye: Growing the Medical IT Enterprise
By: Robert F. Higgins, Rosie O'Donnell, Sophie LaMontagne and Brent Kazan
In mid-March 2007, Chris Kryder sat in his office and thought about how to best finance his company's growth. Over the previous five years as founder and CEO of D2Hawkeye, a Waltham, Massachusetts-based healthcare analytics company, Kryder had grown the firm from a... View Details
Keywords: Strategy Development; Strategic Positioning; Strategic Vision; Venture Capital; Small Business; Investment; Growth Management; Expansion; Business Growth and Maturation; Decision Choices and Conditions; Financing and Loans; Business Startups; Financial Strategy; Business Strategy; Service Industry; Health Industry; Waltham
Higgins, Robert F., Rosie O'Donnell, Sophie LaMontagne, and Brent Kazan. "D2Hawkeye: Growing the Medical IT Enterprise." Harvard Business School Case 808-006, November 2007. (Revised August 2014.)
- 02 Jul 2019
- Working Paper Summaries
Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices
- 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
Wells, John R., and Galen Danskin. "Radiometer, 2003." Harvard Business School Case 715-409, September 2014.
- 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
Hamermesh, Richard, and Liz Kind. "Fred Khosravi and AccessClosure (A)." Harvard Business School Case 806-044, December 2005. (Revised October 2013.)
- 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
- 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
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- April 2006 (Revised May 2009)
- Case
Inverness Medical Innovations - Born Global (A)
Ron Zwanziger has just started his third company, having just sold the last one for $1.3 billion to Johnson & Johnson. As part of the deal with J&J, certain assets were transferred to the new company, Inverness Medical Innovations, which, at the time of its creation,... View Details
Keywords: Globalized Firms and Management; Mergers and Acquisitions; Entrepreneurship; Health Care and Treatment; Corporate Finance; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Waltham
Isenberg, Daniel J. "Inverness Medical Innovations - Born Global (A)." Harvard Business School Case 806-177, April 2006. (Revised May 2009.)
- August 2002 (Revised June 2003)
- Teaching Note
General Electric Medical Systems (TN)
By: Tarun Khanna
Teaching Note for (9-702-428). View Details
- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised January 2024.)
- January 2014
- Supplement
Fred Khosravi and AccessClosure (C)
By: Richard Hamermesh and Lauren Barley
On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the... 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
Hamermesh, Richard, and Lauren Barley. "Fred Khosravi and AccessClosure (C)." Harvard Business School Supplement 814-074, January 2014.
- April 2006
- Case
Medical Innovation Beyond MedStar: Mobilizing for National Impact
By: Rosabeth M. Kanter, Ryan Raffaelli and Michelle Heskett
Dr. Craig Feied, director of MedStar Health's Medical Informatics programs, wanted his innovations to influence national health care. Since joining Washington Hospital Center's Emergency Department in 1995 with Dr. Mark Smith, their information system had become the... View Details
Keywords: Collaborative Innovation and Invention; Innovation Strategy; Technological Innovation; Policy; Government and Politics; Innovation and Management; Projects; Corporate Social Responsibility and Impact; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Washington (state, US)
- May 1977 (Revised March 1985)
- Teaching Note
Searle Medical Instruments Group (A), Teaching Note
Keywords: Medical Devices and Supplies Industry
- 10 May 2017
- Research & Ideas
Amazon Web Services Changed the Way VCs Fund Startups
More entrepreneurs are receiving initial funding from VCs thanks to technologies such as the cloud. Source: PeopleImages As cloud technologies allow startups to build companies faster and cheaper than ever before, venture capitalists are... View Details
- March 2015 (Revised February 2022)
- Supplement
CV Ingenuity (B): Epilogue
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors?
The... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Strategy; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (B): Epilogue." Harvard Business School Supplement 315-087, March 2015. (Revised February 2022.)
- 2022
- Book
Corporate Explorer: How Corporations Beat Startups at the Innovation Game
By: Andrew Binns, Charles A. O'Reilly III and Michael Tushman
Innovation used to be seen as a game best left to entrepreneurs, but now a new breed of corporate managers is flipping this logic on its head. These Corporate Explorers have the insight, resilience, and discipline to overcome the obstacles and build new ventures from... View Details
Keywords: Organization Change And Adaptation; Disruptive Innovation; Organizational Change and Adaptation; Innovation and Management; Leading Change
Binns, Andrew, Charles A. O'Reilly III, and Michael Tushman. Corporate Explorer: How Corporations Beat Startups at the Innovation Game. Hoboken, NJ: Wiley, 2022.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).