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    • News  (72)
    • Research  (436)
    • Multimedia  (1)
  • Faculty Publications  (301)
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  • 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.
  • 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 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.
  • February 1996
  • Background Note

Note on the FDA Review Process for Medical Devices

Describes the FDA's classification scheme for the three classes of medical devices and the review processes. View Details
Keywords: Business and Government Relations; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States
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Teisberg, Elizabeth O., and James Leonard. "Note on the FDA Review Process for Medical Devices." Harvard Business School Background Note 796-063, February 1996.
  • April 2009 (Revised June 2010)
  • Case

Supply Chain Partners: Virginia Mason and Owens & Minor (A)

By: V.G. Narayanan and Lisa Brem
Virginia Mason Medical Center (VM) hired Owens & Minor (O&M) as its alpha vendor for medical/surgical supplies in 2004. By 2005, O&M was performing Just-in-Time and Low Unit of Measure services for VM, but they believed the pricing model in the industry was outdated.... View Details
Keywords: Activity Based Costing and Management; Price; Distribution; Supply Chain Management; Medical Devices and Supplies Industry
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Narayanan, V.G., and Lisa Brem. "Supply Chain Partners: Virginia Mason and Owens & Minor (A)." Harvard Business School Case 109-076, April 2009. (Revised June 2010.)
  • 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
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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
Keywords: Medical Devices and Supplies Industry; China
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Khanna, Tarun. "General Electric Medical Systems (TN)." Harvard Business School Teaching Note 703-413, August 2002. (Revised June 2003.)
  • 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
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Herzlinger, Regina E., and Ben Creo. "Ajax Health: A New Model for Medical Technology Innovation." Harvard Business School Case 323-043, 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.
  • June 2023
  • Article

Managing Medical Device Liability Through Innovation: A Strategic Approach

By: Alberto Galasso and Hong Luo
In this article, we discuss several aspects of the relationships among product liability risk, safety, and innovation strategies of medical device companies. View Details
Keywords: Safety; Public Opinion; Legal Liability; Product; Medical Devices and Supplies Industry
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Galasso, Alberto, and Hong Luo. "Managing Medical Device Liability Through Innovation: A Strategic Approach." Health Management, Policy and Innovation 8, no. 1 (June 2023).
  • 01 Oct 2018
  • Working Paper Summaries

Negative Shocks and Innovation: Evidence from Medical Device Recalls

Keywords: by George P. Ball, Jeffrey T. Macher, and Ariel Dora Stern; Medical Devices & Supplies; Medical Devices & Supplies
  • May 1977 (Revised March 1985)
  • Teaching Note

Searle Medical Instruments Group (A), Teaching Note

By: Steven C. Wheelwright
Keywords: Medical Devices and Supplies Industry
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Wheelwright, Steven C. "Searle Medical Instruments Group (A), Teaching Note." Harvard Business School Teaching Note 677-242, May 1977. (Revised March 1985.)
  • 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.
  • 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)
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Kanter, Rosabeth M., Ryan Raffaelli, and Michelle Heskett. "Medical Innovation Beyond MedStar: Mobilizing for National Impact." Harvard Business School Case 306-096, April 2006.
  • 28 Aug 2019
  • Working Paper Summaries

Who Drives Digital Innovation? Evidence from the US Medical Device Industry

Keywords: by Cirrus Foroughi and Ariel Dora Stern; Medical Devices & Supplies; Medical Devices & Supplies
  • 28 Nov 2016
  • Research & Ideas

Challenging the Belief that Liability Laws Kill Medical Device Innovation

Doctors are afraid of getting sued. According to some accounts, 75 percent of them perform more tests and procedures than necessary to avoid potential lawsuits over medical malpractice. The phenomenon of “defensive medicine” has been... View Details
Keywords: by Michael Blanding; Medical Devices & Supplies
  • 2023
  • Article

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
  • February 1981
  • Case

Medical and Environmental Electronic Devices Corp. (B)

By: Michael Beer
Keywords: Medical Devices and Supplies Industry
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Beer, Michael. "Medical and Environmental Electronic Devices Corp. (B)." Harvard Business School Case 481-063, February 1981.
  • April 2009 (Revised June 2010)
  • Supplement

Supply Chain Partners: Virginia Mason and Owens & Minor (B)

By: V.G. Narayanan and Lisa Brem
The epilogue to Supply Chain Partners: Virginia Mason and Owens & Minor (A), the B case details the outcome of the issues discussed in Case A; namely that Virginia Mason and Owens & Minor did implement the TSCC contract. Virginia Mason also kept the suture contract... View Details
Keywords: Health Care and Treatment; Supply Chain Management; Partners and Partnerships; Measurement and Metrics; Contracts; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
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Narayanan, V.G., and Lisa Brem. "Supply Chain Partners: Virginia Mason and Owens & Minor (B)." Harvard Business School Supplement 109-077, April 2009. (Revised June 2010.)
  • 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.
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