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- All HBS Web
(849)
- People (3)
- News (512)
- Research (225)
- Multimedia (7)
- Faculty Publications (66)
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- 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
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.
- October 2010 (Revised January 2011)
- Case
Toyota Recalls (A): Hitting the Skids
By: John A. Quelch, Carin-Isabel Knoop and Ryan Johnson
In the fall of 2009, Toyota Motor Corporation, once revered for its commitment to quality and reliability, faced a highly publicized series of recalls in the United States representing approximately a year's worth of sales in one of its most important markets. While... View Details
Keywords: Communication Strategy; Crisis Management; Brands and Branding; Quality; Public Opinion; Auto Industry; Japan; United States
Quelch, John A., Carin-Isabel Knoop, and Ryan Johnson. "Toyota Recalls (A): Hitting the Skids." Harvard Business School Case 511-016, October 2010. (Revised January 2011.)
- 2022
- Working Paper
Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions
By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern
Medical device firms operate at the frontiers of innovation. When functioning properly, innovative medical devices can prolong and improve lives; when malfunctioning, the same devices may harm patients and lead to product recalls. Product recalls create significant... View Details
Keywords: New Product Development; Recalls; Product Failures; Medical Devices; FDA; Health Care; Product Development; Product; Failure; Competition; Opportunities; Medical Devices and Supplies Industry
Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern. "Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions." Harvard Business School Working Paper, No. 19-028, September 2018. (Revised March 2022.)
- 27 Aug 2007
- Op-Ed
Mattel: Getting a Toy Recall Right
Harvard Business School professor John Quelch is debuting a blog on marketing issues at Harvard Business Online. HBS Working Knowledge is reprinting his first entry, which looks at the Mattel toy recall.Mattel has been criticized heavily for having to View Details
- October 2010
- Supplement
Toyota Recalls (C): Bumpy Road Ahead
By: John A. Quelch, Carin-Isabel Knoop and Ryan Johnson
Between February and July 2010, Toyota sales recover thanks to the use of extensive PR and sales incentives. Yet recalls continue. Can Toyota stem the tide and correct its organizational flaws to address the underlying issues? View Details
Quelch, John A., Carin-Isabel Knoop, and Ryan Johnson. "Toyota Recalls (C): Bumpy Road Ahead." Harvard Business School Supplement 511-042, October 2010.
- July 2001 (Revised February 2003)
- Case
Recall 2000: Bridgestone Corp. (A)
By: Lynn S. Paine
In September 2000, the president of Bridgestone-Firestone, the U.S. subsidiary of Japan's Bridgestone Corp., was invited to appear before a U.S. congressional subcommittee investigating the August 2000 recall of more than 6.5 million tires made by the subsidiary. The... View Details
Keywords: History; Crisis Management; Business Processes; Cross-Cultural and Cross-Border Issues; Manufacturing Industry; Auto Industry; Rubber Industry; Japan; United States
Paine, Lynn S. "Recall 2000: Bridgestone Corp. (A)." Harvard Business School Case 302-013, July 2001. (Revised February 2003.)
- July 2005 (Revised October 2006)
- Case
Recall 2000: Bridgestone Corp. (A) (Abridged)
By: Lynn S. Paine
In September 2000, the president of Bridgestone-Firestone, the U.S. subsidiary of Japan's Bridgestone Corp., was invited to appear before a U.S. congressional subcommittee investigating the August 2000 recall of more than 6.5 million tires made by the subsidiary. The... View Details
Keywords: Business or Company Management; Crisis Management; Cross-Cultural and Cross-Border Issues; Product; Trade; Organizational Culture; Corporate Social Responsibility and Impact; Auto Industry; United States; Japan
Paine, Lynn S. "Recall 2000: Bridgestone Corp. (A) (Abridged)." Harvard Business School Case 306-020, July 2005. (Revised October 2006.)
- 01 Oct 2018
- Working Paper Summaries
Negative Shocks and Innovation: Evidence from Medical Device Recalls
- July 2001 (Revised September 2001)
- Case
Recall 2000: Bridgestone Corp. (B)
By: Lynn S. Paine
Supplements the (A) case. A rewritten version of an earlier supplement. View Details
Paine, Lynn S. "Recall 2000: Bridgestone Corp. (B)." Harvard Business School Case 302-014, July 2001. (Revised September 2001.)
- September–October 1996
- Article
A Strategic Approach to Managing Product Recalls
By: N. Craig Smith, Robert J. Thomas and John A. Quelch
Smith, N. Craig, Robert J. Thomas, and John A. Quelch. "A Strategic Approach to Managing Product Recalls." Harvard Business Review 74, no. 5 (September–October 1996): 102–113.
- 27 Feb 2019
- Research & Ideas
The Hidden Cost of a Product Recall
Drivers on Interstate 25 in Colorado have been speculating about the fate of hundreds of Volkswagen cars sitting in a lot near Pikes Peak International Raceway. It’s one of 37 sites in the United States where the automaker is storing 300,000 diesel cars it View Details
- October 2010 (Revised August 2016)
- Case
On Weldon's Watch: Recalls at Johnson & Johnson from 2009 to 2010
By: Clayton S. Rose, Sandra J. Sucher, Rachel Gordon and Matthew Preble
In October of 2010, Johnson & Johnson (J&J) was unable to extricate itself from a year long recall crisis that had subjected the firm to criticism from Congress and regulators, resulted in the resignation of one of the firm's most senior officers, and cost hundreds of... View Details
Keywords: Decision Choices and Conditions; Values and Beliefs; Leadership; Crisis Management; Corporate Social Responsibility and Impact; Organizational Change and Adaptation; Organizational Culture; Quality; Pharmaceutical Industry
Rose, Clayton S., Sandra J. Sucher, Rachel Gordon, and Matthew Preble. "On Weldon's Watch: Recalls at Johnson & Johnson from 2009 to 2010." Harvard Business School Case 311-029, October 2010. (Revised August 2016.)
- September 11, 2008
- Article
9/11 Victims Recalled As Names, Not Numbers
By: John A. Quelch
Quelch, John A. "9/11 Victims Recalled As Names, Not Numbers." Boston Herald (September 11, 2008), 25.
- November 18 2004
- Article
Merck's Recall of Rofecoxib: A Strategic Perspective
By: Felix Oberholzer-Gee and Noorein Inamdar
Oberholzer-Gee, Felix, and Noorein Inamdar. "Merck's Recall of Rofecoxib: A Strategic Perspective." New England Journal of Medicine 351, no. 21 (November 18 2004): 2147–2149.
- Article
Responsibility and Responsiveness: Black & Decker Designs a Recall
By: Craig Smith, John A. Quelch and Gael Simonson
Smith, Craig, John A. Quelch, and Gael Simonson. "Responsibility and Responsiveness: Black & Decker Designs a Recall." Design Management Journal 2, no. 4 (Fall 1991): 16–21.
- November 2012
- Teaching Note
On Weldon's Watch: Recalls at Johnson & Johnson from 2009 to 2010 (TN)
By: Sandra J. Sucher and Clayton S. Rose
Teaching Note for On Weldon's Watch: Recalls at Johnson & Johnson from 2009 to 2010 HBS case 311-029. View Details
- October 2010
- Supplement
Toyota Recalls (B): Mr. Toyoda Goes to Washington
By: John A. Quelch, Carin-Isabel Knoop and Ryan Johnson
Case describes the testimony to the U.S. Congress of the Toyota CEO and the head of its U.S. motor sales. View Details
Quelch, John A., Carin-Isabel Knoop, and Ryan Johnson. "Toyota Recalls (B): Mr. Toyoda Goes to Washington." Harvard Business School Supplement 511-041, October 2010.
- 2013
- White Paper
Temporal Profiles of Instant Utility during Anticipation and Recall
By: Manel Baucells and Silvia Bellezza
- 2007
- Blog
Harvard Business Online—Marketing Know:How: How To Run A Recall
By: John A. Quelch
Quelch, John A. "How To Run A Recall." Harvard Business Online—Marketing Know:How (blog). August 22, 2007. https://hbr.org/2007/08/how-to-run-a-recall/.
- May 9, 2023
- Response
Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
Everhart, Alexander O., Yi Zhu, and Ariel D. Stern. "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 18 (May 9, 2023): 1609–1610. (Reply to original paper.)