Publications

2024
Working Paper

Gastrointestinal Endoscopy--Without Cutting In: Case Histories of Transformational Advances

By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins

This case history describes how endoscopy transformed the diagnosis of ulcers, cancerous polyps, and other alimentary canal diseases and enabled “minimally invasive” surgeries to treat such diseases. Specifically, we chronicle how: 1) flexible glass fiber endoscopes... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

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

11 Dec 2012
First Look

First Look: Dec. 11

of Health Care Reform Oberholzer-Gee, Felix, Raffaella Sadun, and Richard G. HamermeshHarvard Business School Case 711-403 Per the Patient Protection and Affordable Care Act (PPACA), which President Obama... View Details

Keywords: Sean Silverthorne

20 Jan 2017
Research & Ideas

Here’s How Businessman Trump Is Likely to Approach the Presidency

vantage point, not in sight here. I don’t see it. And I’m most troubled by that. Push and pull marketing to build public support John A. Quelch, Charles Edward Wilson Professor of Business Administration and professor in health policy and... View Details

Keywords: by Christina Pazzanese

November 2009 (Revised March 2010)
Case

Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story

By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon

In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Marketing Strategy; Product Positioning; Genetics; Biotechnology Industry; Europe; United States

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January 2009 (Revised July 2009)
Case

Targanta Therapeutics: Hitting a Moving Target

By: Arthur A. Daemmrich

This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful... View Details

Keywords: Decision Choices and Conditions; Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Business and Government Relations; Business Strategy; Biotechnology Industry; Pharmaceutical Industry

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2024
Working Paper

Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances

By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins

This case history describes how Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically, we chronicle 1) the development of foundational techniques and prototypes (through the 1970s);... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

2024
Working Paper

Mammography - Early Detection, Precise Diagnoses: Case Histories of Transformational Advances

By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins

This case history describes how the development of x-ray-based techniques and equipment (“mammography”) led to widespread screening for breast cancer and enabled “minimally invasive” biopsies of breast tumors. Specifically, we chronicle how: 1) new protocols and... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

2024
Working Paper

Antibiotic Treatments for Ulcers--Eradicating H-Pylori Infections: Case Histories of Transformational Advances

By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins

This case history describes how a chance discovery of bacteria that infect stomach linings completely changed how physicians treat ulcers. Specifically, we chronicle how: 1) two Australian physicians brought the bacterial infection to the world’s attention and... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

11 Dec 2018
First Look

New Research and Ideas, December 11, 2018

2018 Oxford University Press Food Citizenship: Food System Advocates in an Era of Distrust By: Goldberg, Ray A. Abstract—The global food system is the largest segment of the world's economy. As agribusiness-studies pioneer Ray Goldberg suggests, it is also the largest... View Details

Keywords: Dina Gerdeman

09 Jul 2001
Research & Ideas

Does Misery Love Companies? How Social Performance Pays Off

micrograms of total suspended particulates per cubic meter, yet the World Health Organization establishes 90 as a maximum safe level (Berlin's level is 50). Over 25,000 square kilometers of land were deforested in Brazil each year from... View Details

Keywords: by Joshua D. Margolis & James P. Walsh

August 2008 (Revised May 2009)
Background Note

Note on Generic Drugs in the European Union

By: Robert C. Pozen and Elizabeth M. Leonard

Rules governing the introduction of generic drugs in U.S. and EU have some similarities but significant differences because of the Hatch-Waxman Act in the U.S. View Details

Keywords: Governing Rules, Regulations, and Reforms; Government Legislation; Health Care and Treatment; Trademarks; Brands and Branding; Pharmaceutical Industry; European Union; United States

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August 2001
Case

Scios, Inc.

By: Regina E. Herzlinger

Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process. View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Cost Management; Cost vs Benefits; Social Issues; Pharmaceutical Industry; United States

June 2020 (Revised February 2021)
Supplement

Accounting for Leases at American Airlines (B)

By: Jonas Heese, Gerardo Pérez Cavazos and Julia Kelley

This is a supplement to the “Accounting for Leases at American Airlines (A)” case. The (B) case describes American Airlines’ financial results for the first quarter of 2020, as well as the continuing effects of coronavirus on the airline industry. View Details

Keywords: Accounting; Financial Reporting; Financial Statements; Finance; Governance; Corporate Accountability; Corporate Governance; Governing Rules, Regulations, and Reforms; Governing and Advisory Boards; Leasing; Health Pandemics; Accounting Industry; Air Transportation Industry; North and Central America; United States

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03 Oct 2017
First Look

First Look at Research and Ideas, October 3, 2017

greater marriage age gaps, increased marital abuse, lower reported autonomy, and poorer health. My results are robust to a TS2SLS specification employing distance to a major health center as my instrument. As the first cohort of females... View Details

Keywords: by Sean Silverthorne

20 Mar 2000
Research & Ideas

No Place Like Home: America’s Housing Crisis and Its Impact on Business

affordable housing is the low-income housing tax credit, part of the Tax Reform Act of 1986," she says. "In essence, it provides a tax benefit to private investors — typically banks and insurance companies — in return for their... View Details

Keywords: by Garry Emmons; Construction; Real Estate

November 2001
Case

Aventis CropScience and StarLink Corn

By: Ray A. Goldberg and James M Beagle

Aventis CropScience responds to the discovery of an unapproved corn variety in food supplies and draws lessons for the company, industry, and governments. View Details

Keywords: Policy; Governing Rules, Regulations, and Reforms; Food; Science-Based Business; Outcome or Result; Governance Compliance; Problems and Challenges; Nutrition; Food and Beverage Industry

January 2022
Article

Global Behaviors, Perceptions, and the Emergence of Social Norms at the Onset of the COVID-19 Pandemic

By: Lukas Hensel, Marc Witte, Stefano Caria, Thiemo Fetzer, Stefano Fiorin, Friedrich M. Goetz, Margarita Gomez, Johannes Haushofer, Andriy Ivchenko, Gordon T. Kraft-Todd, Elena Reutskaja, Christopher Roth, Erez Yoeli and Jon M. Jachimowicz

We conducted a large-scale survey covering 58 countries and over 100,000 respondents between late March and early April 2020 to study beliefs and attitudes towards citizens' and governments' responses at the onset of the COVID-19 pandemic. Most respondents reported... View Details

Keywords: COVID-19; Government Regulation; Social Norms; Health Pandemics; Governing Rules, Regulations, and Reforms; Behavior; Perception; Global Range; Surveys

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