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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...
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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.
- January 2023
- Case
Natura: Weathering the Pandemic at Brazil's Cosmetic Giant
By: Brian Trelstad, Pedro Levindo and Carla Larangeira
Brazil's Natura, a multi-brand cosmetics group, has taken several measures to safeguard the livelihoods of its thousands of employees and millions of sales representatives during the COVID-19 health and economic crisis. The company has also made strides in its efforts...
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Keywords:
COVID-19 Pandemic;
ESG Reporting;
Acquisition;
Customer Focus and Relationships;
Decision Making;
Social Entrepreneurship;
Environmental Sustainability;
Environmental Management;
Climate Change;
Ethics;
Moral Sensibility;
Values and Beliefs;
Global Strategy;
Corporate Governance;
Health Pandemics;
Human Resources;
Human Capital;
Crisis Management;
Growth and Development Strategy;
Marketing;
Distribution Channels;
Supply Chain;
Corporate Social Responsibility and Impact;
Mission and Purpose;
Organizational Culture;
Customer Ownership;
Relationships;
Business and Community Relations;
Business and Stakeholder Relations;
Networks;
Partners and Partnerships;
Science-Based Business;
Reputation;
Human Needs;
Social Issues;
Strategy;
Equality and Inequality;
Beauty and Cosmetics Industry;
Brazil;
Latin America
- January 2023
- Module Note
LCA Action Planning: Responsibility and Accountability
By: Sandra J. Sucher and Marilyn Morgan Westner
LCA action plans integrate responsibility and accountability into decision-making and planning. This module note was designed for the LCA course and reviews six steps leaders can follow to develop a practical LCA action plan for their business. It shows how integrating...
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- January 2023
- Supplement
Apple: Privacy vs. Safety (B)
By: Henry McGee, Nien-hê Hsieh and Christian Godwin
In 2020, as the COVID-19 pandemic swept across the globe, Apple and Google partnered to develop a contact tracing application that would collect information about users infected with the disease and notify those who they had been in contact with. While Apple/Google’s...
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Keywords:
Iphone;
Encryption;
Data Privacy;
Customers;
Customer Focus and Relationships;
Decision Making;
Ethics;
Values and Beliefs;
Globalized Firms and Management;
Government and Politics;
Health;
Health Pandemics;
Leadership;
Markets;
Safety;
Social Issues;
Information Technology;
Telecommunications Industry;
Technology Industry;
Consumer Products Industry;
Electronics Industry;
Health Industry;
United States;
Europe
McGee, Henry, Nien-hê Hsieh, and Christian Godwin. "Apple: Privacy vs. Safety (B)." Harvard Business School Supplement 323-066, January 2023.
- 2023
- Working Paper
Is Pay Transparency Good?
By: Zoë Cullen
Countries around the world are designing pay transparency policies with the intention of combating pay discrimination. Are these policies working as intended? Most focus on revealing pay gaps between co-workers within a firm, with the goal of arming workers with...
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Keywords:
Pay Transparency;
Trends;
Transition;
Communication Strategy;
Wages;
Policy;
Europe;
North America;
Australia
Cullen, Zoë. "Is Pay Transparency Good?" Harvard Business School Working Paper, No. 23-039, January 2023.
- January 2023
- Supplement
The END Fund (B)
By: V. Kasturi Rangan and Courtney Han
Founded in 2012, the END fund focused on eliminating five Neglected Tropical Diseases that accounted for 80% of the tropical diseases affecting nearly 1.5 billion people worldwide. Its roughly $25 million/year annual budget was fully committed when it got news that the...
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- January 2023
- Case
The END Fund: To Eliminate Neglected Tropical Diseases
By: V. Kasturi Rangan and Courtney Han
Founded in 2012, the END fund focused on eliminating five Neglected Tropical Diseases that accounted for 80% of the tropical diseases affecting nearly 1.5 billion people worldwide. Its roughly $25 million/year annual budget was fully committed when it got news that the...
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- 2023
- Working Paper
Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor?
By: Katherine Baicker, Amitabh Chandra and Mark Shepard
The United States spends substantially more on health care than most developed countries, yet leaves a greater share of the population uninsured. We suggest that incremental insurance expansions focused on addressing market failures will propagate inefficiencies and...
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Baicker, Katherine, Amitabh Chandra, and Mark Shepard. "Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor?" NBER Working Paper Series, No. 30854, January 2023.
- January 2023
- Article
Racial Diversity and Racial Policy Preferences: The Great Migration and Civil Rights
By: Alvaro Calderon, Vasiliki Fouka and Marco Tabellini
Between 1940 and 1970, more than 4 million African Americans moved from the South to the North of the United States, during the Second Great Migration. This same period witnessed the struggle and eventual success of the civil rights movement in ending institutionalized...
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Keywords:
Civil Rights;
Great Migration;
History;
Race;
Rights;
Prejudice and Bias;
Government Legislation
Calderon, Alvaro, Vasiliki Fouka, and Marco Tabellini. "Racial Diversity and Racial Policy Preferences: The Great Migration and Civil Rights." Review of Economic Studies 90, no. 1 (January 2023): 165–200. (Available also from VOX, Broadstreet, and VOX EU.)
- January 2023
- Article
Social Networks, Ethnicity, and Entrepreneurship
By: William R. Kerr and Martin Mandorff
We study the relationship between ethnicity, occupational choice, and entrepreneurship. Immigrant groups in the United States cluster in specific business sectors. For example, Koreans are 34 times more concentrated in self-employment for dry cleaning than other...
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Kerr, William R., and Martin Mandorff. "Social Networks, Ethnicity, and Entrepreneurship." Journal of Human Resources 58, no. 1 (January 2023): 183–220.
- 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...
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Keywords:
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Medical Devices and Supplies Industry
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.
- December 2022 (Revised January 2023)
- Case
Marfrig's Quest for Greener Beef
By: Jose B. Alvarez, Pedro Levindo and Ruth Costas
Marfrig, one of the world’s leading meatpackers, strived to comply with its commitment to have a deforestation-free value chain in Brazil by 2030. The company also pledged to reduce its emissions of greenhouse gases in accordance with the guidelines set by the...
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Keywords:
Agribusiness;
Animal-Based Agribusiness;
Plant-Based Agribusiness;
Acquisition;
Family Business;
Communication Strategy;
Environmental Management;
Climate Change;
Environmental Regulation;
Environmental Sustainability;
Bonds;
Food;
Global Strategy;
Goods and Commodities;
Government and Politics;
Political Elections;
Leading Change;
Marketing;
Product Marketing;
Product Positioning;
Supply Chain;
Supply Chain Management;
Corporate Social Responsibility and Impact;
Business and Government Relations;
Business and Stakeholder Relations;
Partners and Partnerships;
Strategy;
Adaptation;
Business Strategy;
Commercialization;
Competitive Strategy;
Corporate Strategy;
Diversification;
Expansion;
Agriculture and Agribusiness Industry;
Food and Beverage Industry;
Brazil;
Latin America;
Argentina;
Uruguay;
North America;
United States;
Europe;
Asia;
China
- December 2022 (Revised January 2023)
- Case
Cann: High Hopes for Cannabis Infused Beverages
By: Ayelet Israeli and Anne V. Wilson
Founded in 2018 by Jake Bullock and Luke Anderson, Cann sold “social tonics,” or cannabis-infused beverages. By 2022, the company had several notable celebrity investors and talent partners, had sold over 10 million beverages to consumers, was distributing in six...
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Keywords:
Stigma;
Product Innovation;
Product Introduction;
Product Differentiation;
New Products;
New Product Marketing;
New Product Management;
Brand Management;
Branding;
Packaging;
Positioning;
Growth Strategy And Execution;
Growth;
Cannabis Industry;
Purpose;
Purpose Brands;
LGBTQ;
Direct-to-consumer;
DTC;
Regulations;
Channels Of Distribution;
Product Development;
Product Marketing;
Product Positioning;
Product;
Innovation and Invention;
Brands and Branding;
Marketing;
Marketing Communications;
Marketing Channels;
Advertising;
Advertising Campaigns;
Digital Marketing;
Market Entry and Exit;
Governing Rules, Regulations, and Reforms;
Consumer Products Industry;
Food and Beverage Industry;
United States;
Canada;
North America
Israeli, Ayelet, and Anne V. Wilson. "Cann: High Hopes for Cannabis Infused Beverages." Harvard Business School Case 523-074, December 2022. (Revised January 2023.)
- December 8, 2022
- Article
The New China Shock: How Beijing’s Party-State Capitalism Is Changing the Global Economy
By: Margaret M. Pearson, Meg Rithmire and Kellee S. Tsai
In the wake of the global financial crisis of 2008, China began to move away from the market-based approach that had shaped its economic policies for three decades, and toward something that might be termed “party-state capitalism,” which involves a high degree of...
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Pearson, Margaret M., Meg Rithmire, and Kellee S. Tsai. "The New China Shock: How Beijing’s Party-State Capitalism Is Changing the Global Economy." ForeignAffairs.com (December 8, 2022).
- December 2022
- Background Note
Brief Note on Staggered Boards
By: Lynn S. Paine and Will Hurwitz
This background note discusses the evolution, use, and prevalence of staggered boards. By comparison with unitary boards whose members are all elected annually for one-year terms, staggered boards are divided into subsets of directors, with one subset up for election...
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Keywords:
Corporate Governance;
Governing and Advisory Boards;
Business History;
Trends;
Decision Choices and Conditions;
United States
Paine, Lynn S., and Will Hurwitz. "Brief Note on Staggered Boards." Harvard Business School Background Note 323-040, December 2022.
- December 2022
- Article
Does Industry Employment of Active Regulators Weaken Oversight?
By: Jonas Heese
I study whether industry employment of active regulators weakens oversight. To examine this question, I exploit that the Financial Reporting Enforcement Panel (FREP), the German capital-market regulator responsible for enforcing public firms’ compliance with accounting...
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Keywords:
Conflict-of-interest Policies;
Directorships;
Enforcement Actions;
Industry Employment;
Self-regulatory Organizations;
Governance Compliance;
Governing and Advisory Boards;
Policy;
Conflict of Interests
Heese, Jonas. "Does Industry Employment of Active Regulators Weaken Oversight?" Management Science 68, no. 12 (December 2022).
- December 2022
- Supplement
Freelancer, Ltd. Case Supplement
By: Christopher Stanton, Karim R. Lakhani, Jin Hyun Paik and Nina Cohodes
Over the course of the 2010s, the rapid advancement of mobile technologies and the rise of online freelancing platforms seemed to portend a radical transformation of labor markets into on-demand, flexible talent pools. Even though several Fortune 500 companies,...
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Keywords:
Labor Markets;
Freelancers;
Change Management;
Corporate Entrepreneurship;
Globalized Firms and Management;
Human Capital;
Employment;
Digital Platforms;
Global Range;
Adoption;
Governing Rules, Regulations, and Reforms;
Growth and Development Strategy;
Computer Industry;
Electronics Industry;
Employment Industry;
Information Industry;
Australia;
United States;
Philippines
Stanton, Christopher, Karim R. Lakhani, Jin Hyun Paik, and Nina Cohodes. "Freelancer, Ltd. Case Supplement." Harvard Business School Multimedia/Video Supplement 823-707, December 2022.
- 2022
- Article
Leadership & Overconfidence
By: Don A Moore and Max H. Bazerman
Expressions of confidence can give leaders credibility. In the political realm, they can earn votes and public approval for decisions made in office. Such support is justified when the confidence displayed is truly a sign that a leader (whether a candidate or an...
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Moore, Don A., and Max H. Bazerman. "Leadership & Overconfidence." Behavioral Science & Policy 8, no. 2 (2022): 59–69.
- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
- December 2022 (Revised December 2022)
- Case
Ribbit Capital and the Gauntlet Investment Opportunity
By: Shai Bernstein and Allison M. Ciechanover
Ten-year-old, Palo Alto-based Ribbit Capital is best-known for its global investments in fintech. The firm was also an early advocate of crypto and blockchain, having invested in more than two dozen startups in the space in the past decade. In the Spring of 2022,...
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