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- February 2024
- Teaching Note
Fusion Industry Association: Igniting the Future of Clean Energy
Teaching Note for HBS Case No. 624-064. This Teaching Note explores the Fusion Industry Association's efforts to advance commercial fusion energy, highlighting challenges in innovation, regulation, market structure, and financing within the emerging technology sector...
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- 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...
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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).
- 2023
- Working Paper
When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets
By: Pari Sastry, Ishita Sen and Ana-Maria Tenekedjieva
This paper studies how homeowners insurance markets respond to growing climate losses and how this impacts mortgage market dynamics. Using Florida as a case study, we show that traditional insurers are exiting high risk areas, and new lower quality insurers are...
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Keywords:
Insurance;
Natural Disasters;
Governing Rules, Regulations, and Reforms;
Insurance Industry;
Florida
Sastry, Pari, Ishita Sen, and Ana-Maria Tenekedjieva. "When Insurers Exit: Climate Losses, Fragile Insurers, and Mortgage Markets." Harvard Business School Working Paper, No. 24-051, February 2024. (SSRN Working Paper Series, No. 4674279, December 2023.)
- 2024
- Working Paper
Antitrust Platform Regulation and Entrepreneurship: Evidence from China
By: Ke Rong, D. Daniel Sokol, Di Zhou and Feng Zhu
Many jurisdictions have launched antitrust enforcement and brought in regulation of large tech platforms. The swift and strict implementation of China’s Anti-Monopoly Guidelines for the Platform Economy (Platform Guidelines) provides a quasi-natural experiment...
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Keywords:
Governing Rules, Regulations, and Reforms;
Competition;
Venture Capital;
Market Entry and Exit;
Supply and Industry;
China
Rong, Ke, D. Daniel Sokol, Di Zhou, and Feng Zhu. "Antitrust Platform Regulation and Entrepreneurship: Evidence from China." Harvard Business School Working Paper, No. 24-039, January 2024.
- January 11, 2024
- Article
Understanding the Tradeoffs of the Amazon Antitrust Case
By: Chiara Farronato, Andrey Fradkin, Andrei Hagiu and Dionne Lomax
Regulators in the United States and Europe have been taking on Big Tech, challenging what they say are the companies’ anti-competitive and predatory strategies that harm consumers and third-party users of their platforms. This article examines the FTC’s case against...
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Keywords:
Monopoly;
Governing Rules, Regulations, and Reforms;
Market Design;
Lawsuits and Litigation
Farronato, Chiara, Andrey Fradkin, Andrei Hagiu, and Dionne Lomax. "Understanding the Tradeoffs of the Amazon Antitrust Case." Harvard Business Review Digital Articles (January 11, 2024).
- September 2023
- Case
The Rise and Fall of FTX
In November 2022, Sam Bankman-Fried's multi-billion-dollar crypto exchange, FTX, collapsed, wiping out investors and throwing the crypto industry into disarray. As FTX's founder and CEO, Bankman-Fried developed a reputation for his unerring business sense and...
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Keywords:
Cryptocurrency;
Crime and Corruption;
Financial Statements;
Misleading and Fraudulent Advertising;
Insolvency and Bankruptcy;
Corporate Governance;
Governing Rules, Regulations, and Reforms;
Failure;
Restructuring;
United States;
Hong Kong;
Bahamas
Dey, Aiyesha, Jonas Heese, Joseph Pacelli, and Max Hancock. "The Rise and Fall of FTX." Harvard Business School Case 124-014, September 2023.
- September 2023
- Article
(Not) Paying for Diversity: Repugnant Market Concerns Associated with Transactional Approaches to Diversity Recruitment
In a 20-month ethnographic study, I examine how a technology firm, ShopCo (a pseudonym), considered 13 different recruitment platforms to attract racial minority engineering candidates. I find that when choosing whether to adopt recruitment platforms focused on racial...
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Jackson, Summer R. "(Not) Paying for Diversity: Repugnant Market Concerns Associated with Transactional Approaches to Diversity Recruitment." Administrative Science Quarterly 68, no. 3 (September 2023): 824–866.
- August 2023 (Revised October 2023)
- Case
Beyond the Barricades: Chile 2023
Chile, often considered among Latin America's greatest economic success stories, suffered a shocking wave of protests in October 2019, as its citizens demanded reforms across healthcare and education systems, and protested inequality and rising costs of living. As...
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Keywords:
Government Administration;
Developing Countries and Economies;
Economic Growth;
Social Issues;
Wealth and Poverty;
Public Opinion;
Equality and Inequality;
Public Administration Industry;
Chile;
Latin America;
South America
Spar, Debora, Willis Emmons, Leonard A. Schlesinger, and Ruth Costas. "Beyond the Barricades: Chile 2023." Harvard Business School Case 324-005, August 2023. (Revised October 2023.)
- 2023
- Other Unpublished Work
Urgent: The IMF Must Reform
By: Laura Alfaro, Guillermo Calvo, José de Gregorio, Augusto de la Torre, Roque Fernandez, Pablo Guidotti, Enrique Mendoza, Ernesto Talvi, Liliana Rojas-Suarez and Andrés Velasco
Alfaro, Laura, Guillermo Calvo, José de Gregorio, Augusto de la Torre, Roque Fernandez, Pablo Guidotti, Enrique Mendoza, Ernesto Talvi, Liliana Rojas-Suarez, and Andrés Velasco. "Urgent: The IMF Must Reform." Comité Latinoamericano de Asuntos Financieros (CLAAF) Statement, 46, June 2023.
- April 17, 2023
- Article
Crypto-Influencers Give Poor Investment Advice—and the SEC Is Taking Notice
By: Joseph Pacelli
Keywords:
Cryptocurrency;
Power and Influence;
Investment;
Governing Rules, Regulations, and Reforms;
Investment Return;
Consumer Behavior
Pacelli, Joseph. "Crypto-Influencers Give Poor Investment Advice—and the SEC Is Taking Notice." Promarket (April 17, 2023).
- March 2023
- Article
Not from Concentrate: Collusion in Collaborative Industries
By: Jordan M. Barry, John William Hatfield, Scott Duke Kominers and Richard Lowery
The chief principle of antitrust law and theory is that reducing market concentration—having more, smaller firms instead of fewer, bigger ones—reduces anticompetitive behavior. We demonstrate that this principle is fundamentally incomplete.
In many... View Details
In many... View Details
Keywords:
Antitrust;
Antitrust Law;
Antitrust Theory;
Law And Economics;
Collusion;
Collaboration;
Collaborative Industries;
Regulation;
"Repeated Games";
IPOs;
Initial Public Offerings;
Underwriters;
Real Estate;
Real Estate Agents;
Realtors;
Syndicated Markets;
Syndication;
Brokers;
Market Concentration;
Competition;
Law;
Economics;
Collaborative Innovation and Invention;
Governing Rules, Regulations, and Reforms;
Game Theory;
Initial Public Offering
Barry, Jordan M., John William Hatfield, Scott Duke Kominers, and Richard Lowery. "Not from Concentrate: Collusion in Collaborative Industries." Iowa Law Review 108, no. 3 (March 2023): 1089–1148.
- 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 (Revised December 2023)
- Case
OhmConnect: Energizing the Future
By: Jeffrey F. Rayport, Jennifer Fonstad and Nicole Tempest Keller
Founded in 2013, OhmConnect was a free consumer web app that alerted customers about peak hours of electricity demand, and paid them to lower their energy use at home during these periods. The company sold the aggregated reductions generated by thousands of households...
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Keywords:
App Development;
Renewable Energy;
Electricity Usage;
Regulations;
VC;
Technology;
Customer Acquisition Cost (CAC);
Scalability;
Applications and Software;
Growth and Development Strategy;
Governing Rules, Regulations, and Reforms;
Business Model;
Venture Capital;
Energy Industry;
United States;
California;
Texas;
Europe
Rayport, Jeffrey F., Jennifer Fonstad, and Nicole Tempest Keller. "OhmConnect: Energizing the Future." Harvard Business School Case 823-065, January 2023. (Revised December 2023.)
- December 2022 (Revised February 2023)
- Case
Daniel Defense: Responding to the Shooting at the Robb Elementary School in Uvalde, TX
By: Benjamin C. Esty and Daniel Fisher
At 11:33am on May 24, 2022, an 18-year-old man from Uvalde, Texas walked into the Robb Elementary School carrying a semi-automatic "AR-15-style” rifle manufactured by Daniel Defense and killed 19 children and two adults. Three days later, Representative Carolyn Maloney...
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Keywords:
Gun Violence;
Gun Policy;
Second Amendment;
Legal Liability;
Government Legislation;
Marketing Strategy;
Business or Company Management;
Product Marketing;
Ethics;
Corporate Accountability;
Corporate Social Responsibility and Impact;
Moral Sensibility;
Crime and Corruption;
Governing Rules, Regulations, and Reforms;
Manufacturing Industry;
Advertising Industry;
United States
Esty, Benjamin C., and Daniel Fisher. "Daniel Defense: Responding to the Shooting at the Robb Elementary School in Uvalde, TX." Harvard Business School Case 323-058, December 2022. (Revised February 2023.)
- 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 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. (Click here to access this case.)
- 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
- Article
Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics
By: Cheng Gao and Rory McDonald
In nascent industries—whose new technologies are often poorly understood
by regulators—contending with regulatory uncertainty can be crucial to organizational survival and growth. Prior research on nonmarket strategy has largely
focused on established firms in mature...
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Keywords:
Technological Change;
Innovation;
Qualitative Methods;
New Categories;
Entrepreneurship;
Technological Innovation;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Strategy
Gao, Cheng, and Rory McDonald. "Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics." Administrative Science Quarterly 67, no. 4 (December 2022): 915–967.
- November 2022
- Case
The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales
By: Regina E. Herzlinger and Tiffany Farrell
Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous...
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Keywords:
DTC;
Internet and the Web;
Marketing Channels;
Customer Value and Value Chain;
Governing Rules, Regulations, and Reforms;
Competitive Strategy;
Service Delivery;
Growth and Development Strategy;
Pharmaceutical Industry;
Health Industry;
Retail Industry
Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
- 2022
- Chapter
The Origins of the Developmental State: The European Experience
Book Abstract: There has been a major revival of interest in State Capitalism: what it is, where it is found, and why it is seemingly becoming more ubiquitous. As a concept, it has evolved from radical critiques of the Soviet Union, to being deployed by neo-liberals to...
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Keywords:
State Capitalism;
History;
Macroeconomics;
Developing Countries and Economies;
Economic Systems;
Europe
Reinert, Sophus A. "The Origins of the Developmental State: The European Experience." Chap. 3 in The Oxford Handbook of State Capitalism and the Firm, edited by Mike Wright, Geoffrey T. Wood, Alvaro Cuervo-Cazurra, Pei Sun, Ilya Okhmatovskiy, and Anna Grosman, 53–77. Oxford University Press, 2022.