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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.
- 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
- 2022
- Working Paper
Pay-As-You-Go Insurance: Experimental Evidence on Consumer Demand and Behavior
By: Ray Kluender
Pay-as-you-go contracts reduce minimum purchase requirements which may increase market participation. We randomize the introduction and price(s) of a novel pay-as-you-go contract to the California auto insurance market where 17 percent of drivers are uninsured. The...
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Kluender, Ray. "Pay-As-You-Go Insurance: Experimental Evidence on Consumer Demand and Behavior." Harvard Business School Working Paper, No. 23-030, December 2022.
- December 2022
- Case
Iberdrola: Leading the Energy Revolution
By: Juan Alcácer and Emer Moloney
At the end of 2019, Ignacio Galán, the Chairman and CEO of the world's third largest utility, Iberdrola, relected on his almost 20 years at the company. He managed a portfolio of three very different businesses, each with their own specific opportunities and...
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Keywords:
Energy;
Energy Generation;
Energy Sources;
Non-Renewable Energy;
Renewable Energy;
Engineering;
Innovation and Management;
Innovation Leadership;
Innovation Strategy;
Technological Innovation;
Leadership;
Growth and Development Strategy;
Market Timing;
Industry Growth;
Mission and Purpose;
Strategy;
Energy Industry;
Green Technology Industry;
Utilities Industry;
Transportation Industry;
Auto Industry;
Spain;
United Kingdom;
United States;
Brazil;
Mexico
- 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
- Article
Competition, Contracts, and Creativity: Evidence from Novel Writing in a Platform Market
By: Yanhui Wu and Feng Zhu
A growing number of people today are participating in the gig economy, working as independent contractors on short-term projects. We study the effects of competition on gig workers' effort and creativity on a Chinese novel-writing platform. Authors produce and sell...
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Keywords:
Gig Workers;
Platform-based Markets;
Novel Writing;
Creative Production;
Platform Bias;
Employment;
Digital Platforms;
Creativity;
Books;
Competition;
Contracts
Wu, Yanhui, and Feng Zhu. "Competition, Contracts, and Creativity: Evidence from Novel Writing in a Platform Market." Management Science 68, no. 12 (December 2022): 8613–8634.
- December 2022
- Article
Conflicting Interests and the Effect of Fiduciary Duty: Evidence from Variable Annuities
By: Mark Egan, Shan Ge and Johnny Tang
We examine the variable annuity market to study conflicts of interest and the effect of fiduciary duty in brokerage markets. Insurers typically pay brokers higher commissions for selling more expensive annuities. Our results indicate that sales are four times as...
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Keywords:
Variable Annuity;
Brokers;
Fiduciary Duty;
Finance;
Investment;
Insurance;
Conflict of Interests;
Insurance Industry;
Insurance Industry;
United States
Egan, Mark, Shan Ge, and Johnny Tang. "Conflicting Interests and the Effect of Fiduciary Duty: Evidence from Variable Annuities." Review of Financial Studies 35, no. 12 (December 2022): 5334–5386.
- 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 (Revised December 2022)
- Case
Replika AI: Monetizing a Chatbot
By: Julian De Freitas and Nicole Tempest Keller
In early 2018, Eugenia Kuyda, co-founder and CEO of San Francisco-based chatbot Replika AI, was deciding how to monetize the app she had built. Launched in 2017, Replika was a consumer AI “companion app” developed by a team of AI software engineers originally based in...
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- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This slide deck provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This case provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- 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 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 technological innovation...
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- September 2022 (Revised December 2022)
- Case
Navya: Steering Toward a Driverless Future
By: Julian De Freitas, Elie Ofek, Shaun Ingledew and Tonia Labruyere
In 2022, Sophie Desormière arrived at French roboshuttle producer Navya, tasked with charting a new course in a challenging sector. The company, which had recently listed on the Paris Stock Exchange, was burning through cash reserves and needed to transform the promise...
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Keywords:
Autonomous Vehicles;
Market Entry and Exit;
Opportunities;
Governing Rules, Regulations, and Reforms;
Consumer Behavior;
Business Model;
Auto Industry;
Transportation Industry;
France;
United States
De Freitas, Julian, Elie Ofek, Shaun Ingledew, and Tonia Labruyere. "Navya: Steering Toward a Driverless Future." Harvard Business School Case 523-046, September 2022. (Revised December 2022.)
- 2022
- Article
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander MacKay and Samuel N. Weinstein
Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...
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Keywords:
Competition Policy;
Regulation;
Algorithmic Pricing;
Dynamic Pricing;
Economics;
Law And Economics;
Law And Regulation;
Consumer Protection;
Antitrust Law;
Industrial Organization;
Antitrust Issues And Policies;
Technological Change: Choices And Consequences;
Competition;
Policy;
Price;
Governing Rules, Regulations, and Reforms;
Microeconomics;
Duopoly and Oligopoly;
Law
MacKay, Alexander, and Samuel N. Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Washington University Law Review 100, no. 1 (2022): 111–174. (Direct download.)
- August 2022
- Case
Icario Health: AI to Drive Health Engagement
By: David C. Edelman
Icario Health has built a market-leading AI engine to help health insurers drive better health behaviors for their members, enabling the insurers to improve their Medicare.
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- August 2022
- Case
Air Wars: Deregulating the U.S. Airline Industry
By: Tom Nicholas and James Weber
In the early decades of the twentieth century, the U.S. government assisted in the development of an airline industry by subsidizing the delivery of mail and allowing mail carriers to also fly passengers. Because the government awarded mail routes to the lowest...
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Keywords:
Government Regulation;
Deregulation;
Change Management;
Economics;
Entrepreneurship;
Financial Management;
Business History;
Human Resources;
Compensation and Benefits;
Labor;
Labor Unions;
Leading Change;
Leadership Style;
Crisis Management;
Industry Structures;
Operations;
Strategy;
Adaptation;
Competition;
Air Transportation;
Air Transportation Industry;
United States
- July 2022
- Article
The Pass-Through of Uncertainty Shocks to Households
By: Marco Di Maggio, Amir Kermani, Rodney Ramcharan, Vincent Yao and Edison Yu
Using new employer-employee matched data, this paper investigates the impact of uncertainty, as measured by idiosyncratic stock market volatility, on individual outcomes. We find that firms provide at best partial insurance to their workers. An increase in firm-level...
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Keywords:
Employment Risk;
Consumption;
Employment;
Risk and Uncertainty;
System Shocks;
Insurance;
Household;
Spending
Di Maggio, Marco, Amir Kermani, Rodney Ramcharan, Vincent Yao, and Edison Yu. "The Pass-Through of Uncertainty Shocks to Households." Journal of Financial Economics 145, no. 1 (July 2022): 85–104.
- June 2022
- Case
Business Implications from Regulating Carbon Emissions in the EU
By: George Serafeim and Benjamin Maletta
In the beginning of the 21st century, the European Union (the EU) had led the global fight against climate change with a wide array of policy measures. The EU’s primary approach to climate policy had been taxation via the European Union Emissions Trading System (EU...
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Keywords:
Regulation;
Carbon Emissions;
Trade;
Sustainability;
Decarbonization;
Performance;
Climate Change;
Analysis;
Strategy;
Taxation;
Policy;
Environmental Regulation;
Industry Structures;
European Union
Serafeim, George, and Benjamin Maletta. "Business Implications from Regulating Carbon Emissions in the EU." Harvard Business School Case 122-106, June 2022.
- April 2022
- Article
AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care
By: Ariel Dora Stern, Avi Goldfarb, Timo Minssen and W. Nicholson Price II
Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those...
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Keywords:
Artificial Intelligence;
Medicine;
Health Care and Treatment;
Legal Liability;
Insurance;
Technology Adoption;
AI and Machine Learning
Stern, Ariel Dora, Avi Goldfarb, Timo Minssen, and W. Nicholson Price II. "AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care." NEJM Catalyst Innovations in Care Delivery 3, no. 4 (April 2022).