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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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- January 2023
- Teaching Note
The Opioid Settlement and Executive Pay at AmerisourceBergen
By: Suraj Srinivasan and Li-Kuan Ni
Teaching Note for HBS Case No 122-014. In 2020, AmerisourceBergen Corporation, a Fortune 50 company in the drug distribution industry, agreed to settle thousands of lawsuits filed nationwide against the company for its opioid distribution practices that critics alleged...
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Keywords:
Opioids;
Shareholder Activism;
Investment Activism;
Corporate Accountability;
Corporate Governance;
Governance Compliance;
Governance Controls;
Executive Compensation;
Risk Management;
Corporate Social Responsibility and Impact;
Business and Shareholder Relations;
Business and Stakeholder Relations;
Distribution Industry;
Health Industry;
Pharmaceutical Industry;
United States;
West Virginia;
Tennessee;
Ohio;
Pennsylvania
- 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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- 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
- 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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- 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
- 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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- 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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- 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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- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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- 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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- 2022
- White Paper
The Options Multiplier: Decoding the CareerWise Youth Apprentice Journey
By: Joseph B. Fuller, Rachel Lipson, Farah Mallah, Girish Pendse and Rachel Snyder
As more Americans question the appeal of costly
higher education programs, earn-and-learn models,
like apprenticeship, are attracting increasing
attention from policymakers and employers alike. While apprenticeship is widespread in many
parts of Europe,...
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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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- September 2022 (Revised November 2022)
- Case
The Uyghur Forced Labor Prevention Act: Forced Labor and Genocide in U.S.-China Relations
By: Jeremy Friedman and David Lane
On June 21, 2022, the Uyghur Forced Labor Prevention Act (UFLPA) went into effect, requiring companies to prove that goods imported from the People’s Republic of China were not made with forced labor. The bill was a reaction to reports of products being made with...
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Keywords:
Ethics;
Multinational Firms and Management;
Globalized Markets and Industries;
Governing Rules, Regulations, and Reforms;
Policy;
Government Legislation;
International Relations;
Labor;
Wages;
Law Enforcement;
Law;
Rights;
Operations;
Supply Chain Management;
Business and Government Relations;
Agriculture and Agribusiness Industry;
Manufacturing Industry;
Mining Industry;
China;
United States
- Fall 2022
- Article
China's Political Economy and International Backlash: From Interdependence to Security Dilemma Dynamics
By: Margaret Pearson, Meg Rithmire and Kellee Tsai
Contrary to expectations that economic interdependence might lessen security conflict between China and the U.S. and its allies, much of the contestation between China and several OECD countries has focused on firms and economic links. This paper explains the...
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- 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
- September 2022
- Article
Health Externalities and Policy: The Role of Social Preferences
By: Laura Alfaro, Ester Faia, Nora Lamersdorf and Farzad Saidi
Social preferences facilitate the internalization of health externalities, for example by reducing mobility during a pandemic. We test this hypothesis using mobility data from 258 cities worldwide alongside experimentally validated measures of social preferences....
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- August 2022
- Case
One Tiger Per Mountain: The He Family Office
By: Lauren Cohen, Fei Wu and Grace Headinger
Roy He, founder and majority shareholder of his family construction material production company, was preparing to pass down the family business through its first generational handover to his children. His decision would establish his familial legacy and set a precedent...
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