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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
- 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
- Case
Velong: Rethinking 'Made in China'
By: Krishna G. Palepu, Nancy Hua Dai and Billy Chan
Velong is a supplier of kitchen equipment and backyard grills for major global brands and store brands of large western retailers. In light of the Covid-related disruptions to the global supply chains, and the evolving trade tensions between China and the Western...
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Keywords:
Globalization;
Supply Chain Management;
Risk Management;
Manufacturing Industry;
China;
India;
Mexico;
Turkey;
Viet Nam
- 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;
Distribution Industry;
Distribution Industry;
United States;
West Virginia;
Tennessee;
Ohio;
Pennsylvania
- January 2023 (Revised January 2023)
- Case
Belden and Digital Transformation: From Product Sales to Solutions Sales
By: Frank V. Cespedes and Amy Klopfenstein
This case provides an overview of a sales transformation in the industrial automation division at Belden, a hardware manufacturer. While Belden historically sold products such as cables, wires, and other networking devices, EVP of Industrial Automation Ashish Chand...
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- 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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- 2022
- Working Paper
Institutional Emplacement and the Novel Resurgence of Independent Bookstores
By: Ryan Raffaelli and Ryann Noe
This study reveals how actors leverage physical place as an asset to facilitate organizational
adaptation and industry evolution. Through a longitudinal, qualitative analysis of the U.S.
independent bookselling industry from 1995 to 2019, we outline how dispersed...
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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;
Agriculture and Agribusiness Industry;
Brazil;
Latin America;
Argentina;
Uruguay;
North America;
United States;
Europe;
Asia;
China
- December 2022
- Case
Mission Produce in 2022
By: Forest Reinhardt, Jose B. Alvarez and Natalie Kindred
Founded by CEO Steve Barnard in 1983, California-based Mission Produce was a leading supplier of Hass avocados with a global sourcing, marketing, and distribution network and $892 million in 2021 sales. Barnard had been influential in the global avocado trade’s...
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- 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;
Energy Industry;
Energy Industry;
Energy Industry;
Energy Industry;
Spain;
United Kingdom;
United States;
Brazil;
Mexico
- Winter 2022
- Article
Distributing a Billion Vaccines: COVAX Successes, Challenges, and Opportunities
By: Eric Budish, Hannah Kettler, Scott Duke Kominers, Erik Osland, Canice Prendergast and Andrew A. Torkelson
By January 2022, the COVAX international vaccine collaboration had allocated over a billion vaccines to over 140 countries. We describe and review the allocation process chosen, which reflected both an objective of equitably distributing vaccines across the world and...
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- December 2022
- Supplement
Driving Decarbonization at BMW - Video Supplement
Videos of Thomas Becker, Vice President of Sustainability and Mobility at BMW Group, in support of the case "Driving Decarbonization at BMW" (HBS No. 123-008)
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Keywords:
Decarbonization;
Auto Manufacturing;
Carbon Accounting;
Accounting;
Environmental Accounting;
Energy;
Environmental Management;
Climate Change;
Environmental Sustainability;
Pollution;
Product;
Supply Chain;
Supply Chain Management;
Production;
Product Design;
Transportation;
Transportation Industry;
Europe;
United States;
China
- 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
Ajax Health: A New Model for Medical Technology Innovation
By: Regina E. Herzlinger and Ben Creo
This case teaches key success factors for both startups and established medtech firms. It examines how to structure a firm to maximize financial returns. Medtech entrepreneur Duke Rohlen is proposing a new model for innovation and business growth. From 2007 to 2019,...
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- November 2022
- Teaching Note
Driving Decarbonization at BMW - Teaching Note
Teaching note in support of the case "Driving Decarbonization at BMW" (HBS No. 123-008)
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Keywords:
Decarbonization;
Environment;
Sustainability;
Carbon Accounting;
Carbon;
Carbon Abatement;
Electric Vehicles;
Automobiles;
Transportation;
Environmental Accounting;
Accounting;
Environmental Management;
Environmental Sustainability;
Strategy;
Technological Innovation;
Supply Chain;
Business and Stakeholder Relations;
Climate Change;
Transportation Industry;
Transportation Industry;
Germany;
Europe;
China;
United States
- November 2022
- Teaching Note
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern, Alpana Thapar and Menna Hassan
Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...
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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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- November 15, 2022
- Article
What Really Makes Toyota’s Production System Resilient
By: Willy C. Shih
Toyota has fared better than many of its competitors in riding out the supply chain disruptions of recent years. But focusing on how Toyota had stockpiled semiconductors and the problems of other manufacturers, some observers jumped to the conclusion that the era of...
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Keywords:
Supplier Relationships;
Manufacturing;
Supply Chain;
Production;
Auto Industry;
United States;
Japan
- November 2022 (Revised November 2022)
- Case
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication...
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- 2022
- Working Paper
How Do Investors Value ESG?
By: Malcolm Baker, Mark Egan and Suproteem K. Sarkar
Environmental, social, and governance (ESG) objectives have risen to near the top of the agenda for corporate executives and boards, driven in large part by their perceptions of shareholder interest. We quantify the value that shareholders place on ESG using a revealed...
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