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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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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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...  View Details
      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
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      Trelstad, Brian, Pedro Levindo, and Carla Larangeira. "Natura: Weathering the Pandemic at Brazil's Cosmetic Giant." Harvard Business School Case 323-065, January 2023.
      • 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...  View Details
      Keywords: Globalization; Supply Chain Management; Risk Management; Manufacturing Industry; China; India; Mexico; Turkey; Viet Nam
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      Palepu, Krishna G., Nancy Hua Dai, and Billy Chan. "Velong: Rethinking 'Made in China'." Harvard Business School Case 323-064, January 2023.
      • 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...  View Details
      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
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      Srinivasan, Suraj, and Li-Kuan Ni. "The Opioid Settlement and Executive Pay at AmerisourceBergen." Harvard Business School Teaching Note 123-067, January 2023.
      • 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...  View Details
      Keywords: Implementation; Sales Cycle; Digital Transformation; Sales; Product Positioning; Business Model; Market Entry and Exit; Customer Focus and Relationships; Business and Stakeholder Relations; Supply and Industry; Technology Industry; North America; United States
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      Cespedes, Frank V., and Amy Klopfenstein. "Belden and Digital Transformation: From Product Sales to Solutions Sales." Harvard Business School Case 823-002, January 2023. (Revised January 2023.)
      • 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...  View Details
      Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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      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.
      • 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...  View Details
      Keywords: Industry Growth; Small Business; Organizational Change and Adaptation; Business Processes; Retail Industry; Retail Industry; United States
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      Raffaelli, Ryan, and Ryann Noe. "Institutional Emplacement and the Novel Resurgence of Independent Bookstores." Harvard Business School Working Paper, No. 23-033, December 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...  View Details
      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
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      Alvarez, Jose B., Pedro Levindo, and Ruth Costas. "Marfrig's Quest for Greener Beef." Harvard Business School Case 523-073, December 2022. (Revised January 2023.)
      • 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...  View Details
      Keywords: Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; United States; California; Peru; Guatemala; Colombia; Mexico; Chile
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      Reinhardt, Forest, Jose B. Alvarez, and Natalie Kindred. "Mission Produce in 2022." Harvard Business School Case 723-026, 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...  View Details
      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
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      Alcácer, Juan, and Emer Moloney. "Iberdrola: Leading the Energy Revolution." Harvard Business School Case 723-398, December 2022.
      • 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...  View Details
      Keywords: Vaccines; Pandemics; Health Care and Treatment; Health Pandemics; Distribution; Supply Chain; Equality and Inequality
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      Budish, Eric, Hannah Kettler, Scott Duke Kominers, Erik Osland, Canice Prendergast, and Andrew A. Torkelson. "Distributing a Billion Vaccines: COVAX Successes, Challenges, and Opportunities." Oxford Review of Economic Policy 38, no. 4 (Winter 2022): 941–974.
      • December 2022
      • Supplement

      Driving Decarbonization at BMW - Video Supplement

      By: Shirley Lu, George Serafeim and Michael W. Toffel
      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)  View Details
      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
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      Lu, Shirley, George Serafeim, and Michael W. Toffel. "Driving Decarbonization at BMW - Video Supplement." Harvard Business School Multimedia/Video Supplement 123-706, December 2022.
      • 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...  View Details
      Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
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      Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
      • 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,...  View Details
      Keywords: Business Startups; Success; Innovation Strategy; Mergers and Acquisitions; Market Entry and Exit; Financial Strategy; Business Model; Partners and Partnerships; Entrepreneurship; Private Equity; Technology Industry; Technology Industry
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      Herzlinger, Regina E., and Ben Creo. "Ajax Health: A New Model for Medical Technology Innovation." Harvard Business School Case 323-043, November 2022.
      • November 2022
      • Teaching Note

      Driving Decarbonization at BMW - Teaching Note

      By: Shirley Lu, George Serafeim and Michael W. Toffel
      Teaching note in support of the case "Driving Decarbonization at BMW" (HBS No. 123-008)  View Details
      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
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      Lu, Shirley, George Serafeim, and Michael W. Toffel. "Driving Decarbonization at BMW - Teaching Note." Harvard Business School Teaching Note 123-049, November 2022.
      • 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),...  View Details
      Keywords: Technological Innovation; Business Growth and Maturation; Growth and Development Strategy; Corporate Social Responsibility and Impact; Decision Making; Health Industry; Health Industry
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      Stern, Ariel D., Alpana Thapar, and Menna Hassan. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Teaching Note 623-034, November 2022.
      • 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...  View Details
      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; Pharmaceutical Industry; Pharmaceutical Industry
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      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.
      • 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...  View Details
      Keywords: Supplier Relationships; Manufacturing; Supply Chain; Production; Auto Industry; United States; Japan
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      Shih, Willy C. "What Really Makes Toyota’s Production System Resilient." Harvard Business Review Digital Articles (November 15, 2022).
      • 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...  View Details
      Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Pharmaceutical Industry; Pharmaceutical Industry; United States; District of Columbia
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      Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised November 2022.)
      • 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...  View Details
      Keywords: Investment; Investment Portfolio; Corporate Social Responsibility and Impact; Business and Shareholder Relations; Environmental Sustainability; Governance; Financial Services Industry; United States
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      Baker, Malcolm, Mark Egan, and Suproteem K. Sarkar. "How Do Investors Value ESG?" NBER Working Paper Series, No. 30708, December 2022. (Harvard Business School Working Paper, No. 23-028, November 2022.)
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