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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
      • 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; Health Industry; Pharmaceutical 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.
      • 2023
      • Working Paper

      Public Perception and Autonomous Vehicle Liability

      By: Julian De Freitas, Xilin Zhou, Margherita Atzei, Shoshana Boardman and Luigi Di Lillo
      The deployment of autonomous vehicles (AVs) and the accompanying societal and economic benefits will greatly depend on how much liability AV firms will have to carry for accidents involving these vehicles, which in turn impacts their insurability and associated...  View Details
      Keywords: Autonomous Vehicles; Moral Judgment; Liabilities; Harm; Insurance; Moral Sensibility; Legal Liability; Risk and Uncertainty; Technological Innovation; Public Opinion
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      De Freitas, Julian, Xilin Zhou, Margherita Atzei, Shoshana Boardman, and Luigi Di Lillo. "Public Perception and Autonomous Vehicle Liability." Harvard Business School Working Paper, No. 23-036, January 2023. (Revised January 2023.)
      • 2023
      • Working Paper

      Life After Death: A Field Experiment with Small Businesses on Information Frictions, Stigma, and Bankruptcy

      By: Shai Benjamin Bernstein, Emanuele Colonnelli, Mitchell Hoffman and Benjamin Iverson
      In an randomized control trial (RCT) with U.S. small businesses, we document that a large share of firms are not well-informed about bankruptcy. Many assume that bankruptcy necessarily entails the death of a business and do not know about Chapter 11 bankruptcy, where...  View Details
      Keywords: Small Business; Insolvency and Bankruptcy; Knowledge Dissemination; Outcome or Result
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      Bernstein, Shai Benjamin, Emanuele Colonnelli, Mitchell Hoffman, and Benjamin Iverson. "Life After Death: A Field Experiment with Small Businesses on Information Frictions, Stigma, and Bankruptcy." Working Paper, 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.
      • December 2022
      • Case

      Taylor Farms: Adding Value to Fresh Produce

      By: Forest L. Reinhardt, Jose B. Alvarez, Jenyfeer Martinez Buitrago and Pedro Levindo
      In October 2022, Bruce Taylor (HBS MBA, 1981), Chairman and CEO of Taylor Farms, the leading producer of salads and healthy fresh foods in the United States, wondered whether this was the right time for Taylor Farms to venture into the Controlled Environment...  View Details
      Keywords: Technology Adoption; Cost vs Benefits; Logistics; Environmental Sustainability; Agriculture and Agribusiness Industry
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      Reinhardt, Forest L., Jose B. Alvarez, Jenyfeer Martinez Buitrago, and Pedro Levindo. "Taylor Farms: Adding Value to Fresh Produce." Harvard Business School Case 523-041, 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.)
      • 2022
      • Working Paper

      Nailing Prediction: Experimental Evidence on the Value of Tools in Predictive Model Development

      By: Daniel Yue, Paul Hamilton and Iavor Bojinov
      Predictive model development is understudied despite its importance to modern businesses. Although prior discussions highlight advances in methods (along the dimensions of data, computing power, and algorithms) as the primary driver of model quality, the value of tools...  View Details
      Keywords: Analytics and Data Science
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      Yue, Daniel, Paul Hamilton, and Iavor Bojinov. "Nailing Prediction: Experimental Evidence on the Value of Tools in Predictive Model Development." Harvard Business School Working Paper, No. 23-029, 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; Green Technology Industry; Utilities Industry; Transportation Industry; Auto 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.
      • 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...  View Details
      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; Food and Beverage Industry; Food and Beverage Industry; United States; Canada; North America
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      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 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...  View Details
      Keywords: International Relations; Globalized Economies and Regions; Economic Systems; Trade; China
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      Pearson, Margaret M., Meg Rithmire, and Kellee S. Tsai. "The New China Shock: How Beijing’s Party-State Capitalism Is Changing the Global Economy." ForeignAffairs.com (December 8, 2022).
      • 2022
      • Working Paper

      Stories, Statistics and Memory

      By: Thomas Graeber, Christopher Roth and Florian Zimmermann
      For most decisions, we rely on information encountered over the course of days, months or years. We consume this information in various forms, including abstract summaries of multiple data points – statistics – and contextualized anecdotes about individual instances...  View Details
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      Graeber, Thomas, Christopher Roth, and Florian Zimmermann. "Stories, Statistics and Memory." Working Paper, December 2022.
      • 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,...  View Details
      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
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      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...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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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 (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,...  View Details
      Keywords: Alternative Assets; Cryptocurrency; Business Startups; Investment Portfolio; Decision Choices and Conditions; Negotiation Deal; Governing Rules, Regulations, and Reforms; Financial Services Industry; California
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      Bernstein, Shai, and Allison M. Ciechanover. "Ribbit Capital and the Gauntlet Investment Opportunity." Harvard Business School Case 823-038, December 2022. (Revised 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...  View Details
      Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy
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      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.
      • 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
      • 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; Medical Devices and Supplies Industry; Medical Devices and Supplies 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; Health Industry; Retail 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.
      • 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,...  View Details
      Keywords: Apprenticeship; Higher Education; Training; Personal Development and Career; Cost vs Benefits; Success; Governing Rules, Regulations, and Reforms
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      Fuller, Joseph B., Rachel Lipson, Farah Mallah, Girish Pendse, and Rachel Snyder. "The Options Multiplier: Decoding the CareerWise Youth Apprentice Journey." White Paper, Project on Workforce at Harvard, November 2022.
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