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- May 2024 (Revised May 2024)
- Case
Market by Met Council: Revolutionizing Food Pantries in the Digital Age
By: Elisabeth Paulson and Michael W. Toffel
In fall 2023, the Food Program of Met Council—America’s largest Jewish charity dedicated to fighting poverty—completed the rollout of the newest version of its digital pantry platform to twelve food pantries in the Met Council food pantry network. The digital...
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Paulson, Elisabeth, and Michael W. Toffel. "Market by Met Council: Revolutionizing Food Pantries in the Digital Age." Harvard Business School Case 624-060, May 2024. (Revised May 2024.)
- March 2024
- Article
Do Safety Management System Standards Indicate Safer Operations? Evidence from the OHSAS 18001 Occupational Health and Safety Standard
By: Kala Viswanathan, Matthew S. Johnson and Michael W. Toffel
Problem definition: Given the enormous disruptions and costs of occupational injuries, companies and buyers are increasingly looking to voluntary occupational health and safety standards to improve worker safety. Yet because these standards only require...
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Keywords:
Occupational Health;
Occupational Safety;
Program Evaluation;
Safety Performance;
Injuries;
OHSAS 18001;
ISO 45001;
Working Conditions;
Safety;
Standards
Viswanathan, Kala, Matthew S. Johnson, and Michael W. Toffel. "Do Safety Management System Standards Indicate Safer Operations? Evidence from the OHSAS 18001 Occupational Health and Safety Standard." Art. 106383. Safety Science 171 (March 2024).
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- 2023
- Working Paper
Managing Remote Work Quality: Evidence from Management Systems Standards Auditing
By: Ashley Palmarozzo and Michael W. Toffel
Remote work has become more common, providing operational flexibility and productivity benefits, but questions remain about whether and how it affects quality. This study investigates the quality effects of remote work in a diagnostic service context in which remote...
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Keywords:
Audit;
Auditing;
Remote Work;
Compliance;
Assessment;
Environment;
Management Systems;
Quality Management;
Quality Management System;
Quality;
Operations;
Supply Chain Management;
Environmental Management;
Safety
Palmarozzo, Ashley, and Michael W. Toffel. "Managing Remote Work Quality: Evidence from Management Systems Standards Auditing." Harvard Business School Working Paper, No. 24-002, July 2023.
- 2022
- Working Paper
Social Protection and Social Distancing During the Pandemic: Mobile Money Transfers in Ghana
By: Dean Karlan, Matt Lowe, Robert Osei, Isaac Osei-Akoto, Benjamin N. Roth and Christopher Udry
We study the impact of mobile money transfers to a representative sample of low-income
Ghanaians during the COVID-19 pandemic. The announcement of the upcoming transfers
affects neither consumption, well-being, nor social distancing. Once disbursed,...
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Karlan, Dean, Matt Lowe, Robert Osei, Isaac Osei-Akoto, Benjamin N. Roth, and Christopher Udry. "Social Protection and Social Distancing During the Pandemic: Mobile Money Transfers in Ghana." Harvard Business School Working Paper, No. 23-010, July 2022.
- Article
A Career Life-Cycle Perspective on Women's Health and Safety
By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health...
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Keywords:
Women's Health;
Healthcare Access;
Workplace Design;
Military Health System;
Occupational Health;
Medical Equipment & Devices;
Employees;
Gender;
Personal Development and Career
Kaplan, Robert S., Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator, and Michael D. Parkinson. "A Career Life-Cycle Perspective on Women's Health and Safety." Journal of Occupational and Environmental Medicine 64, no. 4 (April 2022): 267–270.
- 2022
- Case
A Sweet Dilemma: Sourcing Palm Oil with Ferrero SpA and Nestlé
This case focuses on Ferrero SpA's sustainable palm oil sourcing strategy in light of its acquisition of Nestlé's U.S. confectionery brands, which in many ways does not comply with Ferrero's sustainable sourcing commitments. The case reviews Ferrero's rich family...
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Hoffman, Andrew J. "A Sweet Dilemma: Sourcing Palm Oil with Ferrero SpA and Nestlé." William Davidson Institute Case 7-951-326, 2022.
- 2021
- Article
Public Health Risks Arising from Food Supply Chains: Challenges and Opportunities
By: Lu Chen, Donovan Guittieres, Retsef Levi, Elisabeth Paulson, Georgia Perakis, Nicholas Renegar and Stacy Springs
Safe, healthy, and resilient food supply chains are essential to ensuring the livelihood and well-being of humans and societies, as well as local and global economies. However, the ability to provide and sustain access to nutritious and safe food continues to be a...
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Keywords:
Food Safety;
Adulteration;
Malnutrition;
Supply Chain;
Health;
Government Administration;
Food and Beverage Industry
Chen, Lu, Donovan Guittieres, Retsef Levi, Elisabeth Paulson, Georgia Perakis, Nicholas Renegar, and Stacy Springs. "Public Health Risks Arising from Food Supply Chains: Challenges and Opportunities." Special Issue on OR Models for Developmental Studies. Naval Research Logistics Quarterly 68, no. 8 (2021): 1098–1112.
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- 2021
- Case
Walmart's Blockchain Quest: Integrating New Technology into a Complex Supply Chain
Blockchain is a digital, distributed, immutable ledger designed to build trust among parties without requiring an independent, third-party arbitrator or intermediary. The technology has potential to improve a variety of industries, including the complex, fragmented,...
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Hoffman, Andrew J. "Walmart's Blockchain Quest: Integrating New Technology into a Complex Supply Chain." William Davidson Institute Case 4-290-769, 2021.
- November 2020
- Case
Truebird—An AlleyCorp Venture
By: Shikhar Ghosh and Shweta Bagai
In December 2018, Kevin Ryan and Wendy Tsu faced an important decision – to finalize the CEO candidate for Truebird, an innovative, automated coffee café concept. Like many of AlleyCorp and Ryan’s companies, Truebird started with the observation of an unmet need – an...
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Keywords:
Startup;
Hiring;
Staffing;
Recruiting;
Business Startups;
Finance;
Leadership;
Management Skills;
Management Teams;
Jobs and Positions;
Job Interviews;
Human Resources;
Recruitment;
Selection and Staffing;
Food and Beverage Industry;
Food and Beverage Industry;
United States
Ghosh, Shikhar, and Shweta Bagai. "Truebird—An AlleyCorp Venture." Harvard Business School Case 821-030, November 2020.
- 2021
- Working Paper
Accounting for Product Impact in the Consumer-Packaged Foods Industry
By: Amanda Rischbieth, George Serafeim and Katie Trinh
We apply the product impact measurement framework of the Impact-Weighted Accounts Initiative (IWAI) in two competitor companies within the consumer-packaged goods industry. We design a methodology that allows us to calculate monetary impact estimates on customer...
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Keywords:
Product Innovation;
Impact;
Impact Investing;
Impact Measurement;
ESG;
ESG (Environmental, Social, Governance) Performance;
ESG Ratings;
Social Corporate Responsibility;
Corporate Social Responsibility;
Social Impact;
Nutrition Database;
Nutritional Information;
CPG;
Consumer Packaged Goods;
IWAI;
Product Design;
Product Positioning;
Society;
Environmental Sustainability;
Corporate Social Responsibility and Impact;
Nutrition;
Product;
Safety;
Consumer Products Industry
Rischbieth, Amanda, George Serafeim, and Katie Trinh. "Accounting for Product Impact in the Consumer-Packaged Foods Industry." Harvard Business School Working Paper, No. 21-051, October 2020. (Revised October 2021.)
- September 2020 (Revised October 2020)
- Case
Briscola—Pizza Society: Scaling Affordable Luxury
By: Gary P. Pisano and Federica Gabrieli
Riccardo Cortese and Federico Pinna were the CEOs of Briscola—Pizza Society, a restaurant chain they had founded in 2014 with a clear ambition: create a distinctive international pizza chain that would combine a fast-casual format with the devotion to quality that...
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Keywords:
Entrepreneurship;
Growth and Development Strategy;
Expansion;
Geographic Location;
Business Model;
Ownership Type;
Food and Beverage Industry;
Europe;
Italy
Pisano, Gary P., and Federica Gabrieli. "Briscola—Pizza Society: Scaling Affordable Luxury." Harvard Business School Case 621-031, September 2020. (Revised October 2020.)
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes...
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Keywords:
Assessment;
Bias;
Inspection;
Scheduling;
Econometric Analysis;
Empirical Research;
Regulation;
Health;
Food;
Safety;
Quality;
Performance Consistency;
Governing Rules, Regulations, and Reforms
Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Management Science 66, no. 6 (June 2020): 2396–2416. (Revised February 2019. Featured in Harvard Business Review, Forbes, Food Safety Magazine, Food Safety News, and KelloggInsight. (2020 MSOM Responsible Research Finalist.))
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- 2020
- Book
Think Outside the Building: How Advanced Leaders Can Change the World One Smart Innovation at a Time
Over a decade ago, renowned innovation expert Rosabeth Moss Kanter co-founded and then directed Harvard’s Advanced Leadership Initiative. Her breakthrough work with hundreds of successful professionals and executives, as well as aspiring young entrepreneurs, identifies...
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Keywords:
Leaders;
Advanced Leadership;
Advanced Leadership Initiative;
Community;
Change Leadership;
Innovation;
Problem Solving;
Cross-sector Collaboration;
Institutional Change;
Leadership;
Change;
Leading Change;
Communication;
Innovation Leadership;
Collaborative Innovation and Invention;
Organizational Change and Adaptation;
Business and Community Relations;
Civil Society or Community
Kanter, Rosabeth Moss. Think Outside the Building: How Advanced Leaders Can Change the World One Smart Innovation at a Time. New York: PublicAffairs, 2020.
- December 2019 (Revised June 2021)
- Case
Mãe Terra and Unilever (A)
By: Lynn S. Paine, Ruth Costas and Priscilla Zogbi
The case concerns the sale of Mãe Terra, one of Brazil's leading brands for packaged organic foods, to the consumer goods giant Unilever in 2017. Working with Unilever management, Mãe Terra’s CEO Alexandre Borges must determine whether and how to keep Mãe Terra's B...
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Keywords:
Mergers & Acquisitions;
Brand Management;
Sustainability;
Mergers and Acquisitions;
Mission and Purpose;
Social Enterprise;
Corporate Governance;
Governing and Advisory Boards;
Environmental Sustainability;
Organizational Culture;
Food and Beverage Industry;
Food and Beverage Industry;
Brazil;
Latin America
Paine, Lynn S., Ruth Costas, and Priscilla Zogbi. "Mãe Terra and Unilever (A)." Harvard Business School Case 320-075, December 2019. (Revised June 2021.)
- September 2019 (Revised May 2020)
- Case
Keroche (A): Fighting for Share in the Kenyan Alcoholic Drinks Market
By: Ramon Casadesus-Masanell and Pippa Tubman Armerding
This case discusses the challenges faced by Kenyan alcoholic drinks producer Keroche Industries Limited in 2003, when the Kenyan government accused the company of manufacturing and selling substandard alcoholic drinks, revoked its liquor licenses, and shut down its...
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Keywords:
Keroche;
Alcohol;
Wine;
Manufacturing;
Informal Market;
Regulation;
Illicit;
Illegal;
Shutdown;
Factory;
Low-income Consumers;
Multinational;
Local;
Government;
Allegations;
Accusations;
Negative Press;
EABL;
Tusker;
Beer;
SAB;
Chang'aa;
Naivasha;
Rift Valley;
East Africa;
Lawsuit;
Legal Battle;
Business Ventures;
Business Exit or Shutdown;
Business Growth and Maturation;
Business Startups;
Production;
Safety;
Quality;
Distribution;
Small Business;
Family Business;
Crime and Corruption;
Customer Focus and Relationships;
Decisions;
Income;
Demographics;
Geographic Scope;
Geographic Location;
Goods and Commodities;
Government Legislation;
Growth and Development;
Business History;
Lawsuits and Litigation;
Laws and Statutes;
Lawfulness;
Goals and Objectives;
Consumer Behavior;
Market Entry and Exit;
Problems and Challenges;
Social Issues;
Poverty;
Strategy;
Competition;
Entrepreneurship;
Food and Beverage Industry;
Food and Beverage Industry;
Kenya;
Nairobi;
Africa
Casadesus-Masanell, Ramon, and Pippa Tubman Armerding. "Keroche (A): Fighting for Share in the Kenyan Alcoholic Drinks Market." Harvard Business School Case 720-390, September 2019. (Revised May 2020.)
- September 2019
- Supplement
Keroche (B): Considering Entry into the Kenyan Beer Market
By: Ramon Casadesus-Masanell and Pippa Tubman Armerding
This case discusses the situation of the Kenyan alcoholic drinks producer Keroche in July 2004, when co-founder Tabitha Karanja was debating whether to enter the Kenyan beer market. Doing so would mean direct competition with the multinational EABL in an industry and...
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Keywords:
Keroche;
Alcohol;
Alcoholic Drinks;
Alcoholic Beverages;
Beverages;
Drinks;
Wine Industry;
Wine;
Fortified Wine;
Viena;
Beer;
Beer Market;
Manufacturing;
Production Capacity;
Capacity;
Growth;
Regulated;
Unregulated;
Informal;
Informal Market;
Regulation;
Illicit;
Illegal;
Substandard;
Dangerous;
Shutdown;
Factory;
Safe;
Affordable;
Low-income Consumers;
Business Growth and Maturation;
Business Startups;
Production;
Investment;
Safety;
Quality;
Small Business;
Family Business;
Crime and Corruption;
Customer Focus and Relationships;
Decisions;
Income;
Demographics;
Geographic Scope;
Geographic Location;
Goods and Commodities;
Government Legislation;
Growth and Development;
Business History;
Lawsuits and Litigation;
Laws and Statutes;
Lawfulness;
Goals and Objectives;
Consumer Behavior;
Market Entry and Exit;
Problems and Challenges;
Social Issues;
Poverty;
Strategy;
Competition;
Entrepreneurship;
Marketing;
Food and Beverage Industry;
Food and Beverage Industry;
Kenya;
Nairobi;
Africa
Casadesus-Masanell, Ramon, and Pippa Tubman Armerding. "Keroche (B): Considering Entry into the Kenyan Beer Market." Harvard Business School Supplement 720-391, September 2019.