Publications

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... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

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February 2023 (Revised February 2025)
Case

Doing Business in Accra, Ghana

By: Hakeem Belo-Osagie, Leonard Schlesinger and Namrata Arora

This case examines the challenges and opportunities of doing business in Ghana. It highlights Ghana economic transformation in the decades leading up to 2024 in the context of its history, culture, and politics. The case gives an overview of some of the main obstacles... View Details

Keywords: Business History; Business and Government Relations; Technological Innovation; Foreign Direct Investment; Economic Growth; Financial Crisis; Agribusiness; Food and Beverage Industry; Food and Beverage Industry; Ghana

03 Mar 2009
First Look

First Look: March 3, 2009

this case: http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=609061 The World Food Programme during the Global Food Crisis (A) Harvard Business School Case 709-024 Rising View Details

Keywords: Martha Lagace

February 2008
Case

Campbell Soup Company: Selling Channel Innovation to Customers

Campbell Soup, like most food manufacturers, faced grocery chain and wholesale demand for its goods driven by Campbell's own promotional pricing structure rather than retail consumer demand. Former policies to encourage overstock created huge swings in production and... View Details

Keywords: Information Technology; Distribution Channels; Order Taking and Fulfillment; Manufacturing Industry; Manufacturing Industry

August 2006
Case

Dreyer's Slow Churned(TM) Ice Cream

By: Noel H. Watson, Steven C. Wheelwright and Brian DeLacey

Examines capacity forecasting and planning in a complex new product introduction scenario. The introduction at Dreyer's, a large dairy snack manufacturer, involves not only a new product but a new manufacturing process and product package, thus implying a significant... View Details

Keywords: Advertising; Forecasting and Prediction; Growth and Development Strategy; Brands and Branding; Product Launch; Product Development; Planning; Food and Beverage Industry; United States

November 1997 (Revised May 1998)
Case

ASIMCO: The Alliance Brewing Group

ASIMCO is a direct investment fund with $350 million invested in 17 Chinese joint ventures in the brewing and auto components industries. The CEO must decide whether to invest in distribution to grow the brewing business or to invest in additional manufacturing joint... View Details

Keywords: Production; Distribution; Joint Ventures; Decision Making; Investment Funds; Growth and Development Strategy; Manufacturing Industry; Manufacturing Industry; Manufacturing Industry; China

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Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

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January 2020
Case

The June Oven

By: Leonard A. Schlesinger and Christian Godwin

The June Oven was a smart oven which was capable of identifying food and cooking it accordingly. This type of smart oven represented the next step in the long history of oven and stove development. Due to the widespread use of traditional ovens, the market for the June... View Details

April 1995 (Revised April 1995)
Case

Pillsbury: Customer Driven Reengineering

By: Robert S. Kaplan

Pillsbury is transforming itself from an integrated producer of flour and bakery products to a value-added supplier of premium branded products. After initial successes applying activity-based costing to manufacturing operations, two senior executives decide to... View Details

Keywords: Organizational Change and Adaptation; Production; Cost Management; Activity Based Costing and Management; Customer Value and Value Chain; Food and Beverage Industry

Teaching Interest

Doing Business in Africa

By: John D. Macomber

This course introduces frameworks and models for smart and focused investing and operations across sectors, nations, industries, and time frames in Africa. Students will learn tools and skills to help navigate the business landscape of Africa in terms of selection... View Details

Keywords: Africa

October 2013 (Revised February 2019)
Case

Chobani: Growing a Live and Active Culture (Abridged)

By: Joshua D. Margolis and Matthew Preble

Hamdi Ulukaya, CEO of the Greek yogurt company Chobani, Inc., was reflecting on what explained his young company's meteoric rise. The company held over half of the U.S. Greek yogurt market and nearly 20% of the total yogurt market. The company's innovative approach to... View Details

Keywords: Innovation; Culture; Growth Strategy; Growth Management; Yogurt; Innovation Strategy; Leadership; Organizational Culture; Entrepreneurship; Marketing; Growth and Development Strategy; Agribusiness; Manufacturing Industry; Manufacturing Industry; United States; Canada; Australia

20 Nov 2012
First Look

First Look: November 20

costs of peer comparison. Download the paper: https://www.hbs.edu/faculty/Pages/item.aspx?num=43633 Highway to Success: The Impact of the Golden Quadrilateral Project for the Location and Performance of Indian Manufacturing Authors:Ejaz Ghani, Arti... View Details

Keywords: Sean Silverthorne

Paul W. Marshall

MBA Class of 1960 Professor of Management, Paul W. Marshall, is affiliated with the Entrepreneurial Management Unit and teaches The Entrepreneurial Manager in the Turnaround Environment. This Elective Curriculum course focuses on the role of... View Details

Keywords: manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing; manufacturing

January 1998 (Revised July 2019)
Case

Cafes Monte Bianco: Building a Profit Plan

By: Robert L. Simons and Antonio Davila

Alert: This case has been revised since its original publication; all amounts have been converted to euros and the dates have been updated to 2020. If you’ve taught with this case in the past, please note that changes may affect teaching plans and classroom use. Using... View Details

Keywords: Strategic Planning; Cash Flow; Investment Return; Profit; Financial Statements; Food and Beverage Industry; Italy

December 2017
Case

International Institute of Tropical Agriculture

By: Jose B. Alvarez and Sarah Mehta

It is July 2017, and Dr. Nteranya Sanginga, the director general of the Nigeria-based International Institute of Tropical Agriculture (IITA), is making progress toward two of his primary strategic objectives for the nonprofit research Institute: 1) to scale the impact... View Details

Keywords: Scaling Technologies; Youth Unemployment; Innovation In Nonprofits; Agribusiness; Plant-Based Agribusiness; Cash Flow; Labor; Employment; Commercialization; Problems and Challenges; Agriculture and Agribusiness Industry; Africa; Nigeria