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- Faculty Publications (366)
Show Results For
- All HBS Web (823)
- Faculty Publications (366)
- 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
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).
- April 2025 (Revised June 2025)
- Case
Governing Sustainability in a Shifting Context (A)
By: Lynn S. Paine and Will Hurwitz
In early 2025, boards of directors had to rethink corporate responsibility and sustainability efforts amid rapidly-shifting social, legal, regulatory, and economic forces. While just a few years earlier, calls to address racial justice and climate change reached into... View Details
Keywords: Climate Change; Corporate Governance; Diversity; Leadership; Business or Company Management; Mission and Purpose; Social Media; Race; Environmental Sustainability; Governing Rules, Regulations, and Reforms; Governing and Advisory Boards; Lawfulness; Lawsuits and Litigation; Measurement and Metrics; Corporate Social Responsibility and Impact; Business and Shareholder Relations; Social Issues; Retail Industry; Food and Beverage Industry; Banking Industry; United States
Paine, Lynn S., and Will Hurwitz. "Governing Sustainability in a Shifting Context (A)." Harvard Business School Case 325-121, April 2025. (Revised June 2025.)
- 2017
- Working Paper
Business and Green Knowledge Production in Sweden 1960s–1980s
By: Ann-Kristin Bergquist and Kristina Söderholm
This working paper contributes to the burgeoning historical literature that has transformed our understanding about the relationship between big business and the environmental regulation. Previously, it was believed that corporate managers resisted the extra costs... View Details
Keywords: Environmental Sustainability; Governing Rules, Regulations, and Reforms; Business and Government Relations; Research and Development; History; Sweden
Bergquist, Ann-Kristin, and Kristina Söderholm. "Business and Green Knowledge Production in Sweden 1960s–1980s." Harvard Business School Working Paper, No. 18-050, December 2017.
- 29 Mar 2016
- First Look
March 29, 2016
nature of strategy, organizational design, and leadership. Management: An Integrated Approach is the only introductory management text on the market to address this challenge by taking an integrated and holistic approach to management, as... View Details
Keywords: Sean Silverthorne
- 13 Mar 2012
- First Look
First Look: March 13
census. We document a shift to smaller shops following a 1996 regulatory change that increased the costs of opening large stores. Our analysis suggests that total factor productivity (TFP) of multi-store retail chains fell after the introduction of the View Details
Keywords: Sean Silverthorne
- 12 Jun 2018
- First Look
New Research and Ideas, June 12, 2018
their interconnected early history. Even the 18th century had its “socialists,” but unlike those of the 19th, they paradoxically sought to make the world safe for “capitalists.” The word “socialists” was first used in Northern Italy as a term of contempt for the... View Details
Keywords: Dina Gerdeman
- 21 Apr 2015
- First Look
First Look: April 21
to the support of companies, investors, and the initiatives of a number of NGOs, widespread regulatory intervention has yet to materialize. Outside of South Africa, adoption remains voluntary, accomplished via social movement abetted, to varying degrees, by View Details
Keywords: Carmen Nobel & Sean Silverthorne
- Person Page
Media
Media
This lists media reports covering my firm dollarDEX Investments or me (or my colleagues), or columns written by me (or my colleagues). There are all... View Details
- November – December 2008
- Article
Chief Risk Officers at Crunch Time: Compliance Champions or Business Partners?
By: Anette Mikes
Risk management departments in financial institutions have been undergoing major transformations. New regulatory requirements have raised the bar on compliance, and expanded the remit of risk management significantly. The compliance imperative requires banks to... View Details
Keywords: Banks and Banking; Corporate Governance; Governance Compliance; Governing Rules, Regulations, and Reforms; Managerial Roles; Risk Management; Partners and Partnerships
Mikes, Anette. "Chief Risk Officers at Crunch Time: Compliance Champions or Business Partners?" Journal of Risk Management in Financial Institutions 2, no. 1 (November–December 2008).
- 11 Jan 2021
- News
Strengthening Democracy
it poses. HBS Club of Dallas Explores Election Reform and Political Innovation The nonpartisan group Reform Elections Now (REN)—led by HBS alumni—gave a virtual presentation to the HBS Club of Dallas in... View Details
- 01 Sep 2007
- News
Paulson Speaks on China at HBS
Treasury Secretary Hank Paulson (MBA 1970) told an HBS audience in May that in addition to China’s economic influence, its energy and environmental policies will have a far-reaching global impact for years to come. He also spoke of China’s need for View Details
- 01 Apr 1998
- News
Emerging Information
offices in 18 countries. The firm's main product, ISI Emerging Markets, is a continually evolving resource of information covering emerging markets in Europe, Latin America, and Asia. Contracting with local information providers - from... View Details
Keywords: Paul Michelman
- 01 Dec 2008
- News
Lack of Energy: The Problem of Human Inertia
of the Negotiation, Organizations & Markets unit. In a democracy of citizens and taxpayers, such dithering largely comes down to a human foible. “When present losses loom larger than future gains,” states Bazerman, “we fail to act in time... View Details
- 01 Sep 2009
- News
Over the Top
right to nominate directors into something that is real — and has a real chance of holding boards of directors accountable to company owners.” Major business groups lost no time denouncing the reform measures as vehicles for ceding... View Details
- 12 PM – 1 PM EST, 06 Nov 2018
- Webinars: Trending@HBS
China in the Age of Xi Jinping: Domestic Changes and Global Ambitions
China's outward push will remake the global economic and political environment, and business leaders need an understanding of China's leadership to navigate this new world. Join Associate Professor Rithmire to discuss the evolution of the business landscape in China. View Details
- 01 Dec 2008
- News
Where Are They Now?
media wanted Glauber’s expert opinion. After all, he played a key role in setting up the Resolution Trust Corporation to handle the S&L bailout in the late 1980s, and he helped formulate regulatory reform of commercial banks in the early... View Details
- 01 Jun 2011
- News
What’s after Fannie and Freddie?
Scharfstein: “Whenever you mix government guarantees with private, for-profit entities, those private entities put the government at risk.” Reforming the U.S. housing finance system remains perhaps the largest piece of unfinished business... View Details
- 11 May 2016
- News
World Bank Vice President and Treasurer: Negative Rates Not the Answer
markets and her zero tolerance for improper acts earned her the nickname "Iron Lady." The reform efforts she champions have been hugely successful, as the country’s stock View Details
- 10 Mar 2008
- Research & Ideas
Encouraging Entrepreneurs: Lessons for Government Policy
funding. The natural experiment created by this tax reform shows that, contrary to popular belief, a certain efficiency exists in the market when it comes to which businesses get off the ground and which... View Details
Keywords: by Julia Hanna
- 01 Mar 2003
- News
Books
investment (FDI) in China has been viewed both as evidence of a Western desire to gain a toehold in the country and as confirmation that China’s economy presents increasingly sound investment opportunities. But in his new book, Selling China: Foreign Direct Investment... View Details