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Publications
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- 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...
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- 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...
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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;
Consumer Products Industry;
Food and Beverage Industry;
United States;
Canada;
North America
- 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...
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- 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...
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- 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...
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- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This slide deck provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This case provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- 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...
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- 13 Oct 2022
- Other Presentation
4 Business Ideas That Changed the World: Disruptive Innovation
By: Amy Bernstein, Rita McGrath, Felix Oberholzer-Gee and Derek van Bever
A roundtable conversation takes stock of Clayton Christensen’s influential theory. This first in a series of roundtable conversations assessing the origins and impact of four breakthrough ideas.
In the 1980s, Clayton Christensen cofounded a startup that... View Details
In the 1980s, Clayton Christensen cofounded a startup that... View Details
Keywords:
Disruptive Innovation
- 2022
- Working Paper
You've Got Mail! The Late 19th Century U.S. Postal Service Expansion, Entrepreneurship, and Firm Performance
By: Astrid Marinoni and Maria P. Roche
We analyze the impact of the US Postal Service's western expansion in the late 19th century, a major institutional innovation, on entrepreneurship and its heterogeneous influence on firm performance. Exploiting a novel dataset constructed from digitized archival...
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- October 2022
- Case
Masdar City: Aiming for Sustainable and Profitable Real Estate
By: Boris Vallee and Fares Khrais
Masdar City broke ground in 2008 and was conceived by the Abu Dhabi government to be an international beacon of innovation in sustainable energy and real estate. It was also to be a profitable investment for the government. At first glance, the two goals pulled in...
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Keywords:
Analysis;
Green Building;
Business Growth And Maturation;
Decisions;
Public Sector;
Financial Crisis;
Construction;
Climate Change;
Green Technology;
Borrowing And Debt;
Corporate Finance;
Capital;
Capital Budgeting;
Capital Structure;
Cost Of Capital;
Equity;
REIT;
Financial Management;
Financial Strategy;
Initial Public Offering;
Innovation;
Growth And Development Strategy;
Emerging Markets;
Urban Development;
Middle East;
United Arab Emirates;
Sustainable Cities;
Green Buildings;
Business and Government Relations;
Decision Choices and Conditions;
Financing and Loans;
Real Estate Industry;
Construction Industry;
Energy Industry;
Green Technology Industry;
Abu Dhabi
- 2022
- Article
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander MacKay and Samuel N. Weinstein
Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...
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Keywords:
Competition Policy;
Regulation;
Algorithmic Pricing;
Dynamic Pricing;
Economics;
Law And Economics;
Law And Regulation;
Consumer Protection;
Antitrust Law;
Industrial Organization;
Antitrust Issues And Policies;
Technological Change: Choices And Consequences;
Competition;
Policy;
Price;
Governing Rules, Regulations, and Reforms;
Microeconomics;
Duopoly and Oligopoly;
Law
- August 2022
- Case
NewLab: Scaling an Innovation Engine
By: Tarun Khanna and George Gonzalez
Silicon Valley-veteran Shaun Stewart is the CEO of NewLab, a dynamic technology hub headquartered in the storied Brooklyn Navy Yard. Founded in 2016, NewLab fostered a community of entrepreneurs, corporate and government partners, and investors, all seeking to apply...
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- August 2022
- Case
In-Q-Tel: Innovation On A Mission
By: Joshua Lev Krieger and Josh Lerner
In 2022, the leaders of In-Q-Tel (IQT) considered what was next for the unique mission-driven organization. Since 1999, IQT had one mission: to be the most sophisticated source of strategic technical knowledge and capabilities to the U.S. government and its allies. IQT...
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- August 2022
- Case
SuperRare: Turning an NFT Marketplace into a DAO
By: Jeffrey J. Bussgang, Scott Duke Kominers and Amy Klopfenstein
In June 2021, John Crain and Jonathan Perkins, the founders of SuperRare, a marketplace for non-fungible tokens (NFTs), contemplate whether to transform their company into a decentralized autonomous organization (DAO). Crain and Perkins founded SuperRare in 2018 to...
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Keywords:
NFTs;
Crypto Economy;
Alternative Assets;
DAOs;
Arts;
Governance;
Governance Controls;
Governing Rules, Regulations, and Reforms;
Information Technology;
Technology Adoption;
Internet and the Web;
Digital Platforms;
Innovation and Invention;
Technological Innovation;
Disruptive Innovation;
Finance;
Currency;
Investment;
Markets;
Auctions;
Bids and Bidding;
Demand and Consumers;
Network Effects;
Market Design;
Market Transactions;
Market Timing;
Web Services Industry;
North and Central America;
United States
- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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- July 2022
- Case
Metaverse Seoul
By: Mitchell Weiss and Samantha Markowitz
In May 2022, the Seoul Metropolitan Government (SMG) launched the pilot of Metaverse Seoul, a government-run metaverse. SMG had delivered a virtual version of Seoul’s mayor’s office. The team aimed to gain insights as they worked towards building a broad, immersive,...
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- July 2022
- Teaching Note
TraceTogether
By: Mitchell Weiss and Sarah Mehta
This Note provides guidance for teaching "TraceTogether," HBS Case No. 820-111.
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Keywords:
Government Administration;
Crisis Management;
Health;
Health Pandemics;
Innovation and Invention;
Innovation Leadership;
Innovation Strategy;
Technological Innovation;
Social Issues;
Mobile and Wireless Technology;
Technology Adoption;
Health Industry;
Public Administration Industry;
Singapore
- 2022
- Working Paper
Laboratory Safety and Research Productivity
By: Alberto Galasso, Hong Luo and Brooklynn Zhu
Are laboratory safety practices a tax on scientific productivity? We examine this question by exploiting the substantial increase in safety regulations at the University of California following the shocking accidental death of a research assistant in 2008....
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- March 2022 (Revised August 2022)
- Case
Swvl: Smart Mobility for the Masses
By: Krishna Palepu, Esel Çekin and Menna Hassan
The case focuses on strategy and governance issues at Swvl, a tech-enabled mass mobility marketplace. It describes the journey of CEO and Chairman Mostafa Kandil on his journey from founding the company to its listing on Nasdaq. Since its founding in Egypt in 2017,...
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