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All HBS Web
(1,934)
- Faculty Publications (302)
- 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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Keywords:
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Medical Devices and Supplies Industry
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 (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;
Food and Beverage Industry;
Food and Beverage Industry;
United States;
Canada;
North America
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 2022
- Article
I Don't 'Recall': The Decision to Delay Innovation Launch to Avoid Costly Product Failure
By: Byungyeon Kim, Oded Koenigsberg and Elie Ofek
Innovations embody novel features or cutting-edge components aimed at delivering desired customer benefits.
Oftentimes, however, we observe the need to recall new products shortly after their introduction. Indeed, a firm
may rush an innovation to market in an attempt...
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Keywords:
Innovation Management;
Innovation And Strategy;
Product Development Strategy;
Product Introduction;
Quality Control;
Product Recalls;
Game Theory;
Market Timing;
Innovation Strategy;
Product Launch;
Product Development
Kim, Byungyeon, Oded Koenigsberg, and Elie Ofek. "I Don't 'Recall': The Decision to Delay Innovation Launch to Avoid Costly Product Failure." Management Science 68, no. 12 (December 2022): 8889–8908.
- 2022
- Article
Pills in a World of Activism and ESG
By: Guhan Subramanian and Caley Petrucci
Easterbrook and Fischel’s The Economic Structure of Corporate Law advances their now famous passivity thesis, which posits that managers should remain passive in the face of an unsolicited tender offer for the company’s shares. Consistent with the broader...
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Subramanian, Guhan, and Caley Petrucci. "Pills in a World of Activism and ESG." University of Chicago Business Law Review 1 (2022): 417–439.
- 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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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
- 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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Keywords:
Technological Change;
Innovation;
Qualitative Methods;
New Categories;
Entrepreneurship;
Technological Innovation;
Governing Rules, Regulations, and Reforms;
Risk and Uncertainty;
Strategy
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...
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Keywords:
AI and Machine Learning;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
Technological Innovation;
Medical Devices and Supplies Industry
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),...
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- 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, direct-to-consumer 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...
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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
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.
- November 2022
- Technical Note
National Security and Transnational Capitalism
By: Meg Rithmire
Though the relationship between national security and transnational commerce had long been interrogated and contested, the 2020s saw the escalation of concerns about insecurity and interdependence. These concerns manifested in a suite of institutional innovations and...
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Rithmire, Meg. "National Security and Transnational Capitalism." Harvard Business School Technical Note 723-016, November 2022.
- October 2022 (Revised February 2024)
- 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;
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 Building;
Business and Government Relations;
Decision Choices and Conditions;
Financing and Loans;
Real Estate Industry;
Construction Industry;
Energy Industry;
Green Technology Industry;
Abu Dhabi
Vallee, Boris, and Fares Khrais. "Masdar City: Aiming for Sustainable and Profitable Real Estate." Harvard Business School Case 223-036, October 2022. (Revised February 2024.)
- September 2022 (Revised August 2023)
- Case
Audrey Tang: Using Technology to Strengthen Democracy in Taiwan
By: Shikhar Ghosh and Shweta Bagai
Since the early days of the internet, Taiwan had a vibrant community of civic hackers and open-source programmers who engaged with social issues. Audrey Tang was one of them. She spearheaded the 2014 Sunflower Student Movement in Taiwan, where protestors peacefully...
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Keywords:
Democracy;
Internet;
Web Technology;
Digital Transformation;
Digital Platform;
COVID;
Information Technology;
Applications and Software;
Governance;
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Taiwan;
China;
Asia
Ghosh, Shikhar, and Shweta Bagai. "Audrey Tang: Using Technology to Strengthen Democracy in Taiwan." Harvard Business School Case 823-048, September 2022. (Revised August 2023.)
- 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
MacKay, Alexander, and Samuel N. Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Washington University Law Review 100, no. 1 (2022): 111–174. (Direct download.)
- 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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Keywords:
Mission and Purpose;
National Security;
Technological Innovation;
Research;
Geopolitical Units;
Risk Management;
Recruitment;
Growth and Development Strategy;
Venture Capital;
Knowledge Management;
Information Industry;
Banking Industry
Krieger, Joshua Lev, and Josh Lerner. "In-Q-Tel: Innovation On A Mission." Harvard Business School Case 823-031, August 2022.
- 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
Bussgang, Jeffrey J., Scott Duke Kominers, and Amy Klopfenstein. "SuperRare: Turning an NFT Marketplace into a DAO." Harvard Business School Case 823-027, August 2022.
- 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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Keywords:
Emerging Technologies;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- Article
Online Experimentation: Benefits, Operational and Methodological Challenges, and Scaling Guide
By: Iavor Bojinov and Somit Gupta
In the past decade, online controlled experimentation, or A/B testing, at scale has proved to be a significant driver of business innovation. The practice was first pioneered by the technology sector and, more recently, has been adopted by traditional companies...
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Keywords:
A/B Testing;
Experimentation;
Data-driven Culture;
Product Development;
Innovation and Invention;
Digital Transformation
Bojinov, Iavor, and Somit Gupta. "Online Experimentation: Benefits, Operational and Methodological Challenges, and Scaling Guide." Harvard Data Science Review, no. 4.3 (Summer, 2022).
- June 2022
- Teaching Plan
GreenLight Fund
By: Brian Trelstad and Mel Martin
Teaching Note for HBS Case No. 320-053. As Tara Noland, the Executive Director (ED) of GreenLight Cincinnati, reflected on her first few years on the job. Noland had delivered on what she had been hired to do in the city: work with leading philanthropists and nonprofit...
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- May 27, 2022
- Article
How 'Digital Nomad' Visas Can Boost Local Economies
More and more companies are offering their employees the option to “work from anywhere,” whether in their home office, in another state, or even halfway around the globe. A growing group of remote professionals are taking the “anywhere” in work-from-anywhere to new...
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Keywords:
Remote Work;
COVID-19 Pandemic;
Collaboration;
Work-Life Balance;
Human Resources;
Collaborative Innovation and Invention
Choudhury, Prithwiraj. "How 'Digital Nomad' Visas Can Boost Local Economies." Harvard Business Review (website) (May 27, 2022).
- Article
The Translucent Hand of Managed Ecosystems: Engaging Communities for Value Creation and Capture
By: Elizabeth J. Altman, Frank Nagle and Michael Tushman
Management research has increasingly explored the domains of ecosystems, platforms, and open/user/distributed innovation—governance structures focused on engaging with external communities. While these research areas include substantial empirical and theoretical work...
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Keywords:
Ecosystems;
Platforms;
Open And User Innovation Strategy;
Capabilities;
Governance;
Innovation Strategy;
Organizational Change and Adaptation;
Value Creation
Altman, Elizabeth J., Frank Nagle, and Michael Tushman. "The Translucent Hand of Managed Ecosystems: Engaging Communities for Value Creation and Capture." Academy of Management Annals 16, no. 1 (January 2022): 70–101.