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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- January 2023
- Supplement
Apple: Privacy vs. Safety (B)
By: Henry McGee, Nien-hê Hsieh and Christian Godwin
In 2020, as the COVID-19 pandemic swept across the globe, Apple and Google partnered to develop a contact tracing application that would collect information about users infected with the disease and notify those who they had been in contact with. While Apple/Google’s...
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Keywords:
Iphone;
Encryption;
Data Privacy;
Customers;
Customer Focus and Relationships;
Decision Making;
Ethics;
Values and Beliefs;
Globalized Firms and Management;
Government and Politics;
Health;
Health Pandemics;
Leadership;
Markets;
Safety;
Social Issues;
Information Technology;
Telecommunications Industry;
Technology Industry;
Consumer Products Industry;
Electronics Industry;
Health Industry;
United States;
Europe
McGee, Henry, Nien-hê Hsieh, and Christian Godwin. "Apple: Privacy vs. Safety (B)." Harvard Business School Supplement 323-066, January 2023.
- 2023
- Working Paper
Is Pay Transparency Good?
By: Zoë Cullen
Countries around the world are designing pay transparency policies with the intention of combating pay discrimination. Are these policies working as intended? Most focus on revealing pay gaps between co-workers within a firm, with the goal of arming workers with...
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Keywords:
Pay Transparency;
Trends;
Transition;
Communication Strategy;
Wages;
Policy;
Europe;
North America;
Australia
Cullen, Zoë. "Is Pay Transparency Good?" Harvard Business School Working Paper, No. 23-039, January 2023.
- January 2023
- Case
Proday: Calling the Right Play
By: Lindsay N. Hyde, Thomas R. Eisenmann and Tom Quinn
Sarah Kunst knew the elements of a successful startup from her tenure at venture capital firms. In April 2018, however, her own app – Proday, a home fitness platform featuring exercises filmed by professional sports stars – was floundering. Kunst theorized that...
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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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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.
- Working Paper
Diversification as an Adaptive Learning Process: An Empirical Study of General-Purpose and Market-Specific Technological Know-How in New Market Entry
By: Dominika Kinga Randle and Gary P. Pisano
An enduring trait of modern corporations is their propensity to diversify into multiple lines of business. Penrosian theories conceptualize diversification as a strategy to exploit a firm’s fungible, yet “untradeable,” resources and point to redeployment of...
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Keywords:
Growth and Development Strategy;
Technology Adoption;
Diversification;
Market Entry and Exit;
Transformation
Randle, Dominika Kinga, and Gary P. Pisano. "Diversification as an Adaptive Learning Process: An Empirical Study of General-Purpose and Market-Specific Technological Know-How in New Market Entry." Harvard Business School Working Paper, No. 23-032, December 2022.
- 2022
- Working Paper
Nailing Prediction: Experimental Evidence on the Value of Tools in Predictive Model Development
Predictive model development is understudied despite its importance to modern businesses. Although prior discussions highlight advances in methods (along the dimensions of data, computing power, and algorithms) as the primary driver of model quality, the value of tools...
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Keywords:
Analytics and Data Science
Yue, Daniel, Paul Hamilton, and Iavor Bojinov. "Nailing Prediction: Experimental Evidence on the Value of Tools in Predictive Model Development." Harvard Business School Working Paper, No. 23-029, December 2022.
- 2022
- Working Paper
Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions
We empirically analyze how managerial overrides to a commercial algorithm that forecasts demand and schedules labor affect store performance. We analyze administrative data from a large grocery retailer that utilizes a commercial algorithm to forecast demand and...
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Keywords:
Employees;
Human Capital;
Performance;
Applications and Software;
Management Skills;
Management Practices and Processes;
Retail Industry
Kwon, Caleb, Ananth Raman, and Jorge Tamayo. "Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions." Working Paper, December 2022.
- 2022
- Article
OpenXAI: Towards a Transparent Evaluation of Model Explanations
By: Chirag Agarwal, Satyapriya Krishna, Eshika Saxena, Martin Pawelczyk, Nari Johnson, Isha Puri, Marinka Zitnik and Himabindu Lakkaraju
While several types of post hoc explanation methods have been proposed in recent literature, there is very little work on systematically benchmarking these methods. Here, we introduce OpenXAI, a comprehensive and extensible opensource framework for evaluating and...
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Agarwal, Chirag, Satyapriya Krishna, Eshika Saxena, Martin Pawelczyk, Nari Johnson, Isha Puri, Marinka Zitnik, and Himabindu Lakkaraju. "OpenXAI: Towards a Transparent Evaluation of Model Explanations." Advances in Neural Information Processing Systems (NeurIPS) (2022).
- 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 (Revised December 2022)
- Case
Replika AI: Monetizing a Chatbot
By: Julian De Freitas and Nicole Tempest Keller
In early 2018, Eugenia Kuyda, co-founder and CEO of San Francisco-based chatbot Replika AI, was deciding how to monetize the app she had built. Launched in 2017, Replika was a consumer AI “companion app” developed by a team of AI software engineers originally based in...
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- 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 (Revised December 2022)
- Case
Ava Labs: Navigating the Next Blockchain
By: Marco Di Maggio and Wenyao Sha
John Wu, President of Ava Labs, the primary developer of the Avalanche blockchain, and Emin Gün Sirer, the software company’s Founder and CEO, team up to develop a lending and borrowing protocol that would jumpstart the Decentralized finance (DeFi) economy on...
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Keywords:
Blockchain;
Decentralized Finance;
Alternative Assets;
Financial Instruments;
Assets;
Decisions;
Financing and Loans;
Technology Industry;
Financial Services Industry
Di Maggio, Marco, and Wenyao Sha. "Ava Labs: Navigating the Next Blockchain." Harvard Business School Case 223-027, November 2022. (Revised December 2022.)
- November 2022
- Case
Para: Pay Transparency and Gig Drivers’ Rights
By: Christopher Stanton and George Gonzalez
The case presents the founding vision and early days of a young startup that seeks to empower delivery drivers with tools and transparency. The company's flagship mobile app has been taken up by tens of thousands of delivery drivers across major U.S. cities who use it...
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- October 2022
- Case
Volt Lines: Leading a B2B Service Provider through a Crisis (A)
By: Navid Mojir and Gamze Yucaoglu
Volt Lines was a next-generation transportation service in Istanbul, Turkey. The company was trying to disrupt the traditional corporate transportation market by developing software that allowed it to offer subscription-based transportation. Under the subscription...
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Keywords:
Business To Business Marketing;
B2B Marketing;
B2B Pricing;
Subscription Model;
Crisis Marketing;
Startup;
Service Management;
Information Technology;
Transportation;
COVID-19 Pandemic;
Disruptive Innovation;
Digital Platforms;
Business Model;
Price;
Crisis Management;
Opportunities;
Transportation Industry;
Technology Industry;
Turkey
Mojir, Navid, and Gamze Yucaoglu. "Volt Lines: Leading a B2B Service Provider through a Crisis (A)." Harvard Business School Case 523-037, October 2022.
- October 2022 (Revised December 2022)
- Case
SMART: AI and Machine Learning for Wildlife Conservation
By: Brian Trelstad and Bonnie Yining Cao
Spatial Monitoring and Reporting Tool (SMART), a set of software and analytical tools designed for the purpose of wildlife conservation, had demonstrated significant improvements in patrol coverage, with some observed reductions in poaching and contributing to wildlife...
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Keywords:
Business and Government Relations;
Emerging Markets;
Technology Adoption;
Strategy;
Management;
Ethics;
Social Enterprise;
AI and Machine Learning;
Analytics and Data Science;
Natural Environment;
Technology Industry;
Cambodia;
United States;
Africa
Trelstad, Brian, and Bonnie Yining Cao. "SMART: AI and Machine Learning for Wildlife Conservation." Harvard Business School Case 323-036, October 2022. (Revised December 2022.)
- October 2022
- Case
Founders First Capital Partners
By: Brian Trelstad, Mel Martin and Amy Klopfenstein
In June 2021, Kim T. Folsom, the founder and CEO of revenue-based financing firm Founders First Capital Partners (FFCP), must decide whether to issue another loan to OnShore Technology Group, an up-and-coming software validation company. FFCP provided revenue-based...
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Keywords:
Finance;
Financial Instruments;
Financing and Loans;
Interest Rates;
Investment Return;
Revenue;
Capital;
Financial Services Industry;
North and Central America;
United States
Trelstad, Brian, Mel Martin, and Amy Klopfenstein. "Founders First Capital Partners." Harvard Business School Case 323-013, October 2022.
- October 17, 2022
- Article
Relational Diversity in Social Portfolios Predicts Well-Being
We document a link between the relational diversity of one’s social portfolio—the richness and evenness of relationship types across one’s social interactions—and well-being. Across four distinct samples, respondents from the United States who completed a preregistered...
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Keywords:
Social Interaction;
Social Engagement;
Well-being;
Happiness;
Social and Collaborative Networks;
Family and Family Relationships
Collins, Hanne K., Serena F. Hagerty, Jordi Quoidbach, Michael I. Norton, and Alison Wood Brooks. "Relational Diversity in Social Portfolios Predicts Well-Being." Proceedings of the National Academy of Sciences 119, no. 43 (October 17, 2022).
- 2022
- Working Paper
The Ties That No Longer Bind: Inventor Mobility and Patent Litigation
By: Daniel Jay Brown and Maria Roche
The retention of inventor-employees represents a core strategic concern for firms in innovative industries. In this paper, we examine the impact of reduced patent enforceability on the mobility of inventor-employees and explore the related influence on firms’...
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Keywords:
Mobility;
Inventors;
Patent Enforceability;
Skills;
Strategic Human Capital;
Retention;
Innovation and Invention;
Intellectual Property
Brown, Daniel Jay, and Maria Roche. "The Ties That No Longer Bind: Inventor Mobility and Patent Litigation." Harvard Business School Working Paper, No. 23-021, October 2022.
- October 2022
- Article
A Structural Model of Organizational Buying for Business-to-Business Markets: Innovation Adoption with Share-of-Wallet Contracts
By: Navid Mojir and K. Sudhir
The paper develops the first structural model of organizational buying to study innovation diffusion in a B2B market. Our model is particularly applicable for routinized exchange relationships, whereby centralized buyers periodically evaluate and choose contracts,...
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Keywords:
Organizational Buying Behavior;
Healthcare Marketing;
B2B Markets;
B2B Innovation;
New Product Diffusion;
New Product Adoption;
Organizations;
Acquisition;
Behavior;
Health Care and Treatment;
Marketing;
Innovation and Invention
Mojir, Navid, and K. Sudhir. "A Structural Model of Organizational Buying for Business-to-Business Markets: Innovation Adoption with Share-of-Wallet Contracts." Journal of Marketing Research (JMR) 59, no. 5 (October 2022): 883–907.