Publications
Publications
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- Faculty Publications (202)
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- September 2022
- Technical Note
Addressing Social Determinants of Health in the American Landscape
By: Susanna Gallani and Jacob Riegler
- 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
- Teaching Note
The DivaCup: Navigating Distribution and Growth
By: Ayelet Israeli
Teaching Note for HBS Case No. 519-055. When the mother-daughter founders of DivaCup set out with a mission to disrupt the menstrual care industry with an innovative product form, they initially struggled to gain legitimacy and convince retailers to carry their unique...
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Keywords:
Female;
Female Ceo;
Female Entrepreneur;
Female Protagonist;
Health ＆ Wellness;
Healthcare;
Price Policies;
Minimum Advertised Price;
Differentiation;
Positioning;
Growth;
Health;
Health Care and Treatment;
Price;
Disruption;
Distribution;
Distribution Channels;
Competitive Strategy;
Competition;
Growth Management;
Mission and Purpose;
Product Development;
Product Marketing;
Product Launch;
Product Positioning;
Advertising;
Business Startups;
Internet and the Web;
Entrepreneurship;
Social Entrepreneurship;
Social Issues;
Social Enterprise;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Canada;
United States;
United Kingdom
- May 2022
- Case
Byte
By: Boris Groysberg, Katherine Connolly Baden and Julia Kelley
In January 2021, Byte co-founders Scott Cohen and Blake Johnson reflected on how far their Los Angeles-based direct-to-consumer (DTC) orthodontics company had come since launching its clear aligners just a little over two years earlier. Cohen and Johnson were both...
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- May 2022
- Article
When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants
By: Alberto Galasso and Hong Luo
Liability laws designed to compensate for harms caused by defective products may also affect innovation. We examine this issue by exploiting a major quasi-exogenous increase in liability risk faced by U.S. suppliers of polymers used to manufacture medical implants....
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- Article
A Career Life-Cycle Perspective on Women's Health and Safety
By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health...
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- March 2022 (Revised August 2022)
- Case
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern and Alpana Thapar
In mid-January 2022, Nadine Hachach-Haram, founder and CEO of Proximie, was thinking about the company’s growth plans. Launched in 2016, Proximie was a platform that enabled clinicians, proctors, and medical device company personnel to be virtually present in operating...
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- March 2022 (Revised April 2022)
- Case
Pittsburgh: A Successful City?
Pittsburgh, PA, was once the crown jewel of American heavy industry. During the 19th and 20th centuries, the city was an undisputed leader in steel production, boasting some of the largest companies and wealthiest individuals in the world. Its abundance of...
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Keywords:
Economic And Social Disparities;
Economic Development;
Local Economic Development;
Contextual Intelligence;
Contextual Knowledge;
Context;
City Growth;
City Innovation;
City Leadership;
Pittsburgh;
Local Government;
Local Stakeholders;
Business And Community;
Business And Community Relations;
Community Engagement;
Community Relations;
Cross-sector Collaboration;
Innovation;
Innovation Economy;
Innovation Clusters;
Innovation Ecosystems;
Shared Prosperity;
Equality Of Opportunity;
Equity;
Inclusion;
Business And Government;
Business ＆ Government Relations;
Business And Government Relations;
Business And Society;
Neighborhoods;
Race And Ethnicity;
Innovation ＆ Entrepreneurship;
Diversity;
Ethnicity;
Race;
Household;
Income;
Economic Growth;
Economic Sectors;
Economics;
Local Range;
Urban Development;
Urban Scope;
City;
Cross-Cultural and Cross-Border Issues;
Government and Politics;
Government Administration;
Growth and Development;
History;
Leadership;
Goals and Objectives;
Philanthropy and Charitable Giving;
Society;
Civil Society or Community;
Culture;
Human Needs;
Public Opinion;
Public Sector;
Social Issues;
Poverty;
Equality and Inequality;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States;
Pittsburgh;
Pennsylvania
- March 2022 (Revised July 2022)
- Case
Nexleaf Analytics: Saving the World Using the Internet of Things
By: Frank Nagle
In 2019, a decade after co-founding Nexleaf Analytics, CEO Nithya Ramanathan faced an important decision that would impact the ability of the small, but growing, not-for-profit organization to thrive for another decade. Their sensor technologies and big data analytics...
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Keywords:
Corporate Strategy;
Collaborative Innovation and Invention;
Technological Innovation;
Nonprofit Organizations;
Competitive Strategy;
Patents;
Expansion;
Information Technology;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
- November 2021
- Case
Kermit PPI
By: Kyle Myers, Matt Grennan and Sarah Mehta
Launched in 2011, Kermit PPI helped hospitals save money on expensive orthopedic implants and devices by enabling them to renegotiate their contracts with device manufacturers and better monitor compliance. In 2021, as they look to grow, they are entertaining two...
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Keywords:
Health;
Health Care and Treatment;
Strategy;
Expansion;
Information Technology;
Applications and Software;
Supply Chain;
Supply Chain Management;
Contracts;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States;
Maryland
- July–August 2021
- Article
Lowering the Bar? External Conditions, Opportunity Costs, and High-Tech Startup Outcomes
By: Annamaria Conti and Maria P. Roche
We assess the heterogeneous impact of economic downturns on individuals’ decisions to bring high-technology ideas to the market in the form of new ventures. We thereby examine how worsening labor market conditions influence individuals’ opportunity costs of starting...
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- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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- May 2021
- Article
Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices
By: Alberto Galasso and Hong Luo
We study the impact of consumers’ risk perception on firm innovation. Our analysis exploits a major surge in the perceived risk of radiation diagnostic devices following extensive media coverage of a set of over-radiation accidents involving CT scanners in late 2009....
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- March 2021
- Case
VideaHealth: Building the AI Factory
By: Karim R. Lakhani and Amy Klopfenstein
Florian Hillen, co-founder and CEO of VideaHealth, a startup that used artificial intelligence (AI) to detect dental conditions on x-rays, spent the early years of his company laying the groundwork for an AI factory. A process for quickly building and iterating on new...
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Keywords:
Artificial Intelligence;
Innovation and Invention;
Disruptive Innovation;
Technological Innovation;
Information Technology;
Applications and Software;
Technology Adoption;
Digital Platforms;
Entrepreneurship;
AI and Machine Learning;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
North and Central America;
United States;
Massachusetts;
Cambridge
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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- January 2021
- Article
Veil-of-Ignorance Reasoning Mitigates Self-Serving Bias in Resource Allocation During the COVID-19 Crisis
By: Karen Huang, Regan Bernhard, Netta Barak-Corren, Max Bazerman and Joshua D. Greene
The COVID-19 crisis has forced healthcare professionals to make tragic decisions concerning which patients to save. Furthermore, the COVID-19 crisis has foregrounded the influence of self-serving bias in debates on how to allocate scarce resources. A utilitarian...
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- August 2020 (Revised January 2022)
- Case
1928 Diagnostics: Fighting Antibiotics Resistance
By: Ariel D. Stern and Daniela Beyersdorfer
In 2019, the co-founders of the Swedish medical start-up 1928 Diagnostics, CEO Dr. Kristina Lagerstedt and COO Dr. Susanne Staaf, had to pick the right business model to commercialize their novel technology to hospitals and health care providers. Developed in...
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Keywords:
Health Care and Treatment;
Entrepreneurship;
Leadership;
Science-Based Business;
Growth and Development Strategy;
Business Growth and Maturation;
Business Model;
Information Technology;
Digital Platforms;
Health Disorders;
Market Entry and Exit;
Value Creation;
Business and Stakeholder Relations;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Europe;
Sweden
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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- May 2020 (Revised March 2022)
- Case
The Coronavirus (COVID-19) Pandemic and the Global Economy (A)
By: Alberto Cavallo and Christian Godwin
In April 2020, the world struggled to contain the exponential escalation of the coronavirus (COVID-19) pandemic. Dozens of countries had imposed restrictions on travel, work, and social gatherings. A large share of the global population was under lockdowns and...
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Keywords:
COVID-19 Pandemic;
Demand and Consumers;
Supply and Industry;
Finance;
Central Banking;
Financial Markets;
International Finance;
Globalization;
Government and Politics;
Health Pandemics;
Decision Making;
Macroeconomics;
Employment;
Crisis Management;
Supply Chain;
Risk and Uncertainty;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Asia;
China;
Europe;
Latin America;
Africa;
United States
- March 2020
- Case
EyeControl: Inspiring Communication
By: Paul A. Gompers and Danielle Golan
Eye-controlled communication device startup EyeControl was founded in Tel Aviv, Israel in 2016 by cofounders with a shared personal connection to locked-in syndrome—a neurological disorder that left sufferers cognitively sound, yet paralyzed, with the exception of eye...
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