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All HBS Web
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- Faculty Publications (242)
- 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).
- July 2022 (Revised February 2024)
- 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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Keywords:
Product Liability;
Innovation;
Tort;
Medical Devices;
Vertical Foreclosure;
Product;
Innovation and Invention;
Legal Liability;
Laws and Statutes;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants." American Economic Journal: Economic Policy 14, no. 2 (May 2022): 366–401.
- 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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Keywords:
Women's Health;
Healthcare Access;
Workplace Design;
Military Health System;
Occupational Health;
Medical Equipment & Devices;
Employees;
Gender;
Personal Development and Career
Kaplan, Robert S., Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator, and Michael D. Parkinson. "A Career Life-Cycle Perspective on Women's Health and Safety." Journal of Occupational and Environmental Medicine 64, no. 4 (April 2022): 267–270.
- 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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Keywords:
Growth and Development Strategy;
Technological Innovation;
Partners and Partnerships;
Strategic Planning;
Health Care and Treatment;
Analytics and Data Science;
Digital Platforms;
Health Industry;
Lebanon;
United Kingdom;
United States
Stern, Ariel D., and Alpana Thapar. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Case 622-082, March 2022. (Revised August 2022.)
- March 2022 (Revised April 2023)
- 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
Mills, Karen, Caroline Elkins, Vikram Gandhi, Gabriella Elanbeck, and Zeke Gillman. "Pittsburgh: A Successful City?" Harvard Business School Case 322-080, March 2022. (Revised April 2023.)
- 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
Nagle, Frank. "Nexleaf Analytics: Saving the World Using the Internet of Things." Harvard Business School Case 722-414, March 2022. (Revised July 2022.)
- 2022
- Book
Corporate Explorer: How Corporations Beat Startups at the Innovation Game
By: Andrew Binns, Charles A. O'Reilly III and Michael Tushman
Innovation used to be seen as a game best left to entrepreneurs, but now a new breed of corporate managers is flipping this logic on its head. These Corporate Explorers have the insight, resilience, and discipline to overcome the obstacles and build new ventures from...
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Keywords:
Organization Change And Adaptation;
Disruptive Innovation;
Organizational Change and Adaptation;
Innovation and Management;
Leading Change
Binns, Andrew, Charles A. O'Reilly III, and Michael Tushman. Corporate Explorer: How Corporations Beat Startups at the Innovation Game. Hoboken, NJ: Wiley, 2022.
- January 2022
- Supplement
Somatus: Value-Based Kidney Care (B)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
Set in early 2020, this (B) case provides an update to the (A) case (no. 622-009) and provides additional context regarding the challenges facing Somatus.
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Keywords:
Business Startups;
Disruption;
Entrepreneurship;
Health;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Innovation and Invention;
Disruptive Innovation;
Management;
Strategy;
Business Strategy;
Value;
Value Creation;
Health Industry;
United States;
Virginia
Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (B)." Harvard Business School Supplement 622-045, January 2022.
- January 2022
- Case
Somatus: Value-Based Kidney Care (A)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
When Dr. Ikenna Okezie founded Somatus, a value-based kidney care provider, his goal had been nothing short of transforming kidney care delivery in the United States. Rather than relying on dialysis, a costly and intensive treatment for late-stage kidney disease, the...
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Keywords:
Business Startups;
Disruption;
Entrepreneurship;
Health;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Innovation and Invention;
Disruptive Innovation;
Management;
Strategy;
Business Strategy;
Value;
Value Creation;
Health Industry;
United States;
Virginia
Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (A)." Harvard Business School Case 622-009, January 2022.
- 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
Myers, Kyle, Matt Grennan, and Sarah Mehta. "Kermit PPI." Harvard Business School Case 622-007, November 2021.
- August 2021
- Case
Livongo: Scaling a Purpose-Driven Organization in Healthcare
By: Ranjay Gulati, Aseem Shukla and Reva Nohria
When seasoned entrepreneur Glen Tullman founded the chronic health care startup Livongo in 2014, it was personal. His son lived with diabetes, and Tullman knew firsthand how taxing it could be to manage such an unrelenting disease. Livongo set out to empower people...
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Keywords:
Healthcare Industry;
Scaling;
Telehealth;
Health Care and Treatment;
Small Business;
Internet and the Web;
Customer Focus and Relationships;
Growth and Development Strategy;
Opportunities;
Mergers and Acquisitions;
Health Industry
Gulati, Ranjay, Aseem Shukla, and Reva Nohria. "Livongo: Scaling a Purpose-Driven Organization in Healthcare." Harvard Business School Case 422-017, August 2021.
- 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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Keywords:
Necessity Entrepreneurship;
Economic Conditions;
Recessions;
High-tech Startups;
Opportunity Costs;
Entrepreneurship;
Economic Slowdown and Stagnation;
Business Startups;
Information Technology;
Performance;
Labor
Conti, Annamaria, and Maria P. Roche. "Lowering the Bar? External Conditions, Opportunity Costs, and High-Tech Startup Outcomes." Organization Science 32, no. 4 (July–August 2021): 965–986.
- 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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Keywords:
Wearables;
Regulatory Changes;
Medical Technology;
Medical Devices;
Market Access;
Market Entry and Exit;
Information Technology;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
United States;
Germany;
Belgium
Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
- May 2021
- Case
Inclusive Innovation at Mass General Brigham
By: Katherine Baldiga Coffman and Olivia Hull
Massachusetts General Brigham (MGB) Chief Innovation Officer Christopher Coburn had overseen a period of exciting transformation and growth in healthcare innovation at MGB. In November 2019, the health system was the largest recipient of National Institutes of Health...
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Keywords:
Inclusion;
Innovation;
Invention;
Gender;
Business Startups;
Investment Funds;
Private Equity;
Health Care and Treatment;
Innovation Strategy;
Technological Innovation;
Intellectual Property;
Copyright;
Patents;
Research;
Research and Development;
Diversification;
Technology;
Health Industry;
Massachusetts;
Boston
Coffman, Katherine Baldiga, and Olivia Hull. "Inclusive Innovation at Mass General Brigham." Harvard Business School Case 921-006, May 2021.
- 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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Keywords:
Risk Perception;
Innovation;
Medical Devices;
Liability Risk;
Risk and Uncertainty;
Perception;
Technological Innovation
Galasso, Alberto, and Hong Luo. "Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices." Management Science 67, no. 5 (May 2021): 3022–3040.
- 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
Lakhani, Karim R., and Amy Klopfenstein. "VideaHealth: Building the AI Factory." Harvard Business School Case 621-021, March 2021.
- February 2021 (Revised March 2022)
- Case
Marvin: A Personalized Telehealth Approach to Mental Health
By: Regina E. Herzlinger, Eshani Sharma, Andrew Nguyen, Thomas Arsenault, Carin-Isabel Knoop and Julia Kelley
More than one third of Americans were said to suffer some type of behavioral health ailment at some point in their lifetime, with many people requiring chronic therapy or intervention. Despite significant clinical needs, access to reliable treatment has been difficult...
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Keywords:
Mental Health;
Applications;
Startup Management;
Telehealth;
Health Care Entrepreneurship;
Health & Wellness;
Health Care;
Health Care and Treatment;
Customization and Personalization;
Internet and the Web;
Entrepreneurship;
Growth and Development Strategy;
Applications and Software
Herzlinger, Regina E., Eshani Sharma, Andrew Nguyen, Thomas Arsenault, Carin-Isabel Knoop, and Julia Kelley. "Marvin: A Personalized Telehealth Approach to Mental Health." Harvard Business School Case 321-127, February 2021. (Revised March 2022.)
- 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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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).