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- Faculty Publications (242)
- 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).
- 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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Keywords:
Self-serving Bias;
Procedural Justice;
Bioethics;
COVID-19;
Fairness;
Health Pandemics;
Resource Allocation;
Decision Making
Huang, Karen, Regan Bernhard, Netta Barak-Corren, Max Bazerman, and Joshua D. Greene. "Veil-of-Ignorance Reasoning Mitigates Self-Serving Bias in Resource Allocation During the COVID-19 Crisis." Judgment and Decision Making 16, no. 1 (January 2021): 1–19.
- November 2020 (Revised March 2023)
- Case
Zipline: The World's Largest Drone Delivery Network
By: Tarun Khanna and George Gonzalez
Zipline established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones. The company is now looking to expand in the U.S. and partnered with Walmart to expand into home delivery. Zipline must...
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Keywords:
Drones;
Business Startups;
Expansion;
Growth and Development Strategy;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry;
United States;
Africa
Khanna, Tarun, and George Gonzalez. "Zipline: The World's Largest Drone Delivery Network." Harvard Business School Case 721-366, November 2020. (Revised March 2023.)
- 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
Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020. (Revised January 2022.)
- July 2020
- Supplement
Instabeat—Crossing the Finish Line
By: Shikhar Ghosh, Nicole Tempest Keller and Alpana Thapar
Lebanese entrepreneur Hind Hobeika was just 21 years old when she launched her startup, Instabeat, which had developed the first real-time bio-feedback device for swimmers to monitor and improve their performance. It had been an extremely testing 10-year journey to...
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Keywords:
Start-up;
Wearables;
Entrepreneurship;
Business Startups;
Information Technology;
Information Infrastructure;
Strategy;
Operations;
Management;
United States;
Lebanon
Ghosh, Shikhar, Nicole Tempest Keller, and Alpana Thapar. "Instabeat—Crossing the Finish Line." Harvard Business School Supplement 821-012, July 2020.
- 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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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- 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
Cavallo, Alberto, and Christian Godwin. "The Coronavirus (COVID-19) Pandemic and the Global Economy (A)." Harvard Business School Case 720-031, May 2020. (Revised March 2022.)
- March 2020 (Revised June 2023)
- 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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Keywords:
Health Disorders;
Communication Technology;
Business Startups;
Expansion;
Finance;
Decision Making;
Social Enterprise;
Medical Devices and Supplies Industry
Gompers, Paul A., and Danielle Golan. "EyeControl: Inspiring Communication." Harvard Business School Case 820-078, March 2020. (Revised June 2023.)
- February 2020
- Teaching Note
Theranos: Who Has Blood on Their Hands? (A) and (B)
By: Nien-he Hsieh and Christina R. Wing
Teaching Note for HBS Nos. 619-039 and 320-091.
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- February 2020
- Supplement
Theranos: Who Has Blood on Their Hands? (B)
By: Nien-he Hsieh, Christina R. Wing and John Masko
This supplemental case tracks the results of the Colman and Taubman-Dye class action suit against Theranos as well as Theranos’ other legal challenges and chronicles the final demise of the company in 2019.
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Keywords:
Health Testing and Trials;
Corporate Accountability;
Organizational Culture;
Misleading and Fraudulent Advertising;
Crime and Corruption;
Entrepreneurship;
Lawsuits and Litigation;
Business Exit or Shutdown;
Medical Devices and Supplies Industry;
California;
United States
Hsieh, Nien-he, Christina R. Wing, and John Masko. "Theranos: Who Has Blood on Their Hands? (B)." Harvard Business School Supplement 320-091, February 2020.
- January 2020 (Revised March 2020)
- Case
SmileDirectClub: Better Is Better
By: Leonard A. Schlesinger and Aldo Sesia
Keywords:
Direct-to-consumer;
Brands and Branding;
Strategy;
Expansion;
Online Technology;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
Schlesinger, Leonard A., and Aldo Sesia. "SmileDirectClub: Better Is Better." Harvard Business School Case 320-016, January 2020. (Revised March 2020.)
- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
- November 26, 2019
- Article
Veil-of-Ignorance Reasoning Favors the Greater Good
By: Karen Huang, Joshua D. Greene and Max Bazerman
The “veil of ignorance” is a moral reasoning device designed to promote impartial decision-making by denying decision-makers access to potentially biasing information about who will benefit most or least from the available options. Veil-of-ignorance reasoning was...
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Huang, Karen, Joshua D. Greene, and Max Bazerman. "Veil-of-Ignorance Reasoning Favors the Greater Good." Proceedings of the National Academy of Sciences 116, no. 48 (November 26, 2019).
- July 2019
- Article
Challenges and Opportunities in Software-Driven Medical Devices
By: William J. Gordon and Ariel Dora Stern
The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.
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Keywords:
Medical Devices;
Healthcare;
Health Care;
Health Care and Treatment;
Applications and Software;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
- 2019
- Working Paper
Veil-of-Ignorance Reasoning Favors the Greater Good
By: Karen Huang, Joshua D. Greene and Max Bazerman
The “veil of ignorance” is a moral reasoning device designed to promote impartial decision-making by denying decision-makers access to potentially biasing information about who will benefit most or least from the available options. Veil-of-ignorance reasoning was...
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Huang, Karen, Joshua D. Greene, and Max Bazerman. "Veil-of-Ignorance Reasoning Favors the Greater Good." Working Paper, October 2019.
- June 2019
- Teaching Note
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working...
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- 2019
- Working Paper
Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry
By: Cirrus Foroughi and Ariel Dora Stern
Does the large-scale technological change that is characteristic of an industry-wide digital transformation entrench industry leaders or enable the rise of new entrants? We offer a novel approach to this question by studying the medical device industry, a unique...
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Keywords:
Innovation;
Medical Devices;
Digitization;
Medical Technology;
Technological Innovation;
Applications and Software;
Market Entry and Exit;
Industry Growth;
Medical Devices and Supplies Industry;
United States
Foroughi, Cirrus, and Ariel Dora Stern. "Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry." Harvard Business School Working Paper, No. 19-120, June 2019.
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords:
Digital;
Medicine;
FDA;
Health Care and Treatment;
Applications and Software;
Safety;
Cybersecurity;
Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- April 2019
- Case
Barber Cardiosystems
By: Ranjay Gulati and Paul S. Myers
Barber Cardiosystems, based in Melbourne, Australia, designs and manufactures therapeutic devices used for treatment of coronary conditions. Over four decades, it has grown to be among the top 200 medical device companies in the world. It competes against much larger...
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Keywords:
Organizational Behavior;
Strategic Alignment;
Cost Management;
Performance Productivity;
Organizational Culture;
Motivation and Incentives;
Organizational Design;
Strategy;
Leadership;
Medical Devices and Supplies Industry;
Australia
Gulati, Ranjay, and Paul S. Myers. "Barber Cardiosystems." Harvard Business School Brief Case 919-505, April 2019.
- March 2019 (Revised April 2021)
- Case
The DivaCup: Navigating Distribution and Growth
By: Ayelet Israeli
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 product. Fifteen years later, the...
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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
Israeli, Ayelet. "The DivaCup: Navigating Distribution and Growth." Harvard Business School Case 519-055, March 2019. (Revised April 2021.)