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- 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;
Technology;
Software;
Technology Adoption;
Technology Platform;
Entrepreneurship;
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 October 2020)
- 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;
Technology;
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 June 2020)
- 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:
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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- 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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- January 2020 (Revised March 2020)
- Case
SmileDirectClub: Better Is Better
By: Leonard A. Schlesinger and Aldo Sesia
- 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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- 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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- 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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- 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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- 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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- 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