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Does the large-scale technological change that is characteristic of an industry-wide digital transformation entrench industry leaders or enable the...
The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all...
- 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;
Technology Industry;
Technology Industry;
North and Central America;
United States;
Massachusetts;
Cambridge
- 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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- 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;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation Industry;
Air Transportation 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
- 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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- 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
- 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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- 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;
Entrepreneurship;
Social Entrepreneurship;
Social Issues;
Social Enterprise;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Retail Industry;
Canada;
United States;
United Kingdom
- February 2019 (Revised September 2019)
- Case
Theranos: The Unicorn That Wasn't
By: Joseph B. Fuller and John Masko
In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains...
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Keywords:
Theranos;
Blood;
Lab Testing;
Fraud;
Holmes;
Balwani;
Shultz;
Carreyrou;
Securities And Exchange Commission;
Food And Drug Administration;
FDA;
SEC;
Health Testing and Trials;
Corporate Accountability;
Organizational Culture;
Misleading and Fraudulent Advertising;
Crime and Corruption;
Entrepreneurship;
Medical Devices and Supplies Industry
- November 2018 (Revised January 2019)
- Case
Investor Relations Practices at Edwards Lifesciences
By: C. Fritz Foley and F. Katelynn Boland
In January 2017, the senior leadership team at Edwards Lifesciences were preparing for the quarterly earnings call that would cover the fourth quarter of 2016. They faced questions about what types of information they should disclose on the call, as well as during...
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- October 2018 (Revised August 2019)
- Case
Beth Israel Deaconess: Consolidating to Strengthen, or to Stave Off, Competition?
By: Leemore Dafny
In July 2017, CEO Kevin Tabb of Boston's Beth Israel Deaconess Medical Center announced his plan to consolidate 11 Massachusetts hospitals under a common management structure. These hospitals collectively generated $5 billion in patient revenue and 25% of...
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- September 2018 (Revised December 2019)
- Case
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making...
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Keywords:
Radiology;
Machine Learning;
X-ray;
CT Scan;
Medical Technology;
Probability;
FDA 510(k);
Diagnosis;
Business Startups;
Health Care and Treatment;
Technology;
Software;
Competitive Strategy;
Product Development;
Commercialization;
Decision Choices and Conditions;
Health Industry;
Health Industry;
Health Industry;
Israel
- 2020
- Working Paper
Product Recalls and New Product Development: Own Firm Distractions and Competitor Firm Opportunities
By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern
Product recalls create significant challenges for R&D intensive firms, but simultaneously generate
potentially lucrative opportunities for competitors. Using the U.S. medical device industry as an empirical setting, we develop predictions and provide evidence that own...
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- September 2018
- Article
An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India
By: Budhaditya Gupta and Stefan Thomke
Recent research has studied innovation in emerging economies. However, microlevel product development processes in these economies are relatively unexplored, and the mechanisms by which the emerging economy context might affect such processes are still unclear. In this...
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- 2019
- Working Paper
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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