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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;
Health industry;
medical devices And supplies industry;
Technology industry;
Europe;
Sweden
Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020. (Revised October 2020.)
- 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;
Banking industry;
Consumer Products industry;
Employment industry;
Financial Services industry;
Food And Beverage industry;
Health industry;
medical devices And supplies industry;
Pharmaceutical industry;
Public Administration industry;
Retail industry;
Service industry;
Shipping industry;
Tourism industry;
Travel 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 June 2020.)
- 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...
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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
- Case
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 Case 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;
Health industry;
medical devices And supplies industry;
Retail industry
Schlesinger, Leonard A., and Aldo Sesia. "SmileDirectClub: Better Is Better." Harvard Business School Case 320-016, January 2020. (Revised March 2020.)
- 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;
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.
- 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;
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;
Cybersecurity;
Health Care And Treatment;
Software;
Safety;
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 September 2019)
- 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;
medical devices And supplies industry;
Manufacturing industry;
Health industry;
Green Technology industry;
Education industry;
Distribution industry;
Consumer Products industry;
Canada;
United States;
United Kingdom
Israeli, Ayelet. "The DivaCup: Navigating Distribution and Growth." Harvard Business School Case 519-055, March 2019. (Revised September 2019.)
- 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
Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 2019.)
- 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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Keywords:
Investor Relations;
Medical Devices;
Corporate Disclosure;
Decisions;
Business And Shareholder Relations;
medical devices And supplies industry;
United States
Foley, C. Fritz, and F. Katelynn Boland. "Investor Relations Practices at Edwards Lifesciences." Harvard Business School Case 219-058, November 2018. (Revised January 2019.)
- 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;
medical devices And supplies industry;
Technology industry;
Israel
Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Case 619-014, September 2018. (Revised December 2019.)
- 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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Keywords:
New Product Development;
Recalls;
Product Failures;
Medical Devices;
Fda;
Health Care;
Product Development;
Product;
Failure;
Competition;
Opportunities;
medical devices And supplies industry
Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern. "Product Recalls and New Product Development: Own Firm Distractions and Competitor Firm Opportunities." Harvard Business School Working Paper, No. 19-028, September 2018. (Revised August 2020.)
- 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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Keywords:
Product Development;
India;
Product Development;
Emerging Markets;
Situation Or Environment;
medical devices And supplies industry;
India
Gupta, Budhaditya, and Stefan Thomke. "An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India." R&D Management 48, no. 4 (September 2018): 485–501.
- 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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Keywords:
Product Liability;
Innovation;
Tort;
Medical Devices;
Vertical Foreclosure;
Legal Liability;
Innovation And Invention;
Laws And Statutes;
medical devices And supplies industry
Galasso, Alberto, and Hong Luo. "When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants." Harvard Business School Working Paper, No. 19-002, July 2018. (Revised July 2019.)
- February 2018
- Article
Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience
By: Bradley R. Staats, Diwas S. KC and F. Gino
Many models in operations management involve dynamic decision making that assumes optimal updating in response to information revelation. However, behavioral theory suggests that rather than updating their beliefs, individuals may persevere in their prior beliefs. In...
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Keywords:
Information;
Announcements;
Service Operations;
Decision Making;
medical Specialties;
Experience And Expertise;
medical devices And supplies industry
Staats, Bradley R., Diwas S. KC, and F. Gino. "Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience." Management Science 64, no. 2 (February 2018): 804–824.
- January 2018 (Revised June 2018)
- Case
Medtronic: Navigating a Shifting Healthcare Landscape
Medtronic is adapting its strategy to changes in healthcare competition and payments. It has decided to develop new relationships with payers, hospitals, and physicians to become more accountable for patient outcomes and total costs. The case describes new forms of...
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Keywords:
Value Based Health Care;
Bundled Payments;
Health Care And Treatment;
Cost Management;
Value Creation;
supply Chain Management;
Customer Value And Value Chain;
Health industry;
medical devices And supplies industry;
United States;
Netherlands
Kaplan, Robert S., Michael E. Porter, Thomas W. Feeley, and Alee Hernandez. "Medtronic: Navigating a Shifting Healthcare Landscape." Harvard Business School Case 718-471, January 2018. (Revised June 2018.)