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All HBS Web
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- Faculty Publications (216)
- 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.)
- 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.)
- 2020
- Working Paper
Pioneer (Dis-)advantages in Markets for Technology
By: Moritz Fischer, Joachim Henkel and Ariel Dora Stern
This study sheds new light on first- and early-mover advantages in the context of product innovation. Research on this classic topic often assumes that each firm participates in the entirety of the innovation and commercialization process. However, a division of labor...
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Keywords:
First-mover Advantage;
Product;
Innovation Strategy;
Market Entry and Exit;
Acquisition;
Technology
Fischer, Moritz, Joachim Henkel, and Ariel Dora Stern. "Pioneer (Dis-)advantages in Markets for Technology." Harvard Business School Working Paper, No. 19-043, October 2018. (Revised March 2020.)
- 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;
Information Technology;
Applications and Software;
Competitive Strategy;
Product Development;
Commercialization;
Decision Choices and Conditions;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Israel
Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Case 619-014, September 2018. (Revised December 2019.)
- 2022
- Working Paper
Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions
By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern
Medical device firms operate at the frontiers of innovation. When functioning properly, innovative medical devices can prolong and improve lives; when malfunctioning, the same devices may harm patients and lead to product recalls. Product recalls create significant...
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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. "Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions." Harvard Business School Working Paper, No. 19-028, September 2018. (Revised March 2022.)
- 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:
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.
- 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
By: Robert S. Kaplan, Michael E. Porter, Thomas W. Feeley and Alee Hernandez
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;
Medical Devices and Supplies 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.)
- January 2018
- Teaching Note
Suominen Wipes the Slate Clean
By: Boris Groysberg, Kalle Heikkinen, Michael Norris and James Barnett
In 2016, after successfully turning around Finnish nonwovens manufacturer Suominen, CEO Nina Kopola faces a decision on the company’s strategy moving forward.
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- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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Keywords:
Health Testing and Trials;
Business and Government Relations;
Governing Rules, Regulations, and Reforms;
Information Publishing;
Medical Devices and Supplies Industry;
United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- August 2017
- Case
RoboTech: Storming into the U.S. Market
By: Christopher A. Bartlett, Rachel Gordon and John J. Lafkas
This case describes the challenges facing the CEO of a small, Singapore-based industrial robotics company that decides to diversify away from its core industrial robot business by leveraging its expertise into the medical-devices industry. It launches an innovative...
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Keywords:
Market Entry and Exit;
Diversification;
Product Launch;
Competitive Strategy;
Globalized Firms and Management;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Singapore;
United States
Bartlett, Christopher A., Rachel Gordon, and John J. Lafkas. "RoboTech: Storming into the U.S. Market." Harvard Business School Brief Case 918-501, August 2017.