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- Faculty Publications (211)
- 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.)
- 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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Keywords:
Beth Israel Deaconess;
Lahey;
Partners;
Health Care;
Hospitals;
Payers;
Providers;
Anti-trust;
Health Care Regulation;
Mergers and Acquisitions;
Health Care and Treatment;
Market Design;
Duopoly and Oligopoly;
Negotiation;
Consolidation;
Competition;
Health Industry;
Massachusetts;
Boston
Dafny, Leemore. "Beth Israel Deaconess: Consolidating to Strengthen, or to Stave Off, Competition?" Harvard Business School Case 319-026, October 2018. (Revised August 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;
Information Technology;
Applications and Software;
Competitive Strategy;
Product Development;
Commercialization;
Decision Choices and Conditions;
Health Industry;
Health Industry;
Health 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;
Health Industry;
Health 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.
- 2017
- Working Paper
Tort Reform and Innovation
By: Alberto Galasso and Hong Luo
Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model which predicts that the...
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Keywords:
Lawsuits and Litigation;
Laws and Statutes;
Innovation and Invention;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Tort Reform and Innovation." Working Paper, August 2017. (Accepted for publication in Journal of Law and Economics.)
- August 2017
- Article
Tort Reform and Innovation
By: Alberto Galasso and Hong Luo
Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model that predicts that the impact...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technological Innovation;
Legal Liability;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Tort Reform and Innovation." Journal of Law & Economics 60, no. 3 (August 2017): 385–412.
- July 2017 (Revised October 2017)
- Supplement
Becton Dickinson: Innovation and Growth (B)
By: Raffaella Sadun, Michael Beer and James Weber
This (B) case supplements the (A) case by providing additional information and updates through early 2016.
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Keywords:
Transformation;
Change Management;
Innovation Leadership;
Mergers and Acquisitions;
Organizational Change and Adaptation;
Organizational Culture;
Organizational Design;
Strategy;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States
Sadun, Raffaella, Michael Beer, and James Weber. "Becton Dickinson: Innovation and Growth (B)." Harvard Business School Supplement 717-504, July 2017. (Revised October 2017.)
- June 2017 (Revised October 2017)
- Case
Becton Dickinson: Innovation and Growth (A)
By: Raffaella Sadun, Michael Beer and James Weber
In late 2015, CEO Vince Forlenza was reviewing Becton Dickinson’s transformation efforts designed to enable the company to innovate and grow in a changing environment. Becton Dickinson had been a successful medical device company for over 100 years. In recent years,...
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Keywords:
Transformation;
Change Management;
Innovation Leadership;
Mergers and Acquisitions;
Organizational Change and Adaptation;
Organizational Culture;
Organizational Design;
Strategy;
Growth and Development Strategy;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States
Sadun, Raffaella, Michael Beer, and James Weber. "Becton Dickinson: Innovation and Growth (A)." Harvard Business School Case 717-419, June 2017. (Revised October 2017.)
- May 2017 (Revised June 2017)
- Case
ATH Technologies (A): Making the Numbers
By: Robert Simons and Jennifer Packard
An exercise that takes students through five stages of growth in an entrepreneurial start-up in the medical devices industry: 1) founding, 2) growth, 3) push to profitability, 4) refocusing process, and 5) takeover by new management. At each stage, students must...
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Keywords:
Strategy And Execution;
Management Control Systems;
Balancing Innovation And Control;
Performance Management;
Business Growth and Maturation;
Business Startups;
Profit;
Geographic Location;
Governance Controls;
Innovation and Invention;
Management Succession;
Performance Evaluation;
Medical Devices and Supplies Industry
Simons, Robert, and Jennifer Packard. "ATH Technologies (A): Making the Numbers." Harvard Business School Case 117-013, May 2017. (Revised June 2017.)
- May 2017
- Case
ATH Technologies: Making the Numbers
By: Robert Simons and Jennifer Packard
An exercise that takes students through five stages of growth in an entrepreneurial start-up in the medical devices industry: 1) founding, 2) growth, 3) push to profitability, 4) relocation process, and 5) takeover by new management. At each stage, students must...
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Keywords:
Balancing Innovation And Control;
Performance Evaluation;
Strategy And Execution;
Management Control Systems;
Risk Management;
Business Growth and Maturation;
Business Startups;
Profit;
Geographic Location;
Governance Controls;
Innovation and Invention;
Management Succession;
Medical Devices and Supplies Industry
Simons, Robert, and Jennifer Packard. "ATH Technologies: Making the Numbers." Harvard Business School Case 117-012, May 2017.
- Article
Drivers of the Variation in Prosthetic Implant Purchase Prices for Total Knee and Total Hip Arthroplasties
By: Derek A. Haas, Kevin J Bozic, Anthony M. DiGioia, Zirui Song and Robert S. Kaplan
Previous studies have documented wide variation in health-care spending and prices; however, the causes for the variation in supply purchase prices across providers are not well understood. The purpose of this study was to determine the drivers of variation in...
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Keywords:
Costing;
Cost Variation;
Total Knee Arthroplasty;
Total Hip Arthroplasty;
Prosthetic Implant Cost;
Health Care and Treatment;
Cost Management;
Health Industry;
Health Industry
Haas, Derek A., Kevin J Bozic, Anthony M. DiGioia, Zirui Song, and Robert S. Kaplan. "Drivers of the Variation in Prosthetic Implant Purchase Prices for Total Knee and Total Hip Arthroplasties." Journal of Arthroplasty 32, no. 2 (February 2017): 347–350.
- January 2017
- Article
Innovation Under Regulatory Uncertainty: Evidence from Medical Technology
By: Ariel Dora Stern
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)...
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Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
- June 2016
- Case
Suominen Wipes the Slate Clean
By: Boris Groysberg, Kalle Heikkinen and Michael Norris
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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Keywords:
Nonwovens;
Female Protagonist;
Turnaround;
Strategy;
Mergers and Acquisitions;
Pulp and Paper Industry;
Pulp and Paper Industry;
Pulp and Paper Industry;
Pulp and Paper Industry;
Pulp and Paper Industry;
Europe;
United States;
Finland
Groysberg, Boris, Kalle Heikkinen, and Michael Norris. "Suominen Wipes the Slate Clean." Harvard Business School Case 416-047, June 2016.