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All HBS Web
(115,587)
- Faculty Publications (90)
- 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 (Revised June 2019)
- Case
Ariadne Labs: Building Impactful Partnerships
By: Ariel D. Stern and Sarah Mehta
In September 2018, the executive team at Ariadne Labs (Ariadne), a Boston-based organization dedicated to improving health systems through the discovery and implementation of simple tools, faced a number of strategic decisions. Chief among them, the seven-year-old...
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Keywords:
Health;
Health Care and Treatment;
Innovation and Invention;
Social Enterprise;
Nonprofit Organizations;
Partners and Partnerships;
Health Industry;
Boston
Stern, Ariel D., and Sarah Mehta. "Ariadne Labs: Building Impactful Partnerships." Harvard Business School Case 619-017, April 2019. (Revised June 2019.)
- 2019
- Chapter
Characterizing the Drug Development Pipeline for Precision Medicines
By: Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
BOOK ABSTRACT: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement...
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Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. "Characterizing the Drug Development Pipeline for Precision Medicines." Chap. 5 in Economic Dimensions of Personalized and Precision Medicine, edited by Ernest R. Berndt, Dana P. Goldman, and John W. Rowe, 115–158. University of Chicago Press, 2019.
- February 14, 2019
- Other Article
We Should Treat Algorithms like Prescription Drugs
By: Andy Coravos, Irene Chen, Ankit Gordhandas and Ariel Dora Stern
Coravos, Andy, Irene Chen, Ankit Gordhandas, and Ariel Dora Stern. "We Should Treat Algorithms like Prescription Drugs." Quartz (February 14, 2019).
- February 2019
- Article
Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spending
By: David Cutler, Jonathan Skinner, Ariel Dora Stern and David Wennberg
There is considerable controversy about the causes of regional variations in health care expenditures. Using vignettes from patient and physician surveys linked to fee-for-service Medicare expenditures, this study asks whether patient demand-side factors or physician...
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Cutler, David, Jonathan Skinner, Ariel Dora Stern, and David Wennberg. "Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spending." American Economic Journal: Economic Policy 11, no. 1 (February 2019): 192–221.
- December 19, 2018
- Article
It's Time to Reform the Orphan Drug Act
By: Nicholas Bagley, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "It's Time to Reform the Orphan Drug Act." NEJM Catalyst (December 19, 2018).
- 2018
- Chapter
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new...
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Keywords:
Health Care and Treatment;
Laws and Statutes;
Research and Development;
Investment;
Markets;
Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
- 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.)
- October 2018 (Revised April 2019)
- Case
The Brigham and Women's Hospital Innovation Hub: Driving Internal Innovation
By: Ariel D. Stern and Robert S. Huckman
Stern, Ariel D., and Robert S. Huckman. "The Brigham and Women's Hospital Innovation Hub: Driving Internal Innovation." Harvard Business School Case 619-026, October 2018. (Revised April 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.)
- August 2018
- Article
The Impact of the Entry of Biosimilars: Evidence from Europe
By: Fiona M. Scott Morton, Ariel Dora Stern and Scott Stern
Biologics represent a substantial and growing share of the U.S. drug market. Traditional “small molecule” generics quickly erode the price and share of the branded product upon entry; however, only a few biosimilars have been approved in the U.S. since 2015, thereby...
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Keywords:
Health Care;
Biosimilars;
Biologics;
Pharmaceutical Competition;
Healthcare Spending;
Innovation;
Health Care and Treatment;
Spending;
Market Entry and Exit;
Competition;
Innovation and Invention;
Pharmaceutical Industry;
United States;
Europe
Scott Morton, Fiona M., Ariel Dora Stern, and Scott Stern. "The Impact of the Entry of Biosimilars: Evidence from Europe." Review of Industrial Organization 53, no. 1 (August 2018): 173–210.
- Article
Why Apps for Managing Chronic Disease Haven't Been Widely Used, and How to Fix It
By: Robert S. Huckman and Ariel Dora Stern
Keywords:
Health Care;
Digital Health;
Chronic Disease;
App;
Health Information Technology;
Information Technology;
Health Industry;
United States
Huckman, Robert S., and Ariel Dora Stern. "Why Apps for Managing Chronic Disease Haven't Been Widely Used, and How to Fix It." Harvard Business Review (website) (April 4, 2018).
- March 2018
- Teaching Note
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
This teaching note provides guidance and recommendations for teaching HBS Case No. 618-025, entitled “Adaptive Platform Trials: The Clinical Trial of the Future?”
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- March 2018
- Teaching Note
Twine Health
By: Robert S. Huckman and Ariel D. Stern
In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that...
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- January 2018
- Article
Innovation Incentives and Biomarkers
By: Ariel Dora Stern, Brian M. Alexander and Amitabh Chandra
Previously, we have discussed the importance of economic incentives in shaping markets for precision medicines. Here we consider incentives for biomarker development, including discovery and establishment. Biomarkers can reveal valuable information regarding diagnosis...
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Stern, Ariel Dora, Brian M. Alexander, and Amitabh Chandra. "Innovation Incentives and Biomarkers." Clinical Pharmacology & Therapeutics 103, no. 1 (January 2018): 34–36.
- 2018
- Other Unpublished Work
Online Appendix to the paper The Impact of the Entry of Biosimilars: Evidence from Europe
By: Fiona M. Scott Morton, Ariel Dora Stern and Scott Stern
Scott Morton, Fiona M., Ariel Dora Stern, and Scott Stern. "Online Appendix to the paper The Impact of the Entry of Biosimilars: Evidence from Europe."
- 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.
- September 2017 (Revised July 2023)
- Case
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
In July 2017, Dr. Brian M. Alexander, president and CEO of the AGILE Research Foundation, was preparing to launch a new type of clinical trial—an adaptive platform trial—to study potential therapies for glioblastoma (GBM), an aggressive form of brain cancer....
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Keywords:
Clinical Trials;
Cancer;
Adaptive Platform Trials;
Platform Trials;
Adaptive Trials;
Glioblastoma;
Health;
Health Care and Treatment;
Health Testing and Trials;
Business Strategy;
Innovation Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future?" Harvard Business School Case 618-025, September 2017. (Revised July 2023.)
- March 17, 2017
- Article
How Economics Can Shape Precision Medicines
By: Ariel Dora Stern, Brian M. Alexander and Amitabh Chandra
Many public and private efforts in coming years will focus on research in precision medicine, developing biomarkers to indicate which patients are likely to benefit from a certain treatment so that others can be spared the cost—financial and physical—of being treated...
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Stern, Ariel Dora, Brian M. Alexander, and Amitabh Chandra. "How Economics Can Shape Precision Medicines." Science 355, no. 6330 (March 17, 2017): 1131–1133.
- January 2017
- Article
Review Times and Adverse Events for Cardiovascular Devices
By: Ariel Dora Stern, Daniel B. Kramer, Melissa Ouellet and Aaron S. Kesselheim
Stern, Ariel Dora, Daniel B. Kramer, Melissa Ouellet, and Aaron S. Kesselheim. "Review Times and Adverse Events for Cardiovascular Devices." Art. 0013. Nature Biomedical Engineering 1, no. 1 (January 2017).