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- June 2023
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This case...
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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- December 2022 (Revised June 2023)
- Case
Sword Health
By: Regina E. Herzlinger and Annelena Lobb
Virgilio “V” Bento, CEO of Sword Health—a startup that provided virtual physical therapy to patients in self-insured firms via AI and sensor technology with supervision by a physical therapist with a doctorate—considered how to increase its U.S. market share. To do so,...
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Keywords:
Business Growth and Maturation;
Competitive Strategy;
Health Industry;
Technology Industry
Herzlinger, Regina E., and Annelena Lobb. "Sword Health." Harvard Business School Case 323-022, December 2022. (Revised June 2023.)
- October 2022 (Revised May 2023)
- Case
Podimetrics: Next Steps for Diabetes Cases
By: Regina E. Herzlinger and Ben Creo
Podimetrics, a virtual care management company treating adults with acute diabetes, sat at the intersection of medical device technology, digital health, and health services. Its SmartMat had demonstrated that it could help prevent amputations and that people with...
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Keywords:
Health Care;
Health Care Delivery;
Health Care Entrepreneurship;
Health Care Outcomes;
Diabetes;
Chronic Disease;
Chronic Illness;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Technological Innovation;
Innovation Strategy;
Product Development;
Business Model;
Customer Focus and Relationships;
Medical Devices and Supplies Industry;
Health Industry
- September 2022
- Article
Find and Replace: R&D Investment Following the Erosion of Existing Products
By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor
How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first...
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Keywords:
R&D Investments;
Drug Development;
Product Shocks;
M&A;
Biopharmaceutical Industry;
FDA;
System Shocks;
Research and Development;
Investment;
Decision Making;
Pharmaceutical Industry
Krieger, Joshua L., Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Management Science 68, no. 9 (September 2022): 6552–6571.
- 2022
- Article
Missing Novelty in Drug Development
By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to...
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Keywords:
Drug Development;
Risk Aversion;
Research and Development;
Innovation and Invention;
Investment;
Pharmaceutical Industry
Krieger, Joshua, Danielle Li, and Dimitris Papanikolaou. "Missing Novelty in Drug Development." Review of Financial Studies 35, no. 2 (February 2022): 636–679.
- 2021
- Working Paper
Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the...
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Keywords:
Health Care and Treatment;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-132, June 2021.
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- May 2021 (Revised May 2022)
- Case
Headspace vs. Calm: A Mindful Competition
By: Ayelet Israeli and Anne Wilson
By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable...
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Keywords:
Marketing Communication;
Integrated Strategy;
Brand;
Brand & Product Management;
Brand Communication;
Brand Differentiation;
Brand Building;
Brand Management;
E-Commerce Strategy;
Ecommerce;
App;
App Development;
Applications;
COVID;
COVID-19;
Pandemic;
Pricing;
Pricing Strategy;
Subscription Model;
Subscription;
Partnerships;
Strategic Partnerships;
B2B Vs. B2C;
B2B;
Health & Wellness;
Wellbeing;
Digitization;
Commoditization;
Mobile App;
Mobile App Industry;
Mobile Healthcare;
Mobile Marketing;
Digital Brand;
Digital Health;
Consumer Health;
Apps;
Online Business;
Online Competition;
Online Community;
Online Entertainment;
Entertainment And Leisure;
Meditation;
Marketing;
Marketing Communications;
Brands and Branding;
Price;
Strategy;
Competition;
Competitive Strategy;
Competitive Advantage;
Partners and Partnerships;
Health;
Well-being;
Mobile and Wireless Technology;
Communication;
Communication Strategy;
Disruption;
Consumer Behavior;
Digital Marketing;
E-commerce;
Applications and Software;
Health Industry;
Technology Industry;
Communications Industry;
United States;
North America;
United Kingdom
Israeli, Ayelet, and Anne Wilson. "Headspace vs. Calm: A Mindful Competition." Harvard Business School Case 521-102, May 2021. (Revised May 2022.)
- May 2021
- Article
Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices
By: Alberto Galasso and Hong Luo
We study the impact of consumers’ risk perception on firm innovation. Our analysis exploits a major surge in the perceived risk of radiation diagnostic devices following extensive media coverage of a set of over-radiation accidents involving CT scanners in late 2009....
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Keywords:
Risk Perception;
Innovation;
Medical Devices;
Liability Risk;
Risk and Uncertainty;
Perception;
Technological Innovation
Galasso, Alberto, and Hong Luo. "Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices." Management Science 67, no. 5 (May 2021): 3022–3040.
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- 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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- 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).
- 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
- Case
David Hysong and SHEPHERD Therapeutics
By: Ananth Raman, John Masko and Aldo Sesia
In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...
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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;
Information Technology;
Applications and 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.)
- 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.)