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- March 2024
- Case
Angel City Football Club: Scoring a New Model
By: Jeffrey F. Rayport, Jennifer Fonstad and Nicole Tempest Keller
In January 2024, Kara Nortman, Julie Uhrman, and Natalie Portman, the founders of Angel City Football Club (ACFC) were developing the club’s first three-year strategic plan. Founded in 2020, ACFC had a star-studded investor group, including Portman and celebrities such...
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- 2024
- Working Paper
Product Liability Litigation and Innovation: Evidence from Medical Devices
By: Alberto Galasso and Hong Luo
We examine the relationship between product liability litigation and innovation by systematically
combining data on product liability lawsuits with data on new product introductions in a panel dataset of
leading medical device firms. We first document a decline in...
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Keywords:
Lawsuits and Litigation;
Product Development;
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Product Liability Litigation and Innovation: Evidence from Medical Devices." Harvard Business School Working Paper, No. 24-063, March 2024.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- February 2024
- Article
Representation and Extrapolation: Evidence from Clinical Trials
By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
This article examines the consequences and causes of low enrollment of Black patients in clinical
trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is
more relevant for decision-making by physicians and patients when it...
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Keywords:
Representation;
Racial Disparity;
Health Testing and Trials;
Race;
Equality and Inequality;
Innovation and Invention;
Pharmaceutical Industry
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- 2024
- Chapter
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay Agrawal, Joshua Gans, Avi Goldfarb, and Catherine E. Tucker, 107–138. Chicago and London: University of Chicago Press, 2024.
- January 2024
- Teaching Note
Somatus: Value-Based Kidney Care (A) & (B)
By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
This teaching note accompanies case no. 622-009 and 622-045 (Somatus: Value-Based Kidney Care, A and B).
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- January 2024
- Background Note
Evaluating Innovations in the Organization of Primary Care: What Type of Innovation Is It and How Well Does It Align with the Six Factors?
By: Regina E. Herzlinger and James Wallace
How can we evaluate if innovative health care ventures can do good—benefit society—and do well—become financially viable? This question is the topic of the first module in the Innovating in Health Care course book.
This note and "Health Stop (A): What Type... View Details
This note and "Health Stop (A): What Type... View Details
- September 2023
- Teaching Note
Nexleaf Analytics: Saving the World Using the Internet of Things
By: Frank Nagle
Teaching Note for HBS Case 722-414.
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Keywords:
Corporate Strategy;
Collaborative Innovation and Invention;
Technological Innovation;
Nonprofit Organizations;
Competitive Strategy;
Patents;
Expansion;
Information Technology;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
- September 2023
- Supplement
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
This PowerPoint accompanies Regina E. Herzlinger's "Fighting the Battle of the Bulge – Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment" teaching note (HBS Case No.324-013) and is designed for instructors to use in the classroom when teaching this...
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- September 2023
- Teaching Note
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
Teaching Note for HBS Case No. 304-009. The case is part of the first module of the Innovating in Health Care course. Its purpose is to demonstrate how to evaluate the “do good” and do well” potential of a health care innovation.
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- June 2023
- Article
Managing Medical Device Liability Through Innovation: A Strategic Approach
By: Alberto Galasso and Hong Luo
In this article, we discuss several aspects of the relationships among product liability risk, safety, and innovation strategies of medical device companies.
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Galasso, Alberto, and Hong Luo. "Managing Medical Device Liability Through Innovation: A Strategic Approach." Health Management, Policy and Innovation 8, no. 1 (June 2023).
- June 2023
- Case
Verve Therapeutics: Taking DNA Editing to Heart
By: Shikhar Ghosh and Shweta Bagai
Verve Therapeutics, a public biotech company based in Boston, created a novel approach to addressing cardiovascular disease (CVD) - a leading cause of deaths globally. The company's approach was a single shot treatment to permanently lower cholesterol, thus reducing...
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Keywords:
AI;
Genetic Engineering;
Medicine;
Health Care and Treatment;
Genetics;
Innovation Strategy;
Business and Stakeholder Relations;
Medical Specialties;
Innovation and Invention;
Entrepreneurship;
Biotechnology Industry
Ghosh, Shikhar, and Shweta Bagai. "Verve Therapeutics: Taking DNA Editing to Heart." Harvard Business School Case 823-113, June 2023.
- May 2023 (Revised June 2023)
- Case
Novartis (A): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Leadership;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (A): Reimagining Medicine." Harvard Business School Case 723-443, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (B): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Production;
Business Strategy;
Pharmaceutical Industry
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (B): Reimagining Medicine." Harvard Business School Supplement 723-444, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (C): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Testing and Trials;
Health Care and Treatment;
Business Model;
Problems and Challenges;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)
- February 2023
- Article
Maintaining Health Care Innovations After the Pandemic
By: Regina E. Herzlinger, Barak D. Richman and Kevin A. Schulman
The COVID-19 pandemic exposed the worst failings of the health care system, but it also stimulated a flurry of innovations that could lead to a much-improved delivery system. These were innovations that were born out of necessity: telemedicine access and use...
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Keywords:
Health Care;
Health Care Industry;
Health Care Outcomes;
Innovation;
Innovation In Healthcare Delivery;
COVID;
COVID-19 Pandemic;
Pandemics;
Telemedicine;
Telehealth;
Ambulatory Care;
Vaccines;
Innovation and Invention;
Change;
Health Industry
Herzlinger, Regina E., Barak D. Richman, and Kevin A. Schulman. "Maintaining Health Care Innovations After the Pandemic." e225404. JAMA Health Forum 4, no. 2 (February 2023).
- 2022
- Working Paper
Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data
By: Alexander O. Everhart and Ariel D. Stern
Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...
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Keywords:
Technological Innovation;
Safety;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Medical Devices and Supplies Industry
Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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Keywords:
AI and Machine Learning;
Health Care and Treatment;
Governing Rules, Regulations, and Reforms;
Technological Innovation;
Medical Devices and Supplies Industry
Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
- November 2022
- Case
Ajax Health: A New Model for Medical Technology Innovation
By: Regina E. Herzlinger and Ben Creo
This case teaches key success factors for both startup and established MedTech firms. It examines how to structure a firm to maximize innovation and financial returns with organizational structures that better align the incentives for the different skill sets...
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Keywords:
Business Startups;
Success;
Innovation Strategy;
Mergers and Acquisitions;
Market Entry and Exit;
Financial Strategy;
Business Model;
Partners and Partnerships;
Entrepreneurship;
Private Equity;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry
Herzlinger, Regina E., and Ben Creo. "Ajax Health: A New Model for Medical Technology Innovation." Harvard Business School Case 323-043, November 2022.
- November 2022
- Teaching Note
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern, Alpana Thapar and Menna Hassan
Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...
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