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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.
- March 2024
- Article
Differences in Care Team Response to Patient Portal Messages by Patient Race and Ethnicity
By: Mitchell Tang, Rebecca Mishuris, Lily Payvandi and Ariel Dora Stern
Importance: The COVID-19 pandemic was associated with substantial growth in patient portal messaging. Higher message volumes have largely persisted, reflecting a new normal. Prior work has documented lower message use by patients who belong to minoritized racial...
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Keywords:
Health Pandemics;
Technology Adoption;
Prejudice and Bias;
Equality and Inequality;
Communication Technology;
Race;
Ethnicity;
Health Industry
Tang, Mitchell, Rebecca Mishuris, Lily Payvandi, and Ariel Dora Stern. "Differences in Care Team Response to Patient Portal Messages by Patient Race and Ethnicity." JAMA Network Open 7, no. 3 (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
- Case
More than Optics: Olympus's Vision to Become a Leading Global MedTech Company
By: David J. Collis and Haisley Wert
In August 2022, CEO Yasuo Takeuchi reflected on Olympus Corporation’s recent transformation from being known as a Japanese consumer camera company to becoming a leading global medical technology (MedTech) company. Over the past dozen years, Takeuchi and prior...
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Keywords:
Global Human Resource Management;
Medical Technology;
Corporate Strategy;
Transformation;
Globalization;
Business Model;
Leading Change;
Organizational Structure;
Organizational Change and Adaptation;
Medical Devices and Supplies Industry;
Japan;
United States
Collis, David J., and Haisley Wert. "More than Optics: Olympus's Vision to Become a Leading Global MedTech Company." Harvard Business School Case 724-426, February 2024.
- 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.
- 2023
- Article
Benchmarking Large Language Models on CMExam—A Comprehensive Chinese Medical Exam Dataset
By: Junling Liu, Peilin Zhou, Yining Hua, Dading Chong, Zhongyu Tian, Andrew Liu, Helin Wang, Chenyu You, Zhenhua Guo, Lei Zhu and Michael Lingzhi Li
Recent advancements in large language models (LLMs) have transformed the field of question answering (QA). However, evaluating LLMs in the medical field is challenging due to the lack of standardized and comprehensive datasets. To address this gap, we introduce CMExam,...
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Keywords:
Large Language Model;
AI and Machine Learning;
Analytics and Data Science;
Health Industry
Liu, Junling, Peilin Zhou, Yining Hua, Dading Chong, Zhongyu Tian, Andrew Liu, Helin Wang, Chenyu You, Zhenhua Guo, Lei Zhu, and Michael Lingzhi Li. "Benchmarking Large Language Models on CMExam—A Comprehensive Chinese Medical Exam Dataset." Conference on Neural Information Processing Systems (NeurIPS), Datasets and Benchmarks Track 36 (2023).
- 2023
- Article
Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation
By: Jan B. Brönneke, Annika Herr, Simon Reif and Ariel D. Stern
Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the health care delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital...
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Keywords:
Digital Transformation;
Applications and Software;
Product Development;
Insurance;
Policy;
Health Industry;
Germany
Brönneke, Jan B., Annika Herr, Simon Reif, and Ariel D. Stern. "Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation." International Journal of Technology Assessment in Health Care 39, no. 1 (2023).
- 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
- 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.)
- March 2023 (Revised June 2023)
- Teaching Note
Ransomware Attack at Springhill Medical Center
By: Suraj Srinivasan and Li-Kuan (Jason) Ni
Teaching Note for HBS Case No. 123-065. In July, 2019, Springhill Medical Center (“SMC”) in Mobile, Alabama fell prey to a malicious ransomware attack that crippled the hospital’s internal network systems and public-facing web page. While the hospital rushed to...
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Keywords:
Disruption;
Communication;
Communication Strategy;
Decision Making;
Decision Choices and Conditions;
Judgments;
Corporate Accountability;
Corporate Disclosure;
Corporate Governance;
Governance Controls;
Policy;
Employees;
News;
Cybersecurity;
Digital Strategy;
Information Infrastructure;
Information Management;
Internet and the Web;
Crisis Management;
Business or Company Management;
Resource Allocation;
Risk Management;
Negotiation Tactics;
Failure;
Business and Stakeholder Relations;
Attitudes;
Behavior;
Perception;
Reputation;
Trust;
Public Opinion;
Social Issues;
Health Industry;
Alabama;
United States
- February 2023
- Case
Ransomware Attack at Springhill Medical Center
By: Suraj Srinivasan and Li-Kuan (Jason) Ni
In July, 2019, Springhill Medical Center (“SMC”) in Mobile, Alabama, fell prey to a malicious ransomware attack that crippled the hospital’s internal network systems and public-facing web page. While the hospital rushed to securely restore the network, medical...
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Keywords:
Disruption;
Communication;
Communication Strategy;
Decision Making;
Decision Choices and Conditions;
Judgments;
Corporate Accountability;
Corporate Disclosure;
Corporate Governance;
Governance Controls;
Policy;
Employees;
News;
Cybersecurity;
Digital Strategy;
Information Infrastructure;
Information Management;
Internet and the Web;
Crisis Management;
Resource Allocation;
Risk Management;
Negotiation Tactics;
Failure;
Business and Stakeholder Relations;
Attitudes;
Behavior;
Perception;
Reputation;
Trust;
Public Opinion;
Social Issues;
Health Industry;
United States;
Alabama
Srinivasan, Suraj, and Li-Kuan (Jason) Ni. "Ransomware Attack at Springhill Medical Center." Harvard Business School Case 123-065, 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...
View Details
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;
Technology Industry;
Technology 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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- November 2022 (Revised February 2023)
- Case
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication...
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Keywords:
Pharmaceutical Companies;
Technological And Scientific Innovation;
Organ Donation;
Health Care and Treatment;
Health Disorders;
Innovation and Invention;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States;
District of Columbia
Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised February 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;
Medical Devices and Supplies Industry