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- May 2024
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Product Development;
Health Testing and Trials;
Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics 115, no. 5 (May 2024): 988–992.
- 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
- 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
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
- 2023
- Article
Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study
By: Mitchell Tang, Yashoda Sharma, Jennifer C. Goldsack and Ariel Dora Stern
Background: The use of digital health measurement tools has grown substantially in recent years. However, there are concerns that the promised benefits from these products will not be shared equitably. Underserved populations, such as those with lower education and...
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Keywords:
Demographics;
Product Development;
Health Care and Treatment;
Medical Devices and Supplies Industry
Tang, Mitchell, Yashoda Sharma, Jennifer C. Goldsack, and Ariel Dora Stern. "Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study." JMIR Formative Research 7 (2023).
- 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).
- May 9, 2023
- Response
Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
Everhart, Alexander O., Yi Zhu, and Ariel D. Stern. "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 18 (May 9, 2023): 1609–1610. (Reply to original paper.)
- 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.
- 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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- November 2022 (Revised April 2024)
- 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 April 2024.)
- 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
- September 2022
- Technical Note
Addressing Social Determinants of Health in the American Landscape
By: Susanna Gallani and Jacob Riegler
Social determinants of health (SDOH) have gained significant attention in recent years. A growing body of research shows that a person’s health is influenced by a large number of non-genetic factors, most of which operate outside the realm of health care and are...
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Keywords:
Socioeconomic Determinants Of Health;
Social Determinants Of Health;
Population Health;
Health;
Health Care and Treatment;
Social Issues;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States
Gallani, Susanna, and Jacob Riegler. "Addressing Social Determinants of Health in the American Landscape." Harvard Business School Technical Note 123-023, September 2022.
- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a...
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Keywords:
Emerging Technologies;
Governing Rules, Regulations, and Reforms;
Innovation and Invention;
Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- July 2022 (Revised February 2024)
- Teaching Note
The DivaCup: Navigating Distribution and Growth
By: Ayelet Israeli
Teaching Note for HBS Case No. 519-055. When the mother-daughter founders of DivaCup set out with a mission to disrupt the menstrual care industry with an innovative product form, they initially struggled to gain legitimacy and convince retailers to carry their unique...
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Keywords:
Female;
Female Ceo;
Female Entrepreneur;
Female Protagonist;
Health & Wellness;
Healthcare;
Price Policies;
Minimum Advertised Price;
Differentiation;
Positioning;
Growth;
Health;
Health Care and Treatment;
Price;
Disruption;
Distribution;
Distribution Channels;
Competitive Strategy;
Competition;
Growth Management;
Mission and Purpose;
Product Development;
Product Marketing;
Product Launch;
Product Positioning;
Advertising;
Business Startups;
Internet and the Web;
Entrepreneurship;
Social Entrepreneurship;
Social Issues;
Social Enterprise;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Canada;
United States;
United Kingdom