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- 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
- 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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- 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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- 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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- 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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- 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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- October 2022
- 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, data, and health services. Their leadership team considered the best next step for the company to take—would it be expanding the...
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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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- 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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- July 2022
- 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
- May 2022
- Case
Byte
By: Boris Groysberg, Katherine Connolly Baden and Julia Kelley
In January 2021, Byte co-founders Scott Cohen and Blake Johnson reflected on how far their Los Angeles-based direct-to-consumer (DTC) orthodontics company had come since launching its clear aligners just a little over two years earlier. Cohen and Johnson were both...
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- May 2022
- Article
When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants
By: Alberto Galasso and Hong Luo
Liability laws designed to compensate for harms caused by defective products may also affect innovation. We examine this issue by exploiting a major quasi-exogenous increase in liability risk faced by U.S. suppliers of polymers used to manufacture medical implants....
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- Article
A Career Life-Cycle Perspective on Women's Health and Safety
By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health...
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- March 2022 (Revised August 2022)
- Case
Proximie: Using XR Technology to Create Borderless Operating Rooms
By: Ariel D. Stern and Alpana Thapar
In mid-January 2022, Nadine Hachach-Haram, founder and CEO of Proximie, was thinking about the company’s growth plans. Launched in 2016, Proximie was a platform that enabled clinicians, proctors, and medical device company personnel to be virtually present in operating...
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- March 2022 (Revised April 2023)
- Case
Pittsburgh: A Successful City?
Pittsburgh, PA, was once the crown jewel of American heavy industry. During the 19th and 20th centuries, the city was an undisputed leader in steel production, boasting some of the largest companies and wealthiest individuals in the world. Its abundance of...
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Keywords:
Economic And Social Disparities;
Economic Development;
Local Economic Development;
Contextual Intelligence;
Contextual Knowledge;
Context;
City Growth;
City Innovation;
City Leadership;
Pittsburgh;
Local Government;
Local Stakeholders;
Business And Community;
Business And Community Relations;
Community Engagement;
Community Relations;
Cross-sector Collaboration;
Innovation;
Innovation Economy;
Innovation Clusters;
Innovation Ecosystems;
Shared Prosperity;
Equality Of Opportunity;
Equity;
Inclusion;
Business And Government;
Business ＆ Government Relations;
Business And Government Relations;
Business And Society;
Neighborhoods;
Race And Ethnicity;
Innovation ＆ Entrepreneurship;
Diversity;
Ethnicity;
Race;
Household;
Income;
Economic Growth;
Economic Sectors;
Economics;
Local Range;
Urban Development;
Urban Scope;
City;
Cross-Cultural and Cross-Border Issues;
Government and Politics;
Government Administration;
Growth and Development;
History;
Leadership;
Goals and Objectives;
Philanthropy and Charitable Giving;
Society;
Civil Society or Community;
Culture;
Human Needs;
Public Opinion;
Public Sector;
Social Issues;
Poverty;
Equality and Inequality;
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;
United States;
Pittsburgh;
Pennsylvania
- March 2022 (Revised July 2022)
- Case
Nexleaf Analytics: Saving the World Using the Internet of Things
By: Frank Nagle
In 2019, a decade after co-founding Nexleaf Analytics, CEO Nithya Ramanathan faced an important decision that would impact the ability of the small, but growing, not-for-profit organization to thrive for another decade. Their sensor technologies and big data analytics...
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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
- November 2021
- Case
Kermit PPI
By: Kyle Myers, Matt Grennan and Sarah Mehta
Launched in 2011, Kermit PPI helped hospitals save money on expensive orthopedic implants and devices by enabling them to renegotiate their contracts with device manufacturers and better monitor compliance. In 2021, as they look to grow, they are entertaining two...
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Keywords:
Health;
Health Care and Treatment;
Strategy;
Expansion;
Information Technology;
Applications and Software;
Supply Chain;
Supply Chain Management;
Contracts;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States;
Maryland
- July–August 2021
- Article
Lowering the Bar? External Conditions, Opportunity Costs, and High-Tech Startup Outcomes
By: Annamaria Conti and Maria P. Roche
We assess the heterogeneous impact of economic downturns on individuals’ decisions to bring high-technology ideas to the market in the form of new ventures. We thereby examine how worsening labor market conditions influence individuals’ opportunity costs of starting...
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- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern...
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