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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 startups and established medtech firms. It examines how to structure a firm to maximize financial returns. Medtech entrepreneur Duke Rohlen is proposing a new model for innovation and business growth. From 2007 to 2019,...
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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 November 2022)
- 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
- Case
Proactive for Her
By: Rembrand Koning and Kairavi Dey
Proactive for Her began amid the COVID-19 pandemic, in August 2020 as a digital platform to provide accessible, evidence-based, primary, preventive non-judgmental healthcare services for Indian women, who were often dissuaded from seeking help as premarital sex and...
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- August 3, 2022
- Article
How Will Amazon Approach U.S. Primary Care?
By: Robert S. Huckman and Bradley Staats
Amazon has a playbook for reinventing businesses that it enters. It includes simplifying processes, experimenting to determine which new approaches work best, and continuously recombining its existing assets to come up with a better way to do things. It is likely to...
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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
- April 2022
- Article
AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care
By: Ariel Dora Stern, Avi Goldfarb, Timo Minssen and W. Nicholson Price II
Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those...
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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 2022)
- 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
- Article
Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation
By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can...
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- 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
- February 2022
- Case
Cleveland Clinic Abu Dhabi
By: Linda A. Hill and Emily Tedards
In 2006, the Cleveland Clinic and Mubadala Investment Company partnered with a bold ambition to deliver world class healthcare in the United Arab Emirates. In 2015, after nearly a decade of planning and construction, Cleveland Clinic Abu Dhabi opened its doors. By...
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Keywords:
Organizational Behavior;
Culture;
Alignment;
Organizational Effectiveness;
Purpose;
Impact;
Leadership Development;
Diversity;
Collaboration;
Co-creation;
Learning Organizations;
Empowerment;
Teams;
Team Dynamics;
Teamwork;
Team Effectiveness;
Trust;
Talent;
Talent Development And Retention;
Psychological Safety;
Organizational Evolution;
Coaching;
Board;
Analytics;
Innovation;
Data;
Data Visualization;
Digital Technology;
Digital;
Customer Experience;
Experimentation;
Change Management;
Data-driven Decision-making;
Debates;
Ecosystem;
Partnership;
Telemedicine;
Sustainability;
Global Organizations;
Local;
Hospital;
Healthcare;
United Arab Emirates;
Health Care and Treatment;
Partners and Partnerships;
Globalization;
Quality;
Organizational Culture;
Mission and Purpose;
Innovation and Management;
Information Technology;
Joint Ventures;
Leadership;
Performance Effectiveness;
Abu Dhabi;
United Arab Emirates
- February 2022
- Case
Cleveland Clinic Abu Dhabi (Abridged)
By: Linda A. Hill and Emily Tedards
In 2006, the Cleveland Clinic and Mubadala Investment Company partnered with a bold ambition to deliver world class healthcare in the United Arab Emirates. In 2015, after nearly a decade of planning and construction, Cleveland Clinic Abu Dhabi opened its doors. By...
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Keywords:
Organization Behavior;
Culture;
Alignment;
Organizational Effectiveness;
Purpose;
Impact;
Leadership Development;
Diversity;
Collaboration;
Co-creation;
Learning Organizations;
Empowerment;
Teams;
Team Dynamics;
Teamwork;
Team Effectiveness;
Trust;
Talent;
Talent Development And Retention;
Psychological Safety;
Organizational Evolution;
Coaching;
Board;
Analytics;
Innovation;
Data;
Data Visualization;
Digital Technology;
Digital;
Customer Experience;
Experimentation;
Change Management;
Data-driven Decision-making;
Debates;
Ecosystem;
Partnership;
Telemedicine;
Sustainability;
Global Organizations;
Local;
Hospital;
Healthcare;
United Arab Emirates;
Health Care and Treatment;
Partners and Partnerships;
Globalization;
Quality;
Organizational Culture;
Mission and Purpose;
Innovation and Management;
Information Technology;
Joint Ventures;
Leadership;
Performance Effectiveness;
Abu Dhabi;
United Arab Emirates
- 2 Dec 2021
- Interview
How To Make Healthcare Innovation Happen
Regina Herzlinger has been called “the godmother of consumer-driven healthcare” because of her groundbreaking scholarly articles and books on the subject. As a professor of business administration at Harvard Business School for nearly 50 years, her focus has supported...
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- November 2021 (Revised December 2021)
- Case
Praava Health: A New Model for Bangladesh
By: Michael Chu
Launched in Dhaka, Bangladesh, in 2018, Praava Health (‘Praava’) delivered high-quality in-clinic primary and specialist care, backed by its own high quality diagnostic laboratories, imaging and pharmacy. Praava was founder Sylvana Sinha’s response to what she saw as a...
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- 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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