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Publications

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      • Faculty Publications  (154)

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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...  View Details
      Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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      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
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      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 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,...  View Details
      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
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      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),...  View Details
      Keywords: Technological Innovation; Business Growth and Maturation; Growth and Development Strategy; Corporate Social Responsibility and Impact; Decision Making; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
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      Stern, Ariel D., Alpana Thapar, and Menna Hassan. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Teaching Note 623-034, November 2022.
      • 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...  View Details
      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
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      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 November 2022.)
      • 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...  View Details
      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
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      Herzlinger, Regina E., and Ben Creo. "Podimetrics: Next Steps for Diabetes Cases." Harvard Business School Case 323-015, October 2022.
      • 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...  View Details
      Keywords: Women's Health; Healthcare; India; Start-up; Telehealth; Digital Platforms; Health Care and Treatment; Customer Focus and Relationships; Business Startups; Health Industry; Asia; South Asia; India
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      Koning, Rembrand, and Kairavi Dey. "Proactive for Her." Harvard Business School Case 723-351, September 2022.
      • 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...  View Details
      Keywords: Amazon; Health Care; Technology; Primary Care; Health Care and Treatment; Information Infrastructure; Technology Industry; Technology Industry; United States
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      Huckman, Robert S., and Bradley Staats. "How Will Amazon Approach U.S. Primary Care?" Harvard Business Review (website) (August 3, 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...  View Details
      Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry
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      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
      • 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...  View Details
      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
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      Israeli, Ayelet. "The DivaCup: Navigating Distribution and Growth." Harvard Business School Teaching Note 523-008, July 2022.
      • 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...  View Details
      Keywords: Artificial Intelligence; Medicine; Health Care and Treatment; Legal Liability; Insurance; Technology Adoption; AI and Machine Learning
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      Stern, Ariel Dora, Avi Goldfarb, Timo Minssen, and W. Nicholson Price II. "AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care." NEJM Catalyst Innovations in Care Delivery 3, no. 4 (April 2022).
      • 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...  View Details
      Keywords: Growth and Development Strategy; Technological Innovation; Partners and Partnerships; Strategic Planning; Health Care and Treatment; Analytics and Data Science; Digital Platforms; Health Industry; Lebanon; United Kingdom; United States
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      Stern, Ariel D., and Alpana Thapar. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Case 622-082, March 2022. (Revised August 2022.)
      • March 2022 (Revised April 2022)
      • Case

      Pittsburgh: A Successful City?

      By: Karen Mills, Caroline Elkins, Vikram Gandhi, Gabriella Elanbeck and Zeke Gillman
      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...  View Details
      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
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      Mills, Karen, Caroline Elkins, Vikram Gandhi, Gabriella Elanbeck, and Zeke Gillman. "Pittsburgh: A Successful City?" Harvard Business School Case 322-080, March 2022. (Revised April 2022.)
      • 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...  View Details
      Keywords: Digital Health; Health Care and Treatment; Technological Innovation
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      Stern, Ariel Dora, 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. "Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation." Lancet Digital Health 4, no. 3 (March 2022): e200–e206.
      • 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...  View Details
      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
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      Nagle, Frank. "Nexleaf Analytics: Saving the World Using the Internet of Things." Harvard Business School Case 722-414, March 2022. (Revised July 2022.)
      • 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...  View Details
      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
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      Hill, Linda A., and Emily Tedards. "Cleveland Clinic Abu Dhabi." Harvard Business School Case 422-058, February 2022.
      • 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...  View Details
      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
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      Hill, Linda A., and Emily Tedards. "Cleveland Clinic Abu Dhabi (Abridged)." Harvard Business School Case 422-056, February 2022.
      • 2 Dec 2021
      • Interview

      How To Make Healthcare Innovation Happen

      By: Regina E. Herzlinger
      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...  View Details
      Keywords: Health Care and Treatment; Innovation and Invention
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      Herzlinger, Regina E. "How To Make Healthcare Innovation Happen." Raise the Line (podcast), Osmosis, December 2, 2021.
      • 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...  View Details
      Keywords: Entrepreneurship; Health Care and Treatment; Investment Return; Mobile and Wireless Technology; Business Model; Growth and Development Strategy; Health Industry; Bangladesh; Asia
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      Chu, Michael. "Praava Health: A New Model for Bangladesh." Harvard Business School Case 322-067, November 2021. (Revised December 2021.)
      • 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...  View Details
      Keywords: Health; Health Care and Treatment; Strategy; Expansion; Information Technology; Applications and Software; Supply Chain; Supply Chain Management; Contracts; Technology Industry; Technology Industry; Technology Industry; United States; Maryland
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      Myers, Kyle, Matt Grennan, and Sarah Mehta. "Kermit PPI." Harvard Business School Case 622-007, November 2021.
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