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      • Faculty Publications  (207)

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      • 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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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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...  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; Medical Devices and Supplies Industry; Medical Devices and Supplies 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
      • 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...  View Details
      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
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      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...  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.
      • 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...  View Details
      Keywords: Growth; Customer Experience; Customer Focused Organization; Innovation; DTC; Growth Management; Expansion; Entrepreneurship; Customer Focus and Relationships; Innovation and Invention; Growth and Development Strategy; Medical Devices and Supplies Industry; United States
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      Groysberg, Boris, Katherine Connolly Baden, and Julia Kelley. "Byte." Harvard Business School Case 422-075, May 2022.
      • 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....  View Details
      Keywords: Product Liability; Innovation; Tort; Medical Devices; Vertical Foreclosure; Product; Innovation and Invention; Legal Liability; Laws and Statutes; Medical Devices and Supplies Industry
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      Galasso, Alberto, and Hong Luo. "When Does Product Liability Risk Chill Innovation? Evidence from Medical Implants." American Economic Journal: Economic Policy 14, no. 2 (May 2022): 366–401.
      • 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...  View Details
      Keywords: Women's Health; Healthcare Access; Workplace Design; Military Health System; Occupational Health; Medical Equipment & Devices; Employees; Gender; Personal Development and Career
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      Kaplan, Robert S., Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator, and Michael D. Parkinson. "A Career Life-Cycle Perspective on Women's Health and Safety." Journal of Occupational and Environmental Medicine 64, no. 4 (April 2022): 267–270.
      • 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.)
      • 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.)
      • 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; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies 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.
      • 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...  View Details
      Keywords: Necessity Entrepreneurship; Economic Conditions; Recessions; High-tech Startups; Opportunity Costs; Entrepreneurship; Economic Slowdown and Stagnation; Business Startups; Information Technology; Performance; Labor
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      Conti, Annamaria, and Maria P. Roche. "Lowering the Bar? External Conditions, Opportunity Costs, and High-Tech Startup Outcomes." Organization Science 32, no. 4 (July–August 2021): 965–986.
      • 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...  View Details
      Keywords: Wearables; Regulatory Changes; Medical Technology; Medical Devices; Market Access; Market Entry and Exit; Information Technology; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States; Germany; Belgium
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      Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Sensors 21, no. 14 (July 2021).
      • May 2021
      • Article

      Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices

      By: Alberto Galasso and Hong Luo
      We study the impact of consumers’ risk perception on firm innovation. Our analysis exploits a major surge in the perceived risk of radiation diagnostic devices following extensive media coverage of a set of over-radiation accidents involving CT scanners in late 2009....  View Details
      Keywords: Risk Perception; Innovation; Medical Devices; Liability Risk; Risk and Uncertainty; Perception; Technological Innovation
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      Galasso, Alberto, and Hong Luo. "Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices." Management Science 67, no. 5 (May 2021): 3022–3040.
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