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      Medical Device Startup Remove Medical Device Startup →

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      • 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; Growth Management; Expansion; Entrepreneurship; Customer Focus and Relationships; Innovation and Invention; 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
      • 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 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.
      • 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
      • 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.
      • 2022
      • Book

      Corporate Explorer: How Corporations Beat Startups at the Innovation Game

      By: Andrew Binns, Charles A. O'Reilly III and Michael Tushman
      Innovation used to be seen as a game best left to entrepreneurs, but now a new breed of corporate managers is flipping this logic on its head. These Corporate Explorers have the insight, resilience, and discipline to overcome the obstacles and build new ventures from...  View Details
      Keywords: Organization Change And Adaptation; Disruptive Innovation; Organizational Change and Adaptation; Innovation and Management; Leading Change
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      Binns, Andrew, Charles A. O'Reilly III, and Michael Tushman. Corporate Explorer: How Corporations Beat Startups at the Innovation Game. Hoboken, NJ: Wiley, 2022.
      • January 2022
      • Supplement

      Somatus: Value-Based Kidney Care (B)

      By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
      Set in early 2020, this (B) case provides an update to the (A) case (no. 622-009) and provides additional context regarding the challenges facing Somatus.  View Details
      Keywords: Business Startups; Disruption; Entrepreneurship; Health; Health Care and Treatment; Health Disorders; Medical Specialties; Innovation and Invention; Disruptive Innovation; Management; Strategy; Business Strategy; Value; Value Creation; Health Industry; United States; Virginia
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      Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (B)." Harvard Business School Supplement 622-045, January 2022.
      • January 2022
      • Case

      Somatus: Value-Based Kidney Care (A)

      By: Ariel D. Stern, Robert S. Huckman and Sarah Mehta
      When Dr. Ikenna Okezie founded Somatus, a value-based kidney care provider, his goal had been nothing short of transforming kidney care delivery in the United States. Rather than relying on dialysis, a costly and intensive treatment for late-stage kidney disease, the...  View Details
      Keywords: Business Startups; Disruption; Entrepreneurship; Health; Health Care and Treatment; Health Disorders; Medical Specialties; Innovation and Invention; Disruptive Innovation; Management; Strategy; Business Strategy; Value; Value Creation; Health Industry; United States; Virginia
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      Stern, Ariel D., Robert S. Huckman, and Sarah Mehta. "Somatus: Value-Based Kidney Care (A)." Harvard Business School Case 622-009, January 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.
      • August 2021
      • Case

      Livongo: Scaling a Purpose-Driven Organization in Healthcare

      By: Ranjay Gulati, Aseem Shukla and Reva Nohria
      When seasoned entrepreneur Glen Tullman founded the chronic health care startup Livongo in 2014, it was personal. His son lived with diabetes, and Tullman knew firsthand how taxing it could be to manage such an unrelenting disease. Livongo set out to empower people...  View Details
      Keywords: Healthcare Industry; Scaling; Telehealth; Health Care and Treatment; Small Business; Internet and the Web; Customer Focus and Relationships; Growth and Development Strategy; Opportunities; Mergers and Acquisitions; Health Industry
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      Gulati, Ranjay, Aseem Shukla, and Reva Nohria. "Livongo: Scaling a Purpose-Driven Organization in Healthcare." Harvard Business School Case 422-017, August 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
      • Case

      Inclusive Innovation at Mass General Brigham

      By: Katherine Baldiga Coffman and Olivia Hull
      Massachusetts General Brigham (MGB) Chief Innovation Officer Christopher Coburn had overseen a period of exciting transformation and growth in healthcare innovation at MGB. In November 2019, the health system was the largest recipient of National Institutes of Health...  View Details
      Keywords: Inclusion; Innovation; Invention; Gender; Business Startups; Investment Funds; Private Equity; Health Care and Treatment; Innovation Strategy; Technological Innovation; Intellectual Property; Copyright; Patents; Research; Research and Development; Diversification; Technology; Health Industry; Massachusetts; Boston
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      Coffman, Katherine Baldiga, and Olivia Hull. "Inclusive Innovation at Mass General Brigham." Harvard Business School Case 921-006, May 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.
      • March 2021
      • Case

      VideaHealth: Building the AI Factory

      By: Karim R. Lakhani and Amy Klopfenstein
      Florian Hillen, co-founder and CEO of VideaHealth, a startup that used artificial intelligence (AI) to detect dental conditions on x-rays, spent the early years of his company laying the groundwork for an AI factory. A process for quickly building and iterating on new...  View Details
      Keywords: Artificial Intelligence; Innovation and Invention; Disruptive Innovation; Technological Innovation; Information Technology; Applications and Software; Technology Adoption; Digital Platforms; Entrepreneurship; AI and Machine Learning; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; North and Central America; United States; Massachusetts; Cambridge
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      Lakhani, Karim R., and Amy Klopfenstein. "VideaHealth: Building the AI Factory." Harvard Business School Case 621-021, March 2021.
      • February 2021 (Revised March 2022)
      • Case

      Marvin: A Personalized Telehealth Approach to Mental Health

      By: Regina E. Herzlinger, Eshani Sharma, Andrew Nguyen, Thomas Arsenault, Carin-Isabel Knoop and Julia Kelley
      More than one third of Americans were said to suffer some type of behavioral health ailment at some point in their lifetime, with many people requiring chronic therapy or intervention. Despite significant clinical needs, access to reliable treatment has been difficult...  View Details
      Keywords: Mental Health; Applications; Startup Management; Telehealth; Health Care Entrepreneurship; Health & Wellness; Health Care; Health Care and Treatment; Customization and Personalization; Internet and the Web; Entrepreneurship; Growth and Development Strategy; Applications and Software
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      Herzlinger, Regina E., Eshani Sharma, Andrew Nguyen, Thomas Arsenault, Carin-Isabel Knoop, and Julia Kelley. "Marvin: A Personalized Telehealth Approach to Mental Health." Harvard Business School Case 321-127, February 2021. (Revised March 2022.)
      • January–February 2021
      • Article

      Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

      By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
      As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...  View Details
      Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards
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      Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
      • January 2021
      • Article

      Veil-of-Ignorance Reasoning Mitigates Self-Serving Bias in Resource Allocation During the COVID-19 Crisis

      By: Karen Huang, Regan Bernhard, Netta Barak-Corren, Max Bazerman and Joshua D. Greene
      The COVID-19 crisis has forced healthcare professionals to make tragic decisions concerning which patients to save. Furthermore, the COVID-19 crisis has foregrounded the influence of self-serving bias in debates on how to allocate scarce resources. A utilitarian...  View Details
      Keywords: Self-serving Bias; Procedural Justice; Bioethics; COVID-19; Fairness; Health Pandemics; Resource Allocation; Decision Making
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      Huang, Karen, Regan Bernhard, Netta Barak-Corren, Max Bazerman, and Joshua D. Greene. "Veil-of-Ignorance Reasoning Mitigates Self-Serving Bias in Resource Allocation During the COVID-19 Crisis." Judgment and Decision Making 16, no. 1 (January 2021): 1–19.
      • November 2020 (Revised January 2021)
      • Case

      Zipline: The World's Largest Drone Delivery Network

      By: Tarun Khanna and George Gonzalez
      Zipline established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones. The company is now looking to expand in the U.S. and partnered with Walmart to expand into home delivery. Zipline must...  View Details
      Keywords: Drones; Business Startups; Expansion; Growth and Development Strategy; Governing Rules, Regulations, and Reforms; United States; Africa
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      Khanna, Tarun, and George Gonzalez. "Zipline: The World's Largest Drone Delivery Network." Harvard Business School Case 721-366, November 2020. (Revised January 2021.)
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