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Publications

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      • Faculty Publications  (198)

      Medical Devices and Supplies Industry Remove Medical Devices and Supplies Industry →

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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.
      • 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; Manufacturing Industry; Manufacturing Industry; Manufacturing Industry; Manufacturing Industry; Manufacturing 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; Health Industry; Health Industry; Health Industry; Health 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.
      • 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; Health Industry; Health Industry; Health 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.
      • 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; Technology Industry; Technology 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.
      • August 2020 (Revised January 2022)
      • Case

      1928 Diagnostics: Fighting Antibiotics Resistance

      By: Ariel D. Stern and Daniela Beyersdorfer
      In 2019, the co-founders of the Swedish medical start-up 1928 Diagnostics, CEO Dr. Kristina Lagerstedt and COO Dr. Susanne Staaf, had to pick the right business model to commercialize their novel technology to hospitals and health care providers. Developed in...  View Details
      Keywords: Health Care and Treatment; Entrepreneurship; Leadership; Science-Based Business; Growth and Development Strategy; Business Growth and Maturation; Business Model; Information Technology; Digital Platforms; Health Disorders; Market Entry and Exit; Value Creation; Business and Stakeholder Relations; Health Industry; Health Industry; Health Industry; Europe; Sweden
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      Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020. (Revised January 2022.)
      • May 2020 (Revised March 2022)
      • Case

      The Coronavirus (COVID-19) Pandemic and the Global Economy (A)

      By: Alberto Cavallo and Christian Godwin
      In April 2020, the world struggled to contain the exponential escalation of the coronavirus (COVID-19) pandemic. Dozens of countries had imposed restrictions on travel, work, and social gatherings. A large share of the global population was under lockdowns and...  View Details
      Keywords: COVID-19 Pandemic; Demand and Consumers; Supply and Industry; Finance; Central Banking; Financial Markets; International Finance; Globalization; Government and Politics; Health Pandemics; Decision Making; Macroeconomics; Employment; Crisis Management; Supply Chain; Risk and Uncertainty; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Air Transportation Industry; Asia; China; Europe; Latin America; Africa; United States
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      Cavallo, Alberto, and Christian Godwin. "The Coronavirus (COVID-19) Pandemic and the Global Economy (A)." Harvard Business School Case 720-031, May 2020. (Revised March 2022.)
      • March 2020
      • Case

      EyeControl: Inspiring Communication

      By: Paul A. Gompers and Danielle Golan
      Eye-controlled communication device startup EyeControl was founded in Tel Aviv, Israel in 2016 by cofounders with a shared personal connection to locked-in syndrome—a neurological disorder that left sufferers cognitively sound, yet paralyzed, with the exception of eye...  View Details
      Keywords: Health Disorders; Communication Technology; Business Startups; Expansion; Finance; Decision Making; Social Enterprise; Medical Devices and Supplies Industry
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      Gompers, Paul A., and Danielle Golan. "EyeControl: Inspiring Communication." Harvard Business School Case 820-078, March 2020.
      • February 2020
      • Teaching Note

      Theranos: Who Has Blood on Their Hands? (A) and (B)

      By: Nien-he Hsieh and Christina R. Wing
      Teaching Note for HBS Nos. 619-039 and 320-091.  View Details
      Keywords: Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Lawsuits and Litigation; Medical Devices and Supplies Industry; California; United States
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      Hsieh, Nien-he, and Christina R. Wing. "Theranos: Who Has Blood on Their Hands? (A) and (B)." Harvard Business School Teaching Note 620-102, February 2020.
      • February 2020
      • Supplement

      Theranos: Who Has Blood on Their Hands? (B)

      By: Nien-he Hsieh, Christina R. Wing and John Masko
      This supplemental case tracks the results of the Colman and Taubman-Dye class action suit against Theranos as well as Theranos’ other legal challenges and chronicles the final demise of the company in 2019.  View Details
      Keywords: Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Lawsuits and Litigation; Business Exit or Shutdown; Medical Devices and Supplies Industry; California; United States
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      Hsieh, Nien-he, Christina R. Wing, and John Masko. "Theranos: Who Has Blood on Their Hands? (B)." Harvard Business School Supplement 320-091, February 2020.
      • January 2020 (Revised March 2020)
      • Case

      SmileDirectClub: Better Is Better

      By: Leonard A. Schlesinger and Aldo Sesia
      Keywords: Direct-to-consumer; Brands and Branding; Strategy; Expansion; Online Technology; Health Industry; Health Industry; Health Industry
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      Schlesinger, Leonard A., and Aldo Sesia. "SmileDirectClub: Better Is Better." Harvard Business School Case 320-016, January 2020. (Revised March 2020.)
      • July 2019
      • Article

      Challenges and Opportunities in Software-Driven Medical Devices

      By: William J. Gordon and Ariel Dora Stern
      The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.  View Details
      Keywords: Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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      Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
      • June 2019
      • Teaching Note

      Zebra Medical Vision

      By: Shane Greenstein and Sarah Gulick
      Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working...  View Details
      Keywords: Business Startups; Science-Based Business; Applications and Software; Patents; Cross-Cultural and Cross-Border Issues; Health Care and Treatment; Health Industry; Health Industry; Health Industry; Israel
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      Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Teaching Note 619-053, June 2019.
      • 2019
      • Working Paper

      Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry

      By: Cirrus Foroughi and Ariel Dora Stern
      Does the large-scale technological change that is characteristic of an industry-wide digital transformation entrench industry leaders or enable the rise of new entrants? We offer a novel approach to this question by studying the medical device industry, a unique...  View Details
      Keywords: Innovation; Medical Devices; Digitization; Medical Technology; Technological Innovation; Applications and Software; Market Entry and Exit; Industry Growth; Medical Devices and Supplies Industry; United States
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      Foroughi, Cirrus, and Ariel Dora Stern. "Who Drives Digital Innovation? Evidence from the U.S. Medical Device Industry." Harvard Business School Working Paper, No. 19-120, June 2019.
      • Article

      Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

      By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
      Objectives:
      To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and...  View Details
      Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry
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      Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
      • April 2019
      • Case

      Barber Cardiosystems

      By: Ranjay Gulati and Paul S. Myers
      Barber Cardiosystems, based in Melbourne, Australia, designs and manufactures therapeutic devices used for treatment of coronary conditions. Over four decades, it has grown to be among the top 200 medical device companies in the world. It competes against much larger...  View Details
      Keywords: Organizational Behavior; Strategic Alignment; Cost Management; Performance Productivity; Organizational Culture; Motivation and Incentives; Organizational Design; Strategy; Leadership; Medical Devices and Supplies Industry; Australia
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      Gulati, Ranjay, and Paul S. Myers. "Barber Cardiosystems." Harvard Business School Brief Case 919-505, April 2019.
      • March 2019 (Revised April 2021)
      • Case

      The DivaCup: Navigating Distribution and Growth

      By: Ayelet Israeli
      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 product. Fifteen years later, the...  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; Retail Industry; Retail Industry; Retail Industry; Retail Industry; Retail Industry; Retail Industry; Retail Industry; Retail Industry; Canada; United States; United Kingdom
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      Israeli, Ayelet. "The DivaCup: Navigating Distribution and Growth." Harvard Business School Case 519-055, March 2019. (Revised April 2021.)
      • February 2019 (Revised September 2019)
      • Case

      Theranos: The Unicorn That Wasn't

      By: Joseph B. Fuller and John Masko
      In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains...  View Details
      Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry
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      Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 2019.)
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