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      • Faculty Publications  (42)

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      • 2022
      • Article

      Missing Novelty in Drug Development

      By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
      We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to...  View Details
      Keywords: Drug Development; Risk Aversion; Research and Development; Innovation and Invention; Investment; Pharmaceutical Industry
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      Krieger, Joshua, Danielle Li, and Dimitris Papanikolaou. "Missing Novelty in Drug Development." Review of Financial Studies 35, no. 2 (February 2022): 636–679.
      • 2021
      • Working Paper

      Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances

      By: Amar Bhide and Srikant M. Datar
      By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the...  View Details
      Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms
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      Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-132, June 2021.
      • 2021
      • Working Paper

      Regulatory Approval and Expanded Market Size

      By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
      Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...  View Details
      Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
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      Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
      • Article

      Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials

      By: Caroline Marra, William J. Gordon and Ariel Dora Stern
      Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...  View Details
      Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Technology
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      Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
      • May 2021 (Revised March 2022)
      • Case

      Headspace vs. Calm: A Mindful Competition

      By: Ayelet Israeli and Anne Wilson
      By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable...  View Details
      Keywords: Marketing Communication; Integrated Strategy; Brand; Brand & Product Management; Brand Communication; Brand Differentiation; Brand Building; Brand Management; E-commerce; E-Commerce Strategy; Ecommerce; App; App Development; Applications; COVID; COVID-19; Pandemic; Pricing; Pricing Strategy; Subscription Model; Subscription; Partnerships; Strategic Partnerships; B2B Vs. B2C; B2B; Health & Wellness; Wellbeing; Digitization; Commoditization; Mobile App; Mobile App Industry; Mobile Healthcare; Mobile Marketing; Digital Brand; Digital Health; Consumer Health; Apps; Online Business; Online Competition; Online Community; Online Entertainment; Entertainment And Leisure; Meditation; Marketing; Marketing Communications; Brands and Branding; Price; Strategy; Competition; Competitive Strategy; Competitive Advantage; Partners and Partnerships; Health; Well-being; Mobile and Wireless Technology; Communication; Communication Strategy; Disruption; Consumer Behavior; Digital Marketing; Health Industry; Technology Industry; Communications Industry; United States; North America; United Kingdom
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      Israeli, Ayelet, and Anne Wilson. "Headspace vs. Calm: A Mindful Competition." Harvard Business School Case 521-102, May 2021. (Revised March 2022.)
      • 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.
      • 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).
      • Article

      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

      By: Noy Alon, Ariel Dora Stern and John Torous
      BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...  View Details
      Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile Technology; Software; Framework
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      Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
      • April 2020
      • Article

      Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

      By: Ariel Dora Stern and W. Nicholson Price, II
      In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...  View Details
      Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms
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      Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
      • 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; Medical Devices and Supplies Industry; Technology Industry; Israel
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      Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Teaching Note 619-053, 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).
      • 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.)
      • November 2018
      • Case

      David Hysong and SHEPHERD Therapeutics

      By: Ananth Raman, John Masko and Aldo Sesia
      In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...  View Details
      Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges
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      Raman, Ananth, John Masko, and Aldo Sesia. "David Hysong and SHEPHERD Therapeutics." Harvard Business School Case 619-012, November 2018.
      • September 2018 (Revised December 2019)
      • Case

      Zebra Medical Vision

      By: Shane Greenstein and Sarah Gulick
      An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making...  View Details
      Keywords: Radiology; Machine Learning; X-ray; CT Scan; Medical Technology; Probability; FDA 510(k); Diagnosis; Business Startups; Health Care and Treatment; Information Technology; Applications and Software; Competitive Strategy; Product Development; Commercialization; Decision Choices and Conditions; Health Industry; Medical Devices and Supplies Industry; Technology Industry; Israel
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      Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Case 619-014, September 2018. (Revised December 2019.)
      • 2022
      • Working Paper

      Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions

      By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern
      Medical device firms operate at the frontiers of innovation. When functioning properly, innovative medical devices can prolong and improve lives; when malfunctioning, the same devices may harm patients and lead to product recalls. Product recalls create significant...  View Details
      Keywords: New Product Development; Recalls; Product Failures; Medical Devices; FDA; Health Care; Product Development; Product; Failure; Competition; Opportunities; Medical Devices and Supplies Industry
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      Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern. "Responding Strategically to Competitors' Failures: Evidence from Medical Device Recalls & New Product Submissions." Harvard Business School Working Paper, No. 19-028, September 2018. (Revised March 2022.)
      • August 2017 (Revised July 2018)
      • Case

      MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work

      By: Elie Ofek and Amanda Dai
      In June 2014, MannKind Corporation announced that after years of development and billions of dollars in expenses, the FDA had finally approved its drug, Afrezza. MannKind would thus be the only company with an inhalable insulin on the market. As an alternative to...  View Details
      Keywords: Health Care and Treatment; Product Launch; Product Positioning; Marketing Strategy; Adoption; Pharmaceutical Industry
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      Ofek, Elie, and Amanda Dai. "MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work." Harvard Business School Case 518-031, August 2017. (Revised July 2018.)
      • April 2017
      • Case

      Imprimis (A)

      By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
      This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in...  View Details
      Keywords: Strategy; Healthcare; Drug Compounding; Pharmaceuticals; Compounding; Drug Development; Decision-making; Mark Baum; Imprimis; Small Business; Decisions; Cost vs Benefits; Business Strategy; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; United States
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      Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (A)." Harvard Business School Case 717-426, April 2017.
      • May 2016 (Revised March 2020)
      • Teaching Note

      Cyberdyne: A Leap to the Future

      By: Doug J. Chung and Mayuka Yamazaki
      Cyberdyne Inc. was a Japanese technology venture founded in 2004 by scientist Yoshiyuki Sankai to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from...  View Details
      Keywords: Health Disorders; Technological Innovation; Marketing Strategy; Decisions; Product Launch; Medical Devices and Supplies Industry
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      Chung, Doug J., and Mayuka Yamazaki. "Cyberdyne: A Leap to the Future." Harvard Business School Teaching Note 516-114, May 2016. (Revised March 2020.)
      • January 2016 (Revised July 2018)
      • Case

      Cyberdyne: A Leap to the Future

      By: Doug J. Chung and Mayuka Yamazaki
      Cyberdyne Inc. was a Japanese technology venture that wanted to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from stroke, spinal cord injury (SCI),...  View Details
      Keywords: Go-to-market Strategy; Pricing; Sales Channel; Technological Innovation; Marketing; Sales; Distribution; Strategy; Medical Devices and Supplies Industry
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      Chung, Doug J., and Mayuka Yamazaki. "Cyberdyne: A Leap to the Future." Harvard Business School Case 516-072, January 2016. (Revised July 2018.)
      • March 2015 (Revised February 2022)
      • Case

      CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

      By: Regina E. Herzlinger and Andrew Otazo
      Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire...  View Details
      Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
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      Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised February 2022.)
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