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  • 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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  • 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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  • March 2015 (Revised January 2024)
  • 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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  • 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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  • 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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  • 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; Information Technology
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  • 30 Jun 2022
  • HBS Case

Peloton Changed the Exercise Game. Can the Company Push Through the Pain?

got a lot of levers to pull.” Despite the risk, Dolan believes Peloton does appear to have a future. “It’s not like they’re a high-tech company, wondering if a drug will get FDA approval,” Dolan says. “No surprises are coming down the... View Details
Keywords: by Lane Lambert; Media & Broadcasting; Health; Bicycle
  • 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 and Wireless Technology; Applications and Software; Framework
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  • 28 Mar 2023
  • Research & Ideas

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

and effective in preventing severe disease, and their accelerated review will go down in history as having saved millions of lives. But COVID vaccines weren’t the first medical products to be brought to market through an expedited process. So how do other new therapies... View Details
Keywords: by Kasandra Brabaw; Pharmaceutical
  • 30 Jun 2014
  • Lessons from the Classroom

The Role of Emotions in Effective Negotiations

A Happier Ending In an "alternate ending" to the story, Kate apologizes for how the negotiation has gotten out of control, and asks if they can start over. She shares her own anxieties and frustrations about an important conference call regarding View Details
Keywords: by Michael Blanding; Entertainment & Recreation; Sports
  • 12 Jun 2018
  • Research & Ideas

In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?

creating, at great time and cost, a successful therapy, and then beating long odds to win FDA approval, the rewards can wane as quickly as a patent expires. And most drug candidates wash out long before even making it to market. That... View Details
Keywords: by Rachel Layne; Health; Pharmaceutical
  • Research Summary

Experience and description-based decision making.

Prof. Barron and his co-authors study the effect of the economic environment on decision making. One example involves the effect of rare (low probability) events. People behave as if they overweight these events in some settings (e.g., when buying insurance and... View Details
  • 14 Dec 2020
  • Research & Ideas

What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?

aspects of the drug trial and approval process, including allowing time for potential issues to materialize. When you see an FDA emergency approval for a COVID-19 vaccine, don't interpret this as a normal “FDA approval.” I understand that... View Details
Keywords: by Danielle Kost; Pharmaceutical; Health
  • 21 Aug 2007
  • First Look

First Look: August 21, 2007

http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807074   PublicationsPerspectives on Risk and Regulation: The FDA at 100 Author:Arthur A. Daemmrich Publication:Chemical Heritage Press, 2007 Abstract Perspectives on Risk and... View Details
Keywords: Martha Lagace
  • 23 Mar 2020
  • Research & Ideas

Product Disasters Can Be Fertile Ground for Innovation

submitted to the FDA. Comparing the new patent applications for safety-related features to other features of radiation diagnostic devices, they found an increase of over 100 percent in the five years after the shock relative to before. Comparing View Details
Keywords: by Michael Blanding; Health; Medical Devices & Supplies
  • 09 Apr 2012
  • Research & Ideas

Who Sways the USDA on GMO Approvals?

Other Agencies Influence Approvals In the case of procedural legitimacy, the researchers found a strong influence from an unlikely source—the USDA's sister agency, the Food and Drug Administration. In the process of approving GMOs, companies have the option of... View Details
Keywords: by Michael Blanding; Food & Beverage; Biotechnology; Agriculture & Agribusiness
  • 31 Oct 2004
  • Research & Ideas

Bypass Marketing: Are Docs Influenced?

directly to consumers as we have come to know it was first advocated by the pharmaceutical industry in 1981. In 1983, the FDA requested a voluntary moratorium on such advertising in order to study its likely effects. The View Details
Keywords: by Manda Salls
  • 07 Aug 2000
  • Research & Ideas

The Business of Biotech

are fundamental to biotech's success.—Gail Maderis Time—a precious asset in any industry—has special value in biotech, particularly since the multiphase FDA approval process can add years to a drug's development. "My biggest source... View Details
Keywords: by Julia Hanna; Biotechnology; Health; Technology
  • 29 May 2001
  • Research & Ideas

Genomics: Can We Start Making Money Now?

about genes. Human trials, for example, could involve specially targeted participants who are most likely to benefit or have adverse effects from a potential drug. The question is, said Lilly's Lechleiter: will the FDA accept that... View Details
Keywords: by Sean Silverthorne
  • 15 Jun 2016
  • Research & Ideas

These VC Partners May Make Your Firm Less Innovative

same VCs. Finally, they determined how “innovative” each company was, based on the number of new products they introduced that were approved by the FDA (averaging one product every two years). The data showed that companies tied to a... View Details
Keywords: by Michael Blanding; Financial Services; Banking

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