Publications
Publications
Show Results For
-
All HBS Web
(160)
- Faculty Publications (42)
FDA
→
Page 1 of
42
Results
→
- 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
- 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
- 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
- May 2021 (Revised September 2021)
- 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;
Digital Marketing;
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 Technology;
Communication;
Communication Strategy;
Disruption;
Consumer Behavior;
Online Advertising;
Health Industry;
Technology Industry;
Communications Industry;
United States;
North America;
United Kingdom
- 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
- 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
- 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
- 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
- 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
- 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
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
- 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
- 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
- November 2018 (Revised January 2020)
- Case
JUUL and the Vaping Revolution
By: Michael W. Toffel, John Masko and Sarah Mehta
In the summer of 2018, San Francisco–based electronic cigarette (e-cigarette) maker JUUL Labs, was experiencing exponential growth. Sales of its JUUL e-cigarette had increased by 783% over the preceding year, projected revenues for 2018 topped $940 million, and the...
View Details
Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Advertising;
Online Advertising;
Customers;
Innovation and Invention;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology;
Technology Industry
- 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;
Technology;
Software;
Competitive Strategy;
Product Development;
Commercialization;
Decision Choices and Conditions;
Health Industry;
Medical Devices and Supplies Industry;
Technology Industry;
Israel
- 2020
- Working Paper
Product Recalls and New Product Development: Own Firm Distractions and Competitor Firm Opportunities
By: George P. Ball, Jeffrey T. Macher and Ariel Dora Stern
Product recalls create significant challenges for R&D intensive firms, but simultaneously generate
potentially lucrative opportunities for competitors. Using the U.S. medical device industry as an empirical setting, we develop predictions and provide evidence that own...
View Details
- 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
- 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
- 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
- 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
- December 2014 (Revised August 2015)
- Case
Improving Melanoma Screening: MELA Sciences
By: Regina E. Herzlinger, Kevin Schulman and Frédéric Dijols
MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and...
View Details