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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

Research Summary

FDA Review Time of New Drug Applications

Study of FDA Review Time of New Drug Applications (NDAs) between 1990-2004. Three main questions are addressed: How the optimal innovation strategy for firms is contingent upon firm status positions in the knowledge domain; how knowledge status both enables and... View Details

2007
Book

Perspectives on Risk and Regulation: The FDA at 100

By: Arthur A. Daemmrich and Joanna Radin

Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific... View Details

Keywords: Private Sector; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Business and Government Relations; Risk and Uncertainty; Cooperation

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February 1996
Background Note

Note on the FDA Review Process for Medical Devices

Describes the FDA's classification scheme for the three classes of medical devices and the review processes. View Details

Keywords: Business and Government Relations; Medical Devices and Supplies Industry; Public Administration Industry; United States

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

September 2022
Article

Find and Replace: R&D Investment Following the Erosion of Existing Products

By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor

How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first... View Details

Keywords: R＆D Investments; Drug Development; Product Shocks; M＆A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry

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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

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

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

10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

innovator. By contrast, previous research by Harvard's David Carpenter and others found that first movers in new chemical drug categories typically receives the fastest FDA approval, with every follow-on drug in the same category taking... View Details

Keywords: by Michael Blanding; Health; Technology

November 1991
Case

Monsanto's March into Biotechnology (B)

By: Dorothy A. Leonard

Monsanto has yet to receive FDA approval for BST, a growth hormone for cows. Anti-BST groups have successfully lobbied Wisconsin and Minnesota, major milk producing states, to ban milk from BST-injected cows; the FDA has charged Monsanto with improperly promoting BST... View Details

Keywords: Animal-Based Agribusiness; Safety; Food; Governing Rules, Regulations, and Reforms; Law Enforcement; Conflict and Resolution; Research and Development; Technology; Agriculture and Agribusiness Industry; Biotechnology Industry; Minnesota; Wisconsin

June 2023 (Revised July 2024)
Case

Biogen and the Aduhelm Melee

By: Amitabh Chandra and Lauren Gunasti

Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.

This... View Details

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

November 2006 (Revised May 2025)
Case

Eli Lilly: Developing Cymbalta

By: Elie Ofek and Ron Laufer

Anticipating the expiration of its Prozac patent, Eli Lilly has to make tough decisions regarding the development of its next-generation antidepressant drug. In particular, the company needs to decide whether to first establish that once-a-day dosing for Cymbalta... View Details

Keywords: Decision Choices and Conditions; Marketing Strategy; Product Launch; Product Development; Research and Development; Pharmaceutical Industry

February 2025
Case

Abiomed: A Change of Heart

By: Satish Tadikonda, Faith Robertson and William Marks

After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details

Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States

March 2008
Case

The Multiple Sclerosis Center of Atlanta

By: Regina E. Herzlinger and Alfred Martin

The Multiple Sclerosis Center of Atlanta wishes to expand beyond Georgia. The factors influencing this decision are discussed, including drug treatments currently available, and the impact of future drugs in the FDA pipeline as well as financing issues. View Details

Keywords: Decision Choices and Conditions; Financing and Loans; Health Care and Treatment; Health Disorders; Medical Specialties; Expansion; Health Industry; Atlanta

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August 2001
Case

Scios, Inc.

By: Regina E. Herzlinger

Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process. View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Cost Management; Cost vs Benefits; Social Issues; Pharmaceutical Industry; United States

January 2007 (Revised January 2007)
Background Note

Note on the U.S. Food and Drug Administration

By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller

Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure. View Details

Keywords: Health; Governance Compliance; Policy; Product Development; Government and Politics; Pharmaceutical Industry; Medical Devices and Supplies Industry; Biotechnology Industry; Public Administration Industry; United States

August 1995 (Revised June 1997)
Case

Hillcrest Research Associates, Inc.

Hillcrest designs and administers testing procedures for drugs to determine whether they pass FDA specifications. As the company grows, it encounters problems with information technology and with the clinical research associates, who feel pressured to report more... View Details

Keywords: Growth Management; Information Technology; Health Testing and Trials; Pharmaceutical Industry

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November 2009 (Revised December 2009)
Case

GTC Biotherapeutics: Developing Medicines in the Milk of Goats

By: Ray A. Goldberg and Sarah Morton

GTC is the first company in the animal world to receive FDA approval of a transgenic pharmaceutical. What are the implications for other firms in plants and animals and their opportunities to produce new medicines in an economical and safe fashion? View Details

Keywords: Health Care and Treatment; Animal-Based Agribusiness; Plant-Based Agribusiness; Science-Based Business; Medical Specialties; Product; Technological Innovation; Health Industry; Pharmaceutical Industry; United States

24 Sep 2007
Research & Ideas

The FDA: What Will the Next 100 Years Bring?

(coauthored with Joanna Radin), Perspectives on Risk and Regulation: The FDA at 100, has just been released. The book collects views on the work and challenges of the agency from FDA officials past and... View Details

Keywords: by Sean Silverthorne; Biotechnology; Consumer Products; Food & Beverage; Health

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