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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
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
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).
- 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
Daemmrich, Arthur A., and Joanna Radin, eds. Perspectives on Risk and Regulation: The FDA at 100. Chemical Heritage Foundation, 2007. (Fulltext.)
- 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
Teisberg, Elizabeth O., and James Leonard. "Note on the FDA Review Process for Medical Devices." Harvard Business School Background Note 796-063, February 1996.
- 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
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).
- 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
Krieger, Joshua L., Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Management Science 68, no. 9 (September 2022): 6552–6571.
- 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
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
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.)
- 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
Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 2019.)
- 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
- November 1991
- Case
Monsanto's March into Biotechnology (B)
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
Leonard, Dorothy A. "Monsanto's March into Biotechnology (B)." Harvard Business School Case 692-066, November 1991.
- 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
This... View Details
Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
- November 2006 (Revised July 2008)
- 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
Ofek, Elie, and Ron Laufer. "Eli Lilly: Developing Cymbalta." Harvard Business School Case 507-044, November 2006. (Revised July 2008.)
- 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
Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)
- August 2001
- Case
Scios, Inc.
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
- 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
Barnes, Louis B. "Hillcrest Research Associates, Inc." Harvard Business School Case 496-021, August 1995. (Revised June 1997.)
- 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
Herzlinger, Regina E., and Alfred Martin. "The Multiple Sclerosis Center of Atlanta." Harvard Business School Case 308-085, March 2008.
- 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
Goldberg, Ray A., and Sarah Morton. "GTC Biotherapeutics: Developing Medicines in the Milk of Goats." Harvard Business School Case 910-403, November 2009. (Revised December 2009.)
- 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
- 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
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.