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FDA →
- 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...
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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...
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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.)
- 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...
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Keywords:
Health Care and Treatment;
Product Launch;
Product Positioning;
Marketing Strategy;
Adoption;
Pharmaceutical Industry
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...
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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
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (A)." Harvard Business School Case 717-426, April 2017.
- 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...
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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
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 January 2024.)
- 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...
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- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was...
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Keywords:
Public Health;
Genome Testing;
Health Care;
Ancestry;
23andMe;
Marketing;
Product Launch;
Health;
Health Care and Treatment;
Health Testing and Trials;
Genetics;
Strategy;
Health Industry;
United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- January 2014
- Supplement
Fred Khosravi and AccessClosure (C)
By: Richard Hamermesh and Lauren Barley
On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the...
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Keywords:
Medical Devices;
Vascular Closure Device;
Patent Litigation;
Patenting;
Biomedical Research;
Biotechnology;
Biotech;
Technological Innovation;
Patents;
Health Care and Treatment;
Biotechnology Industry;
United States
Hamermesh, Richard, and Lauren Barley. "Fred Khosravi and AccessClosure (C)." Harvard Business School Supplement 814-074, January 2014.
- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory...
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Keywords:
Models Of Reimbursement;
Personalized Medicine;
Regulation;
Healthcare Reform;
Health Care and Treatment;
Health Industry;
United States
Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)
- August 2012 (Revised December 2023)
- Background Note
Note on Health Insurance Coverage, Coding, and Payment
By: Regina E. Herzlinger and Jo Ellen Slurzberg
This note explains how health care technology and service innovators receive payment from government insurers, in the U.S. and abroad, and from private insurers. It describes each of the three steps needed to obtain reimbursement: coverage, coding, and payment. It also...
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- October 2010 (Revised November 2010)
- Background Note
Plavix: Drugs in the Age of Personalized Medicine
By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon
PIavix, one of the world's best selling drugs in 2010, appears to have a limited future. Its patent was due to expire soon, and recently new data had been discovered that indicated that a small subset of the population would be at risk for stroke, heart attack, or even...
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Keywords:
Health Care and Treatment;
Product Positioning;
Business and Government Relations;
Genetics;
Competitive Strategy;
Pharmaceutical Industry
Hamermesh, Richard G., Mara G. Aspinall, and Rachel Gordon. "Plavix: Drugs in the Age of Personalized Medicine." Harvard Business School Background Note 811-001, October 2010. (Revised November 2010.)
- July 2010
- Case
Metabical: Positioning and Communications Strategy for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Cambridge Sciences Pharmaceuticals (CSP) expects final approval for its revolutionary weight loss drug, Metabical. Metabical will be the only weight loss drug with FDA approval that is also clinically proven to be effective for moderately overweight people. Barbara...
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Keywords:
Product Positioning;
Marketing Communications;
Product Launch;
Consumer Behavior;
Pharmaceutical Industry;
United States
Quelch, John A., and Heather Beckham. "Metabical: Positioning and Communications Strategy for a New Weight Loss Drug." Harvard Business School Brief Case 104-240, July 2010.
- April 2010
- Case
Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Metabical is a new weight loss drug from Cambridge Sciences Pharmaceuticals intended for moderately overweight individuals. In anticipation of final FDA approval, the senior director of marketing, Barbara Printup, prepares for the product launch and must make several...
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Keywords:
Return On Investment;
Forecasting;
Pricing Policies;
Demand Planning;
Marketing Strategy;
Price;
Consumer Behavior;
Investment Return;
Forecasting and Prediction;
Product Launch;
Planning;
Brands and Branding;
Pharmaceutical Industry
Quelch, John A., and Heather Beckham. "Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug." Harvard Business School Brief Case 104-183, April 2010.
- November 2009 (Revised August 2010)
- Case
NovoCure Ltd.
By: William A. Sahlman and Sarah Flaherty
Venture capitalist William Doyle must raise $35 million for a portfolio company with a promising, novel cancer therapy, just as global capital markets are imploding in the fall of 2008. NovoCure, Ltd., has developed an electrical-field-based therapy, called Tumor...
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Keywords:
Financial Crisis;
Entrepreneurship;
Venture Capital;
Investment;
Health Care and Treatment;
Health Testing and Trials;
Technological Innovation;
Financial Services Industry
Sahlman, William A., and Sarah Flaherty. "NovoCure Ltd." Harvard Business School Case 810-045, November 2009. (Revised August 2010.)
- 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?
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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.)
- September 2009 (Revised August 2012)
- Case
Novasys Medical
By: Richard G. Hamermesh and Lauren Barley
Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Policy;
Health Care and Treatment;
Health Disorders;
Product Development;
Business and Government Relations;
Medical Devices and Supplies Industry;
United States
Hamermesh, Richard G., and Lauren Barley. "Novasys Medical." Harvard Business School Case 810-027, September 2009. (Revised August 2012.)
- 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.
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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 2007
- Case
Antegren: A Beacon of Hope
By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann
The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion...
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Keywords:
Demand and Consumers;
Leadership;
Ethics;
Corporate Social Responsibility and Impact;
Decision Choices and Conditions;
Crisis Management;
Health Testing and Trials;
Biotechnology Industry;
Pharmaceutical Industry
Margolis, Joshua D., Thomas J. DeLong, and Terence Heymann. "Antegren: A Beacon of Hope." Harvard Business School Case 408-025, November 2007.
- 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.
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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.)
- December 2006 (Revised January 2008)
- Case
ViaGen: Revolutionizing the Livestock Industry
By: David E. Bell, Reed Martin and Mary L. Shelman
ViaGen has invested heavily to develop cloning technology for the livestock industry. Cloning has the potential to significantly improve the genetics of livestock, leading to higher quality meat, healthier animals, and more efficient production. Since 2003, the firm...
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Keywords:
Animal-Based Agribusiness;
Business Plan;
Governing Rules, Regulations, and Reforms;
Marketing Communications;
Industry Structures;
Business and Government Relations;
Genetics;
Commercialization;
Agriculture and Agribusiness Industry;
Biotechnology Industry
Bell, David E., Reed Martin, and Mary L. Shelman. "ViaGen: Revolutionizing the Livestock Industry." Harvard Business School Case 507-021, December 2006. (Revised January 2008.)