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- Faculty Publications (313)
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- All HBS Web (630)
- Faculty Publications (313)
- 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; Health 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... View Details
- January 2017
- Case
Kada Orthopedics: A Bone of Contention
By: Kevin Schulman and Matt Strickland
Kada Orthopedics is a small implantable orthopedic device manufacturer founded by industry veterans trying to sell stable-technology products to an increasingly cost-conscious healthcare market. Although they have marginally successful product in early 2016, the... View Details
- March 2015 (Revised February 2022)
- Supplement
CV Ingenuity (B): Epilogue
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors?
The... 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; Strategy; Health Industry; Health Industry; United States; Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (B): Epilogue." Harvard Business School Supplement 315-087, March 2015. (Revised February 2022.)
- February 2024
- Case
More than Optics: Olympus's Vision to Become a Leading Global MedTech Company
By: David J. Collis and Haisley Wert
In August 2022, CEO Yasuo Takeuchi reflected on Olympus Corporation’s recent transformation from being known as a Japanese consumer camera company to becoming a leading global medical technology (MedTech) company. Over the past dozen years, Takeuchi and prior... View Details
Keywords: Global Human Resource Management; Medical Technology; Corporate Strategy; Transformation; Globalization; Business Model; Leading Change; Organizational Structure; Organizational Change and Adaptation; Medical Devices and Supplies Industry; Japan; United States
Collis, David J., and Haisley Wert. "More than Optics: Olympus's Vision to Become a Leading Global MedTech Company." Harvard Business School Case 724-426, February 2024.
- May 2017 (Revised June 2017)
- Case
ATH Technologies (A): Making the Numbers
By: Robert Simons and Jennifer Packard
An exercise that takes students through five stages of growth in an entrepreneurial start-up in the medical devices industry: 1) founding, 2) growth, 3) push to profitability, 4) refocusing process, and 5) takeover by new management. At each stage, students must... View Details
Keywords: Strategy And Execution; Management Control Systems; Balancing Innovation And Control; Performance Management; Business Growth and Maturation; Business Startups; Profit; Geographic Location; Governance Controls; Innovation and Invention; Management Succession; Performance Evaluation; Medical Devices and Supplies Industry
Simons, Robert, and Jennifer Packard. "ATH Technologies (A): Making the Numbers." Harvard Business School Case 117-013, May 2017. (Revised June 2017.)
- 2017
- Working Paper
Tort Reform and Innovation
By: Alberto Galasso and Hong Luo
Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model which predicts that the... View Details
Keywords: Lawsuits and Litigation; Laws and Statutes; Innovation and Invention; Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Tort Reform and Innovation." Working Paper, August 2017. (Accepted for publication in Journal of Law and Economics.)
- August 2017
- Article
Tort Reform and Innovation
By: Alberto Galasso and Hong Luo
Current academic and policy debates focus on the impact of tort reforms on physicians’ behavior and medical costs. This paper examines whether these reforms also affect incentives to develop new technologies. We develop a theoretical model that predicts that the impact... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technological Innovation; Legal Liability; Medical Devices and Supplies Industry
Galasso, Alberto, and Hong Luo. "Tort Reform and Innovation." Journal of Law & Economics 60, no. 3 (August 2017): 385–412.
- November 2022 (Revised April 2024)
- Case
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication... View Details
Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Pharmaceutical Industry; Pharmaceutical Industry; United States; District of Columbia
Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised April 2024.)
- 14 Nov 2017
- First Look
New Research and Ideas: November 14, 2017
the Design and Execution of Medical Device Pivotal Trials By: Stern, Ariel Dora, and Aaron V. Kaplan Abstract—The introduction of new View Details
Keywords: Carmen Nobel
- 20 Oct 2003
- Research & Ideas
Gaps in the Historical Record: Development of the Electronics Industry
begin with consumer electronics. That industry began with radio. Two enterprises commercialized, that is, brought the technology into public use: Radio Corporation of America (RCA), a joint venture of the three leading U.S. electrical... View Details
- 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; Pharmaceutical Industry; Pharmaceutical Industry; Pharmaceutical 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.)
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
transform traditional industries such as banking, real estate, and healthcare. More recently, it has gained attention as a way to finance new ventures, through what is known as an Initial Coin Offering... View Details
Keywords: Dina Gerdeman
- November 2024
- Teaching Note
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
Teaching Note for HBS Case No. 323-039. In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At... View Details
Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Growth and Development Strategy; Product Development; Pharmaceutical Industry; Pharmaceutical Industry; United States; District of Columbia
- May 2017
- Case
ATH Technologies: Making the Numbers
By: Robert Simons and Jennifer Packard
An exercise that takes students through five stages of growth in an entrepreneurial start-up in the medical devices industry: 1) founding, 2) growth, 3) push to profitability, 4) relocation process, and 5) takeover by new management. At each stage, students must... View Details
Keywords: Balancing Innovation And Control; Performance Evaluation; Strategy And Execution; Management Control Systems; Risk Management; Business Growth and Maturation; Business Startups; Profit; Geographic Location; Governance Controls; Innovation and Invention; Management Succession; Medical Devices and Supplies Industry
Simons, Robert, and Jennifer Packard. "ATH Technologies: Making the Numbers." Harvard Business School Case 117-012, May 2017.
- October 2015
- Article
Exposed: Venture Capital, Competitor Ties, and Entrepreneurial Innovation
By: Emily Cox Pahnke, Rory McDonald, Dan Wang and Benjamin Hallen
This paper investigates the impact of early relationships on innovation at entrepreneurial firms. Prior research has largely focused on the benefits of network ties, documenting the many advantages that accrue to firms embedded in a rich network of inter-organizational... View Details
Keywords: Competition; Intellectual Property; Entrepreneurship; Innovation and Invention; Medical Devices and Supplies Industry
Pahnke, Emily Cox, Rory McDonald, Dan Wang, and Benjamin Hallen. "Exposed: Venture Capital, Competitor Ties, and Entrepreneurial Innovation." Academy of Management Journal 58, no. 5 (October 2015): 1334–1360.
- November 2002 (Revised August 2003)
- Case
MedSource Technologies
Considers the issues facing Richard Effress, MedSource's chairman and CEO, as the firm approaches the Precision Cut project--the first test of MedSource's capabilities as an integrated, contract manufacturer in the medical device industry. MedSource Technologies was... View Details
Keywords: Product Development; Production; Mergers and Acquisitions; Product Design; Supply Chain Management; Management Teams; Medical Devices and Supplies Industry; United States
Huckman, Robert S. "MedSource Technologies." Harvard Business School Case 603-081, November 2002. (Revised August 2003.)
- 18 Sep 2019
- Working Paper Summaries
Female Inventors and Inventions
- 29 Jan 2019
- First Look
New Research and Ideas, January 29, 2019
and Competitor Response: Evidence from Medical Device Firms By: Ball, George P., Jeffrey T. Macher, and Ariel Dora Stern Abstract— Innovation... View Details
Keywords: Dina Gerdeman
- 05 Nov 2018
- Working Paper Summaries