Filter Results:
(546)
Show Results For
- All HBS Web
(546)
- People (1)
- News (68)
- Research (397)
- Events (3)
- Multimedia (8)
- Faculty Publications (302)
Show Results For
- All HBS Web
(546)
- People (1)
- News (68)
- Research (397)
- Events (3)
- Multimedia (8)
- Faculty Publications (302)
- May 1977 (Revised March 1985)
- Teaching Note
Searle Medical Instruments Group (A), Teaching Note
Keywords: Medical Devices and Supplies Industry
- Fast Answer
Biotech, Medical devices, and Pharmaceuticals: regulatory information
quick search result. you may modify the search terms or use the filters under "Refine my results" to obtain different results. Medical Devices Medical View Details
- Fast Answer
Biotech, Medical Devices, and Pharmaceuticals: Industry/Market Overview/Analysis
Where to find market overview and analysis for industries of biotech, medical devices and pharmaceuticals? The following are the top databases for industry/market analysis in the spaces of biotech, View Details
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- Fast Answer
Biotech and medical devices: Company Data and Analysis
Where can I find biotech and medical devices company financials and analysis? We suggest that you may use at least more than one of them for your company research. Capital IQ - Data on public and private... View Details
- November 2004
- Case
ClozeX Medical (A): The New Standard of Wound Closure
By: William A. Sahlman and Ryland Matthew Willis
Describes a set of decisions confronting the founder of a company with a revolutionary new wound-closure product. He must decide how to finance and exploit his venture. View Details
- April 2012
- Case
Bella Healthcare India
By: Dorothy Leonard and Sunru Yong
Bella Healthcare India was originally established in Bangalore as a low-cost manufacturing facility for a U.S.-based cardiology equipment developer. Under country manager Joseph Cherian it evolved considerably, developing its own research and development capabilities.... View Details
Keywords: India; Productivity; Organizational Development; International Business; R&D; Cross-cultural Relations; Medical Equipment & Devices; Joint Ventures; Medical Specialties; Research and Development; Product Development; Organizational Change and Adaptation; Strategy; Decision Choices and Conditions; Health Care and Treatment; Product Launch; Failure; Cross-Cultural and Cross-Border Issues; Medical Devices and Supplies Industry; Bangalore
Leonard, Dorothy, and Sunru Yong. "Bella Healthcare India." Harvard Business School Brief Case 124-440, April 2012.
- 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; Medical Devices and Supplies 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.)
- Article
A Career Life-Cycle Perspective on Women's Health and Safety
By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health... View Details
Keywords: Women's Health; Healthcare Access; Workplace Design; Military Health System; Occupational Health; Medical Equipment & Devices; Employees; Gender; Personal Development and Career
Kaplan, Robert S., Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator, and Michael D. Parkinson. "A Career Life-Cycle Perspective on Women's Health and Safety." Journal of Occupational and Environmental Medicine 64, no. 4 (April 2022): 267–270.
- 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; Medical Devices and Supplies Industry; Medical Devices and Supplies 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.
- August 2022
- Article
Regulatory Considerations to Keep Pace with Innovation in Digital Health Products
By: John Torous, Ariel Dora Stern and Florence T. Bourgeois
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a... View Details
Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry
Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).
- May 1999 (Revised September 1999)
- Case
HydroCision, Inc.
By: Gary P. Pisano, Joshua D. Hamermesh, Richard Atsuhiko Kondo, Karen J. Nowiszewski and Erik James Wordelman
Examines the market-entry strategy of a medical device company. View Details
Pisano, Gary P., Joshua D. Hamermesh, Richard Atsuhiko Kondo, Karen J. Nowiszewski, and Erik James Wordelman. "HydroCision, Inc." Harvard Business School Case 699-176, May 1999. (Revised September 1999.)
- 17 Jul 2016
- Working Paper Summaries
Tort Reform and Innovation
- 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
- 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.)
- January 1998
- Case
Jerry Sanders
In 1997, Jay Sanders sold his 10-month-old medical device start-up company for more than $33 million. Looking to the future, he wondered if this was a success he could transform into a medical device brokerage business. As he reviewed his career history and the... View Details
Keywords: Personal Development and Career; Business Startups; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
Burton, M. Diane, and Katherine Lawrence. "Jerry Sanders." Harvard Business School Case 498-021, January 1998.
- November 2003 (Revised September 2008)
- Case
Circle Gastroenterology Products (A)
By: Regina E. Herzlinger and James Weber
A new, minimally invasive medical device has achieved only one-third of its budget. Was the problem one of marketing strategy, sales, reimbursement, and/or clinical trials? View Details
Keywords: Health Testing and Trials; Marketing Strategy; Product Marketing; Sales; Medical Devices and Supplies Industry
Herzlinger, Regina E., and James Weber. "Circle Gastroenterology Products (A)." Harvard Business School Case 304-052, November 2003. (Revised September 2008.)
- 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
- November 2010 (Revised December 2010)
- Background Note
HR 3509
By: David F. Hawkins
HR 3509 ("2010 Health Reform Bill") imposition of a fee in pharmaceutical sales and an excise tax on medical device sales raises accounting issues. View Details
Keywords: Accounting; Governing Rules, Regulations, and Reforms; Government Legislation; Taxation; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States
Hawkins, David F. "HR 3509." Harvard Business School Background Note 111-056, November 2010. (Revised December 2010.)