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Show Results For
-
All HBS Web
(850)
- People (1)
- News (191)
- Research (491)
- Events (3)
- Multimedia (10)
- Faculty Publications (337)
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- 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...
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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).
- 22 Feb 2022
- Research & Ideas
Lack of Female Scientists Means Fewer Medical Treatments for Women
Women are more likely to invent medical treatments for endometriosis, cervical cancer, and other female conditions, but the dearth of women scientists limits the potential for such life-saving innovations. Female research teams are 35...
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Keywords:
by Kristen Senz
- 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.
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- March 2006
- Teaching Note
Stan Lapidus: Profile of a Medical Entrepreneur (TN)
By: Robert F. Higgins, Richard G. Hamermesh and Erin Seefeld
Teaching Note to (805-087).
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- April 2017
- Case
Luminopia: Improving Treatment for Visual Disorders
By: Doug J. Chung and Sarah Mehta
Luminopia—a start-up founded in January 2016 by three Harvard College freshmen—uses virtual reality technology to treat amblyopia (more commonly called “lazy eye”), the single biggest cause of visual disorders among children. By February 2017, the three founders had...
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Keywords:
Pricing;
Virtual Reality;
Startup;
Marketing;
Marketing Channels;
Product Marketing;
Product Launch;
Product Positioning;
Business Startups;
Price;
Medical Devices and Supplies Industry;
Cambridge;
Massachusetts;
United States
Chung, Doug J., and Sarah Mehta. "Luminopia: Improving Treatment for Visual Disorders." Harvard Business School Case 517-065, April 2017.
- 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....
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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.
- 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...
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- February 2015 (Revised June 2017)
- Case
Intrapreneurship at DaVita HealthCare Partners
By: Joseph B. Fuller, David J. Collis and Matthew G. Preble
Josh Golomb, president and general manager of DaVita Rx (Rx), was about to meet with Kent Thiry, CEO of Rx's corporate parent, DaVita Healthcare Partners Inc. (DaVita), in August 2013. The two would discuss whether Golomb should lead a new DaVita venture, Paladina...
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Keywords:
Intrapreneurship;
Entrepreneurial Organizations;
Startup Management;
Startup;
Strategic Positioning;
Corporate Entrepreneurship;
Corporate Strategy;
Business Startups;
Strategic Planning;
Competitive Strategy;
Health Industry;
United States
Fuller, Joseph B., David J. Collis, and Matthew G. Preble. "Intrapreneurship at DaVita HealthCare Partners." Harvard Business School Case 315-046, February 2015. (Revised June 2017.)
- 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...
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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.
- 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...
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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 2016 (Revised August 2016)
- Teaching Note
Intrapreneurship at DaVita Healthcare Partners
By: Joseph B. Fuller and Matthew Preble
DaVita Healthcare Partners Inc. (DaVita) is one of the U.S.'s leading dialysis providers, a process whereby persons with end-stage renal disease (ESRD) are connected to a machine that performs the functions of a healthy kidney. Kent Thiry, DaVita's CEO, has expanded...
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- October 2012 (Revised October 2013)
- Case
Rock Health
By: Robert F. Higgins and Ian McKown Cornell
Rock Health was a San Francisco–based nonprofit organization offering accelerator services to spur innovation at the intersection of healthcare and technology. The company was the creation of Halle Tecco (HBS '11) and her HBS classmate Nate Gross (HBS '11), who met...
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Keywords:
Innovation;
Incubation;
Healthcare Technology;
Startups;
Entrepreneurship;
Innovation and Management;
Health Care and Treatment;
Business Startups;
Health Industry;
San Francisco;
California;
United States
Higgins, Robert F., and Ian McKown Cornell. "Rock Health." Harvard Business School Case 813-035, October 2012. (Revised October 2013.)
- January 2017
- Supplement
Intrapreneurship at DaVita HealthCare Partners: Cash Flow Tool
By: Joseph B. Fuller and Christopher Payton
DaVita Healthcare Partners Inc. (DaVita) is one of the U.S.'s leading dialysis providers, a process whereby persons with end-stage renal disease (ESRD) are connected to a machine that performs the functions of a healthy kidney. Kent Thiry, DaVita's CEO, has expanded...
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- November 2016 (Revised November 2016)
- Case
Radial Analytics Probes Post-Acute Care
By: Richard G. Hamermesh and Olivia Hull
Thaddeus Fulford-Jones and Eric Weiss, founders of healthcare technology startup Radial Analytics, have been busy developing a software program designed to save hospitals money and improve patient outcomes by producing customized care plans for patients leaving the...
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Keywords:
Electronic Medical Records;
Electronic Health Records;
Data Science;
Entrepreneurship;
Health Care and Treatment;
Business Model;
Business Startups;
Innovation and Invention;
Growth Management;
Marketing Strategy;
Product Launch;
Product Positioning;
Science-Based Business;
Business Strategy;
Health Industry;
Technology Industry;
Cambridge;
Massachusetts
Hamermesh, Richard G., and Olivia Hull. "Radial Analytics Probes Post-Acute Care." Harvard Business School Case 817-029, November 2016. (Revised November 2016.)
- October 2016 (Revised November 2016)
- Case
Innovating Beyond Ochsner
By: Richard G. Hamermesh and Olivia Hull
The Ochsner Health System has developed a proprietary software tool designed to treat hypertension. Built into the system’s electronic medical records, the Hypertension Digital Medicine program allows patients to record their blood pressure at home and share readings...
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Keywords:
Electronic Medical Records;
Telemedicine;
Hypertension;
High Blood Pressure;
Chronic Disease;
Entrepreneurship;
Health Disorders;
Business Model;
Business Startups;
Innovation and Invention;
Growth Management;
Marketing Strategy;
Product Launch;
Product Positioning;
Science-Based Business;
Business Strategy;
Health Industry;
Technology Industry;
New Orleans;
Louisiana
Hamermesh, Richard G., and Olivia Hull. "Innovating Beyond Ochsner." Harvard Business School Case 817-028, October 2016. (Revised November 2016.)
- March 2014 (Revised September 2017)
- Case
salaUno: Eliminating Needless Blindness in Mexico
By: Richard Hamermesh, Regina Garcia Cueller and Valeria Moy
In May 2013 the co-founders and co-CEOs of salaUno, Javier Okhuysen and Carlos Orellana, were encouraged by the results of their fledgling start-up. salaUno was founded as a for-profit enterprise in order to have the capital needed for rapid growth and to fulfill its...
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Keywords:
Medical Services;
Developing Countries;
Developing Markets;
Health Care Industry;
Health Services;
Healthcare Ventures;
Healthcare Startups;
Health Care and Treatment;
Health;
Business Startups;
Developing Countries and Economies;
Growth and Development Strategy;
Health Industry;
Mexico;
Mexico City
Hamermesh, Richard, Regina Garcia Cueller, and Valeria Moy. "salaUno: Eliminating Needless Blindness in Mexico." Harvard Business School Case 814-041, March 2014. (Revised September 2017.)
- January 2018 (Revised May 2019)
- Case
Adeo Health Science: Turning a Product into a Brand
By: Elizabeth A. Keenan and Jill Avery
For decades, American parents were warned to avoid introducing potential allergens to their babies prior to their first birthday. But two influential clinical studies caused the medical establishment to radically reverse its position. Parents were now warned that...
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Keywords:
Startup;
Health Care;
Consumer;
Consumer Products;
Branding;
Distribution;
Retailing;
Go To Market Strategy;
Marketing;
Marketing Channels;
Marketing Communications;
Brands and Branding;
Marketing Strategy;
Entrepreneurship;
Health Care and Treatment;
Consumer Products Industry;
Health Industry;
United States;
North America
Keenan, Elizabeth A., and Jill Avery. "Adeo Health Science: Turning a Product into a Brand." Harvard Business School Case 518-065, January 2018. (Revised May 2019.)
- 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.
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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.)
- 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...
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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).
- 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...
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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.