Medical Device Startup - Publications - Faculty & Research - Harvard Business School

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September 2023
Case

Healthy.io: The Negotiation for the Medical Selfie

By: Amit Goldenberg and Kumba Sennaar

Healthy.io, an Israeli digital health company, prepares to enter the U.S. market with its chronic kidney disease test. A product safety approval is delayed, putting the company’s cash runway at risk. How should the CEO negotiate his offer to insurance companies ahead... View Details

Keywords: Negotiation; Entrepreneurship; Venture Capital; Operations; Business Startups; Market Entry and Exit; Health Industry; Israel; United Kingdom; United States

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

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... View Details

Keywords: by Kristen Senz

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

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). View Details

Keywords: Personal Development and Career; Entrepreneurship; Business Startups; Biotechnology Industry; Pharmaceutical Industry

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

Keywords: Business or Company Management; Corporate Entrepreneurship; Product Launch; Medical Specialties; Corporate Finance; Medical Devices and Supplies Industry

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... View Details

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

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

19 Jul 2016
News

HBS Startup Is Developing Tech-Enabled Jewelry to Stop Rapists

(Photo courtesy of Flare Jewelry) Is it possible to create a personal-safety device that can stop a physical assault, call for help, and collect evidence for the police? And be fashionable? Those are questions HBS students Sara de Zarraga... View Details

Keywords: Clothing and Clothing Accessories Stores; Retail Trade

20 Jul 2017
News

Life Lab Nurtures Early Stage Startup Day Zero Diagnostics

and machine learning (Dougal Maclaurin), and Jong Lee (MBA 1999), a former consultant and startup executive with extensive experience in the medical technology space. “There is a huge unmet clinical need for... View Details

Keywords: Scientific Research and Development Services

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... View Details

Keywords: Intrapreneurship; Entrepreneurial Organizations; Startup Management; Startup; Strategic Positioning; Corporate Entrepreneurship; Corporate Strategy; Business Startups; Strategic Planning; Competitive Strategy; Health Industry; United States

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

Keywords: Market Design; Growth And Development Strategy; Health Care; Business Startup; Growth and Development; Health Care and Treatment; Medical Specialties; Business Startups; Supply and Industry; Medical Devices and Supplies Industry; United States

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

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... View Details

Keywords: Intrapreneurship; Entrepreneurial Organizations; Startup Management; Startup; Strategic Positioning; Corporate Entrepreneurship; Corporate Strategy; Business Startups; Strategic Planning; Competitive Strategy; Health Industry; United States

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

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... View Details

Keywords: Intrapreneurship; Entrepreneurial Organizations; Startup Management; Startup; Strategic Positioning; Corporate Entrepreneurship; Corporate Strategy; Business Startups; Strategic Planning; Competitive Strategy; Health Industry; United States

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... View Details

Keywords: Innovation; Incubation; Healthcare Technology; Startups; Entrepreneurship; Innovation and Management; Health Care and Treatment; Business Startups; Health Industry; San Francisco; California; United States

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... View Details

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... View Details

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

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... View Details

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

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