Medical Devices - Publications - Faculty & Research - Harvard Business School

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April 2006
Case

Medical Innovation Beyond MedStar: Mobilizing for National Impact

By: Rosabeth M. Kanter, Ryan Raffaelli and Michelle Heskett

Dr. Craig Feied, director of MedStar Health's Medical Informatics programs, wanted his innovations to influence national health care. Since joining Washington Hospital Center's Emergency Department in 1995 with Dr. Mark Smith, their information system had become the... View Details

Keywords: Collaborative Innovation and Invention; Innovation Strategy; Technological Innovation; Policy; Government and Politics; Innovation and Management; Projects; Corporate Social Responsibility and Impact; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Washington (state, US)

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

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

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

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

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

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

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

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

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

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

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

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

Keywords: Markets; Strategy; Medical Devices and Supplies Industry

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

17 Jul 2016
Working Paper Summaries

Tort Reform and Innovation

Keywords: by Alberto Galasso and Hong Luo; Health; Legal Services

November 2002 (Revised August 2003)
Case

MedSource Technologies

By: Robert S. Huckman

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

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

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

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

Find at Harvard

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

Keywords: Healthcare Industry; Health Care; Health; Health Care and Treatment; Health Testing and Trials; Health Industry; United States

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