Medical Devices and Supplies Industry - Publications - Faculty & Research - Harvard Business School

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November 2022
Case

Ajax Health: A New Model for Medical Technology Innovation

By: Regina E. Herzlinger and Ben Creo

This case teaches key success factors for both startup and established MedTech firms. It examines how to structure a firm to maximize innovation and financial returns with organizational structures that better align the incentives for the different skill sets... View Details

Keywords: Business Startups; Success; Innovation Strategy; Mergers and Acquisitions; Market Entry and Exit; Financial Strategy; Business Model; Partners and Partnerships; Entrepreneurship; Private Equity; Technology Industry; Technology Industry

September 2014
Case

Radiometer, 2003

By: John R. Wells and Galen Danskin

In 2003, Radiometer was the world's leading supplier of blood gas analysis equipment and accessories for critical care patients. Based in Denmark, Radiometer sold through a combination of sales subsidiaries and distributors around the world, and generated sales of over... View Details

Keywords: Medical Devices; Medical Equipment ＆ Devices; Mergers ＆ Acquisitions; Strategic Analysis; Strategic Change; Family Business; Strategy; Medical Devices and Supplies Industry; Denmark; United States

Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

29 Jun 2015
HBS Case

Consumer-centered Health Care Depends on Accessible Medical Records

health, the process is a bit like throwing a lasso around a tsunami. That's why integrated medical data has now become a major goal of health care reform. Integrating patient records, such as physicians' notes, diagnoses, View Details

Keywords: by Dina Gerdeman; Health; Technology

November 2001
Teaching Note

Catalyst Medical Solutions (TN)

By: Richard M.J. Bohmer, Amy C. Edmondson and Laura Feldman

Teaching Note for (9-601-014). View Details

Keywords: Medical Devices and Supplies Industry

August 1995
Teaching Note

Medical Products Company TN

By: Robert H. Hayes

Teaching Note for (9-694-065). View Details

Keywords: Health Industry; Health Industry; Europe

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

April 2006 (Revised May 2009)
Case

Inverness Medical Innovations - Born Global (A)

Ron Zwanziger has just started his third company, having just sold the last one for $1.3 billion to Johnson & Johnson. As part of the deal with J&J, certain assets were transferred to the new company, Inverness Medical Innovations, which, at the time of its creation,... View Details

Keywords: Globalized Firms and Management; Mergers and Acquisitions; Entrepreneurship; Health Care and Treatment; Corporate Finance; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Waltham

August 2002 (Revised June 2003)
Teaching Note

General Electric Medical Systems (TN)

By: Tarun Khanna

Teaching Note for (9-702-428). View Details

Keywords: Medical Devices and Supplies Industry; China

2016
Article

Android and Competition Law: Exploring and Assessing Google's Practices in Mobile

By: Benjamin Edelman and Damien Geradin

Since its launch in 2007, Android has become the dominant mobile device operating system worldwide. In light of this commercial success and certain disputed business practices, Android has come under substantial attention from competition authorities. We present key... View Details

Keywords: Android; Antitrust; Competition Policy; Exclusion; Mobile Communication Devices; Remedies; Tying; Technology Platform; Competition; Monopoly; Policy; Mobile Technology; Telecommunications Industry

May 1977 (Revised March 1985)
Teaching Note

Searle Medical Instruments Group (A), Teaching Note

By: Steven C. Wheelwright

Keywords: Medical Devices and Supplies Industry

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)

August 2013
Case

Contempo Technologies, Inc. and Betty Sievers: A Clash of Interests in an Uncertain Time

By: Srikant M. Datar, Michael R. Jaff D.O. and Caitlin N. Bowler

In an era of rapidly evolving systems of health care delivery, the impact on patients, physicians, hospitals, medical device manufacturers and small business owners are often conflicting. This case highlights these conflicts and stressors from all perspectives,... View Details

Keywords: Health Care Industry; Healthcare; Health Care and Treatment; Health Industry

April 2010
Teaching Note

Supply Chain Partners: Virginia Mason and Owens & Minor (TN) (A), (B), and (A) (Abridged)

By: V.G. Narayanan and Lisa Brem

Teaching Note for [109076], [109077], and [110063].. View Details

Keywords: Medical Devices and Supplies 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

January 1989 (Revised June 1993)
Case

Health Industry Manufacturers Association

By: George C. Lodge

Keywords: Medical Devices and Supplies Industry

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

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

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

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