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

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September 2017 (Revised February 2018)
Case

Becton Dickinson: Global Health Strategy

By: Mark R. Kramer and Sarah Mehta

Becton, Dickinson and Company (BD) was a medical technology firm headquartered in Franklin Lakes, New Jersey, with 43,000 employees and 2016 revenues of $12.5 billion. For several years, the company had pursued developing products that created shared value, defined as... View Details

Keywords: Shared Value; Creating Shared Value; Odon Device; Medical Technology; Value Creation; Values and Beliefs; Philanthropy and Charitable Giving; Health; Health Care and Treatment; Health Testing and Trials; Emerging Markets; Social Issues; Competitive Strategy; Medical Devices and Supplies Industry; Africa; Asia; Middle East

November 2007 (Revised August 2014)
Case

D2Hawkeye: Growing the Medical IT Enterprise

By: Robert F. Higgins, Rosie O'Donnell, Sophie LaMontagne and Brent Kazan

In mid-March 2007, Chris Kryder sat in his office and thought about how to best finance his company's growth. Over the previous five years as founder and CEO of D2Hawkeye, a Waltham, Massachusetts-based healthcare analytics company, Kryder had grown the firm from a... View Details

Keywords: Strategy Development; Strategic Positioning; Strategic Vision; Venture Capital; Small Business; Investment; Growth Management; Expansion; Business Growth and Maturation; Decision Choices and Conditions; Financing and Loans; Business Startups; Financial Strategy; Business Strategy; Service Industry; Health Industry; Waltham

2022
Working Paper

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with... View Details

Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry

Find at Harvard

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

December 2005 (Revised October 2013)
Case

Fred Khosravi and AccessClosure (A)

By: Richard Hamermesh and Liz Kind

Fred Khosravi is a serial medical device entrepreneur. In his latest venture, he must decide whether to sell now or continue to develop his current product and whether to market it, sell the company, or IPO. View Details

Keywords: Negotiation; Medical Devices; Venture Capital; Life Sciences; Health Care Industry; Healthcare Technology; Healthcare Ventures; Business Startups; Decision Choices and Conditions; Entrepreneurship; Growth and Development Strategy; Medical Devices and Supplies Industry; United States

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

02 Jul 2019
Working Paper Summaries

Risk-Mitigating Technologies: The Case of Radiation Diagnostic Devices

Keywords: by Alberto Galasso and Hong Luo; Medical Devices & Supplies

August 1995
Teaching Note

Medical Products Company TN

By: Robert H. Hayes

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

Keywords: Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Europe

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

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

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 2014
Supplement

Fred Khosravi and AccessClosure (C)

By: Richard Hamermesh and Lauren Barley

On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the... View Details

Keywords: Medical Devices; Vascular Closure Device; Patent Litigation; Patenting; Biomedical Research; Biotechnology; Biotech; Technological Innovation; Patents; Health Care and Treatment; Biotechnology Industry; United States

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)

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

10 May 2017
Research & Ideas

Amazon Web Services Changed the Way VCs Fund Startups

More entrepreneurs are receiving initial funding from VCs thanks to technologies such as the cloud. Source: PeopleImages As cloud technologies allow startups to build companies faster and cheaper than ever before, venture capitalists are... View Details

Keywords: by Michael Blanding; Banking; Financial Services; Information Technology

2022
Book

Corporate Explorer: How Corporations Beat Startups at the Innovation Game

By: Andrew Binns, Charles A. O'Reilly III and Michael Tushman

Innovation used to be seen as a game best left to entrepreneurs, but now a new breed of corporate managers is flipping this logic on its head. These Corporate Explorers have the insight, resilience, and discipline to overcome the obstacles and build new ventures from... View Details

Keywords: Organization Change And Adaptation; Disruptive Innovation; Organizational Change and Adaptation; Innovation and Management; Leading Change

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

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