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

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January 2018
Article

The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

By: Aaron V. Kaplan and Ariel D. Stern

The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States

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May 9, 2023
Response

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern

Keywords: Product Design; Safety; Medical Devices and Supplies Industry

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September 2018
Article

An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India

By: Budhaditya Gupta and Stefan Thomke

Recent research has studied innovation in emerging economies. However, microlevel product development processes in these economies are relatively unexplored, and the mechanisms by which the emerging economy context might affect such processes are still unclear. In this... View Details

Keywords: India; Product Development; Emerging Markets; Situation or Environment; Medical Devices and Supplies Industry; India

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January 2010 (Revised April 2010)
Case

Greenbriar Growth Partners and Microsurgery Devices

Greenbriar Growth Partners (GGP), a venture capital (VC) firm, has been an investor in Microsurgery Devices (MSD) for four-plus years and has come into conflict with the company's founder. Should the Board's nominating committee re-nominate the VC investor, and should... View Details

Keywords: Financial Crisis; Venture Capital; Private Equity; Initial Public Offering; Governing and Advisory Boards; Conflict of Interests; Medical Devices and Supplies Industry; 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

August 2003 (Revised August 2006)
Case

I've Got Rhythm: Selling Cardiac Rhythm Management Devices

By: Regina E. Herzlinger, William Lagor, Christopher Perry and Scott St. Germain

The head of sales and marketing in a large medical devices firm must decide how to assign his sales force. He compares selling in the pharma, specialty pharma, and device industries and analyzes the reasons for the differences. View Details

Keywords: Health Care and Treatment; Marketing Strategy; Industry Structures; Sales; Salesforce Management; Medical Devices and Supplies Industry

2018
Working Paper

Two Hundred Years of Health and Medical Care: The Importance of Medical Care for Life Expectancy Gains

By: Maryaline Catillon, David Cutler and Thomas Getzen

Using two hundred years of national and Massachusetts data on medical care and health, we examine how central medical care is to life expectancy gains. While common theories about medical care cost growth stress growing demand, our analysis highlights the importance of... View Details

Keywords: Mortality; Life Expectancy; Medical Care; Productivity; Public Health; Healthcare Spending; Spending Per Year Of Life Gained; Personal Medicine; Technophysio Evolution; Health; Economics; Health Care and Treatment; Spending; Data and Data Sets; Health Industry

September 2018 (Revised December 2019)
Case

Zebra Medical Vision

By: Shane Greenstein and Sarah Gulick

An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making... View Details

March 2017
Case

Cantel Medical

By: John R. Wells and Gabriel Ellsworth

Cantel Medical Corporation provided infection prevention and control products and services for patients, caregivers, and other healthcare providers. In 2016, Cantel generated sales of $665 million and net profits of $60 million, double the levels of five years earlier.... View Details

Keywords: Cantel; Charles Diker; Furniture Industry; Matrix Organization; Acquisition; Mergers and Acquisitions; Business Conglomerates; Business Units; Business Growth and Maturation; Business Organization; For-Profit Firms; Chemicals; Profit; Revenue; Geographic Scope; Multinational Firms and Management; Health; Health Care and Treatment; Business History; Business or Company Management; Goals and Objectives; Growth and Development Strategy; Organizational Structure; Problems and Challenges; Research and Development; Opportunities; Strategy; Adaptation; Business Strategy; Competitive Strategy; Corporate Strategy; Diversification; Expansion; Information Technology; Biotechnology Industry; Biotechnology Industry; Biotechnology Industry; Biotechnology Industry; Biotechnology Industry; Biotechnology Industry; United States; New Jersey

September 2009 (Revised August 2012)
Case

Novasys Medical

By: Richard G. Hamermesh and Lauren Barley

Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Health Disorders; Product Development; Business and Government Relations; Medical Devices and Supplies Industry; United States

October 2013 (Revised January 2014)
Supplement

Fred Khosravi and AccessClosure (B)

By: Richard G. Hamermesh and Lauren Barley

It was January 2013, and Fred Khosravi, chairman of the board of AccessClosure Inc., wondered what the new year had in store for him and AccessClosure, the company he founded in late 2002. Khosravi was cautiously optimistic—the Mountain View, California-based medical... 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; California

April 2014 (Revised March 2015)
Case

GE and the Industrial Internet

By: Karim R. Lakhani, Marco Iansiti and Kerry Herman

CEO Jeff Immelt considers whether GE is moving fast enough on its new Industrial Internet initiative. The undertaking includes building out an Industrial Internet, connecting machines and devices, collecting their data and operations, and providing services to clients... View Details

February 2012 (Revised May 2012)
Case

Boston Physicians Devices

By: Marc Bertoneche

Keywords: Medical Devices and Supplies Industry; United States

April 2001 (Revised February 2003)
Case

Moore Medical Corporation

Moore Medical is a medium-sized distributor of medical supplies to practitioners, such as podiatrists and emergency medical technicians. At the time of the case, it has relied on traditional customer channels such as catalogs, phones, and faxes to communicate product... View Details

Keywords: Change Management; Internet and the Web; Marketing Communications; Information Technology; Order Taking and Fulfillment; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

June 2016
Case

Aggressive Growth Plans For Zimmer Spine

By: Kevin Schulman and Miranda Shaw

Steve Healy, the President of Zimmer Spine, has to transform his organization into a market leader. Zimmer is a major medical device firm, but the Spine division has underperformed, and its core technology did not get the expanded FDA label that had been expected. The... View Details

Keywords: Medical Device; Organizational Innovation; Organizational Growth; Organizations; Growth and Development Strategy; Medical Devices and Supplies Industry

17 Dec 2007
Research & Ideas

The Rise of Medical Tourism

case with professor Felix Oberholzer-Gee and Carin-Isabel Knoop, executive director of the HBS Global Research Group. The medical services industry hasn't been global... View Details

Keywords: by Martha Lagace; Medical Devices & Supplies; Medical Devices & Supplies

April 2009 (Revised June 2010)
Case

Supply Chain Partners: Virginia Mason and Owens & Minor (A)

By: V.G. Narayanan and Lisa Brem

Virginia Mason Medical Center (VM) hired Owens & Minor (O&M) as its alpha vendor for medical/surgical supplies in 2004. By 2005, O&M was performing Just-in-Time and Low Unit of Measure services for VM, but they believed the pricing model in the industry was outdated.... View Details

Keywords: Activity Based Costing and Management; Price; Distribution; Supply Chain Management; Medical Devices and Supplies Industry

June 2019
Teaching Note

Zebra Medical Vision

By: Shane Greenstein and Sarah Gulick

Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working... View Details

Keywords: Business Startups; Science-Based Business; Applications and Software; Patents; Cross-Cultural and Cross-Border Issues; Health Care and Treatment; Health Industry; Health Industry; Health Industry; Israel

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

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

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