Publications

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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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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

May 2024
Article

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

By: Caroline Marra and Ariel D. Stern

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details

Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms

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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

December 1984
Teaching Note

Medical and Environmental Electronic Devices Corp. (A) and (B), Teaching Note

By: Michael Beer

Keywords: Medical Devices and Supplies Industry

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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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

2012
Report

Competing by Saving Lives: How Pharmaceutical and Medical Device Companies Create Shared Value in Global Health

By: Mark R. Kramer, Kyle Peterson, Matthew Rehrig, Mike Stamp and Samuel Kim

Examples of how pharmaceutical and medical companies are addressing unmet health needs in low- and middle- income economies, creating shared value by providing products and services that tackle global health problems. View Details

Keywords: Shared Value; Low- And Middle-income Economies; Health Care and Treatment; Global Range; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

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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

February 2012 (Revised May 2012)
Case

Boston Physicians Devices

By: Marc Bertoneche

Keywords: Medical Devices and Supplies Industry; United States

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

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

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; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Israel

17 Dec 2007
Research & Ideas

The Rise of Medical Tourism

What used to be rare is now commonplace: traveling abroad to receive medical treatment, and to a developing country at that. So-called medical tourism is on the rise for everything from cardiac care to... View Details

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

December 1994 (Revised January 1995)
Case

Zoll Medical Corporation (A)

When is a product ready for the market? In this case, engineers present a prototype medical device product to the CEO for approval. The product, developed under a tight deadline, is essentially identical to the main competitor's product, but that competitor is... View Details

Keywords: Innovation and Management; Product Development; Medical Devices and Supplies Industry

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; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; New Jersey

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

May 2024
Case

SofMedica Group: Managing Growth

By: Boris Groysberg and Sarah L. Abbott

SofMedica Group had expanded from its origins as a medical equipment distributor in Romania to a holding company with four business lines operating in six countries. This expansion had been driven by SofMedica’s mission: to make cutting edge medical technology... View Details