Publications

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

July 2000 (Revised September 2005)
Case

Guidant: Radiation Therapy

Describes a potential new approach to treating cardiac disease--radiation therapy. Guidant, a leading medical device maker, faces a choice about whether to pursue this new and risky technology and, if so with what strategy. View Details

Keywords: Entrepreneurship; Decisions; Innovation Strategy; Health Care and Treatment; Product Design; Corporate Strategy; Medical Specialties; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

August 2010 (Revised August 2011)
Case

Richard Jenkins at SciMat

By: John J. Gabarro, Thomas J. DeLong and Jevan Soo

Written from the point of view of Richard Jenkins, the Executive Vice-President of Medical Devices at SciMat. Presents his reflections on the series of events leading to the firing of one of SciMat's general managers, Erik Peterson. A redisguised and updated version of... View Details

Keywords: Resignation and Termination; Managerial Roles; Situation or Environment; Perspective; Medical Devices and Supplies Industry

2009
Case

Innovamedica: Innovation in an Emerging Market

By: Roberto Charvel, Fernando Fabre and T. Putimahtama

Innovamedica was a medical start up with several state of the art devices such as a silicon substitute heart and other inventions. However, the founding scientist was struggling in attracting talent and fundraising and that had an impact on growth. View Details

Keywords: Biotech; Entrepreneurial Finance; Entrepreneurship; Start-up; Emergent Countries; Business Startups; Talent and Talent Management; Design; Corporate Entrepreneurship; Private Equity; Health Testing and Trials; Innovation and Invention; Managerial Roles; Biotechnology Industry; Latin America; North and Central America

July 2010 (Revised June 2016)
Case

Erik Peterson at Biometra (A)

By: John J. Gabarro, Thomas DeLong and Jevan Soo

Describes the problems facing a recent MBA graduate in his job as general manager of a medical device company owned by a parent corporation. Raises issues of corporate divisional relationships and the difficulties facing an inexperienced manager who seems to be... View Details

Keywords: Business Subsidiaries; Leadership; Managerial Roles; Product Launch; Organizational Structure; Problems and Challenges; Medical Devices and Supplies Industry

14 Nov 2017
First Look

New Research and Ideas: November 14, 2017

the Design and Execution of Medical Device Pivotal Trials By: Stern, Ariel Dora, and Aaron V. Kaplan Abstract—The introduction of new medical View Details

Keywords: Carmen Nobel

May 2017 (Revised June 2017)
Case

ATH Technologies (A): Making the Numbers

By: Robert Simons and Jennifer Packard

An exercise that takes students through five stages of growth in an entrepreneurial start-up in the medical devices industry: 1) founding, 2) growth, 3) push to profitability, 4) refocusing process, and 5) takeover by new management. At each stage, students must... View Details

Keywords: Strategy And Execution; Management Control Systems; Balancing Innovation And Control; Performance Management; Business Growth and Maturation; Business Startups; Profit; Geographic Location; Governance Controls; Innovation and Invention; Management Succession; Performance Evaluation; Medical Devices and Supplies Industry

January 2007 (Revised January 2007)
Background Note

Note on the U.S. Food and Drug Administration

By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller

Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure. View Details

Keywords: Health; Governance Compliance; Policy; Product Development; Government and Politics; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States

27 Mar 2018
First Look

First Look at New Research, March 27, 2018

risks for physicians on innovation may be positive or negative, depending on the characteristics of the technology. Empirically, we find that, on average, laws that limit the liability exposure of healthcare providers are associated with a significant reduction in... View Details

Keywords: Sean Silverthorne

Research Summary

Overview

Patient Portals: The Provider Role
Patient portals are widespread, but evidence of impact is limited. In this study, we use a large dataset spanning 2 years and >1 million patients across 650 primary care practices to explore the "other side" of portals: health... View Details

Keywords: Healthcare Technology; Electronic Health Records; Health Care Delivery

December 1997 (Revised December 1998)
Case

ArthroCare

A young company in the medical devices area, ArthroCare, has been public for six months, and its stock--after initially performing very well--is now dropping. At the same time, the company is confronted with several tactical decisions that could impact near-term... View Details

Keywords: Public Ownership; Decisions; Equity; Medical Devices and Supplies Industry

December 2008 (Revised April 2010)
Case

Proteus Biomedical: Making Pigs Fly

By: Richard G. Hamermesh, Lauren Barley and Ginger Graham

Proteus is a healthcare start-up that has developed technology to embed electronics for computing and sensing in existing medical devices and drugs. The technology could potentially change the basis of competition in the pharmaceutical industry. The company is... View Details

Keywords: Business Startups; Entrepreneurship; Technological Innovation; Rights; Negotiation Deal; Business Strategy; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry