Publications

14 May 2014
News

(Re)moving the Needle

associated with the discomfort of conventional self-injections. "We're not moving the needle, we're removing the needle," he adds, with a laugh. Anquetil is a serial entrepreneur with a special interest in medical technology. Born and... View Details

Keywords: Robert S. Benchley; medical technology; Scientific Research and Development Services

January 2018 (Revised May 2019)
Case

Adeo Health Science: Turning a Product into a Brand

By: Elizabeth A. Keenan and Jill Avery

For decades, American parents were warned to avoid introducing potential allergens to their babies prior to their first birthday. But two influential clinical studies caused the medical establishment to radically reverse its position. Parents were now warned that... View Details

Keywords: Startup; Health Care; Consumer; Consumer Products; Branding; Distribution; Retailing; Go To Market Strategy; Marketing; Marketing Channels; Marketing Communications; Brands and Branding; Marketing Strategy; Entrepreneurship; Health Care and Treatment; Consumer Products Industry; Health Industry; United States; North America

August 2022
Article

Regulatory Considerations to Keep Pace with Innovation in Digital Health Products

By: John Torous, Ariel Dora Stern and Florence T. Bourgeois

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a... View Details

Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry

Read Now

May 1999 (Revised September 1999)
Case

HydroCision, Inc.

By: Gary P. Pisano, Joshua D. Hamermesh, Richard Atsuhiko Kondo, Karen J. Nowiszewski and Erik James Wordelman

Examines the market-entry strategy of a medical device company. View Details

Keywords: Markets; Strategy; Medical Devices and Supplies Industry

January 1998
Case

Jerry Sanders

In 1997, Jay Sanders sold his 10-month-old medical device start-up company for more than $33 million. Looking to the future, he wondered if this was a success he could transform into a medical device brokerage business. As he reviewed his career history and the... View Details

Keywords: Personal Development and Career; Business Startups; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry

17 Jul 2016
Working Paper Summaries

Tort Reform and Innovation

Keywords: by Alberto Galasso and Hong Luo; Health; Legal Services

05 Oct 2021
News

Launch Signals

tech startup producing stylish bracelets with an inobtrusive control button that can send text messages and GPS tracking to friends, a pre-recorded call to a specific phone number, or a direct connection to the police. “Flare gives you... View Details

Keywords: entrepreneurship; startup; safety; wearable tech; women; Computer and Electronic Product Manufacturing; Manufacturing

November 2002 (Revised August 2003)
Case

MedSource Technologies

By: Robert S. Huckman

Considers the issues facing Richard Effress, MedSource's chairman and CEO, as the firm approaches the Precision Cut project--the first test of MedSource's capabilities as an integrated, contract manufacturer in the medical device industry. MedSource Technologies was... View Details

Keywords: Product Development; Production; Mergers and Acquisitions; Product Design; Supply Chain Management; Management Teams; Medical Devices and Supplies Industry; United States

February 2021 (Revised March 2022)
Case

Marvin: A Personalized Telehealth Approach to Mental Health

By: Regina E. Herzlinger, Eshani Sharma, Andrew Nguyen, Thomas Arsenault, Carin-Isabel Knoop and Julia Kelley

More than one third of Americans were said to suffer some type of behavioral health ailment at some point in their lifetime, with many people requiring chronic therapy or intervention. Despite significant clinical needs, access to reliable treatment has been difficult... View Details

Keywords: Mental Health; Applications; Startup Management; Telehealth; Health Care Entrepreneurship; Health ＆ Wellness; Health Care; Health Care and Treatment; Customization and Personalization; Internet and the Web; Entrepreneurship; Growth and Development Strategy; Applications and Software

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

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

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

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

01 Apr 2022
Video

ClearCut Surgical Runner-Up & Crowd Favorite 2022 New Venture Competition Student Business Track

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

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