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2021
Working Paper

Regulatory Approval and Expanded Market Size

By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite

Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details

Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry

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October 2002
Case

A Father's Love: Novazyme Pharmaceuticals, Inc.

By: Richard M.J. Bohmer and Bradley Campbell

John Crowley, CEO of Novazyme Pharmaceuticals, a start-up biotechnology firm developing an orphan drug to treat a rare lysosomal storage disorder from which his children suffer, must choose between a partnership and a buyout to have sufficient funds and support to get... View Details

Keywords: Technological Innovation; Business Startups; Partners and Partnerships; Financing and Loans; Governing Rules, Regulations, and Reforms; Sales; Price; Product Development; Motivation and Incentives; Decision Choices and Conditions; Biotechnology Industry; Pharmaceutical Industry

January 2014 (Revised June 2014)
Case

23andMe: Genetic Testing for Consumers (A)

By: John A. Quelch and Margaret L. Rodriguez

On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details

Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States

2024
Working Paper

Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances

By: Amar Bhide and Srikant M. Datar

By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the... View Details

Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms

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

February 2024
Case

Compass Pathways: Pioneering Psychedelic Treatment

By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu

This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no... View Details

Keywords: Commercialization; Corporate Strategy; Competitive Strategy; Product Launch; Health Testing and Trials; Research and Development; Laws and Statutes; Pharmaceutical Industry; Europe; United States; United Kingdom

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; Medical Devices and Supplies Industry; Technology Industry; Israel

April 2010
Case

Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug

By: John A. Quelch and Heather Beckham

Metabical is a new weight loss drug from Cambridge Sciences Pharmaceuticals intended for moderately overweight individuals. In anticipation of final FDA approval, the senior director of marketing, Barbara Printup, prepares for the product launch and must make several... View Details

Keywords: Return On Investment; Forecasting; Pricing Policies; Demand Planning; Marketing Strategy; Price; Consumer Behavior; Investment Return; Forecasting and Prediction; Product Launch; Planning; Brands and Branding; Pharmaceutical 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

February 1992 (Revised September 2003)
Case

Beech-Nut Nutrition Corporation (A-1)

By: Lynn S. Paine

The CEO of Beech-Nut Nutrition Corp. must decide what to do when he receives information that the company's supply of apple juice concentrate may be adulterated. The concentrate is used in many of the company's juice products. It appears that others in the company may... View Details

Keywords: Quality; Law; Ethics; Nutrition; Management Teams; Decisions; Business or Company Management; Communication; Governance Compliance; Information Management; Corporate Finance; Food and Beverage Industry; United States

July 2010
Case

Metabical: Positioning and Communications Strategy for a New Weight Loss Drug

By: John A. Quelch and Heather Beckham

Cambridge Sciences Pharmaceuticals (CSP) expects final approval for its revolutionary weight loss drug, Metabical. Metabical will be the only weight loss drug with FDA approval that is also clinically proven to be effective for moderately overweight people. Barbara... View Details

Keywords: Product Positioning; Marketing Communications; Product Launch; Consumer Behavior; Pharmaceutical Industry; United States

December 2022 (Revised September 2024)
Case

Sword Health

By: Regina E. Herzlinger, Annelena Lobb and Carin-Isabel Knoop

Virgilio “V” Bento, CEO of Sword Health—a startup that provided virtual physical therapy to patients in self-insured firms via AI and sensor technology with supervision by a physical therapist with a doctorate—considered how to increase its U.S. market share. To do so,... View Details

Keywords: Business Growth and Maturation; Competitive Strategy; Health Industry; Technology Industry

July 2001 (Revised August 2005)
Case

Medicines Company, The

By: John T. Gourville

It is early 2001 and the Medicines Co. just received FDA approval to market Angiomax, a blood thinner to be used during angioplasties and heart procedures. It is intended to be a better alternative to Heparin, an 80-year-old drug that costs less then $10 per dose. The... View Details

Keywords: Business Model; Change Management; Decision Choices and Conditions; Cost Management; Price; Product Marketing; Product Launch; Product Development; Risk and Uncertainty; Health Industry; Pharmaceutical Industry

April 1998
Case

Cephalon, Inc.

By: Peter Tufano

In early 1997, Cephalon, awaited an FDA panel's decision on whether its drug, Myotrophin, would be approved. If the drug was approved, the firm might need substantial additional funds to commercialize as well as to buy back rights to it (which had been sold earlier to... View Details

Keywords: Risk Management; Financing and Loans; Health Care and Treatment; Pharmaceutical Industry; United States

May 2021 (Revised May 2022)
Case

Headspace vs. Calm: A Mindful Competition

By: Ayelet Israeli and Anne Wilson

By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable... View Details

Keywords: Marketing Communication; Integrated Strategy; Brand; Brand ＆ Product Management; Brand Communication; Brand Differentiation; Brand Building; Brand Management; E-Commerce Strategy; Ecommerce; App; App Development; Applications; COVID; COVID-19; Pandemic; Pricing; Pricing Strategy; Subscription Model; Subscription; Partnerships; Strategic Partnerships; B2B Vs. B2C; B2B; Health ＆ Wellness; Wellbeing; Digitization; Commoditization; Mobile App; Mobile App Industry; Mobile Healthcare; Mobile Marketing; Digital Brand; Digital Health; Consumer Health; Apps; Online Business; Online Competition; Online Community; Online Entertainment; Entertainment And Leisure; Meditation; Marketing; Marketing Communications; Brands and Branding; Price; Strategy; Competition; Competitive Strategy; Competitive Advantage; Partners and Partnerships; Health; Well-being; Mobile and Wireless Technology; Communication; Communication Strategy; Disruption; Consumer Behavior; Digital Marketing; E-commerce; Applications and Software; Health Industry; Technology Industry; Communications Industry; United States; North America; United Kingdom

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

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

August 2008 (Revised September 2008)
Case

The Flaxil Label (A)

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Product Launch; Negotiation Process; Business and Government Relations; Safety; Pharmaceutical Industry

October 2024
Case

Allurion: Competing in the Age of GLP-1

By: Satish Tadikonda, Rajiv Lal, David Lane and Sarah Sasso

Shantanu Gaur had built Allurion into a formidable business internationally, providing obesity patients with a less invasive option long before GLP-1 drugs became the latest craze. Selling Allurion's medical device across 60+ countries, he awaited FDA approval to bring... View Details

Keywords: Corporate Entrepreneurship; Health Care and Treatment; Global Strategy; Competitive Strategy; Medical Devices and Supplies Industry; Health Industry; United States; United Kingdom; France; India; Brazil; Middle East

August 2012 (Revised December 2023)
Background Note

Note on Health Insurance Coverage, Coding, and Payment

By: Regina E. Herzlinger and Jo Ellen Slurzberg

This note explains how health care technology and service innovators receive payment from government insurers, in the U.S. and abroad, and from private insurers. It describes each of the three steps needed to obtain reimbursement: coverage, coding, and payment. It also... View Details

Keywords: Health Care Delivery; Health Care Costs; Health Insurance; Health Insurance Marketplaces; Health Care and Treatment; Cost; Insurance; Innovation and Invention; Private Sector; Public Sector; Decision Making; Information Technology; Health Industry; Insurance Industry

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