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2024
Article

Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway

By: Mateo Aboy, Cristina Crespo and Ariel Stern

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

April 1993 (Revised July 1994)
Case

MathSoft, Inc. (A)

By: V. Kasturi Rangan

MathSoft's VP of sales has doubled the size of the company's direct field sales force to support the launch of a new, high-end workstation software product priced at almost $9,000. However, sales of the new product are far below plan. At the same time, the VP of... View Details

Keywords: Information Technology; Corporate Entrepreneurship; Applications and Software; Communication Strategy; Salesforce Management; Marketing Channels; Advertising; Product Launch; Information Technology Industry; Industrial Products Industry; United States

November 2006 (Revised March 2007)
Case

eDonkey--Deciding the Future of File Sharing

By: Felix Oberholzer-Gee

Sam Yagan, CEO of the upstart MetaMachine, Inc., received a letter from the Recording Industry Association of America, Inc. (RIAA) asking him to shut down eDonkey, MetaMachine's popular file-sharing system. In September 2005, more than 30 million users relied on... View Details

Keywords: Applications and Software; Crisis Management; Music Entertainment; Legal Liability; Copyright; Information Technology Industry; Music Industry; United States

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07 Aug 2007
First Look

First Look: August 7, 2007

Working PapersThe New Market for Federal Judicial Law Clerks Authors:Christopher Avery, Christine Jolls, Richard Posner, and Alvin E. Roth Abstract In the past, judges have often hired applicants for judicial clerkships as early as the... View Details

Keywords: Martha Lagace

July 2000 (Revised November 2001)
Case

Catalyst Medical Solutions

By: Amy C. Edmondson, Richard M.J. Bohmer and Naomi Atkins

Faced with a drop in the NASDAQ, four eHealth entrepreneurs must decide between two distribution strategies for their new company's technology. The team, comprised of three full-time resident physicians and an MBA, has developed software to enable electronic... View Details

Keywords: Product Development; Health Care and Treatment; Distribution; Strategy; Venture Capital; Applications and Software; Partners and Partnerships; Borrowing and Debt; Information Technology Industry; Service Industry

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September 2021 (Revised December 2023)
Case

On the Bubble: Startup Bootstrapping

By: Jeffrey J. Bussgang, Tom Quinn and Annelena Lobb

Bubble was a software company in the low-code/no-code market, making tools that allowed users without traditional programming backgrounds or technical skills to build software. The case covers cofounder Joshua Haas’s engineering background, as he experienced a high... View Details

02 Nov 2010
First Look

First Look: November 2, 2010

choose which mobile development software platform to invest in. Written from the perspective of an established consumer bank that is about to commence development on its first downloadable application for... View Details

Keywords: Sean Silverthorne

February 2016 (Revised February 2017)
Case

Mattermark

By: Jeffrey Bussgang and Annelena Lobb

Mattermark, a software-as-a-service company that sold software allowing companies to access financial information about privately-held companies and startups, was at a turning point. CEO Danielle Morrill had to allocate investment funding from a Series A round. She... View Details

Keywords: Entrepreneurship; Applications and Software; Business Startups; Marketing; Strategy; Technology Industry; United States

October 2006
Case

Lean at Wipro Technologies

Wipro Technologies, a rapidly growing software services firm based in India, decided to use principles from the Toyota Production System (also known as lean) to fundamentally change their operating model. Looks at why Wipro chose to use lean and how they went about... View Details

Keywords: Organizational Change and Adaptation; Competitive Advantage; Applications and Software; Operations; Information Technology Industry; India

13 Mar 2012
First Look

First Look: March 13

the reduction in store size was associated with TFP of retail chains falling by 0.4% per annum, or 40% of the post-1995 slowdown in UK retail TFP growth. China's Growing IT Services and Software Industry: Challenges and Implications... View Details

Keywords: Sean Silverthorne

April 2006 (Revised August 2007)
Case

BitTorrent

Involves the copyright issues associated with Bram Cohen's revolutionary software program BitTorrent, which makes it possible to transfer very large files, such as movies, at a high speed over the Internet. The program, which is available for free over the Internet, is... View Details

Keywords: Lawfulness; Lawsuits and Litigation; Applications and Software; Copyright; Internet and the Web

2014
Case

Yonyou 2013

By: F. Warren McFarlan, Zheng Xiaoming and Ziqian Zhao

The case describes how a leading Chinese management software provider Yonyou (formerly known as "UFIDA") disrupted its value chain-based business model to transform itself into a platform provider. The case describes Yonyou's past success, the market forces and... View Details

Keywords: Business Models; ERP; Platforms; Strategy; Transformations; China; Information Technology; Applications and Software; Digital Platforms; China

March 2021
Case

VideaHealth: Building the AI Factory

By: Karim R. Lakhani and Amy Klopfenstein

Florian Hillen, co-founder and CEO of VideaHealth, a startup that used artificial intelligence (AI) to detect dental conditions on x-rays, spent the early years of his company laying the groundwork for an AI factory. A process for quickly building and iterating on new... View Details

Keywords: Artificial Intelligence; Innovation and Invention; Disruptive Innovation; Technological Innovation; Information Technology; Applications and Software; Technology Adoption; Digital Platforms; Entrepreneurship; AI and Machine Learning; Technology Industry; Medical Devices and Supplies Industry; North and Central America; United States; Massachusetts; Cambridge

October 2015 (Revised October 2016)
Case

Building Watson: Not So Elementary, My Dear! (Abridged)

By: Willy C. Shih

This case is set inside IBM Research's efforts to build a computer that can successfully take on human challengers playing the game show Jeopardy! It opens with the machine named Watson offering the incorrect answer "Toronto" to a seemingly simple question during the... View Details

Keywords: Analytics; Big Data; Business Analytics; Product Development Strategy; Machine Learning; Machine Intelligence; Artificial Intelligence; Product Development; AI and Machine Learning; Information Technology; Analytics and Data Science; Information Technology Industry; United States

Web

2+2 Program - MBA

roles ( e.g. engineering, software development, scientific research, and medical functions. These roles typically require a high level of specialized knowledge, skills, and expertise in a particular field. ) View Details

May 2008 (Revised May 2008)
Case

Symyx Technologies, Inc.

By: H. Kent Bowen, Courtney Purrington and Thomas D. Perry

Symyx is a science-based company spun out of Berkeley. Its unique materials technology has been exploited for 10 years, but the company needs a new business model. The company concept required the invention of hardware and software to do high throughput materials... View Details

Keywords: Business Model; Transition; Engineering; Technological Innovation; Resource Allocation; Product Development; Partners and Partnerships; Science-Based Business; Information Infrastructure; Applications and Software

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2023
Article

Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation

By: Jan B. Brönneke, Annika Herr, Simon Reif and Ariel D. Stern

Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the health care delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital... View Details

Keywords: Digital Transformation; Applications and Software; Product Development; Insurance; Policy; Health Industry; Germany

September 2014 (Revised February 2017)
Case

Belk: Towards Exceptional Scheduling

By: Ethan Bernstein, Saravanan Kesavan, Bradley Staats and Luke Hassall

With 24,000 staff and over 300 stores, Belk Inc. sought to replace its entirely manual labor scheduling system with an automated software solution from Reflexis. Belk hoped the upgrade would simplify scheduling, reduce time employees spent in non-customer-facing roles,... View Details

Program

Competing in the Age of AI—Virtual

will delve into diverse applications of AI, machine learning, predictive modeling, and data science; explore network effects and platform strategies; and learn how to build an AI factory that enables your company to compete successfully... View Details

October 1991 (Revised June 1996)
Case

Lotus MarketPlace: Households

By: Lynn S. Paine

Managers at Lotus and Equifax must decide what to do about their new jointly developed database and software product Lotus MarketPlace which has been criticized as a threat to individual privacy. The Product, which would allow small businesses to buy targeting mail... View Details

Keywords: Information; Business or Company Management; Rights; Ethics; Marketing Communications; Applications and Software; Product Marketing; Information Technology Industry

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