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Show Results For
- All HBS Web
(2,822)
- People (8)
- News (334)
- Research (2,181)
- Events (3)
- Multimedia (5)
- Faculty Publications (1,710)
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 01 Mar 2011
- News
The Path to Economic Revival
becomes more and more problematic. We see the symptoms of decline, which are driven by things like labor arbitrage and industries moving assembly overseas, followed by more and more sophisticated work. The thesis that we advance is that... View Details
- 13 May 2013
- Blog Post
"I never thought I would be a business person until…”
minored in Media Studies at Korea University. I never thought I would be a business person until I interned at The Boston Consulting Group. I worked on a technology incubation project for a Korean heavy industries conglomerate. I was... View Details
Keywords: Manufacturing
- 01 Dec 2009
- News
Losing Our Competitive Edge
critical components of solar panels, among others. How did this happen? A big part of the reason is the outsourcing of development and manufacturing work to companies abroad. The result: a damaging deterioration in the collective... View Details
- 17 Mar 2011
- News
Make or Break for the USA?
earlier this year, Barack Obama appointed General Electric CEO Jeff Immelt (MBA ’79) to head the President’s Council on Jobs and Competitiveness. Historically, HBS and its alumni have played a key role in the country’s manufacturing and... View Details
- 06 Apr 2020
- Research & Ideas
Where Do Workers Go When the Robots Arrive?
Economics researchers have long studied how local workers respond when an industry such as steel manufacturing is squashed by obsolescence or competition. Is the region able to regenerate with new View Details
- 06 Jan 2012
- News
Where Are They Now?
his company, Sundaram Medical Devices, was awarded in 2010 in the first annual HBS Alumni New Venture Contest. But Mahesh, the founder and CEO of Sundaram, a manufacturing start-up in Chennai, India, that is building high-quality,... View Details
- 01 Aug 2001
- News
William F. Connell (MBA '63)
manufacturing, announced that Ogden would spin off its shipyard and six manufacturing companies. Bill Connell, then 47, was executive vice president of Ogden, and after seventeen years with the company, he was not willing to accept the... View Details
- 01 Jun 2012
- News
Made in the USA
Wisconsin cheddar, but how about Wisconsin Ackawi or Wisconsin Asadero? Twenty years ago, Paul Scharfman (MBA 1979) acquired a small, undercapitalized cheese manufacturing operation in rural Wisconsin, about an hour’s drive from Madison.... View Details
- 01 Dec 2014
- News
Instilling Production with Principles
Video Embed The Esquel Group has reduced water consumption at its factories by more than 50 percent in the last nine years. Asia–based Esquel Group is one of the world’s largest manufacturers of high-end cotton shirts, producing about 100... View Details
- 23 Jul 2024
- In Practice
The New Rules of Trade with China: Navigating Tariffs, Turmoil, and Opportunities
world’s leading rail car manufacturer headquartered in Beijing. These cars are assembled by American workers in Springfield, Massachusetts, a city that until 1920 was the center of US railway manufacturing. CRRC has made the largest View Details
- 25 Feb 2020
- News
Beyond the Plastisphere
bacteria, previous attempts to manufacture it at industrial scale were stymied by the need for expensive feedstocks such as sugar and seed oils. Full Cycle, however, coaxes microbes to make PHA from organic... View Details
- 10 Apr 2006
- Research & Ideas
American Auto’s Troubled Road
industry shaped how America lived, worked, and played, helping the country grow into the colossus of the twentieth century. But now the U.S. industry, once the bellwether of the nation's economy, may become just another, ordinary player... View Details
- 10 Oct 2005
- Research & Ideas
Homers: Secrets on the Factory Floor
alongside the official engine productions. Many craft industries, specifically metal industries, have traditions of homer making. In a recent survey conducted in France, 28 percent of male factory workers reported that on the job they frequently or occasionally View Details
- 30 Oct 2018
- News
Paths of Victory
company is planning to add 50 employees over the next year and currently is serving more than 500 clients in 50 industries throughout Brazil, as well as clients in Turkey, Argentina, and Portugal. “Hanging a three-foot check for $50,000... View Details
- 01 Feb 2002
- News
If You're #1, Watch Out
required to achieve better and better results. When the product the customers use isn't good enough, its architecture is proprietary and its manufacturers make money. When it's more than good enough, its architecture becomes modular,... View Details
- 01 Sep 2010
- News
Start-Ups Make Their Pitch
their start-up pitches to a panel of judges in late April. To his surprise, Mahesh, representing the HBS Club of India, took top honors and was awarded a $25,000 cash prize for his plan to manufacture low-cost medical beds for Indian... View Details
- 17 Dec 2015
- News
Acquiring Business Skills To Advance A Career Trajectory
technology is expanding rapidly as the industry is being reinvigorated with new competitors and advanced electronics, materials, and manufacturing processes,” says Sondecker. His interest in aerospace began... View Details
- 01 Sep 2016
- News
The Untold Story of the US Auto Bailout
The US automotive industry collapse was one of the most important business stories to come out of the 2008 financial crisis—and like so many events of that time, it was big on headlines but short on nuance. To address that shortfall,... View Details
- 01 Dec 2015
- News
3-Minute Briefing: Michelle Ross (MBA 2011)
Math and science were always a part of me. And I’m the oldest child in my family, too, so I don’t want to say that I like to boss people around—but it came more naturally to me to delegate. Kettering University had a co-op program, so as I earned my degree in View Details