After two patients died and serveral more were sickened by drug-resistant bacteria traced to endoscopes, many want to know who dropped the ball, the manufacturer or regulators.

Jamie Hartford

It’s the kind of story anyone in the medical device industry—or anyone at all, for that matter—dreads to hear: Two patients at UCLA’s Ronald Reagan Medical Center were already dead, several others had been sickened, and nearly 200 more had potentially been exposed to carbapenem-resistant enterobacteriaceae (CRE), an drug-resistant superbug, traced to contaminated endoscopes.

When that story broke this past February, it was hard to escape, screamed from print and digital headlines, morning shows, and cable news loops. While at first the media homed in on the frightening facts, as the...

April 1st, 2015
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Manufacturers that implement adaptive trial design, health economics, and risk-based monitoring will have a competitive advantage.

Vicki Anastasi and James Eaton

Regulatory and reimbursement reform is moving rapidly on a global level. Regulators and payers expect real-world evidence that demonstrates efficacy, safety, and an improvement over standard-of-care relative to the cost of the device.

To stay competitive, medical device manufacturers must take a three-pillared approach to product development:

  • adopt adaptive designs to acquire higher quality clinical evidence that improves trial and portfolio decision-making
  • collect solid health economic data to justify pricing and reimbursement
  • employ error-analysis driven risk-based monitoring approaches...
March 31st, 2015
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Republican Senator Ted Cruz wants to dismantle Obamacare word for word, but physicians seem to be on board with many of the changes the law has wrought. 

Arundhati Parmar

Conservative Republican Senator Ted Cruz launched his presidential campaign saying he wants to "repeal every single word of Obamacare. 

That was before personal circumstances at home - his wife, through whose employer the Senator from Texas receives healthcare coverage, decided to stop working to help on the campaign - led him to...

March 31st, 2015
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Searching for a new CEO is tough, but a thoughtful and timely action plan can make the process smooth while ensuring the ideal person is found.

John McLean

For medical device, diagnostics, and other life sciences firms, nothing creates unease like the need for a new CEO.

Whether the current CEO is leaving on amicable or contentious terms, the prospect of having to find a new captain for the ship is daunting. The instinct is to jump right in and start naming names of potential successors. Who do we know? Who out there seems like a good fit? Is there someone internally who can take over the top job?

As much as a firm would like to find out who quickly, it is important to hit the pause button and consider the what and how questions: What type of leader do we really need for this juncture in our...

March 31st, 2015
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Gary Michelson ($1.55B)

Gary Michelson is a prolific inventor, with more than 250 U.S. patents and over 750 worldwide issued or pending patents for devices and procedures to treat spine and orthopedic problems. It was some of these patents that led to his wealth—after years of litigation with Medtronic, he was awarded a $1.35 billion settlement.

He founded The Michelson Twenty Million Minds Foundation (20MM) to replace expensive college textbooks with an open architecture digital platform. Michelson is also passionate about stray animal causes, founding the Found Animals Foundation to care for these animals. He is also offering a $25 million prize to the inventor of a non-surgical pet sterilization...

March 27th, 2015
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Elizabeth Holmes ($4.6B)

Elizabeth Holmes founded Theranos in 2003 after dropping out of Stanford University’s School of Engineering. The Theranos technology allows dozens of diagnostic tests to be run using just one drop of blood from a fingerstick. Fortune reported in 2014 that Theranos is valued at more than $9 billion.

Walgreens has partnered with Theranos; the lab testing platform is available at pharmacies in the Phoenix, AZ, and Palo Alto, CA, areas.

In an interview with TEDMED, Holmes said she believes “Theranos is a new...

March 27th, 2015
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Judy Faulkner ($2.8B)

Judy Faulkner founded Epic Systems Corp. in 1979 and is the company's chief executive officer. Epic is a private company known for its electronic health record (EHR) software. The Epic EHR is used for the medical records of 180 million patients and concentrates on 315 health organization customers.

Before founding Epic, Faulkner taught computer science at the University of Wisconsin. She is a member of the Institute of Medicine (IOM) and sits on IOM's Roundtable on Value and Science-Driven Health Care.

In early March, Modern Healthcare reported that Faulkner plans to leave her wealth to a charitable...

March 27th, 2015
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James Leininger ($1.34B)

While working in the emergency room, James Leininger founded Kinetic Concepts Inc. in 1976. Kinetic Concepts offers a range of advanced wound care products, including a negative pressure technology and the Graftjacket Regenerative Tissue Matrix. Kinetic Concepts was acquired in 2011 by Apax Partners, the Canada Pension Plan Investment Board, and the Public Sector Pension Investment Board in a transaction worth $6.1 billion. In September 2014, Kinetic Concepts was combined with LifeCell Corp. and Systagenix Wound Management Ltd. to form Acelity.

Leininger earned his medical degree from the Indiana University Medical School. He served in the Army Medical Corps during the...

March 27th, 2015
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Alfred Mann ($1.18B)

Alfred Mann's long-standing contributions to the medical device industry include founding 17 companies to treat a wide swath of diseases, including blindness and diabetes. Several of Mann's companies were acquired by large companies, including the diabetes company MiniMed Inc., the neurostimulation company Advanced Bionics Corp., and pacemaker company Pacesetter Systems Inc.. MiniMed was acquired by Medtronic in 2001, Advanced Bionics was purchased by Boston Scientific in 2004, and Pacesetter is now part of St. Jude Medical. .

Until earlier this year, Mann was chief executive officer of MannKind. He is now the company's executive chairman. MannKind won FDA approval in 2014...

March 27th, 2015
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The Stryker Family and John Brown

      

From left to right: Ronda, Pat, and Jon Stryker; John Brown

Sibling heirs Ronda ($3.7B), Pat ($2.2B), and Jon Stryker ($1.93B), as well as long-time company chief executive officer John Brown ($2B), all became wealthy through Kalamazoo, MI-based Stryker Corp...

March 26th, 2015
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