As value-based payment models increasingly shift risk and accountability to healthcare provider, medical device companies must change the way they do business.

Kim White and Matt Althage

The healthcare industry is facing enormous pressure in the form of spiraling cost inflation, lagging quality indicators, rising insurance premiums, and increased demand for price transparency to deliver better health outcomes at lower prices. The historical fee-for-service business model that rewards the volume of treatments and encourages unnecessary care without reference to outcomes is being challenged by public and private payers. Payers are experimenting with value-based payment models, such as bundled payments, population health management, and capitated payments...

August 22nd, 2016
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Medtech startup RenovaCare has developed a device to spray stem cells on burn injuries in an effort to regrow new skin. Here's the latest on the company's progress.

Frank Vinluan

RenovaCare developed the SkinGun, an experimental handheld device that gently sprays stem cells that grow to form new skin on burn injuries. 

Burn victims whose injuries require skin grafts face a long recovery even when the procedure is successful. Removing skin from one part of the body and transplanting it to injured area leaves the patient with two sites that need to heal. Grafted skin can restrict joint movement, as it is unable to grow with the patient. The procedure also leaves scarring and patients typically need physical therapy...

August 19th, 2016
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Once focused on medical imaging, Israel's innovative medical device sector is starting to spread its wings.

 

The 15th Annual IATI BIOMED 2016 Conference and Exhibition was held May 24–26, 2016, in Tel Aviv, Israel. As a long-time medical development person and someone who has attended many medical conferences and expos over the years, I found it an interesting opportunity to compare and contrast the development environment in what has become one of the most significant medical development hubs outside of the United States. In the...

August 19th, 2016
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David Perez

 

In April 2016, David Perez was sentenced to 30 months in jail for selling an unapproved medical device called "Energy Wave" online and mailing them to customers across the United States. According to a U.S. Department of Justice press release, Perez advertised the Energy Wave through a website as a way to treat medical...

August 19th, 2016
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Occasionally, medical devices are tools for criminal acts. Here are five astonishing medical device-related crimes.

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When medical devices get mixed up in criminal acts, patients are the ones harmed. In some cases, the crimes are the result of oversight or lax processes. But in other situations—most of the cases highlighted here—criminals intentionally trick patients for profit.  

The impact on patients is cringe-worthy, appalling, hazardous, and at worst, fatal.

Read on to learn more about five recent crimes that involved medical devices. 

August 19th, 2016
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Pharmaceutical Innovations Inc.

In July 2016, Pharmaceutical Innovations Inc. of Newark, NJ, pleaded guilty to criminal charges around its distribution of ultrasound gel contaminated with bacteria, according to a U.S. Department of Justice press release

According to...

August 19th, 2016
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Paul Singh

In March 2016, Paul Singh was sentenced to six months in prison followed by one year of home detention for defrauding patients and insurers by using unapproved intrauterine devices (IUDs) in patients and billing them as approved IUDs. 

According to a U.S. Department of Justice press release, as a practicing OB/GYN in California, Singh implanted his female patients with non-FDA-approved copper IUDs he had knowingly purchased online. He fraudulently billed for these implants...

August 19th, 2016
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Vinnie Lysander Taylor

In May 2016, Vinnie Lysander Taylor pleaded guilty to charges of "receiving and selling industrial grade silicone, but representing to customers that it was medical grade silicone," according to a U.S. Department of Justice press release.

The DOJ release noted that Taylor admitted that though he was not licensed to do so, he delivered silicone injections into customers' buttocks between 2008 and December 2014. He told customers who were seeking fuller buttocks that this silicone was medical grade, but he admitted in his plea agreement...

August 19th, 2016
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Antonella Carpenter

In February 2016, a jury convicted Antonella Carpenter of attempting to defraud patients by claiming to cure cancer, according to a U.S. Department of Justice press release.

Carpenter was the owner of Lase Med Inc., which was supposed to be a cancer treatment clinic. According to court documents and trial evidence cited in the DOJ release...

August 19th, 2016
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IT cybersecurity and medical product cybersecurity have different priorities. Here's how to ensure your IT team has the tools it needs.

Stephanie Domas

Manufacturers are at various levels of preparedness when it comes to cybersecurity for medical devices, but are sincerely trying to get up to speed. The latest thinking in this space—by regulators, manufacturers, and solution providers—revolves around the difference between IT cybersecurity on the corporate/enterprise level and product cybersecurity

While IT security is traditionally focused on compliance and securing enterprise systems such as laptops and servers, medical product cybersecurity is focused on risk management, hardware and software development.

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August 18th, 2016
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