Gary Winner

In February 2012, Gary Winner was sentenced to 37 months in prison for health care fruad, money laundering, and introduction of an adulterated and misbranded medical device into interstate commerce, according to a U.S. Department of Justice press release. The release states that Winner defrauded Medicare of more than $2.2 million through orders for unnecessary medical equipment. 

Between 2005 and early 2009, Winner was the owner of durable medical equipment supplier Planned Eldercare. According to the release, Winner made employees find patients with diabetes or arthritis via telemarketing and in order to get the...

August 17th, 2015
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Donald Alan Pepin

In December 2011, Donald Alan Pepin was sentenced to 28 months in prison for buying and selling stolen insulin and test strips, according to a U.S. Department of Justice press release. Pepin was part of a large plot that led authorities to target more than fifty individuals and businesses for prosecution, according to the release.

Investigators found that Pepin paid more than $9.8 million over five years to people who stole the medical products before reselling the items to pharmacies and distributors through his company, First Medical Resources, Inc. The release also notes that the insulin was not properly refrigerated...

August 17th, 2015
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Occasionally, the medtech industry is the setting for illegal behavior. Here are 10 medical device-related crimes that landed perpetrators in jail.

Headlines about medical devices usually tout a life-saving procedure or exciting technological advances. Sometimes, though, medical devices make the news for the wrong reasons, mixed up in crimes committed by people inside and outside the medtech industry. 

Here are 10 crimes that involved medical devices and led to jail sentences for wrongdoers.

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August 14th, 2015
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Charlie Chi

In June 2015, Charlie Chi, who was formerly CEO of OtisMed Corporation, was sentenced to two years in prison. His crime? Distributing the company's OtisKnee orthopedic cutting guide after FDA turned the device down for regulatory approval.

According to a U.S. Department of Justice release, the OtisKnee cutting guide started being sold in May 2006 before FDA evaluation. The company submitted a pre-market notification to FDA in October 2008 for approval, but FDA told the company in September 2009 that approval was denied because the device had not been shown to meet safety and effectiveness standards. 

At...

August 14th, 2015
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Tonya Rushing

In May 2015, Tonya Rushing, former CEO of Endoscopy Center of Southern Nevada, was sentenced to one year and one day in prison. According to the U.S. Department of Justice release, between January 2005 and February 2008, Rushing worked with center owner Dipak Desai to overcharge private insurers, Medicare, and Medicaid for procedures done at the center. The two made employees pack procedure schedules and record a longer amount of time for anesthesia procedures. The pair also set up another company, owned by Rushing, to handle the anesthesia billing and that company kept about 9% of the money collected. The employees...

August 14th, 2015
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It's your turn. If you've had interactions with FDA, we want to hear how you'd grade the regulator.

We asked regulatory experts to tell us how they think FDA is doing, so they weighed in on the agency's performance on a number of criteria. MD+DI's FDA Report Card 2015 awarded the agency solid marks for review times and cooperation with industry, but gave lower grades on issues like transparency and enforcement.

But many of you, our readers, have had firsthand interactions with FDA too and have formed your own opinions. We want to hear from you. Take our reader poll on FDA's performance and have your (anonymous) voice heard. 

Voting ends Tuesday, August 25...

August 14th, 2015
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Intellectual property considerations need to be made at every stage of a medical device product lifecycyle to ensure strong protection and increases chances of commercial success. 

Mike McPherson

The demands placed on medical devices companies – strong regulatory control requiring high quality products with close to perfect reliability – often lead to high product development costs and long lead times to market, creating a commercial need for long product lifetimes.

In such an arena, the management of intellectual property (IP) matters to protect innovative products from competitive action, is central to commercial success. This is demonstrated by the high and growing level of patent filings in this area....

August 14th, 2015
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 Use of advanced analytics can lead to fewer recalls and safer medical devices. 

Joy Gandhi

Medical device production is on the upswing. The market has been forecasted to grow tremendously in the next five years. At the same time, devices are trending toward miniaturization and complex functionality. This is pushing the limits to manufacturability and defect detection.

Proof of these challenges in electronics, for example, is the fact that four out of the five devices with the highest number of Class I recalls in the past five years are complex electronic devices. This calls for very powerful means of analyzing complex manufacturing and design data to detect defects and process issues in order to prevent field failures. Big data analytics techniques’ ability to handle...

August 13th, 2015
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New models of care delivery are being tested for a population that is rapidly aging, but for healthcare data to flow seamlessly, interoperability is a must. 

Arundhati Parmar

As the healthcare system in the United States undergoes a seismic change from being fee-based and volume-based to one that rewards value, a big shift is occurring in demographics concurrently.

Soon, seniors will account for a big chunk of the U.S. population. The population aged 65 and over is projected to increase between 2012 and 2050, and this group will account for more than 20% of the total U.S. population by 2050, according to a 2014 Census report

Older patients with chronic diseases are a particular burden on the...

August 13th, 2015
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New research from Harvard Business School finds first mover devices have a regulatory disadvantage at FDA, making it particularly hard for small firms to be first to market. The reasons for delay may surprise you.

Marie Thibault

You've heard of the first mover advantage, but what about a first mover disadvantage? It appears that new medical devices that are the first of their kind have a slower process through FDA. Since the technology is new, it make some sense that the process at FDA would take longer, right?

But new research from Harvard Business School finds that unfamiliarity with the technology isn't the cause of this delay. Lack of familiarity with protocol is actually what makes the FDA process take longer, assistant professor of business administration Ariel Dora Stern,...

August 12th, 2015
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