Delving deeper on FDA’s final guidance for reprocessing medical devices in healthcare settings.

Marie Thibault

After digesting last week’s final FDA guidance on medical device reprocessing, stakeholders discussed their impressions of the agency’s recommendations. A lawyer points out a new quirk manufacturers will need to consider, while a patient advocate explains why he believes the guidance does not address the underlying problem.

The Basics

As reported last week, FDA has released its final guidance on...

March 20th, 2015
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A new report from PricewaterhouseCoopers shows that the Affordable Care Act has directly and indirectly spawned new companies as savvy entrepreneurs rush to avail of new opportunities.

Arundhati Parmar

Obamacare or the Affordable Care Act leads to strong emotions for and against the law that is now five years old.

But in a new report from PricewaterhouseCooper's Health Research Institute about the five trends emerging from the law, one thing seems to be clear.  

It appears that Obamacare has been a veritable engine of innovation. 

" The ACA - by bringing millions more paying customers into the market, promoting transparency,...

March 20th, 2015
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The controversial law has now been in effect for five years and a new report seeks to evaluate the five trends it has helped create or accelerate. 

Arundhati Parmar

 

Love it or hate, there's no denying that the Affordable Care Act or Obamacare, has wrought a significant amount of change in the world of healthcare.

PricewaterhouseCoopers's Health Research Institute took a deeper dive into those very changes and in its latest report, enumerate the five trends to watch.

"Not since the Telecommunications Act of 1996, has a piece of legislation sparked such significant changes in a leading sector of the economy," the report posits and few would argue about...

March 19th, 2015
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Despite being a regular target for criticism, FDA’s Center for Devices and Radiological Health is scoring high on its customer satisfaction survey.

Marie Thibault

 

FDA’s Center for Devices and Radiological Health (CDRH) is seemingly always being scrutinized for its device recalls, guidance documents, and rules. Its audience is made up of industry, providers, and patients, many of whom have polar oppositve views on key issues. CDRH simply isn't in the business of making people happy. So last year, when CDRH set itself a high bar with the reported ambition of reaching at least 70% customer satisfaction in 2014 and 90% satisfaction by the end of 2015, onlookers were...

March 17th, 2015
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Government dysfunction can be seen in the Centers for Medicare and Medicaid Services' efforts to put the brakes on linking unique device identifiers with claims data.

Jim Dickinson

Despite the decade-long FDA effort to cover every possible aspect of the uses for a unique device identifier (UDI), its resulting final rule promulgated on September 2, 2013 failed to anticipate the huge mess the UDI could make if it were applied to health insurance claims forms.

Yet UDI’s potential value on those very forms was outlined in some detail in an economic impact analysis FDA made of the final rule. There, the agency said that “Distributors, hospitals, group purchasing...

March 17th, 2015
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Traditional device makers and consumer technology companies are crossing paths in making investment in a new breed of digital health companies.

Arundhati Parmar

Glooko's MeterSync Blue device can pull data from 30+plus glucose meters to Apple/Android devices

With the collission of consumer technology and medical technology, a new breed of companies is attracting strategic investors who would have been unlikely to team up on investment deals in the past.

One such company is digital health company Glooko targeting diabetes management. The Palo Alto, California company announced Tuesday that it has raised $16.5 million in a...

March 17th, 2015
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Electronic health records have now become common, but sharing and implementation of that health data is still not widespread. What gives?

Marie Thibault

Electronic health records (EHRs) have now become relatively commonplace, showing up in hospitals and doctors’ offices, but has the doctor visit or hospital stay changed much as a result? Just because all your doctors have EHRs, this doesn’t mean one specialist has all the information that your primary care physician or another specialist does. When will patient data become truly portably and impact care?

Well, according to one report at least, it seems that EHRs have been suffering from too many strict rules and not enough business sense....

March 16th, 2015
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Learn details about the potential impact of the new European Medical Device Regulation (EMDR) for medical device manufacturers and suppliers of outsource manufacturing.

By Rob Packard

During the last two decades, there has been a steady increase in the outsourcing of medical device manufacturing to contract manufacturers, service providers, and component suppliers. However, over the past few years there has also been an increase in the frequency of recalls and increased scrutiny of the supply chain by regulators. The new European Medical Device Regulation (EMDR) places additional burden on manufacturers and their suppliers. Ultimately, this may hurt the profitability of contract manufacturers and the willingness of manufacturers to outsource manufacturing. Here are some examples of how the EMDR...

March 16th, 2015
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Despite life-saving capabilities, medical devices may be causing medical errors and preventable deaths because they don’t share data, says a new survey.

Marie Thibault


Nurses are frustrated by the lack of interoperability between medical devices and believe it to be the source of at least some medical errors. A survey released this week found that 74% of nurses surveyed strongly agree that it is burdensome to coordinate data from medical devices and 50% of nurses said they have witnessed a medical error due to lack of device coordination.

The survey seeks to draw a connection between the estimated hundreds of thousands of deaths due to medical errors each year and...

March 13th, 2015
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Apple introduced its ResearchKit platform to help boost medical research, but intriguing as it is, there are real limitations. 

Arundhati Parmar

The cardiovascular app is one of the five research apps available through Apple's Research Kit platform immediately.

Apple introduced its ResearchKit platform on Monday and within 24 hours several thousand people signed up for a cardiovascular study.

Clinical trials are notorious for slow recruitment and the ResearchKit can be a game changer in that model of enrolling patients.

But...

March 13th, 2015
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