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Category: Medical Device Industry

Nov
02

Budgeting for a Pharmaceutical or Medical Device Recall

It’s budgeting season, and most leaders are hoping and planning for a banner year. New product developments. Innovative strategies. Expanded market share. Everyone hopes they will avoid any sort of crisis in the coming year, and as a result, few plan for one. But one of the most disruptive crises medical device and pharmaceutical companies will face is also among the most likely – product recalls. Consider this: Through Q3 2017, 144 companies experienced more than one pharmaceutical or medical device recall.

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Aug
29

A Bitter Pill: Recalled Pharmaceutical Units Increase 444 Percent in Q2

By ExpertSolutions Tags: Recall Index,

Pharmaceutical recall activity saw a disturbing rise not only in the volume of products recalled last quarter, but also in the severity of risk to consumers, according to the Q2 2017 Recall Index. Pharmaceutical recalls increased 6 percent over the previous quarter to 86. More jarring, the volume of recalled drug units circulating in homes and store shelves climbed 444 percent over the previous quarter, making it the most active quarter since Q4 2014.

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Aug
11

Device Disconnect: UDI and EHR Challenges in Medical Device Recalls

Medical device manufacturers have worked to meet the Food and Drug Administration’s (FDA’s) stricter regulations for Unique Device Identification (UDIs) every year since September 2014. Now humans and computers can access vital product information like never before, all from the special barcodes on the latest medical devices.

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Jun
20

Digital Devices: The FDA’s Latest Initiatives

The role of digital technology in medical devices has received a lot of attention in recent years – and raised a lot of questions. Where do consumer products end and medical devices begin? What are the potential privacy implications? How will the regulations governing these products evolve? The Food and Drug Administration (FDA) recently made new announcements regarding its approach to these devices in a new

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Jun
01

How Outdated Data Impacts Medical Device Recalls

A medical device recall that affects only the provider and physician level sounds like it should be a simpler process than one that impacts the patient level. But these recalls can still involve serious pitfalls, especially when it comes to data – specifically, outdated data.   While a brick-and-mortar hospital doesn’t change sites often, smaller clinics and other facilities may move locations much more frequently.

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