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Posts Tagged ‘medical device’

3D printing’s breakthrough in the life science market

March 24, 2016 Leave a comment

16661915478_b89cf8096e_qA new item is being introduced into the life science market and it’s getting wide recognition for being the first of its kind: 3D printing. There has been much talk regarding the world of 3D printing but it has not been previously connected with the life science industry. The FDA has approved the first 3D printing drug, produced by Aprecia Pharmaceuticals and its being made to treat seizures and epilepsy.

The 3D pill hit the market earlier this year and questions as to whether the same guidelines apply to the production are arising. When a new drug is introduced, there are several markers that the company must follow, what companies are wondering now is if the same rules apply for a drug that is being 3D printed. Will there be similar guidelines for equipment use and quality control? Quality assurance has been one of the biggest questions surrounding 3D printing in terms of products; with the product now being of a medical background the quality control guidelines are going to be strictly followed and monitored to be sure the product comes out the same as it would under a mechanically generated pill. Read more…

Life science companies face increased risk of cyber exposure

November 3, 2015 Leave a comment

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Cyber hackers frequently target life sciences companies due to the amount of sensitive data that they possess. Vulnerabilities within the industry often include outsourcing information technology services, limited data storage protection, and inadequate IT policies and procedures. A PwC survey was recently conducted and revealed that almost 50 percent of pharmaceutical and life science organizations have experienced a security breach in the past year; and the biggest threats to these two industries are sophisticated viruses such as Advanced Persistent Threats (APTs) and malware exploits. Read more…

Attention doctors and drug makers: Sunshine Act database goes live Sept. 30th

September 18, 2014 Leave a comment

money_medical_computerOn September 30th, the Centers for Medicare and Medicaid Services (“CMS”) will publicly release all sales and marketing expenses from drug companies to doctors and hospitals. While cost transparency tends to focus on medical providers and insurers, the financial relationships between drug manufacturers, physicians and teaching hospitals have become heavily scrutinized. The initiative, arising from a section of PPACA commonly known as the “Sunshine Act,” is part of nationwide effort to promote transparency throughout the healthcare industry. The law requires applicable manufacturers of covered drugs, devices, biological products and medical supplies to report to CMS information about payments made to physicians and teaching hospitals as well as any ownership and investment interests held. Submitting the information to a federal entity will hopefully reduce gifts and kickbacks that doctors sometimes receive when agreeing to use a drug company’s product.  Read more…

FDA’s new cyber security lab tests for “fuzzing” to promote medical device safety

August 26, 2013 Leave a comment

pacemakerThe FDA will reportedly launch a new cyber security laboratory to address security concerns for medical devices. The administration says that it is in the midst of developing new product regulations for medical device manufacturers to guard against hacking attempts. The labs will be used to test medical devices for vulnerabilities to data “bugs” that cause software to crash and disable system functions. The process, called “fuzzing” subjects a piece of software in the device to an influx of unintended input data requests in order to test how the device responds. The results help determine any vulnerabilities and allow manufacturers to fix them before the product is released, thus making products safer for patients and less likely to break down.

The announcement comes in response to several warnings from the National Institute of Standards and Technology (NIST), security researchers and other government agencies about the need Read more…