St Jude

Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

[Read More]

Cybersecurity: Lessons learned in a hacker’s era

Monday, October 2, 2017

Cybersecurity is back in the public eye, with multiple incidents of malware attacks across the globe. Merck recently suffered an attack that disrupted the company’s manufacturing capabilities. Citing concerns about the drug supply, the U.S. House Committee on Energy and Commerce has asked Merck for an update by this week. The potential for cybersecurity intrusions also touches the medical device industry. Most recently, the U.S. Department of Homeland Security and ICS-CERT issued an advisory identifying eight cyber security vulnerabilities in an infusion pump from Smiths Medical. Previously, the FDA issued safety communications regarding vulnerabilities found in certain St. Jude Medical/Abbott cardiac pacemakers and Hospira infusion pumps.

[Read More]

Report: Global medtech sales forecast to reach $522B by 2022

Tuesday, September 26, 2017

The “EvaluateMedTech World Preview 2017, Outlook to 2022” report from life science commercial intelligence firm Evaluate, reveals Medtronic was the leading medtech company in 2016 with sales of almost $30 billion and will retain the crown in 2022, with sales forecast to reach $37.7 billion. Abbott to jump to 3rd place as its acquisition of St. Jude creates the world’s second largest cardiology company.

[Read More]

Abbott addresses pacemaker hacking fears

Tuesday, September 5, 2017

On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the pacemaker).

[Read More]

St. Jude cybersecurity vulnerabilities spark medical device hacking debate

Monday, January 16, 2017

A recent cybersecurity scandal involving St. Jude’s Merlin@home device sparked a renewed discussion within the medical device industry about the best way to address security flaws discovered by independent security experts, sometimes called “white hat” hackers. As medical devices become increasingly vulnerable to cyber attack, the industry has broadly accepted its new responsibility of continuously protecting approved devices from potential security breaches.

[Read More]

An exciting year for the medical technology industry

Monday, December 19, 2016

The Pulse on Global Trials by Matthew Howes

In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

[Read More]

St. Jude Medical sues Muddy Waters and MedSec

Monday, September 12, 2016

St. Jude Medical, a global medical device company, has filed a lawsuit against Muddy Waters Consulting, Muddy Waters Capital, MedSec Holdings, MedSec and three individual defendants who are principals in these firms, for false statements, false advertising, conspiracy and the related manipulation of the public markets in connection with St. Jude Medical’s implantable cardiac management devices.

[Read More]