Category Archives: Quality

14Feb/18
thinking

What is FDA Thinking? We Asked, They Answered!

An Interview with Francisco (Cisco) Vicenty – US FDA

By: Daniel R. Matlis, President

That is a question I often hear from industry executives around the globe.

To answer this question, I sat down with FDA’s Francisco Vicenty, for over an hour, to discuss a wide range of topics and gain an understanding of FDA’s current thinking on these topics. Cisco Vicenty is the Case for Quality Program Manager at FDA’s Office of Compliance, CDRH.

FDA-Axendia-Webinar

Driving a Culture of Quality in Industry

The overarching drive at FDA is enabling high levels of product excellence and innovation across industry and to provide patients with access to high quality, safe, and effective medical devices.  The agency wants to incentivize industry to adopt quality best practices; to adopt product quality excellence that drives improved patient outcomes.


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11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as:

11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

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03Nov/17
CLOUD IMAGE

ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions

By: Daniel R. Matlis

Axendia was recently briefed by ComplianceQuest’s executive team.  The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.Network_Navy_F

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

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07Sep/17
cyber security copy

FDA confirms: Hacking a pacemaker only requires commercially available equipment

By: Giselle C. Matlis, Research Assistant

On August 29, 2017 the FDA published a Safety Communication, Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers , where they announced that they have reviewed information concerning potential cybersecurity vulnerabilities associated with implantable cardiac pacemakers.cyber security copy

In its Safety Communication, FDA confirmed that if exploited, these vulnerabilities could allow an unauthorized user with commercially available equipment to access a patient’s device and could be used to modify programming commands to the implanted pacemaker.  This could result in patient harm from rapid battery depletion or administration of inappropriate pacing. At this point, there have been no known patient harm, however, the FDA has approved a firmware update that addresses these cybersecurity vulnerabilities and reduces the risk of exploitation and subsequent patient harm.

In fact, former Vice President Dick Cheney discussed his fears that terrorists could hack into his pacemaker, a fear he saw come to life while watching an episode of “Homeland.”Indeed, when doctors implanted Cheney’s pacemaker in 2007, they disabled the wireless feature out of fear that someone could manipulate it and disrupt his heartbeat.

The FDA has been warning about cybersecurity on medical devices for over a decade.  As Eric Luyer stated in his March 2017 article “the time to implement a proactive, comprehensive risk management program to eliminate cybersecurity threats is now”.

Cybersecurity of connected medical devices must be a key step in the design process.  Medical Device manufacturers must be proactive instead of reactive to cybersecurity concerns when developing new products.