Category Archives: Quality

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.

30Aug/17
Data_Integrity_Text

WHY Is Data Integrity the Foundation of Good Science?

By: Sandra Rodriguez, Market Analyst and Ellyn McMullin, Research Associate, Axendia Inc.

Data_Integrity_TextOne of the basic tenets of investigative reporting is getting to the facts by asking ALL the relevant questions:  Who, what, where, when and why?  The issues, concerns and proposed solutions surrounding Data Integrity deserve no less a rigorous analysis.

While several articles have been published on data integrity addressing the: who, what, where and when, the most important question is left unanswered.  WHY Is Data Integrity the Foundation of Good Science?

Answering who, what, where and when is a mechanical process.

  • Create a procedure requiring people to sign-wet or electronic: Who
  • Record the data element: What
  • Establish the source of the data element: Where
  • Record the time: When

The “Why” is the rationale for the procedure: “Data Integrity IS The Foundation of Good Science.”

Continue reading

25Apr/17
Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.

08Mar/17
Supply-Chain-Squares (3)

QUALITY MANAGEMENT ACROSS YOUR GLOBAL SUPPLY CHAIN

How Can the Cloud Help with Data Integrity and Quality Issues Across your Global Supply Chain?

REGISTER TODAY
Date: MARCH 22, 2017
Time: 1:30 PM EST

All your data used to be close by — under your control — and easily monitored. Now, as you outsource more and more, your direct control on quality is weakened. By using a cloud based solution you can take back control. You can monitor your quality metrics in real time wherever they’re being generated and head off issues way before an FDA investigator even sets foot in your facility.

In this session, you will learn how to:

  • Drive enhanced product quality at reduced costs and risks while assuring compliance with all applicable regulatory requirements
  • Leverage modern quality systems to improve visibility, control and collaboration across your supply chain
  • Shift from just documents to also including data to support quality metrics across global and externalized supply chain networks
  • Reduce inspection frequency and risk through modern quality systems and real-time quality metrics
  • Reduce data integrity risks before they occur
  • Sleep better at night!

Attend the Webinar – Sponsored by Veeva

28Feb/17
online-survey

Medical Device Industry Survey

Do Medical Device Manufacturers Have a Culture of Innovation and Quality?

Help Us Find Out!

Flat line alert on a heart monitor - 3d render on detail pixellated screeen

  • Are you Manufacturing Innovative Medical Devices?
  • Is your company building a culture of innovation and quality?
  • How do your actions compare with your peers?

To find answers to these and other questions of interest to the medical device community, we are asking for your participation in this global research study.

The survey also seeks to understand:

  • What practical steps medical manufacturers are taking to evolve their quality practices
  • The role of automation in supporting best practices for compliance and quality
  • How manufacturers are incorporating smart, connected sensors across their product portfolio
  • The impact of the Internet of Things (IoT) on medical device manufacturers

As a survey participant, you may register to receive a complimentary copy of the research report.  Please Note: All individuals responses will be kept strictly confidential and only aggregated data will be used.

Follow this link to begin the survey.

This primary research is being conducted by Axendia and sponsored by PTC.