All posts by Administrator

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.”

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24Aug/17
3DS-Life-Modeling

Engineering the Precision Medicine Revolution

From Quantum Mechanics to Population Health Modeling

By:  Daniel R. Matlis, President

“The Holy Grail of Life Science and Healthcare is the development of a virtual human model; to enable medical experiments in-silico, rather than in-vivo[i].” That was the opening line of my 2015 Dassault Systèmes Analyst Conference Brief: “Medical Experiments on your Digital Twin

At this year’s conference, Dassault Systèmes demonstrated that they are at the forefront of engineering the Precision Medicine Revolution.  The company’s goal is to unify the real and virtual worlds, to optimize Patient and Physician experience through the best collaborative science.

Healthcare is shifting away from episodic care at a hospital or a medical practitioner’s office. There is also a movement away from the traditional reactive model healthcare to proactively addressing potential issues and offering preventive care.  This is driving Life-Science organizations to engineer more holistic and personalized approaches to care.

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26Jul/17
New Idea

#newidea or #throwbackthursday?

By: Giselle C. Matlis, Research Assistant

Outcome based Medicine

On Monday June 26th 2017, Medtronic announced that they will be using a “new outcomes-based [payment] agreement with Aetna (NYSE:AET) for type 1 and type 2 diabetes patients”. Hooman Hakami, president of the Diabetes Group at Medtronic stated that “this agreement reinforces our shift towards value-based healthcare. We know technology alone isn’t enough and ultimately improved outcomes are what matter…Our goal is to continue to lead by driving innovation that demonstrably improves patient outcomes, elevates patient experience and lowers the total cost of care”.

This sounds like a great new idea.

Ironically, Axendia President, Daniel Matlis, predicted this ten years ago!

In a June 4, 2007 blog post on Axendia.com, Mr. Matlis noted that Sear’s Craftsman line of tools had a lifetime guarantee. This was a business decision by Sears to gamble that the high quality of their tools would minimize warranty costs. He then suggested that a similar approach could work in the healthcare industry and projected that out-come based billing would be the next big thing for the pharmaceutical world. He stated that this approach could, “enable a new health care paradigm, where all involved have the proverbial ‘skin in the game’. Patients get access to drugs that are nearly certain to be effective. Health care payers can ‘afford’ to make new, and let’s face it, expensive, treatments available to patients since they are provided a degree of confidence of treatment effectiveness, and limited downside through a refund”.

So, you decide: #newidea or #throwbackthursday?

06Jul/17
Mind-Boggling-Change

Thriving in the Age of Mind Boggling Change

By: Daniel R. Matlis, President Axendia, Inc.

Thriving in the Age of Mind Boggling Change

“Change is the Only Constant” said Heraclitus of Ephesus two and a half millennia ago.  While change has been the constant throughout human history, the rate of change seems to be accelerating exponentially.

Change, and the need to adapt to “Mind Boggling Change” was a key theme at QAD Explore 2017 in Detroit last month.  “Adapting to this rapid change is an imperative,” said Pam Lopker President of QAD. Ray Kurzweil, inventor, futurist and Director of Engineering at Google explained that while the human brain operates linearly, the rate of change growing is exponential. In information technology, this is represented by Moore’s law. Correspondingly, the rate of information processing is growing exponentially.

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