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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.


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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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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Siemens Industry Analyst Conference 2015

By Sandra K. Rodriguez, Research Associate

Digital Twins Enable Time Travel

If you had a time machine, would you rather take a peek in to the future or change something in the past?   If you could build a digital twin that enabled time travel, would you?

The theme of this year’s Siemens Industry Analyst Conference was Realizing Innovation.   Virtualization and digitalization capabilities throughout the product lifecycle are giving industry the opportunity to do something new – time travel.

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An Anti-DRIP Campaign

By Ellyn McMullin, Research Associate

Unlocking Big Data to Achieve Business Value

Of the many workshop type of meetings I have attended, this is the best one I have gone to…there was an actual success story!  This is the feedback from one participant at the Executive Roundtable on Big Data in Life Sciences.

That’s what happens when a leading business transformation company provides an environment for its clients and partners to discuss mutual concerns and potential solutions.  On August 27th, Trace3 brought together Executives from Merck, Novo Nordisk, NNIT, BMS, and J&J Janssen to discuss Big Data in Life Sciences in Princeton, NJ.

Trace3 is a business transformation partner, helping organizations through high-end consultancy.  The company empowers organizations to keep pace with the rapidly changing IT landscape by leveraging innovative technologies and organizational health.  Trace3 has a Big Data practice and had one of their principals, Carey Moretti, moderating the roundtable.

The Executive Roundtable explored the challenges and rewards of implementing Big Data and analytics within the complex regulated Life Sciences space. Axendia’s President discussed industry wide trends and FDA’s perspective on Big Data.  He offered insight on how to leverage a multitude of varying data sources from new and legacy systems to gain greater visibility and how to improve product quality while improving revenue and lowering costs.

Jerry Megaro, Merck & Co.

Jerry Megaro, Merck & Co.

The keynote speaker, Jerry Megaro, Director of Innovation and Analytics at Merck & Co. has a degree in Chemical Engineering from NJIT and 15 years of experience of working in Merck’s Manufacturing arena.   He is currently leading initiatives to transform Merck Manufacturing into a data driven organization to enhance Merck’s performance across the Supply Chain.

Reverse the DRIP

Remember GIGO (Garbage in, Garbage out)?  It refers to the fact that computers, since they operate by logical processes, will unquestioningly process unintended input data (“garbage in”) and produce undesired, often nonsensical, output (“garbage out”).  The issue about the quality of the data generally is no longer a major concern, but the use of the data output is.  Unfortunately many companies are the sufferers of DRIP!  DATA  RICH  INTELLIGENCE POOR

Life-Science companies have vast amounts of data (Big Data) generated by a multitude of systems (SCADA, Historian, MES, ERP, EAM, LIMS, etc.) but unfortunately have very little Intelligence on how this information can be harnessed to produce a better quality product.

To request a copy of the Executive Roundtable event note and learn how Merck & Co., Unlocked Big Data to Achieve Business Value, please click here.