Category Archives: Business

25Oct/17
blackswan

Two Black Swans, One Devastated Region

A Hurricane Named Maria 

By:  Sandra K. Rodriguez, Market Analyst

Disclaimer:  Being based in Puerto Rico, I lived through Irma and Maria; however best practices recommendations apply to anywhere in the world that may suffer a catastrophic event.

A black swan event is one that is extremely rare and unlikely.  Hurricane Irma stormed through the Caribbean on September 6, 2017.  Two weeks later, on September 20, 2017, Hurricane Maria made landfall in Puerto Rico and collided with the supply chains of leading life science companies who have a manufacturing presence on the island.

Scott Gottlieb, M.D., Commissioner of the FDA, took notice immediately and issued a press release within five days to address how the agency would help the island recover and what steps should be taken to avoid critical drug supply shortages for US citizens residing on the island and the US mainland.  Gottlieb wrote, “News coverage has touched on an issue about which we at FDA are very concerned and we are working around the clock to address – the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island.” Continue reading

11Oct/17
SIAC17

New Versions of Everything, New Expectations

Realizing the Digital Twin – 2017 Siemens Analyst Conference

By:  Sandra K. Rodriguez, Market Analyst

The Siemens Analyst Conference took place in Boston from September 6 – 7, 2017.  Dr. Jan Mrosik, CEO Siemens Digital Factory Division, opened the conference with a clear message:

“Digitalization changes everything and a common digital thread enables continuous business transformation!”

Siemens has invested $6.5B since 2013 in its digital enterprise suite, beginning with the acquisition of LMS International which expanded its strategy for system validation and verification.  The company is also seeking to establish a leadership role in electronics and semiconductor product and process simulation by adding Mentor Graphics to its Digital Factory division.

A Digital Twin is not a concept, it is a disruptive technology.  It enables companies to competitively change the way products are realized, come to life and evolve.  Adding digital twin technology within a smart factory offers companies three unique benefits:

  • The ability to predict profitability through analysis of production scenarios
  • Improved efficiencies through the digital thread and virtual commissioning
  • Optimized production through the comparison of real and digital production systems

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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.

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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