Category Archives: Technology

04Dec/18
veeva logo

Veeva is Building the Life Sciences Cloud with High Speed and Velocity

Veeva 2018 Summit Event Brief

By: Daniel R. Matlis, President

Introduction

“We are building the industry cloud for life sciences,” said Peter Gassner, president and CEO of Veeva during his keynote at the company’s summit in Philadelphia. “We want the industry and your company to be more efficient and effective – supporting your journey to improve and extend human life,” Gassner added.

The event brought together more than 1,400 life science professionals and experts showcasing the latest advancements for speeding product development in the industry.

Right Speed, Right Velocity

“Speed is one of Veeva’s core values,” said Gassner. I have a slightly different perspective.  I took Gassner aside and explained that Axendia’s analysis of the company shows that Veeva is operating at the right velocity – not simply at high speed.

veeva imageUnfortunately, our industry is ripe with examples where companies have adopted systems at breakneck speed – often to mitigate a regulatory finding, only to realize the application brought them in the wrong direction.  Testament to the ‘right speed, wrong velocity approach’ are the multitude of QMS point solutions that were implemented as a reaction to 483’s and warning letters.

Veeva has been moving with speed in the right direction; working closely with their industry customers to provide mature, preconfigured out-of-the-box suites of unified applications on a single cloud platform that support key areas across the entire product lifecycle.

Veeva has become a strategic technology partner to more than 675 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is focused on customer success through its commitment to innovation and product excellence.

My interactions with industry executives at the Summit confirm that Veeva is enabling life science companies to realize the benefits of a modern, cloud-based architecture and mobile applications for critical business functions – without compromising on industry-specific functionality or regulatory compliance.

To learn how Bristol-Myers Squibb, Gilead and Sysmex America are using Veeva’s cloud for life sciences.

Register to receive the full event brief.

 

15Nov/18
IoT Image

See Who’s Soaring to the Cloud in Support of Quality and Compliance

Companies Are Taking a Cloud-First Approach

By: Daniel R. Matlis, President and Sandra K. Rodriguez, Market Analyst

Life-Science organizations have implemented on premise electronic Quality Management Systems (QMS) for decades to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings and in response to the “Whack-a-Mole” relationship between Industry and Regulators.

WHACK A MOLE

As a result, many companies implemented “Paper on Glass”, simply duplicating existing paper quality processes in electronic QMS. This approach created an environment of a mixed bag of disparate eQMS installations throughout the enterprise that have high degrees of customization. Now, IT and quality teams are faced with the daunting challenge of upgrading, migrating, and validating outdated legacy on premise QMS systems.

However, based on Axendia’s primary research on the adoption of Cloud QMS in the Life-Science Industry, we quickly determined that companies large and small, are taking a different course and are soaring to the modern cloud.

Our latest Voice of the Customer Report highlights interviews with 10 industry executives and represents 3 innovative Cloud QMS vendors.  This comprehensive reports outlines:

  • Why Cloud is No Longer Taboo
  • Clouds Come in Many Shapes and Sizes – Not All Clouds are Created Equal
  • Executive Accounts of Cloud QMS
  • Why Life-Science Companies Are Moving to the Cloud
  • End-To-End Cloud QMS Capabilities
  • The Pros, Cons and Pitfalls to Avoid
  • Recommendations and Thoughts to Consider

You are welcome to download your complimentary preview here.

To request the full report, please contact: Axendia Research.

05Nov/18
GoogleGlass_OR

Augmented Reality in Today’s Operating Rooms – Update

Novarad’s OpenSight Augmented Reality System

By: Eric M. Luyer, Sr. Market Analyst

In June 2016, I wrote an article around the use of Augmented Reality in Today’s Operating Rooms and I used the example of Google Glass as a new technology that helps improve surgical efficiencies and aiding compliance and education.  Another great example of Augmented Reality being used in surgery was announced last week when Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company’s augmented reality headset and is the first solution for Microsoft HoloLens 510(k) cleared by the FDA for medical use.

Building upon decades of Novarad’s experience in image processing, OpenSight renders 2D, 3D and 4D images of patients interactively, while accurately overlaying them directly onto the patients’ body during surgery. The system lets clinicians see both the 3D patient image from previous scans, as well as the patient physically in front of them. OpenSight was designed to help surgeons plan for an operation and gives clinicians the tools to highlight specific body parts as well as structures that should be avoided during the procedure, according to the company. For more, see the press release.

Image Courtesy of Novarad

Image Courtesy of Novarad

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22Sep/18
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Whether Identical or Fraternal, Digital Twins Offer Deep Product, Process and Performance Insights

Siemens Industry Analyst Conference 2018 Event Brief

By: Sandra K. Rodriguez, Market Analyst

The mercury was climbing outside of the Boston Marriott Long Wharf as Siemens executives took the stage to kick off Siemens’ 11th Annual Industry Analyst conference August 27-30, 2018.  “The boundaries between systems are disappearing,” said Tony Hemmelgarn, President and CEO at Siemens PLM Software.   Over the past eleven years, the company has invested $11B in mergers and acquisitions.  As a result, Siemens has optimized its integrated solutions portfolio for next generation product development, manufacturing and service.

siemens imageIn contrast to prior conferences, where the focus was on pulling the “Digital Thread” throughout the enterprise, the theme for this year’s event was ‘Innovation Without Boundaries.’  In support of the theme, multiple customers took the stage to demonstrate how their organizations were innovating without boundaries.      

Less than 2 hours into the conference, I was struck by the possibilities of Medical Device companies accessing and sharing product, process or performance data and having the ability to feedback information to the master digital twin in one platform.  The real power of a master digital twin lead me to think about the concept of ‘digital fraternal twins’ for not only closed-loop product lifecycle management but also change and configuration management in Med-Tech.    

Register to learn why I think the power of digital fraternal twins holds significant value for Life-Sciences companies. 

I also review how companies like Hackrod, Tronrud, Visteon, KUKA and W.L.Gore and others are leveraging the Siemens portfolio.  

13Sep/18
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Survey: Modeling and Simulation in Life-Sciences

Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics and Chair of FDA’s Modeling and Simulation Working Group recently presented initiatives underway at the agency to advance the use of Modeling and Simulation.
FDA routinely advises industry on using modeling and simulation to, for example:
  • Predict clinical outcomes
  • Inform clinical trial designs
  • Support evidence of effectiveness
  • Identify the most relevant patients to study
  • Predict product safety
Axendia would appreciate your input on a survey that focuses on the current use and perceived value of Modeling and Simulation in Life-Sciences.

The survey should take no longer than 10 minutes to complete and all individual responses will be kept strictly confidential.  You are also welcome to register to receive a copy of the survey outcome.