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 Now, IT and quality teams are faced with the daunting challenge of upgrading, migrating, and validating outdated legacy on premise QMS systems.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

Continue reading

04Oct/18
EU MDR Infographics Header copy

EU MDR – New Rules Require Greater Traceability, Data Transparency

Webinar Now Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.  Medical device companies are set to experience an enormous impact on all phases of the CE mark process including Design, Manufacturer Obligations, Evidence Collection, Conformity Assessment, Registration and Post Market Surveillance and Vigilance.

The schedule is aggressive – the rules will apply to some previously unregulated products and there will be no grandfathering of previously approved medical devices.  Controls on notified bodies that can approve the marketing of medical devices and the reporting on clinical trials will also be tightened.  Once devices are available for use on the market, manufacturers will be obligated to collect performance data to support tighter post-market surveillance requirements.  In addition, a new system will apply to in vitro diagnostic medical devices.

Concerns are quickly mounting throughout the industry.  We interviewed executives to determine what steps they were taking to prepare for the looming May 2020 deadline.  We heard:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “Our challenge is showing management what the cost is per product from a compliance standpoint”
  • “Imagine tracking down paper records for products from the 60s and 70s!”
  • “We will probably have to do a complete revamp of technical files to do resubmission”
  • “Our organization is behind on the IT curve. It will likely take three to four years to implement a robust global product data management system like that to support EU MDR”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

In a recent webinar sponsored by Sparta Systems, we discussed why Digital Transformation is a necessary journey for EU MDR compliance and beyond. The recording is now available on-demand.

It is important to note that MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both EU MDR and IVDR until full readiness of the system has been achieved.”  However, Med-Tech companies must begin to take a long view on EU MDR now and begin their digital transformation journey to support EU MDR and beyond.

Is your organization ready to achieve sustainable, positive disruption? Contact us today.

22Sep/18
siemens-new-logo-600

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
Brain - small - low res

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.