All posts by Administrator

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.
06Sep/18
68530 Connected Doctor

The Value of Analytics in Value-Based Healthcare

Perspectives from Key Stakeholders in the Healthcare Ecosystem

By: Daniel R. Matlis, President

The primary drivers for Healthcare today are improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs while maximizing patient benefit.

Healthcare ecosystem stakeholders, including physicians, clinicians and supply chain professionals utilize data to make value-based procurement decisions for medical devices to ensure and improve patient access to high quality devices.  The integrity of these decisions depends upon the accuracy and completeness of unbiased analysis of underlying data to support patient care decisions.

To gain insights from key stakeholders on the use of analytics to support the transition to value based healthcare, Axendia interviewed a group of thought-leaders representing the Medical Device Innovation Consortium (MDIC) Case for Quality Product Quality Outcomes Analytics (PQOA) working group.

Each stakeholder offered their unique perspective on the value proposition for the PQOA Dashboard.

These thought-leaders are (in alphabetical order):

Stephanie Christopher – Program Director at Medical Device Innovation Consortium (MDIC).

Garth Conrad VP Quality at BD Peripheral Intervention.

Michael Ruhlen – MD, MHCM, FAAP, VP Division of Medical Education, Atrium Health

Michael Schiller – CMRP, Senior Director at the Association for Healthcare Resource & Materials Management (AHRMM)

Nathan Soderborg PhD, Principal Scientist, Statistical and Data Sciences, Exponent.

Francisco (Cisco) Vicenty Program Manager for Case for Quality, Office of Compliance, CDRH, FDA (OPEQ Pilot: Immediate Office, Strategic Initiatives Staff)

Register to Receive this Report.

22Aug/18
FDA-Pre-Check

Do You Want Less FDA Inspections? Here is FDA’s RX

Quality Metrics Program Update: We Asked and FDA Answered

By: Sandra K. Rodriguez, Market Analyst

The Quality Metrics program is a key step in the Agency’s objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.  

FDA recently published two announcements on the Quality Metrics program in the Federal Register: 

  • CDER intends to further develop a Quality Metrics Program through formal meeting requests and a pilot study to gain feedback from those establishments for which meeting requests do not apply 
  • CDER and CBER are initiating a 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programsii 

These announcements prompted a number of industry executive to reach out to Axendia to understand FDA’s current thinking on Quality Metrics. 

For a first-hand account, we reached out to FDA with a few questions – we asked and they answered. [1]

AXENDIA: What drove the delays in the program?

FDA: There were many comments submitted to the docket after the revised draft 2016 guidance was published.  The comments generally indicated that additional feedback and a pilot would be useful.  Further, we took time to listen to additional comments and feedback from industry and industry trade organizations provided at conferences and presentations.  We determined that our next steps should be a Feedback Program and Site Visit Program which would allow individual companies an opportunity to discuss their approaches from different sub-sectors of the industry.  Continue reading

16Aug/18
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Personalized 3D Printing in Life-Sciences

Shaping the Future Today: An Insight Brief on Rize, Inc.

By: Eric Luyer, Industry Research Analyst, & Ellyn McMullin, Research Associate

The interest around 3D Printing or Additive Manufacturing has risen spectacularly the last few years. The use of 3D Printing technology has wide-ranging applications in surgery, healthcare, pharmaceutical and medical device industries and works as a catalyst for personalized medicine, diagnostics, as well as for training or learning practices.  With the use of 3D Printing, Life Sciences companies can break through barriers using new methods of manufacturing processes or using new materials to create unique offerings and can achieve market differentiation.

Image Courtesy of RIZE, Inc.

Image Courtesy of RIZE, Inc.

In Life Sciences, RIZE, Inc., has succeeded in Preclinical Pharmaceutical and Medical Device applications due to the advantages of their unique process.

Our RIZE 3D printing platform, with its clean process, clean materials and completely safe user experience, makes it very suitable for the Life Sciences industry,” said Andy Kalambi, President and CEO of RIZE. “As a result, we are delighted to see the variety of functional use cases in pre-clinical applications developed by our customers. They continue to push the envelope and discover new ways to put the technology to use, cut costs and improve products in ways never seen before in the 3D Printing industry.”

Our insight brief covers:

  • 3D Printers – Components and Capabilities
  • Next Generation 3D Printing
  • Improving Outcomes While Meeting the Regulatory Baseline
  • How CONMED, a global Medical Device manufacturer turned to RIZE, in part, for a unique application – to print molds to produce elastomeric products.

Register here to learn how Life-Science companies are experiencing significant benefits using 3D Printing technologies for complex, additive manufacturing processes in a regulated environment.