Tag Archives: FDA

02Aug/18
Outcome based Medicine-Low-Res

FDA: Simulation is Digital Evidence, Not Made Up Stuff

Digital Evidence is Already Being Used at FDA to Support Regulatory Submissions

By: Daniel R. Matlis, President

Tina Morrison PicFDA is leading the way in the use of simulation and modeling in the medical device industry. “Simulation is digital evidence, not made up stuff,” said Tina Morrison Ph.D., Deputy Director, Division of Applied Mechanics, OSEL, CDRH, U.S. FDA, during her keynote address on Day 2 of the Siemens PLM Industry event, hosted by Medtronic at their operational HQ in Minneapolis, MN.

For details on Day 1 of the event see At 21, Computer System Validation Comes of Age.

Day 2 also included presentations from Medtronic, Atrium Health, Siemens Healthineers, and Agilent Technologies on their use of simulation and modeling across the product lifecycle and the environment of care.

“Access to safe and effective medical device technology calls for Regulatory Grade computer models & simulations,” said Morrison.

“Many companies aim for the Digital Twin and end up getting a Digital Mutant” commented Brent Roberts, Vice President of Medical Supply Chain Strategy at WL Gore.  “I think one of the keys to ensuring you don’t end up with a digital mutant is to stick with partners who understand the journey and rely on them helping you translate your internal view to a rest of the world outlook,” Roberts added.

To receive a copy of this brief, please register here.

We also welcome you to Register for FDA Grand Rounds “Advancing Regulatory Science with Modeling and Simulation at FDA” on August 9, 2018 from 12 – 1pm EST.

19Jul/18
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At 21, Computer System Validation Comes of Age

Stop Validating Computer Systems to Death!

By: Daniel R. Matlis, President

“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices.  When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.

FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”[1]

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. Continue reading

13Jul/18
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Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading

29May/18
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FDA: Consumers and Patients Deserve Six Sigma Quality Products

Compliance vs. Quality – Interphex Edition

By: Daniel R. Matlis, President

Last month, I had the privilege to heaYU-Interphex-2018r Lawrence Yu, PhD, FDA Deputy Director of CDER’s Office of Pharmaceutical Quality (OPQ) at INTERPHEX 2018.

The theme of his presentation “The Future of Pharmaceutical Quality and the Path to Get There,” was that consumers and patients deserve six sigma quality products.

To encourage this effort, the Agency began the drive to modernize its regulation of the pharmaceutical industry to emphasize Quality more than a decade ago with the 21st Century Initiative.

Continue reading

01May/18
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White Paper: 3D Printing and Digital Twins in the Life Science

Driving Innovation and Improving Quality with 3D Printing

By: Eric Luyer, Market Research Analyst

3D printing is driving innovation and improving quality.  By bridging the gap between the digital and the physical environments, innovative Life Science companies are accelerating the delivery of next generation products that are personalized, more precise and higher quality than ever before.

Request your copy of our latest white paper: 3D Printing and Digital Twins in the Life Sciences here.

In this detailed white paper, we address the following topics:

  • 3D Printing: What is it?
  • The FDA’s view on 3D printing/Additive Manufacturing
  • Current applications – Agile tooling and Healthcare devices
  • Real world examples
  • Bio-Printing
  • How other industries are leveraging 3D printing
  • Digital Twin technology (Simulation and Modeling)
  • Benefits of 3D printing
  • Industry feedback
  • Market potential

With the use of the latest technology, life science companies can break through barriers, using new methods of manufacturing processes, or using new materials to create unique offerings and can achieve market differentiation among competitors.

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