Tag Archives: Simulation

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.

24Jul/18
Dassault LS Image

Dassault Targets Life-Sciences with Mind, Body and Soul

2018 Analyst Brief

By: Daniel R. Matlis, President 

At this year’s conference, Dassault Systèmes demonstrated that they are going after Life-Sciences with Mind, Body, and Soul. Under the leadership of Bernard Charlès, Vice Chairman, Chief Executive Officer, the company displays a rare culture focused on long term audacious goals, driven by unbridled passion yet measured by meticulous execution. Charlès has helped instill a culture of ongoing innovation to further consolidate Dassault Systèmes’ scientific capabilities and make science part of the company’s DNA.

According to Charlès, “Dassault is a company with a long term mentality focused on the success of its customers. Dassault is about creating differentiating software that meets the needs of its clients.

Jean Colombel, Vice-President, Life-Sciences at Dassault Systèmes, commented that the company is working to enable innovative patient experiences through an Holistic Patient-Centric strategy.

Daniel R. Matlis, President at Axendia

Daniel R. Matlis, President at Axendia

In this brief, we reveal how Dassault Systèmes is effectively:

  • Going After the Mind: Building on the success of the Living Heart project, Dassault decided to model another “simple” organ, the human brain, the home of the mind.
  • Improving the Body: The 3D Experience platform allows the design and testing of in-silico 3D experiments based on virtual models, informed by real world evidence.
  • Putting its Soul into Health: Digital environments are pushing the bounds of possibility to transform research, science, the pharmaceutical industry, and medicine in general.

Register to read the full event brief.

09Apr/18
Living-heart-project

Simulation for Product, Nature and Life

With 3D Printing and Virtual Human Modeling and Simulation, Life Science companies have the opportunity to innovate faster and with more confidence than ever before

By: Sandra K. Rodriguez, Market Analyst

SIMULIA is one of eleven brands at Dassault Systèmes.  During their Analyst Day, company executives provided an overview of the brand’s simulation offerings under a common theme: Enabling end-to-end digital design to production processes by deploying all multiphysics simulation technologies to enable clients to start making parts and systems that work, faster.

Print to Perform

3D Printing, also referred to as Additive Manufacturing (AM) is a complex process. However, on the 3DEXPERIENCE platform, users can digitally accelerate AM while creating lightweight, yet functional generative designs.  When moving from powder to working parts, there are significant challenges in the real-world process phase of AM. Using simulation for build planning, virtual printing, post-processing and heat treatment effects can optimize the build and ultimately save time by reducing errors and rework. With virtual printing, users can simulate not just a printing process but post-processing procedures and conduct in-service validation. Rather than relying on static documents and experience from expensive physical builds, establishing a digital thread from design to field performance unites all functionality and eliminates silos via a digital platform.  SIMULIA’s Additive Manufacturing message is clear: Print to Perform.

Virtual Human Modeling

Karl D’Souza, Sr. Solution Consultant, SIMULIA Virtual Human Modeling at Dassault Systèmes, pointed out that simulation is widespread in the development of medical devices but that a lot more is possible. In particular, medical device companies are now creating more realistic models of the human body to understand how a product will perform in its intended environment.  Continue reading