Tag Archives: Axendia

16Aug/18
RizeLogoSpectrum_RGB

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.

09Aug/18
EU MDR LSP Tile

Industry Call for EU MDR Freeze

Stop The Clock

MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved.”  This will create opportunities for Med-Tech companies to take a long view on EU MDR and enable Digital Transformation as a Journey to Support EU MDR and Beyond.

See:  Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care of Patients. 

EU MDR LSP TileOur Infographic offers you a road map to sustainable, positive disruption.  We’ve also identified some road hazards and areas of interest along the way.

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.

Executives we’ve talked to have stated:

  • “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”
  • “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”

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Briefing requests can be directed to: info@axendia.com

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.

30Jul/18
LiveWorx-18-logo-tagline

Partnering to do Well, Partnering to do Good

PTC LiveWorx 2018 Event Brief

By: Daniel R. Matlis, President

Partnership was the key theme at LiveWorx 2018. At the event, PTC showcased five major partnerships to highlight the need to embrace Digital Transformation as it navigates the ever-increasing rate of change:

  • ANSYS partnership to augment simulation and modeling
  • Microsoft partnership to augment mixed reality and cloud
  • Rockwell partnership to align smart factory
  • SYSMEX to support improved patient outcomes through IoMT
  • Boston Children’s Hospital to do good for children on the Autistic spectrum

Under the leadership of Jim Heppelmann, PTC President and CEO, the company is shifting its culture to be PTC = Prepared To Change.  Heppelmann described PTC’s own transformation, shifting from perpetual licensing to a subscription business model as well as moving its global headquarters from Needham to the Boston Seaport.

BostonChildren PicFor me, the highlight of the event was the collaboration between PTC and Boston Children’s Hospital on the use of augmented reality (AR) to help children with autism and related disorders communicate and learn more effectively.

Register to read more.

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.