Tag Archives: Axendia

09Apr/18
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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

05Apr/18
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Case Study: SYSMEX Leverages the Internet of Medical Things (IoMT) to Disrupt the Blood Testing Market

Sysmex Aims to Improve Health Care for Millions of Patients by Going Beyond “Building a Better Box” and Leveraging the Power of IoMT

By: Daniel R. Matlis, President and Sandra K. Rodriguez, Market Analyst

Axendia_Sysmex-HighlightToday, the goal of healthcare is improving diagnostics and patient outcomes. To this end, the healthcare ecosystem is undergoing a transformation aimed at improving the quality of care while simultaneously controlling costs. In simple terms, the model is shifting from sick-care to well-care.

The power of the Internet of Medical Things (IoMT) and advanced technologies are enabling businesses to think outside the box.  In the case of Sysmex, the company went beyond just ‘building a better box’ in support of improved patient outcomes.

Learn how the company is disrupting the blood testing market in our latest IoMT Case Study, as we highlight:

  • How Sysmex Disrupted the Blood Testing Market via IoMT powered by PTC’s ThingWorx Platform
  • How IoMT Created a Digital Safety Shields in Support of Patient Safety
  • What are the Four Corner Stones of ‘Going Beyond Building a Better Box’
  • How the Combination of IoMT and AR are Bringing Disruption to the Next Level
  • How Next Generation Connected-Product Improve Patient Outcomes

To receive your copy of the Case Study, please register here.

04Apr/18
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Quality: STOP Working on Compliance

Excessive focus on compliance can create hurdles in cultivating quality and innovation

By: Daniel R. Matlis, President

What is the role of Quality in MedTech? 10% said the primary role of quality is to drive product / process improvement. In sharp contrast, 85% indicated the primary role of quality is ensuring compliance

No wonder, the industry has to overcome some many hurdles when cultivating a culture of quality and innovation.

To compete in today’s global markets, Med-Tech companies must change their approach to Quality, from meeting compliance requirements, to driving product and process improvements across the product life-cycle.

A closed loop approach can help MedTech organizations make this crucial shift by enabling better collaboration, visibility and product quality across the product life-cycle.

Axendia_CultureQuality

Read my latest Soapbox column in MedTech Intelligence for key takeaways from Axendia’s research on this topic.

13Mar/18
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Did We Predict the Future?

Free White Paper: Balancing the Risks and Rewards of Globalization

By: Sandra K. Rodriguez, Market Analyst

Axendia conducted a research study assessing the opportunities and challenges of Globalization across the Med-Tech ecosystem.

We learned Med-Tech Executives were primary concerned with:

  • Complying with an increasingly complex regulatory environment
  • Ensuring the quality of products and raw materials across the globe
  • Maintaining consistent standards across an extended network of internal sites and external partners

Executives reported the TOP business threat is the changing regulatory environment (65%).

Considering that massive regulatory changes are impacting Med-Tech today, they were correct.  Recent guidance documents include:

  • ISO 13485:2016
  • ISO9001:2017
  • Unique Device Identifier (UDI)
  • EU MDR and EU IVDR
  • Real World Evidence (RWE) challenges

Also significant were risks associated with geopolitical unrest and natural disasters (43%). At the time of the survey, Japan’s earthquake and tsunami were fresh in the memories of industry executives.  More recently, Hurricane Maria quickly gained the attention of the FDA. Within 30 days of the storm making landfall in Puerto Rico, the agency identified 50 types of devices that it deemed critically important.  The agency indicated in a press release that it was particularly concerned about the potential shortage of blood-related devices.   Other current day geopolitical events affecting industry include Brexit, tensions on the Korean peninsula, and NAFTA re-negotiations that are far from being completed. Continue reading

06Mar/18
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CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading