Category Archives: Business

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.

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

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

22Feb/18
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New Research: Driving a Culture of Quality Within the Medical Device Ecosystem

Axendia conducted a study focusing on the medical device induCulture of Quality Infographicstry’s ability to build a “Culture of Innovation and Quality.” The goals of this research were to identify and analyze trends, requirements and initiatives organizations are undertaking to proactively manage products and platforms across the product lifecycle.

In support of the research, we surveyed 110 medical device professionals representing 59 medical device manufacturers from 12 countries, and engaged in one-on-one interviews and group discussions with industry thought leaders.

The research resulted in an e-Book: Driving a Culture of Quality Within the Medical Device Manufacturing Ecosystem.  In it, we discuss the value, challenges and opportunities of transitioning medical device companies from the current regulatory and compliance focus – to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.  We also reveal how the Industry is prioritizing investments in technology in support of quality initiatives.

See the Infographic to learn more.

Read the e-Book.

29Jan/18
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SIMULIA is Modeling Humans from Head to Toe –Literally!

Dassault Systèmes SIMULIA Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by executives of the SIMULIA brand of Dassault Systèmes. The SIMULIA brand is responsible for developing realistic 3D simulation and design optimization applications that complement the integrated solutions of Dassault Systèmes 3DEXPERIENCE® platform..

Dassault Systèmes purpose is to provide business and people with 3DEXPERIENCE universes to imagine sustainable innovations capable of harmonizing product, nature and life.   Proof of the company’s long-term commitment to simulation comes with it latest acquisition, Exa Corporation.  A Boston-based company, Exa has a global presence and customer base with reported $72M in revenue for the fiscal year ending January 2017.  Exa is focused on serving the ground transportation,  aerospace, and oil & gas industries and has deep experience in fluid mechanics and simulation.  Dassault Systèmes acquired the company on November 17, 2017.

As part of Dassault Systèmes’ Life Science and Virtual Human Modeling (VHM) update, Steven Levine, Senior Director, SIMULIA Virtual Human Modeling, stated, “SIMULIA VHM is based on two principles:  If you want to design a great user experience, you must include the user in the design.  Healthcare is still in the 1D or 2D world, it’s time we bring them in to 3D to help demystify the complexity of  the human body.”

Continue reading