Tag Archives: FDA

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.

Axendia content is restricted for personal use only. Reproduction or distribution of Axendia content in any form without Axendia’s prior written permission is forbidden. 

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.

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

05Mar/18
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The Need for Cyber Security in the Healthcare System

Cyber security may be expensive, but the cost of a life is more

By: Giselle C. Matlis, Research Assistant

Imagine someone hacks your Facebook account.  You freak out, then figure a way to get the hackers out of your account, notify Facebook, change your password and move on.  Problem solved.

But what if the hacked system isn’t your Facebook?  Instead it’s a pacemaker in someone’s heart, or an entire hospital’s records and devices.  What would you do then?

In recent years, there have been many life-changing medical devices innovations that have helped thousands of people.  Connecting devices to the internet and hospital networks has contributed to this influx.  Medical device connectivity enables doctors to monitor and administer drugs to their patients from a far, allowing patients to live more normal lives.  Connecting them to the internet also helps to electronically update patient charts, minimizing the risk of transcription errors and drives improved patient outcomes.The goal of connected medical devices and aggregated data is to assist physicians in making informed decisions for treatment. Continue reading