Tag Archives: Axendia

13Mar/18
connected-world

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
MDIC_Logo_Tagline_3Color_webready

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
cyber security

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

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.