Tag Archives: FDA

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

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.

16Jun/17
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10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’

By: Daniel R. Matlis, President

The Case for Quality: Why Does It Matter?

Last month, I had the privilege to moderate a discussion with Capt. Sean Boyd, deputy director for regulatory affairs in CDRH’s Office of Compliance, and Francisco (Cisco) Vicenty, acting program manager of Case for Quality in CDRH’s Office of Compliance.

During the webinar hosted by FDAnews, we discussed topics including:

  • The Case for Quality – Why does it matter?
  • Are we playing regulatory whack-a-mole?
  • How is the role of FDA evolving to encourage a culture of quality for device makers?
  • Have “Compliance First” regulatory approaches slowed innovation?
  • Who benefits from a focus on quality?
  • Are there appropriate substitutes for routine FDA inspections or pre-approval inspections?
  • What are the quality outcomes metrics FDA will collect and monitor?
  • How will FDA operate as we shift from documents to data/metrics as a result of using quality tools?

In addition, Capt. Boyd and Mr. Vicenty addressed the following audience questions:

Q1: How is the CfQ program different than Quality by Design?

A1: Quality by Design (QbD) is the systematic approach used in the pharmaceutical space for development that focuses on risk management and predefined objectives for product and process control. QbD is more analogous to Design Controls in Quality System Regulation. Case for Quality is an effort to work together with a community of stakeholders to incentivize performance and product quality. This collaboration will allow for faster and better data to drive purchasing decisions and FDA activity.

Fore more Q&A, read the article in its entirety in FDANews Device Daily Bulletin.

29Jun/16
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FDA and Quality Metrics in Biopharma

By: David R. Somers, Senior Industry Analyst

Moving Right Along 

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution, and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality, and enhance the safety of the supply chain.

To support this initiative, the International Society for Pharmaceutical Engineering (ISPE) created a cohesive, comprehensive series of criteria for the measurement of critical parameters needed to define and control quality in biologic and pharmaceutical manufacturing.  Subsequently, using many of the metrics developed by the ISPE, the FDA submitted a draft guidance document called Request for Quality Metrics.

Continue reading the full article in Outsourced Pharma.