MDIC Device Metrics Initiative led by FDA and Xavier University

Download the Final MDIC Metrics Report provided by FDA and Xavier University:  

Download publications on the MDIC FDA/Xavier Device Metrics Initiative:


• Converting Measures to Metrics: use a methodology developed by SchellingPoint to develop metrics that capture the intent of the top measures identified by the working group.
• Defining the Metrics: utilize a template developed by the Parenteral Drug Association to define the metric, determine the algorithms to use, identify unintended consequences, and suggest mitigation of those unintended consequences.
• Pilot Metrics: Ask for volunteer companies from the working group to implement the apply the metrics to selected products retrospectively for 2-3 years.

Problem Description:
Lack of harmonized, well-defined, stakeholder-verified product quality metrics impedes the ability of all stakeholders to continuously and predictively assess evolving confidence in product quality.

• To convert the top predictive product quality measures identified through the 2014-2015 FDA/Xavier Device Quality Measures Initiative into actual metrics that can be implemented, piloted, and validated for potential FDA and broader stakeholder use.

• Identified, piloted and publicized effective predictive product quality metrics
• Improved assessment and reporting of metrics indicative of the evolving state of product quality
• Improved regulatory analysis of risk associated with product in order to target regulatory resources and improve effectiveness of inspections

Project Scope:
• The working group will identify a 3 select measures from the 2014-2015 FDA/Xavier work product
• All phases of production will be represented
• All classifications of medical device and diagnostic products will be considered

• All other measures from the 2014-2015 FDA/Xavier initiative that the working group does not choose to advance.

Metrics Identification:

  • Increase predictive nature of understanding product quality. Could result in increased CAPAs associated with proactive improvements. Companies will compare their baseline to improvements. Units of measure will be determined through this initiative.
  • Increase awareness of areas of risk to patient safety. Could result in revised risk profiles. Companies will compare their baseline to improvements. Units of measure will be determined through this initiative.
  • Other metrics will be identified by the working group as the metrics to assess are chosen and defined.

• The establishment of predictive quality metrics across the total product lifecycle will provide a harmonized platform through which industry and FDA are able to consistently assess the evolving state of product quality, for the ultimate goal of increased patient safety.
• The outcome of the metrics work will provide a foundation for other MDIC projects under consideration, such as the competency, advanced analytics and maturity model projects.

Action Plan:
June 2015:
a. Identify a select group of 2014-2015 FDA/Xavier measures to develop into metrics (e.g., 1 each per pre-production, production and post-production phases; that meet other considerations such as applying to a range of firm size, product, etc.) that are:
b. Critical to assessing risk to patient safety
c. “Do-able” to define and develop into actual metrics

July – September 2015:
a. Define the metrics (not set actual targets, but rather clarify what exactly is included and how to implement)
b. Establish how to calculate
c. Agree on how to report the data
d. Assess and develop ways to mitigate unintended consequences

October 2015-March 2016:
a. Pilot the metrics through PwC within the companies on the working group
b. Collect data

April-May 2016:
a. Analyze the data collected from the pilot studies
b. Analyze effectiveness of the metrics as defined
c. Share “lessons learned”
d. Recommend next steps

June 2016:
a. Present final metrics proposal to FDA and MDIC at the MDIC Case for Quality Forum.


Team Members:

(The following members are listed with the affiliations and titles they had during the initiative):

Monica Wilkins

Monica Wilkins

Divisional Vice President of Medical, Clinical, Quality and Strategic Support