MDIC Device Metrics Initiative led by FDA and Xavier University

The intent of this FDA/Xavier initiative is to arm industry with practical metrics to implement commensurate with the needs of the business and complexity of the products, such that the Right-First-Time mentality could be shifted as close to the initial days of development as possible. Importantly, the metric calculations are provided as a guide for industry to adjust in a way that makes sense for the products and business in question, while maintaining the intent of the metric.

Final MDIC Metrics Report provided by FDA and Xavier University  

Publications on the MDIC FDA/Xavier Device Metrics Initiative


Process

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 two to three 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.


Objective

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.


Outcomes

  • 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

Included

  • 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

Excluded

  • 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.

Benefit

  • 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:

  • Paul Andreassi, Former VP Quality Assurance & Regulatory Affairs, Fisher & Paykel Healthcare
  • Pat Baird, Product Design Owner, Baxter
  • Anupam Bedi, Manager, Quality Systems and Regulatory Compliance, AtriCure
  • Pankit Bhalodia, Director, Management Consulting - Health Industry Advisory
    PricewaterhouseCoopers
  • Kankshit Bheda, Manager, Health Industries Advisory, PricewaterhouseCoopers
  • Robin Blankenbaker, Divisional Quality Operations Leader, W.L. Gore
  • Gina Brackett, Compliance Officer, FDA
  • Patrick Caines, Director, Quality & Global Post Market Surveillance, Boston Scientific
  • Tony Carr, Vice President, Global Quality Systems, Boston Scientific
  • Kara Carter, Senior Director, Quality Assurance Operations, Abbott
  • Vizma Carver, Founder and CEO, Carver Global Health Group
  • Ryan Eavey, Senior Manager, Quality Systems, Stryker
  • Joanna Engelke, Senior Vice President Global Quality, Boston Scientific
  • Chris Hoag, Director of Global CAPA and Quality eSystems, Stryker
  • Frank Johnston, Corporate Director, Regulatory Compliance, BD
  • Jonathan Lee, Senior Associate, PricewaterhouseCoopers
  • William MacFarland, Director, Division of Enforcement B, Office of Compliance, FDA/CDRH, FDA
  • Kristin McNamara, Senior Advisor to the Deputy Associate Commissioner, FDA
  • Rhonda Mecl, Supervisory CSO, FDA
  • Brian Motter, Vice President, Quality and Compliance, Diabetes, Johnson & Johnson
  • Ravi Nabar, Senior Director Supplier Quality Management, Philips Healthcare
  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding
  • Pete Palermo, Vice President, Quality Assurance, C.R. Bard
  • Marla Phillips, Director, Xavier Health, Xavier University
  • Greg Pierce, President and Founder, EngiSystems
  • Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc
  • Joe Sapiente, Vice President, Quality Assurance and Regulatory Affairs, Hologic, Inc.
  • Benjamin Smith, Vice President, Global Quality System & Compliance, Biomerieux
  • Isabel Tejero, Lead Consumer Safety Officer, FDA
  • Shelley Turcotte, WW Director Quality Information Systems, DePuy Synthes Joint Reconstruction
  • Sam Venugopal, Partner, PricewaterhouseCoopers
  • Marta Villarraga, Principal Biomedical Engineering, Exponent
  • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott