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.

The appraisal focuses on 11 process areas; an overall scorecard is developed and shared with FDA which includes:

  • Estimating
  • Planning
  • Monitor & Control
  • Configuration Management
  • Managing Performance & Measurement
  • Requirements Development and Maintenance
  • Process Quality Assurance
  • Governance
  • Implementation Infrastructure
  • Product Integration
  • Technical Solution

91% of participants who have gone through the appraisal process indicated they identified areas or processes that could improve how work is performed to improve product quality.  100% indicated they found the appraisal to be of value and would recommend the program.

Joe Friedrich, Quality Director at Boston Scientific is an active participant in the pilot program and shared his experience going through the appraisal process.  The four main drivers that lead the company’s decision to the participate in the pilot program were:

  • Product Improvement:  Understand specific areas the site can improve on using a maturity model, rather than a compliance approach
  • Regulatory:  Benefits as they related to PMA submissions, manufacturing site change submissions, and the 30-day regulatory submission process
  • Relationship Builder: Create a relationship with an external partner that is proactive and focused on continuous improvements and overall product quality and patient outcomes
  • Culture Shift: The opportunity to be a part of the shift towards a more patient-centered culture across the medical device industry and FDA

What does an appraisal versus an inspection look like?



  • Capability maturity model appraisal of business practices and processes
  • Inspection of quality system procedures and records
  • Focuses on 11 CMMI Model practice areas
  • Focuses on 21 CFR Part 820 requirements
  • Appraisers conduct group interviews of ‘doers’ responsible for work product
  • Inspectors interrogate quality leaders, process experts and record owners
  • Appraisers engage in discussions to truly understand how the business operates relative to best practices
  • Inspectors review procedures, records, storyboards looking for evidence of noncompliance to regulation
  • Many participants outside of QA
  • Few participants outside of QA
  • Minimal disruption to site resources and no need for Back Room / Front Room
  • Large support team with Back Room / Front Room participation, streams, scribes, etc.
  • Weaknesses are opportunities to improve business process
  • 483s require escalation to CAPA and formal agency response

Francisco (Cisco) Vicenty of FDA CDRH shared that some early patterns are emerging.  Participating companies have scored lowest in Estimating and Implementation Infrastructure and highest in Technical Solution and Product Integration.   He pointed out this is not statistically significant yet since the data is based on only 6 appraisals to date. However, since there appears to be high-maturity in some practice areas, reviewing them may not necessarily add value.  As a result, some practice areas may be modified to create add value.

  • Estimating – Estimation of the size, effort, duration, and cost of the work and resources needed to develop, acquire, or deliver the solution
  • Implementation Infrastructure – Ensure that the processes important to an organization are persistently and habitually used and improve
  • Technical Solution – Cost-effective design and solution that meets customer requirements and reduces rework
  • Product Integration – Assemble and deliver the solution that addresses functionality and quality characteristics

Other early indicators shared by FDA include that performance is not necessarily dependent on product classification.  The agency and appraisal participants are having completely different conversations, leading to the FDA asking different questions that are more focused on improvements rather than enforcement.

The agency has received comments on the docket from AdvaMed and the BRIDGE Coalition.  FDA is currently working to incorporate insights from those comments into the pilot and into the next steps.

Cisco recently discussed how to stop routine and pre-approval inspections in an interview with Axendia.  The recording is available here:  Want to stop FDA routine inspections and pre-approval Inspections? FDA shares how.

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