Enroll in the CDRH Quality Pilot project

Initial enrollment into the pilot program is now open. Click here to enroll in the CDRH Quality Pilot project.

Enrolling your organization at this time provides the following:

  • Initiates recognition of regulatory benefits from the FDA
  • Moves the maturity model program forward for industry, FDA, MDIC and the CMMI Institute as a part of the overall Case for Quality
  • Drives the maturity model program forward to begin initial execution of PMO operational activities
  • Initiates the process of the FDA determining your qualifications for the program, as well as initiates scoping, and scheduling conversations

We encourage you to enroll now as initial early adopter slots will be limited. Contact CMMI if you have questions at medicaldevice@cmmiinstitute.com.

For more information, contact Stephanie Christopher, Program Director
Email: schristopher@mdic.org
Phone: 952-314-2730

 

Frequently Asked Questions about the CDRH Quality Pilot

What is the CDRH Voluntary Medical Device Manufacturing and Product Quality pilot?

Answer:

The CDRH pilot program leverages a proven maturity model, the CMMI framework, by which medical device organizations may measure their capability to produce high quality devices and increase patient safety. This measurement can then be used by the organization to drive targeted continuous improvement activities throughout their facility.

In recognition of manufacturers who complete this independent assessment of quality maturity, FDA will adjust that manufacturer’s engagement activities and change submission requirements.

Why should my company participate? What are the tangible benefits from CDRH? When do I recognize them?

Answer:

There are multiple reasons your company should participate in this program as part of the FDA’s Case for Quality. Industry participation is critical to long term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection.  The FDA is seeking to leverage the maturity model program as a method to drive improvements in areas that are also beneficial to manufacturers, such as

  • Increased manufacturing and product confidence
  • Faster time to market
  • Better information to drive regulatory decisions
  • Improved resource allocation
  • A continuous improvement focus on what is most important to patients

The FDA has confidence in companies that are accepted into this voluntary program, and will remove them from the routine FDA inspection plans at the point of approval into the program and will use independent means to monitor sustained performance.

Additionally, the Agency’s confidence and assurance in your quality system and performance (from program participation) means modifying and reducing the PMA submission requirements for the following manufacturing reviews:

  • 30-Day Notices
  • Site Changes
  • PMA Original manufacturing module

The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections and manufacturing review submissions.   That capacity can be used for manufacturers who have not demonstrated high capability and to engage earlier in the development life cycle of new products.

The benefits provided can also accelerate the implementation of quality improvements at a faster rate and reduce time to market of product improvements and enhancements for patients.

Why did CDRH choose CMMI for this activity?

Answer:

Through collaboration with MDIC over the last 2 years, CMMI was selected for this voluntary pilot program, after a review of several maturity models was performed. CMMI is a framework supporting process level improvement and training, and includes an appraisal method for objectivity and consistency. This program is administered by the CMMI Institute and helps organizations focus the value that they can deliver by building capability in their people and processes. This model has been successfully used in various industries, including information technology, healthcare, automotive, defense, and aerospace, to consistently deliver high quality products and reduce waste and defects.

What is CMMI?

Answer:

From http://cmmiinstitute.com/what-is-cmmi: The Capability Maturity Model Integration (CMMI®) is a capability improvement model that can be adapted to solve any performance issue at any level of the organization in any industry. The Model provides guidelines and recommendations for helping your organization diagnose problems and improve performance. Used by over 5000 organizations from more than 70 countries all over the world, CMMI helps you identify and achieve measurable business goals.

What is the CMMI Institute?

Answer:

From http://cmmiinstitute.com/about-cmmi-institute: CMMI® Institute (CMMIinstitute.com) is the global leader in the advancement of best practices in people, process, and technology. The Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. For over 25 years, thousands of high-performing organizations in a variety of industries, including aerospace, finance, healthcare, software, defense, transportation, and telecommunications, have earned a CMMI maturity level rating and proved they are capable business partners and suppliers.

Are there any examples of medical device manufacturers who have publicized their participation in the CMMI program?

Answer:

The CMMI Institute has a published list of organizations from a broad set of markets available on-line. In addition to these data, multiple medical device manufacturers piloted CMMI appraisals in coordination with the CMMI Institute, the FDA and MDIC to determine how appraisal activity provided continuous and quality improvement feedback to the manufacturer. All organizations participating in the pilot were provided feedback that served as improvements to the quality of their QSR systems, product development and organization capability.

How do I share this program and its value with senior management in their language?

Answer:

Participation in the CDRH Voluntary Quality program will require a small investment of resource, both personnel and money, however there are several benefits.  In general, you should expect to improve your processes and reduce variability that could lead to increased costs of quality and decreased rework.

In addition, the FDA has communicated that there will be increased confidence in companies that are enrolled in this voluntary program, so they may be removed from FDA routine inspection plans.  There will also be some modifications and reductions to certain PMA submissions (30-Day notices, Site Changes, and Manufacturing modules).

Each company will be able to estimate a direct cost benefit by utilizing their own internal data and determining appraisal costs as part of appraisal scheduling with the CMMI Institute.  You can estimate potential of saved costs for quality, submissions and audits. For instance, as shared at the March 30 MDIC Case for Quality Forum, Boston Scientific has estimated that if they were participating in this program, they could have redeployed $500,000 USD of resources who were assigned to write and submit their sixty nine 30 day notices for the year 2016.

You can find answers to additional FAQ at the CMMI Website