CMMI Institute

Medical Device Discovery Appraisal Program

CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What is the Medical Device Discovery Appraisal Program?

A program for medical device stakeholders to work together to enhance device quality and patient safety.

Program participants are eligible for regulatory modifications in the FDA’s pilot, which aims to elevate patient safety by leveraging CMMI as the framework by which medical device manufactures can measure their capability against best practices in a continuous improvement journey from compliance to quality.

The program brings together the FDA, Medical Device Innovation Consortium, and the medical device industry.
The program brings together the FDA, the Medical Device Innovation Consortium, and the medical device industry.

Small Investments, Impressive Returns

Participation in the program requires a small investment of resources, both personnel and fees, however, there are several impressive benefits.

CMMI ROI Results

Reduction in cost of poor quality

HTS CZ was able to analyze and quantify areas for improvement, and improving quality by 50%.

Reduction in non-conformities and defects

Cognizant improved their overall quality by decreasing delivered defects by 22%.

Improved accuracy

By customizing the estimating process, Unisys improved accuracy by 60%.

Reduction in rework

After just six months of CMMI deployment, Chemtech achieved a reduction in rework, saving almost $400,000.

Increased productivity

G&P experienced striking results through the CMMI process improvement framework, with a 93% increase in the first quarter of 2016.

FDA ROI Results

Removal from surveillance inspection workplan

Reduces disruption and costs by $20K-$140K.

30-Day Change Notice

Increased innovation with more submissions, improved employee morale, faster time to market for device improvements, and re-deployment of FTE resources, saving $10k-$500k.

Site Change submissions

Easier and faster transfer of products for reduced distribution costs.

PMA pre-approval inspection waived

With a more streamlined submission process, products can reach market faster, to respond to patient needs.

Improving FDA relationships

Open conversations with the FDA help to improve working relationships.

Gauge Against an Industry Baseline

Understand how your organization compares against the overall medical device industry baseline.

Through a conversational-style approach, our experienced team of appraisers will measure your organization’s capability to deliver high-quality products.

The results are then summarized in a heatmap so that you can quickly identify areas of strength and gaps for improvement.

Discover how your organization compares against the rest of the medical device industry, and become part of a growing community that is learning from each other.

Benchmark against the industry baseline

What Participants Think of the Appraisal Program

The CMMI Institute surveyed early adopters of the Medical Device Discovery Appraisal Program to understand their experience.

  • 91%

    believed the appraisal identified improvement areas to increase overall product quality.

  • 93%

    had a positive experience with the appraisal approach and execution.

  • 100%

    would recommend this program to other organizations.

Participant Insights

The maturity assessment provided us with an evaluation of the health of our operations, engaging individuals most familiar with our day-to-day work.  The assessment helped us identify strengths and weaknesses and opportunities for further consideration.  As important, the assessment helped us develop operational excellence metrics that will measure the continuous execution and quality oversight of our processes.  Now, a cross-functional team is exploring how we can capitalize on what we learned to further advance our processes and our ability to provide world-class products and services to our customers.

Kathie Bardwell, Senior Vice President & Chief Compliance Officer, STERIS Corporation

Innovize has had a great experience going through the MDDAP assessment with experienced and well-trained assessors. The types of concerns found by the assessors provide a great roadmap to help Innovize improve our costs, efficiencies and achieve a higher maturity level.

Mark Rutkiewicz, VP Quality, Innovize

Get Started with MDDAP

Explore the many different ways practitioners and organizations can get started with the MDDAP.

MDDAP Training Course

MDDAP Training Course

In the MDDAP Intro Course, you will learn the CMMI V2.0 model being used in the program, understand how the model can be adopted in the medical device space to achieve measurable business objectives, and be ready to evaluate your organization’s capabilities during your program appraisal.

MDDAP Resources

MDDAP Resources

For answers to some of the more technical questions, see our list of FAQs, as well as the available documents and resources from conferences, webinars, and articles. You can also contact us for more information:

Program Requirements

Enrollment Requirements

  • Must be a U.S. based company/site or global company that distributes medical devices in the U.S. (Class I, II, III).

  • Facilities must be those responsible for the manufacture and processing of medical devices.

    • Facilities must not be under Official Action Indicated (OAI) status or subject to a judicial action. 
    • Companies with OAI can become eligible for benefits when they have provided the FDA with confirmation that appropriate corrective action has been implemented, and those actions have been verified by the FDA during a follow up inspection.
  • Companies must have a [1] prior history or compliance profile, [2] site registration, and [3] listing with the FDA.

    • Examples of ineligibility include: new manufacturers, start-up companies, no FDA inspections, no marketed products in the U.S., etc. 

Participation Requirements

  • Annual program fee to be paid once you are accepted into the pilot program.

  • Participation in a Medical Device Discovery Appraisal within the 90-day target and payment of the associated costs.

  • Check points at defined frequencies to confirm progress and improvement from initial appraisal results.

  • Sustained favorable compliance profile/history as defined in the enrollment requirements.

Regulatory Modifications

  • Upon signing the Discovery Appraisal SOW, your facility will be removed from the FDA's routine inspection list.

  • Upon completion of a Discovery Appraisal, your manufactured medical devices will be eligible for:

    • Streamlined 30-Day Change Notices, bundling multiple products and changes, with accelerated approval.
    • Streamlined site change submission with accelerated approval.
    • Streamlined PMA submission & waived pre-approval inspection.

Enroll in MDDAP Today

See how your organization can improve its focus on medical device quality through fewer regulatory burdens, increased innovation, and faster time to market.

Begin Application