CMMI Institute

Medical Device Discovery Appraisal Program (MDDAP)

Case for Quality Voluntary Improvement Program (CfQ VIP)

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.

See if you qualify
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.

What Participants Think of the Appraisal Program

ISACA surveyed early adopters of the Medical Device Discovery Appraisal Program to understand their experience.

  • 96%

    reported the appraisal had provided overall value to the organization.

  • 85%

    believed the appraisal method provides a direct value to improving product quality.

  • 92%

    had a positive experience with the appraisal and 8% reported a neutral experience. No negative experiences were recorded.

  • 97%

    found no conflict with compliance to regulatory requirements.

Learn more about the Pilot Program’s results in this Case for Quality White Paper.

 
 

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

Still have questions about the appraisal? View our FAQs page for more details.

Request a Follow-Up

Take a proactive approach to regulations and quality today! Submit this form to request a follow-up from an MDDAP representative to learn how to get started.

All fields are required.




 
MDDAP Training Course

Program Requirements

View the program requirements, detailed information on the regulatory modifications, and available training.

MDDAP Resources

Featured Materials

Browse featured materials, and find answers to your outstanding questions by browsing our FAQs.




 

Ready to apply?

Begin the MDDAP Application Today

Apply Now