CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot 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.
Participation in the program requires a small investment of resources, both personnel and fees, however, there are several impressive benefits.
HTS CZ was able to analyze and quantify areas for improvement, and improving quality by 50%.
Cognizant improved their overall quality by decreasing delivered defects by 22%.
By customizing the estimating process, Unisys improved accuracy by 60%.
After just six months of CMMI deployment, Chemtech achieved a reduction in rework, saving almost $400,000.
G&P experienced striking results through the CMMI process improvement framework, with a 93% increase in the first quarter of 2016.
Reduces disruption and costs by $20K-$140K.
Increased innovation with more submissions, improved employee morale, faster time to market for device improvements, and re-deployment of FTE resources, saving $10k-$500k.
Easier and faster transfer of products for reduced distribution costs.
With a more streamlined submission process, products can reach market faster, to respond to patient needs.
Open conversations with the FDA help to improve working relationships.
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.
The CMMI Institute surveyed early adopters of the Medical Device Discovery Appraisal Program to understand their experience.
believed the appraisal identified improvement areas to increase overall product quality.
had a positive experience with the appraisal approach and execution.
would recommend this program to other organizations.
The MDDAP program is significantly different than the regulatory compliance audits we’re used to in the Medical Device industry, in both approach and outcomes. It is a much more conversational review of how activities are performed, providing insights into how this can positively or negatively impact both product quality and business performance. The results present a path for continuous improvement as opposed to a measure of whether a minimum level of performance has been achieved.
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.
Explore the many different ways practitioners and organizations can get started with the MDDAP.
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.
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: MedicalDevice@cmmiinstitute.com.
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.
Companies must have a [1] prior history or compliance profile, [2] site registration, and [3] listing with the FDA.
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.
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:
See how your organization can improve its focus on medical device quality through fewer regulatory burdens, increased innovation, and faster time to market.