When lives depend on your devices, quality becomes job one.
Such is the premise of the Voluntary Improvement Program (VIP), a framework for continuous improvements in quality and patient safety, with structured best practices and regulatory collaborations.
$15M
INCREASE IN PRODUCT SALES
65%
INCREASE IN DAILY PRODUCTION
$286K
IN ANNUAL SAVINGS
70%
DECREASE IN STAFF TURNOVER
Regulatory opportunities
As noted in the FDA guidance Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, VIP adopters may benefit from regulatory opportunities to accelerate improvements to device quality and manufacturing.
Inspections
MDDAP offers a risk-based approach to FDA inspection planning, for routine surveillance, pre-approval and post-market inspections.
30-Day Change Notices
A modified submission format can reduce timeframes (resource permitting) for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE).
Site changes
Modified submission format can reduce timeframes (resource permitting) for PMA and HDE Manufacturing Site Change Supplements.
Manufacturing models
Modified submission format can reduce timeframes (resource permitting) for PMA and HDE Manufacturing Modules.
Reported benefits
- Savings of 1000+ personnel hours and 90% of dedicated resources
- 75-90% faster review and approval of submissions
- Improved product quality, availability & cost
- Accelerated time to market
- Tens of thousands of dollars saved
- Better relationship with FDA via transparency and communication
Get involved with the Voluntary Improvement Program
Appraisal
An experienced appraisal team evaluates your organization’s capabilities via site tours, systems demonstrations and conversations with individual contributors. This evidence is then overlaid on a proven set of best practices—the CMMI model—to identify areas of strength, and opportunities for improvement. An appraisal helps you prioritize the opportunities that best align with your plans, and it offers guidance on improvement projects, and quarterly checkpoints for tracking progress.
Crunch the Numbers
This free ROI calculator helps quantify the potential savings of VIP to medical device makers, including less direct business impacts like CAPA and first-pass yield savings.
Program Eligibility
- Part of lifecycle for medical devices distributed in the US (Class I, II, III)
- This can be any facility which “designs, manufactures, fabricates, assembles, or processes a finished device.”
- Can include, but is not limited to, “those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.”
- Companies should have all of the following:
- Prior compliance history or compliance profile (i.e. US FDA inspection or MDSAP audit)
- Site registration with US FDA
- Device listing with US FDA
- Facilities must not be under Official Action Indicated (OAI) status or subject to a judicial action. Voluntary Action Indicated (VAI) is acceptable.
- Companies with OAI can become eligible 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 may want to seek additional eligibility information if they are a new manufacturer, start-up company, without a compliance profile, or not marketing products in the U.S.
For further guidance view the FDA guidance document Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.
Quality improvement by the numbers
VIP provides a structured series of best practices for improving product quality continuously. It improves business performance by putting better devices in the hands of patients, faster. All of which amounts to a serious competitive advantage.
95%
REDUCTION IN COMPLAINTS PER MILLION
87%
REDUCTION IN TIME TO CREATE NCR AND CAPA REPORTS
32%
REDUCTION YEAR OVER YEAR IN COST OF POOR EXECUTION
27%
DECREASE IN TIME TO CLOSE COMPLAINTS
VIP fosters quality through collaboration
With the FDA
Increased transparency and more frequent communications improve relations with FDA. The investment in continuous improvement builds trust. FDA has seen a systemic downward recall trend in participating facilities.
With industry partners
The Medical Device Innovation Consortium (MDIC) creates a safe space for industry and agency to collaborate together. It also provides an array of tools and programs for VIP partners.
With industry peers
Networking and learning opportunities abound in the VIP program. Our Working Groups, mentorship program and monthly participant calls foster a vibrant community that grows and develops together.
5 Ways to Improve the Quality Mindset of Your Organization
Learn how others are using VIP to create a culture of quality, and how to get your organization started on its journey today.
downloadBecome a VIP appraiser
Expertise in consulting companies through topics such as product lifecycle management, value stream mapping, and workflow automation or digitalization are highly valued skills in the medical device industry. This kind of support can open huge opportunities in assuring consistent and sustainable quality and performance. As a certified appraiser, you’ll be able to work with top device manufacturers around the world to build capability, improve quality and save lives.
You’ll also add new offerings to your portfolio, each with a regular business cycle and recurring income opportunities. And ISACA covers your acquisition costs, so you can pursue new business without sales or marketing overhead.
CMMI LEAD APPRAISERS: WHAT THEY DO AND THE VALUE THEY OFFER
Adopters and appraisers around the world testify to the transformative power of VIP.
The MDDAP Certification Pathway
VIP appraisers are trained in the Medical Device Discovery Appraisal Program (MDDAP), which is a tailored version of the CMMI framework and provides a model and method by which medical device manufactures can better understand, measure, and improve their capability to develop high quality devices. The Voluntary Improvement Program (VIP), which is a specialized program developed in tandem with the FDA and the Medical Device Innovation Consortium (MDIC), uses MDDAP as a key component to support industry. The MDDAP certification entails a mix of coursework, observations, and apprenticeships. The pathway begins with two classes:
Building Organizational Capability
A virtual 4-day introductory course where students learn to use CMMI to cultivate organizational capability in:
- Developing and engineering products
- Delivering and managing services
- Selecting and managing suppliers
- Managing data
- Managing people
- Managing safety and security activities
MDDAP Concepts
A series of interactive, self-paced online modules that prepares learners to participate in their first MDDAP appraisal and provide value to medical device companies.
Download the essential guide to MDDAP Appraiser certification
Become a certified appraiser and open new career opportunities in the Voluntary Improvement Program (VIP). This brochure outlines the certification process, key benefits, and the various ways you can get involved.
Download NowGet 15% Off the MDDAP Appraisal Team Lead Bootcamp
This bootcamp lets you complete your certification for MDDAP Appraisal Team Lead (ATL) in a year, during which you’ll be able to earn as you learn. Many ATLs break even in their first year, and after that compensation can range from $84,000 to $200,000. Don’t wait.
Don't wait. Seats are limited.
*MDDAP ATM: Individual who has the prerequisite experience and training to participate and support an appraisal of an organization against the MDDAP tailored view of the CMMI framework. This includes facilitating discussions, generating notes, and validating and obtaining consensus around results. ATL assigns specific tasks and responsibilities to the ATMs.
*MDDAP ATL: Individual who has prerequisite experience and training to lead an appraisal of an organization against the MDDAP tailored view of the CMMI Framework, including scoping the level of effort, setting the objectives, creating the plan, schedule, logistics, resource management, and risk mitigation - plus managing the appraisal team to support the effort. Continue to meet with organization on quarterly basis to prioritize opportunities and make progress against continuous improvement projects resulting from those opportunities.
The numbers speak for themselves
96%
CUSTOMER RETENTION RATE
+55
NET PROMOTOR SCORE
83%
APPRAISAL ADDS VALUE BEYOND QUALITY
90%
POSITIVE APPRAISAL EXPERIENCE
95%
REPORT OPPORTUNITIES TO IMPROVE QUALITY
A word from our customers
VIP Helps Medical Device Companies Strengthen Supply Chains
VIP benefits the entire healthcare ecosystem. Suppliers, OEMS, CMs and sterilizers all benefit from resilient supply chains, better quality and more efficient production. VIP can even lead to FDA regulatory opportunities for manufacturers. Download the free eBook to find out how.
download now
5 Quality Techniques To Improve Medtech Performance
Regulatory compliance isn’t enough—continuous improvement is key to better patient outcomes. This free playbook explores how the Voluntary Improvement Program (VIP) helps medical device manufacturers strengthen processes, close gaps, and reduce FDA review time.
download nowAdditional resources available
Learn More
Contact us to see how you can begin the application process to become a VIP participant or appraiser!
MDDAP Appraisal - Interest