Editor’s note: The Voluntary Improvement Program (VIP) Portal launched to program collaborators and stakeholders in 2023 after being available to the FDA since 2022. Kim Kaplan, Senior Product Manager at ISACA, provides context on the updates to the MDDAP VIP Portal and the exciting features that participating medical device manufacturers now have access to.
The VIP Portal enables Voluntary Improvement Program collaborators to access various data reports to see industry trends and understand the impact to organizational performance. This system will serve as the main tool to access data for individual site appraisals, check points, performance reports, program resources, industry trends, and more! It was funded by FDA and will be continually optimized.
The vision for the VIP Portal is to create a one-stop shop for all stakeholders involved in VIP. This ideation began a few years when considering ways to make the data ISACA was collecting in the program easier to analyze for key insights.
There are two primary data sets that are collected through this tool: the first set is appraisal results and the second set is performance metrics.
Appraisal Results
As a part of this program, medical device manufacturers voluntarily participate to have a third party evaluate their organization via a tailored version of ISACA’s CMMI maturity model. These facilities are already compliant to FDA's Code of Federal Regulations (CFR) and are looking for ways they can continue to improve above and beyond those regulations. It has been revealed that there are often gaps against ISACA’s proven model of best practices highly regulated business functions connect with less regulated functions. These gaps identify opportunities for efficiencies that help to improve capacity, reduce defects, improve cycle time, cut turnover, and more.
With the VIP Portal, participants can see how they did against these best practices year over year, from site to site, across their organization and against industry. This helps them determine where they want to prioritize next steps in their continuous improvement journey.
FDA can also get a view of the broader industry trends. Program participants begin with the same criteria for a baseline appraisal. When everyone is starting their continuous improvement journey by measuring their capability against the same practices, some important questions can be answered:
- What are the industry strengths?
- Where are the biggest opportunities for improvement?
- How can the FDA use this information to define new guidance that supports industry?
FDA’s final guidance for the Voluntary Improvement Program released in September and includes regulatory opportunities that leverage VIP data to streamline the review of participant improvement submissions. The VIP Portal may support FDA in considering additional regulatory opportunities and updates.
Performance Metrics
Many groups have tried to define the universal set of key performance indicators or quality metrics for the medical device industry; however, this has been incredibly challenging with so much variation in product type, function, and use. The Voluntary Improvement Program is also interested in what metrics matter but is trying a different approach. Organizations are encouraged to self-identify which metrics they actually use to make decisions about their products and what data they are really tracking to understand quality and performance.
By capturing this information quarterly, the program can start to see how metrics change over time as organizations implement continuous improvement projects resulting from their appraisal. Program collaborators hypothesize that during times of change these metrics may dip, but that in the long run, they will improve.
Once enough data is collected, the next step will be to identify any common metrics and allow participants to begin comparing against an industry benchmark. By sharing definitions for these common metrics, the industry can choose whether to align their metrics for additional insights into how they're performing.
Centralized Resources
This tool also gives program collaborators access to a centralized location of resources, this enables quick and easy access to information that is most relevant to where a program participant is in their journey.
There are regular meetings with working groups and monthly update calls, both of which enable peers to come together to learn, share problems, and discuss what worked and what did not. One happy surprise in the program is seeing more cross-industry collaboration.
A future goal is to create an additional forum space where participants can connect to their peers online. The hope is to provide participants with another way to contact those in the same sub-industry or with similar challenges to foster new networks of collaboration and learning.
