编者按: The 自愿改善计划 (VIP) Portal launched to program collaborators and stakeholders in 2023 after being available to the FDA since 2022. 金正日卡普兰, ISACA高级产品经理, 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 自愿改善计划 collaborators to access various data reports to see 行业趋势 and understand the impact to organizational performance. This system will serve as the main tool to access data for individual site appraisals, 检查分, 性能报告, 项目资源, 行业趋势, 和更多的! 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.
评估结果
作为这个项目的一部分, 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 函数s connect with less regulated 函数s. These gaps identify opportunities for efficiencies that help to improve capacity, 减少缺陷, 提高周期时间, 减少营业额, 和更多的.
通过VIP门户, participants can see how they did against these best practices year over year, 从一个站点到另一个站点, 整个组织和整个行业. 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 行业趋势. 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, 一些重要的问题可以得到回答:
- 行业优势是什么?
- 哪里是最大的改进机会?
- How can the FDA use this information to define new guidance that supports industry?
FDA’s final guidance for the 自愿改善计划 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.
性能指标
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, 函数, 和使用. The 自愿改善计划 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.
通过每季度获取这些信息, 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, 但从长远来看, 他们会进步的.
一旦收集到足够的数据, the next step will be to identify any common metrics and allow participants to begin comparing against an industry benchmark. 通过共享这些公共指标的定义, the industry can choose whether to align their metrics for additional insights into how they're performing.
集中资源
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, 分享问题, 讨论一下什么有用，什么没用. 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.
