编者按: The 自愿改善计划 (VIP) recently became the first Case for Quality initiative recognized by the United States Food and Drug Administration (FDA) through formal Draft Guidance published 6 May 2022. VIP利用ISACA的 医疗器械发现鉴定计划(MDDAP) 并于去年从试点项目过渡到全面运营项目. 在2022年7月5日前阅读并评论FDA的指南草案. 金正日卡普兰, ISACA MDDAP高级产品经理, recently visited with ISACA现在 to provide context on how MDDAP arrived at this point and what might be in store going forward. The following is a transcript of the conversation, edited for length and clarity:
ISACA现在: MDDAP是如何形成的?
MDDAP’s successful development is due in part to the Case for Quality (CfQ) being launched from FDA’s own research with a wide variety of stakeholders, which revealed a problem in the industry: compliant manufacturers were still having similar types and frequency of issues as non-compliant manufacturers. While compliance was important, it alone wasn’t going to drive the desired quality outcomes.
FDA wanted to understand how they could build a Case for Quality beyond the regulatory standard, so they established a public-private partnership with the Medical Device Innovation Consortium, 或MDIC, 为整个医疗保健生态系统创造一个安全的协作空间. MDIC成员包括来自制造商的代表, 患者权益团体, 医院和政府机构.
MDIC facilitates working groups to investigate opportunities that might further device quality and patient outcomes. One working group contracted Deloitte to conduct a study of 22 different maturity models and the 能力成熟度模型集成(CMMI) was selected as best option due to its wide adoption as a global standard and flexibility to be fit to purpose.
CMMI提供了一个最佳实践的框架, 当采用, 增加组织按时交付的可能性, 在预算之内, 高质量的. MDDAP is a tailored version of CMMI that enables medical device manufacturers to understand, measure and improve their capabilities to deliver high-quality products to patients.
ISACA现在: Can you touch on the significance of VIP recently becoming the first Case for Quality initiative being recognized by the FDA?
The Case for Quality launched over a decade ago and has had a number of initiatives start and end while others are still trying to figure out their path forward. There has been some hesitancy from industry about investing in an FDA pilot that may not be here to stay. FDA issuing draft guidance for their formal involvement in VIP establishes this program, 它代表了什么, 作为他们愿景和战略的一部分.
ISACA现在: What are some of the most pressing challenges in the medical device industry that MDDAP is helpful in addressing?
我们从VIP参与者那里听到了一些有趣的主题.
首先，质量是一个部门的概念. 我们听说在质量管理体系下, 管制活动是在一个沉重的管理之下进行的, 几乎限制, 流程，而其他业务活动的结构要少得多. As a result, there can be challenges in effectively executing cross-functional activities. MDDAP helps organizations identify more holistic opportunities for improvement.
第二，有针对性地处理合规行为. 我们听到这是处理问题的规定的结果, 制造商通常实施范围狭窄的快速解决方案. 因此，复发的可能性会增加. MDDAP provides the time and support for organizations to develop solutions that are more systemic and sustainable.
ISACA现在:您提到了快速学习和迭代的必要性, 并适应利益相关者的需求. Can you elaborate a bit on that and why it has proven to be so significant?
在一个技术不断进步，环境不断变化的时代, 昨天起作用的可能今天或明天就不起作用了, 所以知道如何快速适应是很重要的. 在COVID, we were able to identify the needs of program stakeholders amidst supply chain disruptions, 停产和裁员. MDDAP shifted to completely virtual service delivery between May and December of 2020 by leveraging a phased, 基于风险的试点测试方法, 通过不断的学习和迭代.
ISACA现在: How has digital transformation entered into the equation with the program’s evolution, 结果是什么呢?
Many activities were performed manually during the pilot, such as data collection. We captured information in Excel workbooks which made it challenging to analyze on a regular basis. This year, ISACA launched the VIP Portal, a software-based data reporting tool for the program. As a result, program stakeholders can now review information in real time. 在系统中输入了200多个历史数据点, the VIP Portal is able to reveal insights regarding continuous improvement journeys as well as common industry strengths and challenges.
在一个 我在MDIC VIP论坛上的演讲, I shared that many first-year facilities struggle to provide adequate funding, 为员工提供培训和发展资源, 保持更新, and execute on the processes required to be successful against objectives. 到了第二年, many of those facilities are able to close that gap and evaluate against higher capabilities, uncovering new opportunities around creating organizational assets that support greater consistency in success from project to project.
ISACA现在:您如何看待该项目未来的发展?
The program will continue to investigate new opportunities to provide value to program collaborators. 除此之外, there are many avenues for VIP to support an even broader set of healthcare stakeholders. 例如, the Accelerate Sustainable Capability (ASC) pilot study is exploring how elements of MDDAP could help sites that are focused on compliance achieve their goals faster and more sustainably.
Although VIP focuses on medical devices, many devices include drug or software components. 在更远的地平线上, there may be opportunities to collaborate with other FDA initiatives such as Digital Health, 专注于将软件作为医疗设备, 或者质量成熟度模型计划, 专注于制药. 比如MDDAP, VIP may one day collaborate with healthcare government agencies in other countries. 可能性是令人兴奋的.
