The medical device manufacturing industry has traditionally been driven by a compliance-focused mindset. 幸运的是, 这种情况正在改变, as device manufacturers increasingly recognize that compliance with regulations as an end goal vs. a starting point does not necessarily translate to device quality.
By helping medical device manufacturers better understand and sharpen their capabilities, ISACA’s 医疗器械发现鉴定计划(MDDAP) is advancing device quality and patient outcomes by driving toward a culture of continuous improvement.
乔治·扎克, 双港咨询公司的负责人和联合创始人, 有限责任公司, puts it this way: when his 16-year-old son had just earned his driver’s license, he was compliant with meeting state requirements by passing the mandatory exam, but characterizing him as a quality driver at that moment would have been misleading. 以他作为MDDAP评估师的角色, Zack sees first-hand the difference between compliance and truly prioritizing quality, and how MDDAP puts medical device manufacturers on a path toward producing more reliable, 经常拯救生命, 患者设备.
能力成熟度模型集成(CMMI) provides a framework of globally respected best practices that help organizations improve quality and efficiency. 作为ISACA MDDAP的高级产品经理Kim Kaplan， 最近表示, “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.”
There is often a misconception that quality refers only to something being of the highest possible caliber – for example, 许多人可能把一顿高质量的饭等同于去一家高级餐厅. But availability, safety and efficacy are among the aspects that help make up quality, 扎克说. 继续餐厅的比喻, 去休闲餐厅, no-frills diner around the corner can be a quality experience for a family looking to grab a quick meal. Organizations can turn those various components of quality into an important competitive advantage by earning the trust of customers and stakeholders.
在医疗器械领域, MDDAP helps organizations with a strong compliance history focus on quality and improving performance in a way that makes sense for their business and customers. Organizations that enroll in MDDAP agree to have independent appraisers come to their site and leverage the CMMI model to evaluate the capabilities of how they are performing against selected practices, and then collect feedback on strengths and opportunities for improvement. Agreeing to proactively have light cast upon their organization’s practices when they are already fully compliant organizations speaks to a culture of continuous improvement from program participants, 扎克说.
MDDAP appraisals allow device manufacturers to understand their gaps and prompt the needed conversations – whether within their site or collaborating with other stakeholders – to improve their performance. An overwhelming 95%+ of program participants report that the appraisal provided value to their organization, and 85%+ indicate the appraisal method provided a direct value to improving product quality.
“我们进行MDDAP评估的方式是, 这是给你的, 这不仅仅是为了让你获得证书, it’s for you to collect information on how your organization can be better,扎克说。. 本着这种精神, I’m not surprised at that those percentages because people see value in that approach.”
Organizational resilience and business continuity have become especially resonant with organizations in the COVID-19 era. The CMMI model utilized in MDDAP enables organizations to make sure their capabilities in those areas are sufficient for today’s volatile business environment.
“CMMI sets up processes to be more defined so organizations should be more resilient,扎克说。. 通过对实践领域的组织进行评估, 我们测试他们是否有习惯性, persistent and sustainable processes that will work not only when things are going well but in times of stress. That is true not just for medical device organizations but anyone assessing against CMMI practices.”
在医疗器械领域, there often are disconnects between the design and manufacturing functions – both between sites and even within an organization’s own four walls. 扎克说 the handoff of processes between these groups is “ripe fruit for an appraisal team to examine the capabilities of these processes.”
Given the importance of medical device quality in patients’ lives, it’s important not to lose sight of what is at stake in organizations’ commitment to improving performance and device quality. Zack relayed an anecdote of patients who have pacemakers installed in their chest being brought as guests to one site so that the manufacturing lines workers could gain a true appreciation of how meaningful the quality of their work is to medical patients.
“这就是这个行业的魅力所在，”扎克说. “It’s very easy to think about it as manufacturing and compliance and business, but the true magic of this is that the people that we get to interact with are truly trying to impact the health and the enjoyability of people’s lives. 这很神奇.”
