Editor’s note: The Voluntary Improvement Program (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the first Case for Quality initiative recognized by the United States Food and Drug Administration (FDA) through formal Draft Guidance published 6 May 2022.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 leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) and transitioned from a pilot to a fully operational program last year. Read and comment on FDA’s Draft Guidance by 5 July 2022. Kim Kaplan, Senior Product Manager for MDDAP at ISACA, recently visited with ISACA Now 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 Now: How did MDDAP come to be?
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, or MDIC, to create a safe space for collaboration across the healthcare ecosystem. MDIC membership includes representatives from manufacturers, patient advocacy groups, hospitals and government agencies.
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 Capability Maturity Model Integration (CMMI) was selected as best option due to its wide adoption as a global standard and flexibility to be fit to purpose.
The CMMI provides a framework of best practices that, when adopted, increases the likelihood an organization will deliver on-time, within budget, and of high-quality. 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 Now: 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, and what it represents, as part of their vision and strategy.
ISACA Now: What are some of the most pressing challenges in the medical device industry that MDDAP is helpful in addressing?
There a couple themes we have heard anecdotally from VIP participants.
First, the notion of quality being a department. We hear that under a Quality Management System, regulated activities are managed under a heavy, almost restrictive, process while other business activities have much less structure. As a result, there can be challenges in effectively executing cross-functional activities. MDDAP helps organizations identify more holistic opportunities for improvement.
Second, addressing compliance actions in a targeted manner. We hear that as a result of regulations for addressing issues, manufacturers often implement fast solutions that are narrow in scope. As a result, there is an increased risk in the likelihood of recurrence. MDDAP provides the time and support for organizations to develop solutions that are more systemic and sustainable.
ISACA Now: You’ve mentioned the need to quickly learn and iterate, and adapt to the needs of stakeholders. Can you elaborate a bit on that and why it has proven to be so significant?
In a time of ever-advancing technologies and shifting landscapes, what worked yesterday might not work today or tomorrow, so it’s important to know how to quickly adapt. During COVID, we were able to identify the needs of program stakeholders amidst supply chain disruptions, production shutdowns and layoffs. MDDAP shifted to completely virtual service delivery between May and December of 2020 by leveraging a phased, risk-based approach to pilot testing, and by learning and iterating along the way.
ISACA Now: How has digital transformation entered into the equation with the program’s evolution, and what have the results of that been?
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. With over 200 historical data points entered in the system, the VIP Portal is able to reveal insights regarding continuous improvement journeys as well as common industry strengths and challenges.
In a presentation I delivered for MDIC’s VIP Forum, I shared that many first-year facilities struggle to provide adequate funding, training and resources for staff to develop, keep updated, and execute on the processes required to be successful against objectives. By their second year, 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 Now: How do you see the program continuing to evolve going forward?
The program will continue to investigate new opportunities to provide value to program collaborators. Beyond that, there are many avenues for VIP to support an even broader set of healthcare stakeholders. For example, 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. Further on the horizon, there may be opportunities to collaborate with other FDA initiatives such as Digital Health, focused on software as a medical device, or the Quality Maturity Model initiative, focused on pharmaceuticals. Perhaps like MDDAP, VIP may one day collaborate with healthcare government agencies in other countries. The possibilities are exciting.
