Partner content with ISACA.
FDA studies have found that in the medical device industry, compliance alone is not enough to ensure improved quality indicators. Why? Because compliant medical-device manufacturers still report similar quality, complaint and performance issues as their uncompliant counterparts.
“Part of the challenge is a cultural thing,” says Kim Kaplan, senior product manager at ISACA. “Many organizations we work with use compliance as an end goal instead of the starting point.”
This conundrum led to the FDA creating the Case for Quality program, which the Voluntary Improvement Program (VIP) is a part of. Its aim is to shift the mindset of medical device manufacturers to go above and beyond regulatory compliance by embracing continuous improvement methodologies.
When an organization’s goal is to maintain a minimum requirement, argues Kaplan, individuals are incentivized to hide their daily issues and challenges in fear of losing accreditations. For VIP participants, like J & J MedTech, it is no longer about passing or failing the assessment. By removing this fear from the equation, the goal shifts to continuous improvement via open dialogs among all stakeholders. The team this creates (which includes stakeholders from the FDA, Medical Device Innovation Consortium (MDIC), ISACA and the VIP participant company) now has one common goal: to proactively address, pain points and barriers to advancing quality.
“FDA and participants agree that the program puts a spotlight on quality opportunities and transitions away from quality being seen as a department that polices,” says Kaplan. “Instead, this process quickly reveals how everyone contributes towards quality whether directly or indirectly, and that quality should be embedded into everything an organization does.”
Chuck Medovich, Vice President & Chief Quality Officer, J&J MedTech agrees based on the benefits VIP has brought to the company.
“J&J MedTech’s participation in the VIP has elevated alignment with industry standards, best practices, predictive processes and capabilities that advance medical device quality and safety to help achieve better patient outcomes,” says Medovich “By moving the focus beyond compliance and using the Capability Maturity Model Integration (CMMI) maturity appraisal, manufacturers can receive more actionable feedback by the appraisal team that supports strategic plans and investments throughout the organization … This commitment can stand as a testament to the dedication and determination of ensuring the continuous safety and supply of products for patients and customers.”
Device manufacturers can benefit from joining VIP, welcoming regular reviews and implementing CMMI-informed workflows. These benefits include:
- Traditional improvements such as increased productivity, efficiency, customer satisfaction, data-driven decisions, stronger risk management and alignment with industry standards.
- Business benefits including competitive advantages, market differentiation, added scalability, market growth and improved reputations and trust.
“I hear all the time that participants wanted more opportunities to communicate with their peers and to learn from each other — they haven’t been able to do that before,” says Kaplan. “[With VIP] we create a community with meetings of peers to share best practices. Relationships with the FDA are improved and become more collaborative than combative. These relationships are transformative for a lot of participants and that’s really unique. It creates a space to find others in the same industry to share common challenges and even resolve some of them.”
To learn more about, the VIP and its relationship to FDA, MDIC, and CMMI, visit www.isaca.org/vip.
