Quality when producing medical devices doesn’t result from just one aspect but rather the entire production process – it starts with the precise design and includes all aspects such as materials, machines, cutting tools, workholding, and metrology. But even with a precise plan, dreaded recalls of a device can happen. However, there’s a new program aimed at guiding improvements.
The Voluntary Improvement Program (VIP), through the Medical Device Innovation Consortium (MDIC), evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals. It’s intended to guide improvement to enhance the quality of devices and builds on the framework piloted through United States Food and Drug Administration’s (FDA) 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program), incorporating some of the successes and learnings from the pilot.
As the first Case for Quality program recognized by the FDA through a formal Draft Guidance published in May 2022, VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) and participants could benefit from several opportunities that accelerate improvements to device quality and manufacturing. These include:
Inspections: Risk-based approach to FDA inspection planning and resource allocation for routine surveillance, pre-approval, post-market inspections
Change notices: Use of a modified submission format with reduced timeframes (resource permitting) for Premarket Approval Application (PMA), Humanitarian Device Exemption (HDE) 30-Day Change Notices
Site changes: Use of a modified submission format with reduced timeframes (resource permitting) for PMA and HDE Manufacturing Site Change Supplements
Manufacturing modules: Use of a modified submission format for PMA or HDE Manufacturing Modules
The program provides a model and method for device makers to understand, measure, and advance capabilities to produce high-quality devices for improved patient outcomes. This framework, the basis for the VIP, is a version of the ISACA Capability Maturity Model Integration (CMMI), customized for this program.
After an experienced appraisal team evaluates an organization’s capabilities, results allow the organization to easily identify areas of strength and opportunities for improvement. Including annual MDDAP appraisals against a set of best practices, quarterly check points with performance reports, and a supportive regulatory environment, VIP enables medtech manufacturers to design, build, and deliver safe, innovative products to market faster.
It’s already showing its success. In a 2021 survey, 89% believe the MDDAP appraisal identified opportunities to improve product quality and 96% believed the appraisal provided broader value add. In one case study, production capacity increased 65%, getting more treatments to patients faster. In another VIP case study, the organization was able to reduce complaint closure time by 27%, increasing product quality. Still other participating organizations claimed that the program produced a culture shift toward a sustainable quality mindset.
With the positive results from the VIP, what is your company doing to increase the quality of medical devices produced? Drop me a line to let me know the steps your company is taking.