Medical device manufacturers seeking to better understand, measure and improve their capabilities have a new avenue to do so.
ISACA, in collaboration with the Medical Device Innovation Consortium, the US Food and Drug Administration (FDA) and industry stakeholders, has developed the Case for Quality Voluntary Improvement Program (VIP) to shift the mindset of medical device manufacturers beyond compliance and toward continuous improvement.
VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP). The MDDAP framework is a tailored implementation of CMMI specifically for the medical device industry. Medical device manufacturers are appraised in MDDAP to identify improvement opportunities against a proven set of best practices to increase performance beyond compliance. MDDAP provides a minimally disruptive and sustainable approach with the goal of improving patient outcomes through medical device quality and organizational performance.
Manufactures’ commitment to a more transparent and collaborative approach to quality allows the FDA to modify internal processes for program participants by accelerating the device improvement process. Program results show increased quality, lower costs and greater efficiency.
“[Our] investment in CMMI’s MDDAP has enabled our start-up medical device company to deliver our cardiovascular innovations at or above the quality levels of larger, more established, medical device competitors,” said Carl St Bernard, CEO, CeloNova Biosciences.
See a related case study from CeloNova Biosciences and find out more about MDDAP at https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program.
