building a culture of quality and innovation...
TRANSCRIPT
AN AXENDIA MEDICAL DEVICE INDUSTRY SURVEY BUILDING A CULTURE OF QUALITY AND INNOVATION
POOR QUALITY
COSTS M E D I C A L D E V I C E M A K E R S 12-18%
OF REVENUE*THAT’S $26 BILLION E ACH YE AR *
IN A CLOSED-LOOP SYSTEM THE OUTPUT IMPROVES BASED ON INPUT.
OUR ANALYSIS SHOWS A STRONG CORRELATION BETWEEN COMPANIES WHO CLOSE THE LOOP AND THOSE WHO USE PLM. TO COMPETE IN TODAY’S
GLOBAL MARKETS, MEDICAL DEVICE COMPANIES MUST SHIFT TO MODERN, CLOSED LOOP, PRODUCT DEVELOPMENT APPROACHES.
1 LEARN
ABOUT THE CASE FOR
QUALITY (CFQ)
ISSUE RESOLVED
ISSUE
ENGINEERING CHANGE
8 OUT OF 10 EXECUTIVES RECOMMEND UNIFYING PLM + QA PROCESSES THROUGH A COMMON TECHNOLOGY PLATFORM.
2 VANQUISH
SILOS
3 ELEVATE
PLM
YET, FEWER THAN 40% OF MEDICAL DEVICE MAKERS CAN CLOSE THE LOOP.
NEARLY 2/3 OF RESPONDENTS WERE UNFAMILIAR WITH THE FDA CASE FOR QUALITY.
0% 10% 20% 30% 40% 50% 60% 70%
63%
54%
30%
27%
60%
RAPID RESPONSES TO QUALITY ISSUES
REAL-TIME VISIBILITY
REDUCED COSTS
BETTER CHANGE MANAGEMENT
IMPROVED AGILITY
*Sources: McKinsey Center for Government, “The Business Case for Medical Device Quality” Survey results courtesy of Axendia, “Driving a Culture of Quality Within the Medical Device Manufacturing Ecosystem”
FDA STATES IT IS TO IMPROVE QUALITY OUTCOMES
THE BENEFITS OF CLOSED-LOOP QUALITY ARE WELL UNDERSTOOD
WHAT WE LEARNED
1/2 OF RESPONDENTS SAID IT WAS TO ENSURE COMPLIANCE
HOW TO FIX IT 3 STEPS TO CLOSING THE LOOP ON QUALITY
WANT TO LEARN MORE?
READ THE WHOLE REPORT. [CLICK HERE]
CAPA
THERE’S CONFUSION AROUND THE
PRIMARY ROLE OFQUALITY
THE CASE FOR QUALITY IS AN FDA INITIATIVE TO SHIFT INDUSTRY’S FOCUS FROM COMPLIANCE TO QUALITY.
© 2018 Axendia, Inc.
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