building a culture of quality and innovation...

AN AXENDIA MEDICAL DEVICE INDUSTRY SURVEY BUILDING A CULTURE OF QUALITY AND INNOVATION POOR QUALITY COSTS MEDICAL DEVICE MAKERS 12-18 % OF REVENUE * THAT’S $26 BILLION EACH YEAR * 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 OF QUALITY THE CASE FOR QUALITY IS AN FDA INITIATIVE TO SHIFT INDUSTRY’S FOCUS FROM COMPLIANCE TO QUALITY. © 2018 Axendia, Inc. PTC presents:

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Page 1: Building a culture of Quality and innovation infographicsaxendia.com/blog/wp-content/uploads/2018/02/Axendia_Infographic-secured.pdf · AN AXENDIA MEDICAL DEVICE INDUSTRY SURVEY BUILDING

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.

PTC presents: