Sandra K. Rodriguez, Research Associate, Axendia08.09.16
Medical devices are in a constant state of evolution: providing new capabilities, addressing defects, adapting to changing markets or regulatory demands, and reacting to competitive threats. Actively managing products with closed loop systems across the total product lifecycle can drive improvements in product quality and accelerate new product introductions while supporting regulatory compliance.
As a result, shifting to closed loop Change and Configuration Management (C&CM) processes across the total product lifecycle has become critical to some but not all, medtech manufacturers.
To evaluate the state of C&CM in the industry, Axendia conducted a research study and surveyed industry practitioners from around the globe.
At first glance, the survey data validates trends most medtech professionals may be able to relate to:
Further analysis uncovered other key trends:
Innovators vs. Laggards
We discovered an eye-opening trend when we compared responses based on answers to the question, “How strongly do you agree with this statement: We have a closed loop system for change and configuration management?“ We labeled respondents that strongly agreed with the statement (8 percent) as innovators; conversely, those that strongly disagreed (17 percent) were identified as laggards.
Defining ‘Closed Loop’
Closed loop is a system in which the desired output depends on the input signal and feedback elements. Open loop is a system in which the desired output depends on only the input signals. As medical devices become more complex, it is increasingly difficult for the change and configuration management process to be successful in an open loop system.
Closing the loop begins with commitment from executive management. Yet the commitment gap for current full commitment versus optimal full commitment is wide at 51 percent. From an organization and technology perspective, more support is needed from management to move an organization from the laggard to the innovator category.
The lack of a closed loop system in support of change and configuration management can also affect an organization’s ability to evaluate the financial impact of a change. While 80 percent of respondents identified as innovators rate their ability to evaluate the financial impact of a change above average, only 9 percent of laggards responded favorably.
Are You Fixing Problems As They Occur?
Fifty-six percent of respondents fix problems as they occur rather than developing predictive approaches most of the time. Industry advisory council members agreed this leads to a difficulty avoiding problems. This can be costly to an organization and top U.S. Food and Drug Administration officials have acknowledged it is possible to distribute poor quality products by complying with all applicable regulations.
Compliance and quality are not equivalent even though they are often used interchangeably. Compliance should be a byproduct of a well-designed and executed closed loop process to reduce opportunities for errors, non-conformances and field actions.
Conclusion
To thrive in today’s shifting business, regulatory and technology landscape, medtech organizations must follow the lead of innovators and implement a harmonized, integrated and closed loop approach to C&CM. The return on investment on closed loop C&CM processes is straightforward—avoiding a single major recall could pay for the implementation of closed loop processes and systems, not only at a single company but for the entire medtech industry.
About the Research
To find quantitative answers about current business, regulatory and technology issues medtech organizations face, Axendia conducted a research study to identify C&CM trends in the industry. Findings are based on a survey of 85 worldwide medtech industry professionals. Industry thought leaders also provided valuable insight on this topic.
To address key findings and analysis on this topic, Axendia is publishing a series of white papers under the title, “The Future of Change and Configuration in the Med-Tech Industry.” Download your complimentary copy with guest access code: MPO16CCM.
The research was sponsored by Deloitte and Siemens PLM.
Sandra Rodriguez is a research associate at Axendia, an analyst firm providing trusted advice to life-science and healthcare executives on business, technology, and regulatory issues. Rodriguez has 15 years of experience working within U.S. Food and Drug Administration-regulated industries and served six years in the U.S. Army Reserve. She can be reached at srodriguez@axendia.com.
As a result, shifting to closed loop Change and Configuration Management (C&CM) processes across the total product lifecycle has become critical to some but not all, medtech manufacturers.
To evaluate the state of C&CM in the industry, Axendia conducted a research study and surveyed industry practitioners from around the globe.
At first glance, the survey data validates trends most medtech professionals may be able to relate to:
- The main driver for C&CM with regards to products or processes is to fix a defect and/or close a corrective and preventive action (CAPA).
- The top industry disruptors are regulatory agencies.
- Better use of technology was the top answer when we asked what could help improve C&CM.
- Sixty-three percent of respondents admitted their C&CM process is only somewhat effective or useless.
Further analysis uncovered other key trends:
- No respondents reported having an ideal C&CM process.
- More than half of all respondents see the rate of making major changes to their products or processes either increasing or staying the same over the next two years.
- Eighty-two percent of industry is documentation drive in their C&CM process.
- Thirty-four percent of respondents reported full commitment from executive management for a closed loop C&CM process.
Innovators vs. Laggards
We discovered an eye-opening trend when we compared responses based on answers to the question, “How strongly do you agree with this statement: We have a closed loop system for change and configuration management?“ We labeled respondents that strongly agreed with the statement (8 percent) as innovators; conversely, those that strongly disagreed (17 percent) were identified as laggards.
Defining ‘Closed Loop’
Closed loop is a system in which the desired output depends on the input signal and feedback elements. Open loop is a system in which the desired output depends on only the input signals. As medical devices become more complex, it is increasingly difficult for the change and configuration management process to be successful in an open loop system.
Closing the loop begins with commitment from executive management. Yet the commitment gap for current full commitment versus optimal full commitment is wide at 51 percent. From an organization and technology perspective, more support is needed from management to move an organization from the laggard to the innovator category.
The lack of a closed loop system in support of change and configuration management can also affect an organization’s ability to evaluate the financial impact of a change. While 80 percent of respondents identified as innovators rate their ability to evaluate the financial impact of a change above average, only 9 percent of laggards responded favorably.
Are You Fixing Problems As They Occur?
Fifty-six percent of respondents fix problems as they occur rather than developing predictive approaches most of the time. Industry advisory council members agreed this leads to a difficulty avoiding problems. This can be costly to an organization and top U.S. Food and Drug Administration officials have acknowledged it is possible to distribute poor quality products by complying with all applicable regulations.
Compliance and quality are not equivalent even though they are often used interchangeably. Compliance should be a byproduct of a well-designed and executed closed loop process to reduce opportunities for errors, non-conformances and field actions.
Conclusion
To thrive in today’s shifting business, regulatory and technology landscape, medtech organizations must follow the lead of innovators and implement a harmonized, integrated and closed loop approach to C&CM. The return on investment on closed loop C&CM processes is straightforward—avoiding a single major recall could pay for the implementation of closed loop processes and systems, not only at a single company but for the entire medtech industry.
About the Research
To find quantitative answers about current business, regulatory and technology issues medtech organizations face, Axendia conducted a research study to identify C&CM trends in the industry. Findings are based on a survey of 85 worldwide medtech industry professionals. Industry thought leaders also provided valuable insight on this topic.
To address key findings and analysis on this topic, Axendia is publishing a series of white papers under the title, “The Future of Change and Configuration in the Med-Tech Industry.” Download your complimentary copy with guest access code: MPO16CCM.
The research was sponsored by Deloitte and Siemens PLM.
Sandra Rodriguez is a research associate at Axendia, an analyst firm providing trusted advice to life-science and healthcare executives on business, technology, and regulatory issues. Rodriguez has 15 years of experience working within U.S. Food and Drug Administration-regulated industries and served six years in the U.S. Army Reserve. She can be reached at srodriguez@axendia.com.