By: Sandra K. Rodriguez, Market Analyst
Life Science Industry Executive Roundtable – Event Brief
Complex – the one word that accurately describes the current environment in Life-Sciences. As products and manufacturing processes become more complex, managing change comes with a higher level of risk. To discuss the importance of managing change in this complex environment, as well as examine key findings from our latest research on Change and Configuration Management, Axendia brought together a select group of executives from leading Life Science companies for a roundtable in Princeton, NJ.
A primary thread of the discussion was the need for closed-loop Change and Configuration Management (C&CM) strategies. Closing the loop is becoming critical to ensuring product quality throughout the product lifecycle.
The research shows that:
- 63% of survey respondents say their C&CM process is only somewhat effective or useless
- Not a single respondent reported they have an idealC&CM system in place
- 55%report that a slow and cumbersome C&CM process keeps them up at night
- 62% rateregulatory and government agencies as their TOP business disruptor
While research also showed that the rate of change is increasing, as one Industry Executive pointed out, “change and configuration management is often an afterthought.” The mindset often goes something like this: “We already have a great product. So, why bother!”
Why Are C&CM Processes Less Than Effective?
This lead us to ask, if the only constant is change, why are C&CM processes less than effective for so many organizations?
The Director of Quality Systems at a Global Life Science company, pointed out: “a solid Product Lifecycle Management (PLM) can do a lot to support C&CM.” However, all participants agreed that the document change control approval process is both cumbersome and time consuming. Often, it becomes a bottleneck with multiple signatures being required from functional areas which are in fact not impacted by the change. Another executive added: “we need to keep our process very simple.” The challenge is that if one time there is a change that impacts a particular department or area, for example health & safety, that department is added to the procedure and approval matrix and it remains there for every subsequent change. Why not simplify the process so only affected groups have to approve a change? The challenge in many companies is that once a group is on the SOP as an approver – it’s difficult to eliminate it.
When it comes to managing C&CM across multiple sites, the Director of Quality Compliance at a Global Medical Device company commented that “Changing the process is difficult. This is especially difficult since often times each site has its own definition of what a best system is or should be.”
Supporting Innovation with Technology Solutions
The research further revealed that 61% of survey respondents selected “Better Use of Technology” as the top answer when asked what would help your organization improved C&CM? Paper-based systems are incapable of supporting visibility and a single source of truth throughout the total product lifecycle.
To address this very real issue, the VP of Quality Assurance at a biopharmaceutical company discussed his company’s use of a cloud-based platform capable of managing product data from R&D through Manufacturing.
The discussions lead us to examine whether politics and organizational culture are a threat to innovation. Every executive agreed; in order to give people the right technology solutions, the right functional areas must be part of the selection process and be empowered to make decisions.
Another observation the group made was that a major obstacle to collaboration is often the physical and geographic location of functional groups, like R&D, Quality and Manufacturing. These areas are typically dispersed throughout a campus, and increasingly across the globe, and not under one roof. Geography and localization can also be an innovation-killer. One executive shared that his company sometimes focuses on a much smaller local market, rather than looking at the global picture. This leads to the question, are life science companies trying to solve a market problem with new devices or a real (world) problem?
The discussion then shifted to another “Hot Topic,” that of Data Integrity. Without data and data integrity, it is impossible to follow the product and not the documents. Yet 83% of survey respondents stated their C&CM process was somehow or mostly paper driven. Is paper industry’s “security blankie?” The executives agreed that it is impossible to refine data for data-based decisions when you cannot trust the data coming out of the system. The underlying issue could be that legacy systems are not updated to support today’s organizations.
Compliance is a Baseline, Quality is the Goal
Another topic of agreement was the need to shift from reactive to predictive stances. 82% of survey respondents who admittedly do not have a closed-loop C&CM process, indicated their company’s approach to C&CM is to fix problems as they occur. This firefighting mentality can be counterproductive when differentiating between quality and compliance. Dr. Jeff Shuren, Director CDRH at FDA stated, “… one manufacturer can meet FDA regulatory requirements and still make a poor quality device. Whereas a second manufacturer may not comply with all FDA requirements, and yet make a high quality device.”
As one executive put it, we often hear: “Quality is our priority, Safety is our priority, Shareholders are our priority…these are NOT priorities….they are principles.”
The consensus of the roundtable participants was that no organization has unlimited resources. Organizations need to be consciously aware of the number of resources needed to put out fires after they occur and the number of fire-fighting activities happening versus prevention. When resources are being allocated to address defects, few are left for preventative, quality driven C&CM activities.
The group also agreed that there is true business value in closing the loop, aside from avoiding the cost of a recall. However, companies are sometimes only willing to improve on product quality as long as it can be done with existing resources and without extending budgets. The final take away of the day was simple: with commitment from executive teams and alignment up front, preventative and predictive closed-loop C&CM strategies can be achieved.
Products and manufacturing processes will continue to become more complex, therefore managing change comes with a higher level of risk. Closing the loop is critical to ensuring product quality throughout the product lifecycle. One executive commented that to make the transition from compliance to quality, “The shift has to happen at the practitioner level.” All the “priorities are meaningless unless people make them happen.”
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The opinions and analysis expressed in this article reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. Primary research was sponsored by SiemensPLM and Deloitte. This document is not intended to endorse any company or product and should not be attributed as such.