In a recent post on Configuration Management (CM), we defined CM and why it is important to medical device manufacturers, drawing on comments by Mike Cislo, specialist leader at Deloitte Consulting, made at a recent webinar. This post examines the challenges of CM.
“Challenges of configuration management normally arise from the impact CM has on organizations, processes, and supporting applications,” says Cislo.
He cites six principal areas of challenge:
- Collaboration across CM program teams
- Current state and form of information
- Collaboration between Product Development and Manufacturing for development of the Device Medical Record (DMR)
- Isolation of product specifications
- Isolation of applications supporting each business function that plays a role in CM
- Integration of third parties
First, collaboration across CM teams can be challenging. Product Development, Manufacturing, Service Management, and Regulatory Enforcement are all involved in supporting CM efforts. “Each team has its own initiatives, mandates, and goals, so getting them to elevate CM to a top priority almost takes an executive mandate,” says Cislo. “It’s difficult to negotiate with these teams, and that is a challenge in every case.” Since CM starts with approved product configurations that can be used directly with other functions, having as-design data available in a form that can be used by downstream functions is challenging and often requires considerable work.
Next, collaboration between Product Development and Manufacturing is essential for development of the DMR, which contains the manufacturing procedures, quality controls, and packaging/labeling specifications for correct product configuration. “These have to be enforced on the manufacturing side, but are typically handed off in paper or ‘thrown over the wall,’ which is problematic,” says Cislo.
Additionally, the isolation of product specifications can also prove challenging. These specs are often embedded in test procedures, drawings, or procedure documents, as opposed to being captured as product data. It’s imperative that specifications are accessible and usable for CM throughout the medical device enterprise.
Moreover, the integration of applications supporting each business function that plays a role in configuration management is essential. Companies need to understand the source for each type of product data being used in the CM process.
The schematic above shows the pervasiveness of this integration across the enterprise. Delivery of the DMR by Product Development to commercial operations, manufacturing and service management provides systemic verification that ordered, as-built and as-serviced configurations are approved. Delivery of Market Clearances by Regulatory Management provides systemic verification that product configurations are cleared for sale and distribution to the market.
Finally, the increasing importance of third parties—design organizations, contract manufacturers, service organizations—and the need to collaborate efficiently across these networks can pose integration problems, a further challenge to CM efforts. “It’s really important that the DMR specifies the DHR as well as service procedures,” says Cislo. “This makes the data more usable to all stakeholders that supply or need access to data.”
While the challenges to implementing CM are significant, thankfully significant technologies are available to support the process. In our final post on this topic, we’ll speak to how MES and other systems support CM in this sector.