I recently took part and chaired an interactive session where executives and other medical device industry specialists came together to discuss challenges in a range of areas of labeling development, data and compliance.
The peer-to-peer learning environment that took place at the 6th Semi-Annual Medical Device Packaging and Labeling Summit on Friday 28th April 2017, focused primarily on ‘Expediting label change management and documentation’. Here is a selection of the questions I posed to delegates and the summary answers included:
1. What are some of the most common bottlenecks in your labeling programs?
The lack of an enterprise labeling solution; design control complexities including many layers of change and label changes lead time; distracted reviewers missing key label information causing re-routing.
2. How is the content for your labels, IFUs and inserts currently managed?
Most teams utilize some type of label control / change management system that is integrated with content or change systems. Some of the discussion revolved around manual or disparate systems and the difficulty in label / IFU design and review touch points.
3. Do you have concerns over sources of truth in terms of documentation and print content?
The biggest issue is the amount of data required for labeling and the constant changes required. Source of truth concerns were also highlighted because of the multiple locations of content. This can create issues with versioning and control of data.
4. How are critical factors in documentation typically mitigated?
The biggest factor raised was with regard to ‘cycle time’ for label review and change. Often as one change is approved, another change is on its way. A constant state of flux is common and the human element becomes the biggest factor. Translation management can also create a backlog of activity. Most internal staff rarely realize how difficult translations can be and therefore struggle to account for the feedback loops.
5. Does anyone have a really well managed documentation system that seems to work seamlessly?
The consensus was that utopia is difficult to realize in terms of label documentation and review but it seems possible with full enterprise label systems that are well designed.
6. Does your group use an external change management system or is the routing manual?
Generally speaking most of the delegates had some type of label management system. One of the participants is struggling with manual processes, but is reviewing possible solutions. The consensus was that a labeling system is critical as a business grows – be that organically or by acquisition.
7. How much does your change management process impact timing and approvals?
Delegates indicated that often label changes impacted by component changes could be a critical time factor. The relationships between parts and labeling are tied together and must be considered to improve cycle times for review.
8. Are the issues with your Change Management program related to process or people?
The general consensus was both. With very large organizations the layers of approvals and change management resets is a huge factor. In addition, however, the issue of whether label changes get the appropriate amount of attention, versus just being an afterthought, was also considered a significant contributing factor to successful, efficient change management.
9. Overall, what would you consider critical factors and best practice for change management?
Manage it closely. Whether using an enterprise system, a more simple system or even a manual process, there has to be clear ownership.
10. If you could change anything about your internal print documentation and change processes for improvement, what would you consider critical?
If a business doesn’t have an enterprise label system, get one justified. ROI costs and process improvements are critical when considering a large capital purchase. Work closely with the executive management team to help them fully understand the value and importance of label management and streamlined processes.
The interactive, peer-to peer session was one of many strands of debate at the 6th Semi-Annual Medical Device Packaging and Labeling Summit, which was designed to elevate discussions around the package design of medical devices and optimizing international labeling operations. We, at PRISYM ID are delighted to have had a positive contribution. With packaging and labeling executives actively looking for new technology and solutions for streamlining programs, the value of sharing best practice cannot be underestimated.