The COVID-19 pandemic has increased pressures across the medical device and clinical trial industries, with a surge in demand for ventilators and other equipment, rapid repurposing of therapeutics and a global race to develop, test and rollout vaccines. Flexibility throughout all aspects of the supply chain has never been more valuable.
For example, as clinical trials for COVID-19 vaccines have been set up and run at exceptional speed, the need to initiate a quick start-up and then support changes in the trial protocol has never been greater.
To help achieve this, clinical research organizations are under increased pressure to dispatch products as soon as a patient is recruited, without creating unacceptable levels of stock overage, or falling foul of regulations.
The just-in-time (JIT) production strategy is unlocked through label postponement where the completion of secondary packaging is delayed, with labels printed at regional depots directly before dispatch, allowing for additions or amendments to be made late into the process.
To successfully adopt the JIT model for clinical trial supply or medical device distribution, companies need to be able to make changes to labels at very short notice and print on demand, using the latest regulated content. However, making amendments can be time-consuming, particularly when large booklets are being produced for multiple countries.
Managing multiple versions can also be costly and risky given that all changes to labels and booklets must be translated into the official language for each destination country. They must also comply with country-specific regulations for label content and formats, which vary between different countries and are subject to frequent change.
Furthermore, if label printing is sub-contracted, then the label print and supply process may take several weeks, and it may not be possible to accommodate the latest updates to label content.
To help companies manage the process, PRISYM ID has developed the only labeling software designed specifically for medical device manufacture and clinical trials labeling. This includes production of Instructions for Use (IFUs) to accompany devices and storage of Investigational Medicinal Product (IMP) and protocol information relating to trials. Compliance of label designs can then be evaluated for compliance with pre-defined regulatory rules.
The PRISYM 360 cloud labeling platform optimizes the label management process further by enabling country-specific phrases, such as dosage instructions, to be defined and approved in advance, ensuring that only those language phrases appropriate for the destination country will be printed on the label.
To deliver JIT or other on-demand packing and shipping, companies need to be able to print single or short runs of labels quickly to avoid disrupting workflow. PRISYM 360 has been designed to deliver optimal performance in this regard. Indeed, its high -performance system design and native print drivers enable fast label generation and printing, making JIT label postponement truly viable and the process can be fully automated.
Another advantage is that PRISYM 360 is fully integrated with print inspection hardware to minimize effort in both set-up and inspection. It enables automated inspection of every label using both the design and content sent to print, to ensure that all print errors are identified.
By automatically logging failures and images in a secure, validated, audited log, full compliance can be achieved giving added peace of mind when changes have been made quickly. This is another important example of the way in which sophisticated software is enabling companies to respond to the need to streamline the supply chain and take an increasingly patient-centric approach by adopting the JIT model.
About the author
Steve Grimison, SVP Global Development, PRISYM ID
Steve has 20 years’ experience of producing software within the Auto-ID industry starting in the food and beverage sector prior to joining PRISYM ID in 2007. He has risen through the ranks at PRISYM ID by maintaining a focus on quality and a commitment to the delivery of market leading software products and solutions. His primary objectives are to target the ongoing investment in research, development and quality effectively; and to lead PRISYM ID’s in-house development, test and validation teams to maintain the market leading position of PRISYM ID’s world class label management software.
Steve holds an honours degree in Physics with Mathematics.