iStock 1320799464v - Delivering a Single Source of Truth for Medical Device Labeling

Delivering a Single Source of Truth for Medical Device Labeling

 

An end-to-end approach to labeling is becoming critical for medical device organizations due to a convergence of emerging demands that introduce overlapping complexities and risks. Driven by external and market forces, there is no single factor driving these industry-wide changes, and no one is exempt from the need to identify solutions for their business.  

 

Challenges with Global Markets & Regulators 

Large and complex markets are inherently associated with risks before you even begin to consider the specific regulatory hurdles that face the medical device industry. Highly regulated products are marketed across as many regions or geographies as is commercially viable. This creates operational complexities, especially in instances where multiple global divisions supply many different products into the same geographic market.  

Country specific market and regulatory requirements mean that product labeling needs to be localized, leading to a vast array of product variations and SKUs, adding further complexity to an already complex and vulnerable supply chain. Manufacturers need to be adept at coping with the continual movement of goalposts due to changes in regulation. While national regulators do tend to try to build upon standards implemented by the largest regional markets, such as the FDA’s UDI or EU’s MDR, true harmonization across regulators remains a challenge, compromised by changes at other stages of the supply chain or by specific local nuances. 

The nature of medical devices themselves is evolving too, with analysts forecasting a surge in demand for personalized medical devices in the near future. Consideration needs to be given to the implications for manufacturing operations, including the potential need for packaging and labeling systems that can be adapted to manage personal data and personal content. 

 

End-to-End Integrated Labeling Systems 

The integration of labeling systems into the manufacturing process should be a core aiStock 1295900106 - Delivering a Single Source of Truth for Medical Device Labeling discipline of any medical device manufacturer. Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES) and Global Labeling Systems (GLS) need to be closely integrated for maximum efficiency of production operations and there needs to be alignment between each of these critical platforms to ensure regulatory compliance.  

Whether it’s because of independent decision making by business units or a series of acquisitions, many manufacturers also face the challenge of managing a disparate and fragmented network of IT systems and applications, including those which manage labeling. It’s not uncommon to encounter multiple labeling systems from different vendors, or sometimes several bespoke in-house developments, each with different standard operating procedures and documentation. In these organizations there is a clear need for consolidation of systems and the proper integration of labeling into product lifecycle management, change control and manufacturing systems. 

Furthermore, with a growing number of organizations adopting an agile mindset, labeling systems and processes need to be capable of managing a variety of different production models, offering just-in-time and on-demand printing as well as traditional batch production processes. These infrastructure changes are necessary to deliver the desired cultural shift that serves as a catalyst for the business to become more responsive, collaborative and customer-focused. 

As we all know, significant inclusions of regulated content are required for each medical device label, creating a content management need that cannot be fully met within a single application. By integrating applications in the right way, we can enable centralized visibility and control of the entire labeling process while maintaining the audit trails necessary to placate regulators. 

Delivering the complete digital integration of labeling data eliminates many of the compliance issues that lead to NCRs and field actions. By coupling smooth data flows between the PLM, GLS and MES, with upstream compliance checks we can ensure integrity at every stage of design and manufacturing processes. This is before we consider the benefits of working with verified content and templates, and how this can greatly improve labeling efficiency by reducing design time and smoothing the review process. 

Any integration should be facilitated by standards-based connectors, for example, using web services based on REST or SOAP. These connectors should provide out of the box integration with the desired associated applications with full testing and certification documentation to demonstrate that integration between the application adheres to the specifications set by each application vendor. 

 

Advantages of Cloud-based Deployment 

A significant proportion of medical device organizations are transitioning to virtual operating models, deploying cloud technologies and services to virtualize their teams, systems and working practices. In addition to facilitating remote or hybrid working, this shift to the cloud can offer significant compliance benefits, especially ensuring GXP compliance. Embracing cloud technologies means an open-ended platform can be established for labeling and other critical business systems laying the foundation for accelerated growth and increased flexibility. 

Ultimately, medical device companies are craving simplicity and a solution that eases the data journey for labeling, reducing their risk profile and increasing the efficiency of operations – they want a singular source of truth and an off the shelf solution that just works.   

 

Siemens & PRISYM ID Partnership & Solutions

Siemens and PRISYM ID have forged a technology partnership that Siemens webinar YT thumbnail - Delivering a Single Source of Truth for Medical Device Labelingmeans medical device organizations can easily integrate a cloud-based PLM and GLS specifically designed for use in medical device manufacturing environments. Offering functionality specific to the medical device industry, including support for UDI and labeled content definition reuse, this combination of systems also allows for print inspection management through GLS into the production control as record keeping enforcement of the MES. 

The beauty of this cloud-based solution is it offers small companies access to the same kind of infrastructure and solutions previously only available to industrial titans, leveling the playing field. It offers incredible scalability and can be configured and deployed in just a few months, with a document pack that ensures it is truly validation ready. An end-to-end labeling approach is not just essential, but deliverable for every medical device business. 

Click here to view the webinar on this subject. 

This article was published on December 8th, 2021