Quality and security for responsible data exchange

Healthy data are key!

This is true for communication processes with public authorities and with partners along the supply chain. In the healthcare industry, a particularly safe and careful approach to data exchange is key. After all, human health is at stake!

Never before have the healthcare industry and related industries been as much in the limelight as in the past year. As a result of the crisis, medical devices, which were previously known mostly in the areas of diagnostics and therapy, have taken center sage: there was an unexpected demand for protective equipment, strict hygiene protocols, and ventilators. In view of mass testing and mass vaccination, manufacturers of medical devices will continue to be under pressure. After all, rapid tests, swabs, needles, and cannulas are also considered “typical medical devices”. However, it is not only this crisis, which is hopefully merely temporary, that poses ever-growing challenges to the industry. An increasingly complex market environment, guidelines imposed by authorities, and fast-paced changes all force companies, especially SMEs, to be quick to adjust and evolve. The increasing competitive and price pressure are also a major concern, which is why streamlined and efficient processes are key.

Data exchange if manual work is no longer an option

There is hardly any other industry where quality and data security play such an important role as in the healthcare industry. The reasons are hard to miss: they can make the difference between life and death. Therefore, extremely high standards regarding labeling, storage, and delivery need to be met, which ultimately leaves no room for error. And yet, it is especially the medical device industry that continues to rely heavily on manual processes, which increases the likelihood of mistakes. A look into other industries (consumer goods, automotive, finance) suffices to see that automation through digital technologies (EDI – Electronic Data Interchange) has successfully been used for years. Over the past decades, EDITEL has established itself as an important player on this market. Via the eXite® data hub, we process more than 400 million electronic transactions per year for more than 20,000 companies worldwide, including major pharmaceutical corporations and manufacturers of medical devices.

The digitalization of logistics processes is also a priority. Pharmaceutical wholesalers and manufacturers use EDITEL’s platform to electronically exchange orders, despatch advices, and invoices. And the best part is that only a single connection is required to get access to all partners in the industry, from presuppliers to manufacturers and different approval authorities all the way to suppliers and wholesalers. Herba Chemosan, a pharmaceutical wholesaler, has shown high innovative potential in this area. The company strives to reach the highest possible EDI coverage.

According to Martin Böse who works in Business Technology Engagement at Herba Chemosan, “this not only allows for a faster supply chain, but also for smooth and error-free communication with our partners.”

UDI, FDA, EUDAMED, and the like: digital specifications defined by the authorities

Another aspect that is becoming increasingly important is digital communication with public authorities and approval authorities. One case in point is the American FDA that requires companies to preregister any medical devices intended for the American market in the centralized GUDID database (Global Unique Data Identification Database). As an officially FDA-approved “third party provider”, EDITEL developed a solution for the automated transmission of required data (“HL7-SPL” format handling, validation, and transmission). EUDAMED, the European counterpart, plans to introduce similar requirements and to start its own database in the fall of 2021. Given the company’s previous experience, Gerd Marlovits, the CEO of EDITEL, sees “EDITEL as the partner of choice for the automated transmission of UDI data to the authorities.”

One connection, many advantages:

• Worldwide real-time communication without any system inconsistency, from order placement all the way to delivery and invoicing
• Accurate and complete data sets as a basis for labeling, certifications, and approvals
• Shortens delivery times and makes manual article recording obsolete
• On-demand production planning
• Unequivocal identification and traceability based on GS1 standards
• Increases efficiency and reduces costs for all logistics processes

The use of global standards (EDIFACT, HL7, VDA, X.12, etc.) allows for the swift and accurate exchange of data among companies. The goal of EDI is to maximize the process automation potential and to ultimately avoid manual and paper-based business processes.