In one sentence: The XTray is a fully developed primary packaging system forsurgical sutures including the complete development documentation accordingthe current valid guidelines. The special feature is that the XTray consists of just two components - the tray and the lid. The lid is securely attached to the tray in a high-frequency process. The tray itself keeps the needle in the needle park in position and the thread whichis attached to the needle while the lid keeps the thread inside the tray in position. Among this all product relevant data are printed onto the lid.

Interesting question – here I think about 2 important points:

As there are approved and proven systems on the market, there is no need for the market leaders with established processes to develop something new.
For all the others, the development of a platform that can withstand the technically mature XTray is very time-consuming and cost-intensive and therefore associated with a high obstacle.

Some points to clarify the complexity of the XTray:

- Flexibility for different needle and thread combinations

- influences from the necessary sterilization processes

- full comprehensive automatability

On one hand it´s the know-how and the expertise around the requirements andexpectations of the user, in our case the doctors and nurses.Because only products who reflect their detailed expectations have a chance onthe market. The needle must be quick and easy to grap and the suture must be able to bepulled out of the XTray with the lowest possible pull force. This sounds simple and easy, but it isn't - because it hides a variety of technicalrefinements and details.In addition, there is the experience and technical knowledge from the variousmanufacturing processes. It requires the selection of the correct materials, the molding process for sucha filigree product and of course the manufacturing of the lid. The winding technology, which ensures the smooth removal of the suture, andthe sophisticated packaging automatization are also important components ofthis complex technology. All together, this is a task that demands a great deal of knowledge, skills and experience. If these points are successfully realized, it is time for the test phase - and hereespecially the interaction of the selected materials under real conditions. Here we have gathered and integrated a lot of experience in order to reach today's high precision.

Of course, as for the XTray the use of a winding machine from Harro Höfliger is required.

Through the perfect coordination of the systems with the XTray technology,the process is significantly faster.An output of up to 20 products/min is possible. This is a great benefit for all manufacturers. And even if the batch sizes are relatively low – a changeover canbe done within a couple of minutes.The machine is able to work with a very wide spectrum of needle-suturecombinations. All the ones which are within the range of the XTray. Summarized: precisely matched modules and processes for many needle-suture combinations.

The system can be used without technical modifications. Of course, some customer related adjustments can be made for individual demands.

The adjustment of the flexible printing parameters such as company names or product names is no problem at all.

Without analyzing a concrete example, of course I can only name ordersof magnitude. But there are many advantages that add up to a great overallpackage in terms of time and money. The biggest advantage from our point of view is: time to market. If you launch your own product based on the XTray to market, you will save 2 - 3 years, as the complete development time of the XTray including the necessary pilot molds - and nearly everything related to them – is covered. Another big advantage is that many different needle-suture combinations canbe packed in the XTray. In addition, there is the elimination of the risk of failure as well as the excellentuser properties for the operators.In figures, it is the time of faster market entry (1-2 years instead of 4-5 years) as well as the flexible application for different combinations which save furtherdevelopment and machine costs. All together, very big savings potential and an invincible package for everyone who thinks in terms of time and money.

Of course, I will do so:

1. The XTray is a ready-developed system that excludes malfunctions and therefore offers a very high level of safety in use.

2. The XTray is the least expensive currently known system which was developed together with the corresponding automation platform.

3. The XTray includes a comprehensive development documentation, which complies with the strict valid medical devices regulation (MDR).