The Xtray

the xtray

one size – fits most Innovative tray technology as a platform for about 80 % of all suture/needle combinations

Challenges and Risks if you develop device and process on your own

50 x 8 x ... > 1,000?

> Tens of thousands of test cycles > Multi-year development period > Major challenges to reach market approval > Material property changes during the ETO-sterilization process > Simple, fast and flawless handling (no jerking, entangling or jamming) > Good market recognition and differentiation > Highest quality requirements > Patent research / patent evaluation

The development of a novel tray system is a challenging task.

The requirements are high: Medical devices must be self-explaining, easy to use and perform every time – and at the same time production must be costefficient. The technical challenges are equally complex.

The development is time consuming with high costs and numerous hurdles. 8 suture types in different lengths and more than

50 possible needles result in a potential of more than 1,000 combinations. So the tray has to be very flexible in use. The annual demand worldwide for trays is several hundreds of millions – and is growing. A uni­ versal platform capable of covering se­veral suture/needle combinations opens up new market opportunities.

Typical suture/ needle combinations

Potentials and market opportunities using the XTray

50 %

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> One platform for many combinations > High automation level at low costs > Best materials and highest quality standards > Immediate usability for rapid market access > Proven production process > Patented design

Needles single armed/double armed

Monofilament

Braided

1/2 curvature 15 – 53 mm

> Polypropylene, non-absorbable > Polyamide 6, non-absorbable > Polyester, non-absorbable > Polyglecarpone 25, absorbable > Polydioxane, absorbable

> Polyamide 6, non-absorbable > Polyester coated, non-absorbable > Silk, absorbable > Polyglactine, absorbable

3/8 curvature 1/4 curvature Straight 15 – 57 mm 15 – 50 mm 15 – 45 mm

the xtray

one solution

for many different combinations One size – fits most

covers more than 80 % of standard suture/Needle combinations.

know how – the process works

Proven production process. developed with the experience of experts.

The challenge was how to cover the spectrum of more than 1,000 suture/needle combinations with one single product? With a unique combination of crea­tivity, ingenuity, process and manufacturing experience, we found an innovative and convincing answer: The XTray. For manufacturers and distributors of medical devices, this technology offers the possibility to quickly enter the market with their own product line in their own branding. More than 80 % of all likely suture/needle combinations can be pro-

duced using the XTray as a base. The required patents and production processes already exist and may be used. It takes only two components to form the XTray: lid and tray. Both are made of high-quality materials in certified processes. The automated production process of suture sets enables production, packaging and customization at low costs. Thus, the multi-year period from development to market readiness is shortened to a few months.

The risks are reduced to a minimum.

High speed – to market

Without development costs and risks – the xtray is available now.

Flexibly designed – For your branding

Can be modified to suit your individual requirements.

Best quality – for high security

From swaging and winding to packaging (suitable for ETO sterilisation).

Convincingly manufactured – in every detail

Patented high speed winding system.

Reliable and flexible needle handling.

Automated product handling.

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winding equipment. The winding module offers highest flexibility with minimum space requirements. In addition to the tray’s suitability for a wide variety of combinations, the lid was designed in such a way that it can be perfectly adapted to your At present, the XTray is the only tray that individual branding. Based on your brand, has been designed in combination with the XTray becomes your product. !

We develop and design the entire production process based on your needle and suture products – from the attach­ment of the needle to the suture, to winding, customization, packaging and sealing.

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tailored the process

high speed ... to high quality The XTray-Advantages less complicated – only 2 pieces no friction between tray and suture no memory effect of the suture The XTray combines innovation, experience and know-how from medical technology, machine engineering and process technology to form a perfectly tailored product.

Our particular focus is on simple, reliable and intelligent function. Highest quality.

Excellent functionality. Easiest handling.

Safe and reliable dispense of the suture is essential.

easy to handle one tray for 80 % of suture/needle combinations high automation level entirely developed tray and lid combination no risk of product development

connecting values – creating solutions

As a manufacturer and distributor of medical devices (surgical suture sets) it is your objective to enter the market quickly with your own branded product.

The use of the XTray-technology allows you to start production within a narrow time frame and to considerably shorten the long process to market approval.

Year 1

Year 2

> Build test equipment for winding > Rapid prototyping injection molded parts > First winding tests > Manufacturing prototype lids > Evaluate behaviour of selected materials during sterilization > First dispense tests > Build 1st prototype mold

Year 4

> Technical evaluation of die cutting the lid > 1st prototype die cutting equipment > Winding test with injection molded parts > Winding test with all kind of suture types > Intensive dispense tests

Year 5

> Shipment test > Adjustments and optimization where necessary > Order of winding equipment > Device test in an auto mated winding process > Stability test > Decide artwork and print method > Approval of printing method

> Test and approve wound product automatically > Train operators and technical personal > Install machine on site > Qualification/validation > Market entry

If you choose the XTray ...

Tray & lid

Process technology DS Technology provides the XTRAY lid and the tray along with the necessary licenses.

Harro Höfliger supplies the machine for the production process.

Suture & needle your brand

You provide needle and suture.

Market entry

> Develop device concept > Patent investigation > Material selection > Automation concept winding > Vendor selection injection molding

Year 3

DS Technology is your innovative partner for bringing your creative product rapidly to market. In close cooperation with you we create bespoke superior solutions on the basis of your input and your needs.

You benefit from our wealth of experience

in pharmaceutical processes, a multitu­de of manufacturing technologies and a care­­ful selection of the most suitable mate­ rials. Our focus is on you, your product and your success.

04/2017

www.d-s.technology

DS-Technology GmbH · Stormstraße 8, 71364 Winnenden · Phone: +49 7195 9578-0 · Fax: +49 7195 9578-99 · hello@d-s.technology