WHAT SERVICES AND BUSINESS MODELS DOES DS-TECHNOLOGY OFFER FOR USING THE XTRAY?

The services of DS-Technology include supply chain management as well as comprehensive documentation according to MDR EU 2017/745 which is required for the approval of the XTray as well as the license required for use.

WHAT PRICE AND CAPACITY MODELS ARE AVAILABLE FOR THE XTRAY?

In principle, our services always focus on individual customer requirements. We have developed very flexible models that offer almost unlimited possibilities, from modular price scales to annual licence fees. Our sales staff will be happy to provide you with precise information on the range of services that meets your requirements.

ARE THERE PARTNERS FOR ACCOMPANYING SERVICES AND OFFERINGS?

When it comes to the production and marketing of the XTray, there are various exclusive partners at our side, some of them already since the development phase. All partner companies are experts in their fields and their services are precisely matched to the XTray.

WHEN IT COMES TO PRODUCTION AND MARKET LAUNCH, WHAT ROLE DOES DS-TECHNOLOGY PLAY FOR CUSTOMERS?

DS -Technology in partnership with Harro Höfliger Verpackungsmaschinen provides support, assistance and advice to customers regarding in many ways during licensing, approval and introduction of the XTray.

  • Establishment of comprehensive service offerings
  • Special technical know-how in the field of surgical sutures
  • Communication with exclusive partners for the production of tray and lid

SWAGING MACHINE : WHICH NEEDLE AND THREAD SIZES ARE POSSIBLE (OUTER DIAMETER, NEEDLE LENGTH)? IS THE MACHINE CAPABLE OF PROCESSING THE ENTIRE FORMAT RANGE?

SWAGING MACHINE :

 

WHICH NEEDLE AND THREAD SIZES ARE POSSIBLE (OUTER DIAMETER, NEEDLE LENGTH)?

IS THE MACHINE CAPABLE OF PROCESSING THE ENTIRE FORMAT RANGE?

 

Needles:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 





The needles to be processed have different needle bends,
for example:

 

 

Atraumatic needles made of steel in various

  • Lengths, thicknesses, bends and cross sections
  • The quality of steel is designated as a 300-series stainless steel and 400-series stainless steel
  • The hole is in the needle body in the longitudinal axis of the needle drilled and 1,0 mm to 2,5 mm deep.
  • The bore diameter is about 40 to 70 microns larger than the diameter of the respective threads but can
    also significantly (for example 120 microns) be larger.
  • The needle bore needs to be in the center of the needle.
    Bores outside the center or blocked with debris will lead to a failing product at the pull test station. The maximum acceptable eccentricity of the needle bore is 25 % of the wall thickness.
  • The needles are supplied in bulk;
    units up to 1.000 pieces (depending on the needles) are delivered to the machine.
  • The needles used are to a large extent, coated with silicone on the surface, however needles which have no silicone coating can also be used.  Excessive amounts of silicone may cause more frequent cleaning of the processing stations. Adhering silicone can make the needles stick together in bundles.

 

  • Half circle
  • Three-eighths circle
  • Quarter circle

Note: Exception and / or a wider range of all above mentioned dimensions possible but have to be evaluated and tested separately

 

 

Needle Length:

 

15 mm – 45 mm – bow length

Note: Exception and / or a wider range of all above mentioned dimensions possible but have to be evaluated and tested separately

Needle Diameter:

American dimension = 15–44 mill ≙ 0,38 mm – 1,12 mm
Note: Exception and / or a wider range of all above mentioned dimensions possible but have to be evaluated and tested separately

Sutures:

Polyamide (PA)

Polypropylene (PP)

Polyester (PET)

Polydioxanone (PDO)

Polyglycolic Acid (PGA)

Polyamide-, Polypropylene-, Polydioxanone (monofilament).

Polyester and Polyglycolic Acid (multifilament)

Polydioxanone and Polyglycolic Acid are absorbable sutures.
->The preparation of these sutures usually requires a controlled RH (relative humidity) in the surrounding area/room.

Suture length:

Suture length; swage module: 45 cm to 90 cm (more to be tested)

Suture size:

 

Suture size 1.0 (5/0) to 4.0 (1)
Note: Exception and / or a wider range of all above mentioned dimensions possible but have to be evaluated and tested separately

 

Strength of connection:

 

How far the machine is able to inspect its connection strength?

 

- The connection strength is defined by the manufacturer. All our customers have different interpretations.
- But in general we are following the strength defined in the Pharmacopeia.
- Different options are available for testing:
      a. 100% pull test inline: every code that has been swaged is tested in the pull tester
                  –> all values filed in the computer system
                  ->  integrated in the machine

      b. destructive pull test: every 100-1000 (number to be defined by customer) codes will be pulled as long until it cracks
                  –> all values filed in the computer system
                  –> integrated into the machine


      c. 360°camera inspection: a camera verifies every swage on the complete circumferential of the swaged area of the needle. This is optionally  

 

1.     Swaging processes

There are two different swaging methods – 2 times of swaging by respectively turning 90 degree and 1 time of swaging without turning
- the swaging is servo driven. It can be chosen how many hits around the needle are required.
- the degree can be chosen (15°30°45°)

 

2.     Types of thread

1)     Is the machine able to process both monofilaments and multifilaments?
- yes, both machines (swager and winder) are able to process both: mono- and multifilaments

2)     If different needle types are mixed, is it possible to detect it? If so, how can it be detected and rejected - only after connecting or before connecting with needle?
- The needles are fed onto a vibratory feeding table. This is a semitransparent table with a bright light source underneath. A camera above the table is verifying the needle position and its front and back end. There is no measurement of the needles.

3)     Is it possible to implement an inspection camera that detects the needle shape and swaging condition?
- yes. The 360°camera can verify the needle after the swaging process

 

 

Winding machine:

3.     Is the machine able to process both plastic tray and paper tray? Since each customer has different tray materials, flexibility is required for such machines.
- The equipment cannot wind sutures into paperfolds. The sutures are wound in an 8-shape in the paperfold and in a 0-shape in the pastic trays

4.     Can the winding machine be flexibly adapted to the customers' trays, size and design?
-The winding machine has been developed for the XTray®. But other plastic trays can be processed as well. But each tray design has to be checked and approved by HH upfront.
And for each different tray a complete set of tools is required
- The main idea behind this business model is to convince the customer of a standardized tray, the XTray®. This reduces cost as well as documentation.
- And the XTray® is completely IP protected and does not infringe any other existing patents of plastic trays

QUESTIONS THAT CAN HELP FOR A FIRST CUSTOMER CONTACT WITH A NEW PROJECT:

1.Is your company already in the Surgical Suture business?

2.If so what kind of business? Services / Swaging / Winging / Packaging

3.Does your company have its own products on the market?

4.Which markets does your company supply? Home country or more?

5.What is your company`s current annual production rate in units per year?

6.What kind of packaging is your company currently using, paperfold or plastic tray?

7.What kind of blister is your company currently using, aluminium or plastic?

8.What kind of sutures is your company currently using, braded or monomaterial? 9.What kind of suture material is your company currently using, Polyamide (PA)/ Polypropylene (PP)/ Polydioxanone (PDO)?

10.What length, 45 / 90 …?

11.What kind of Needles, Straight / Rounded / …?

12.What kind of Products, Single Armed / Double Armed / Pledges / ….?

13.Which needle/ suture sizes are used?

14.Who are the needles/ sutures suppliers?

15.What kind of machines are you using at present, Automatic / Manual?

16.If automatic what kind (swaging / winding / packaging)?

17.Which kind of cleanroom is your company currently using or wants to use?

18.What kind of machine do you want, Swager, winder or a combination? What kind of Packaging Equipment?

19.Are you interested in in-line equipment?

20.What kind of batch sizes are you thinking about in this project?