Additive Manufacturing

prototyping capabilities using additive manufacturing (3D Printing)

Additive Manufacturing

Schivo entered into a partnership with Stratasys in 2015 and invested in 3D FDM (Fused Deposition Modelling) additive printing technology. FDM allows us to create complex durable geometries. The technology works by building up layers of heated and extruded thermoplastic filament into highly accurate complex structures.  Depending on the desired outcome a secondary material can be used to support negative angles and voids during the manufacturing process. This support material is removed after the final product is finished. FDM 3D printing is ideal for the medical device sector as it allows us to print bio-compatible materials such as ABS-M30I and polycarbonate ISO.

Schivo work with a range of different materials to offer our customers the best solution for their device or component needs.

The below table outlines the different plastic materials that we can build with on our Fortus 400mc 3D large production system.

Materials Layer Resolution Tensile Strenght Unique Properties Medical Application
Standard
ABS-M30 0.127mm 31 MPa (XZ Axis), 26 MPa (ZX Axis) Most versatile & widely used FDM material.
Machinable.
Paintable/coatable.

Concept models for sample catheter handles.

Casing for medical equipment outside the body.

ABSi 0.127mm 37MPa Translucent Material. Concept models.
Any application where light transition or flow requires monitoring.
Engineering Plastics
PC 0.127mm

 

40 MPa XZ axis

30 MPa ZX axis

High tensile & flexural strength and a moderate heat resistance.

Opaque material.

Concept models.
Device or instrument casing outside the body.
Nylon 12 0.177mm 32 MPa XZ axis

28 MPa ZX axis

High elongation at break: +30%, high toughness and excellent fatigue resistance.

Lowest water absorption at approx 2% at saturation.

Good chemical resistance.

Concept models.

Catheter handles, electrical insulation, repetitive snap-fit closures.

High Performance
PPSF 0.254mm 55 MPa

High in heat deflection (190oC).

Chemically resistant to petroleum products, solvents and other caustics.

Concept models for devices or implants that require strength and equipment casing outside the body.

Sterilisation trays.

Instrument casing.

Biocompatible
ABS-M30I 0.127mm 31 MPa (XZ Axis), 26 MPa (ZX Axis)

ABS-M30 properties + ISO10993.

Sterilize via gamma or EtO.

Contact with body skin.

Ideal for surgical concept models.

Medical device casing.

Sterilisation trays.

Surgical instruments.

PC-ISO 0.177mm 57 MPa

Best of PC properties + IS0 10993 certification.

Sterilize via gamma or EtO.

Contact with body skin.

Implant trials.

Surgical instruments.

Sterilisation trays.

Dental devices.

ULTEM 1010 0.254mm 64 MPa (XZ Axis), 42 MPa (ZX Axis)

Lowest CTE (of any FDM thermoplastic).

High strength-to-weight ratio and FST.

Offered in a certified grade (for food contact & biocompatibility.)

Implant trials.

Surgical devices and instruments.

Sterilisation trays.

Dental devices.

For prototype parts customers generally use ABS-M30 or ASA.

Some customers who are looking for a very strong material might want to use next generation ULTEM 9085 thermoplastic. These materials have an excellent strength to weight ratio and have an outstanding thermal and chemical resistance, however customers will have to compromise resolution for strength.

We can organise printing on materials other than plastic, for example on different types of metal such as maraging steel, cobalt chrome, stainless steel, titanium and nickel alloy.

Biocompatible materials

If you are looking for a Biocompatible part we recommend printing with ABS-M30I, PC-ISO or ULTEM 1010. ULTEM 1010 has the highest chemical resistance, tensile strength and heat resistance however resolution is compromised for strength.

Can inserts be staked or added during an FDM build?

Washers, nuts, bolts, threaded rods or other objects can be inserted mid build by technicians without secondary operations.

Schivos commitment to high volume manufacturing processes

What are the benefits of additive manufacturing for medical devices?

  1. Prototyping

We understand that time and money are often critical when developing a new device. This process eliminates the time required to build tools to produce prototypes which allows us to offer our customers very fast turnarounds and therefore is an ideal solution for prototyping.

  1. Complex finishes

Materials such as photopolymers can accurately mimic human tissue, calcification and bone structure.

  1. Removes conventional machining constraints

This can enable new innovative design which allow you to reduce the size and streamline a device.

     4. Functional Integration

Allows you to prove and test performance of your device during the development stage.

What are the Advantages of Additive Manufacturing with Schivo

Schivo combine over 20 years experience building medical devices and life science systems with additive manufacturing capabilities to ensure your device/instrument concept incorporates the appropriate applications and best practices for the industry.

These include:
1. Quality

Facilities are ISO13458 certified with S21Lean operations program and have Class 10K/ISO7 cleanrooms available

2. Post processing capabilities

  • Deburr / Removal
  • Cleaning Facility
  • Coating
  • Painting
  • Plating
  • Grinding
  • NDT
  • Mag Particle & Die Penetrant Testing
  • Sealant capabilities

3. Design for manufacture

We can design for manufacture to determine the most cost-effective fastest method to ramp your product concept.

4. In house capabilities for full product build and test

Customers can choose from our in-house capabilities from machining, fabrication, coatings and assembly to build and package your device or subassembly ready to ship. The manufacturing process is supported by full or subsystem test and verification activities.

Vertically integrated manufacturing process

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