SPT Vilecon is a fully integrated provider of development and manufacturing services for the medical device industry. The company works at the interface between design, development and production to enable its customers to develop a new product from concept to market launch and has its own toolmaking facility to ensure the shortest possible lead times. The company is certified to ISO 13485, the European standard for the manufacture of medical devices, and provides product development support, injection molding and other manufacturing services to a large number of companies in Northern Europe.

Recognizing that speed is always of the essence, SPT decided to use Nexa3D Freeform Injection Molding. The aim was to help customers reduce time-to-market for complex medical devices made from challenging medical materials and to expand the range of materials that can be used quickly and reliably for prototyping and early device testing.

Medical device manufacturers are faced with strict legal requirements when launching new products onto the market. A medical device must be safe and effective for its intended purpose and it is the manufacturer’s responsibility to demonstrate that a particular device meets these essential requirements. To this end, manufacturers must develop elaborate testing protocols that evaluate every aspect of the manufacture and use of the device, and they must ensure that the tests are conducted in a manner that accurately reflects the conditions of manufacture and use of the finished medical device. The later these tests are carried out, the more serious the consequences if a test is not passed. Medical device companies are constantly looking for tools and methods to help them improve early-stage device testing to reduce development risks and rework costs.

SPT Vilecon often works with silicones, a group of materials widely used in the medical device industry due to their excellent chemical resistance, mechanical performance and biocompatibility. However, silicone parts are notoriously difficult to prototype and test, as most types need to be injection molded to achieve their full performance.

Bjarne Andersen, CEO STP Vilecon

SPT Vilecon

Injection molding of medical devices

• XiP desktop 3D printer
• xMOLD 3D-printed resin for tools
• FIM Accessories

Silicone injection molding

• Prototyping of silicone molded parts in the same week
• Medical requirements already met at the prototype stage
• Quality of the end product is already achieved at the prototype stage
• No need to invest in metal tools to check performance at an early stage

To meet customer requirements for the rapid prototyping of silicones and other complex medical materials, SPT Vilecon was looking for a prototyping platform that could be seamlessly integrated into its existing toolmaking and injection molding capacities. Other important requirements were biocompatibility, compatibility with the wide range of thermoplastics and silicones already in use and design freedom for prototyping complex parts. In the end, the decision was made to use the XiP desktop system from Nexa3D and free-form injection molding with xMOLD resin. This compact and highly versatile platform was the only alternative that met all the key requirements while allowing SPT Vilecon to expand into new areas of metal and ceramic injection molding.

With Freeform Injection Molding, SPT Vilecon was able to offer a customer developing an intravenous silicone product early design and material verification through the use of 3D printed molds.

Early verification: The use of 3D printed xMOLD tooling enabled the customer to receive injection molded medical grade silicone parts within two days and verify key design and performance aspects.

Fast iterations: At the same time, important design inputs were gathered during the first tests, which could be integrated into a second iteration that only took a few hours. In comparison, the development and procurement of the conventional metal tools normally required for this type of verification would have taken more than six weeks, and the adjustments required for the second iteration would have taken the in-house tool shop a week.

Cost and time savings: The combined cost of the 3D-printed silicone molds for the first and second iteration was less than EUR 2,000. And the two-day construction cycle was more than 90% faster than the speed that can be achieved with conventional metal tools.

Seamless scalability: Based on the design input gathered in the first two iterations, the design of the silicone part was approved and the production of a metal mold could begin with full confidence in the moldability and performance of the part. The design input and knowledge gained enabled the in-house tool shop to produce the metal tool within 4 weeks, without the need for iterations on the final tool.

Medical device manufacturers are under great pressure to bring new and innovative products onto the market. Robust and valid prototyping and verification are key to minimizing the costs, time and risks associated with development. By implementing freeform injection molding, SPT Vilecon has created a new toolbox for medical device companies looking to accelerate innovation and achieve early verification of part performance and moldability.

By using XiP with Freeform Injection Molding, a medical device manufacturer was able to save 6 weeks and 87% of investment in prototyping while removing a difficult silicone component from the critical path of product development.

SPT Vilecon has been able to expand the range of injection molded prototypes into silicone, metal and ceramic injection molding to provide medical device manufacturers with an even wider range of product development and verification services.