Kumovis enables additive manufacturing for medical devices

Medical technology is already one of the most advanced industries when it comes to 3D printing. However, it still faces major challenges. One of them is using additive manufacturing for medical devices adapted to patients’ needs, while still keeping the balance of product costs and additional features. What is more, formulating regulatory road maps for product innovation is usually much too time-consuming to be profitable.

Kumovis offers the holistic approach needed to provide the healthcare industry with a solution that meets these challenges and benefits medtech manufacturers and patients. Let’s tap the potential of medical-grade polymers and industry-specific technologies.

Kumovis enables additive manufacturing for medical devices

Medical technology is already one of the most advanced industries when it comes to 3D printing. However, it still faces major challenges. One of them is using additive manufacturing for medical devices adapted to patients’ needs, while still keeping the balance of product costs and additional features. What is more, formulating regulatory road maps for product innovation is usually much too time-consuming to be profitable.

Kumovis offers the holistic approach needed to provide the healthcare industry with a solution that meets these challenges and benefits medtech manufacturers and patients. Now is the time to tap the full potential of medical-grade polymers and industry-specific technologies.

SOLUTION FOR CRANIOPLASTY

You want to learn more about an example case? Go straight to the end of this page, and explore three fundamental offerings for cranial plate manufacturing.

Hardware

3D printer for medical-grade polymers

Kumovis provides hospitals and medical device companies with the best-in-class 3D printing hardware and dedicated software. The specially designed technologies help meeting the needs of both surgeons and patients.

Automated workflow

Making medical 3D printing feasible

The combination of process and software enables an automated workflow that makes 3D printing medical devices economically feasible. Resulting time and cost savings can be used by healthcare professionals to serve patients even better.

Freedom of design

Innovative and complex products

The demand for functionalization and freedom of design is particularly high in medicine. Kumovis technology allows for medical device manufacturers to individualize and 3D print innovative and complex products, no matter if these are assigned to regulatory class I, II or III.

Value-adding partnership

Acceleration of market-ready products

From medical manufacturing to value-added polymer processing, Kumovis has a high level of expertise. The collaborative approach helps to continuously deepen the understanding of patient requirements, and consequently lead partners to market-ready products faster.

Validated process

Start using additive manufacturing for medical devices

To accelerate market access, Kumovis offers validated processes and technologies. Hospitals as well as medtech companies benefit, among other things, from using the regulatory pathway to additive manufacturing for medical devices. When are you going to start 3D printing?

Now that we have a common idea of how to use additive manufacturing for medical devices, we are ready to meet your needs together.

Saving costs and time

Patient-matched cranial plate manufacturing

Upfront: We are not another 3D printer manufacturer. Kumovis enables hospitals and medtech companies to 3D print patient-matched cranial implants – either at the point of care or at industrial production sites. Our offering includes an end-to-end solution from DICOM data to the final device, or in this case, cranial plates.

For this particular clinical application, Kumovis provides 3D printer hardware, slicer software and regulatory data such as machine qualification as well as biological and mechanical validation. We help you serve the FDA and MDR market, pave the regulatory pathway to smoothly release patient-specific implants to the market.

All of this comes with a transparent business model: You own the 3D printer, and Kumovis installs, qualifies and services it on an annual basis. On top, we give you access to complete regulatory data based on a fee-per-part model. You will benefit from cost savings during the manufacturing process compared to milling or other 3D printing technologies. Patients benefit from optimal anatomical implant fitting and accelerated manufacturing times.

Explore three fundamental offerings for cranial plate manufacturing with Kumovis:

  • Hardware (3D printer and post-processing tools)
  • Process and workflow (design guidelines, material handling, 3D printing parameter sets)
  • Regulatory data (machine qualification, mechanical validation, biological validation)
3D printed PEEK implant with holes for cranioplasty by Kumovis

Hardware

Patient-matched cranial implants are printed on Kumovis R1, a 3D printer featuring a cleanroom environment (ISO class 7) that is dedicated to the additive manufacturing of medical devices. Using highly accurate delta kinematics combined with homogeneous temperature management you can produce patient-specific Evonik PEEK implants. Kumovis also provides reliable tools for post-processing steps such as support structure removal, blasting and laser marking. You can rely on robust industrial hardware providing best-in-class 3D printing results.

Process and workflow

Kumovis provides a complete range of 3D printing parameter sets for the broad variety of implant designs described in a design envelope of cranial plates. We also guide you through the design process (implant thickness, hole position, curvature, etc.) and material handling to ensure optimal 3D printing results. Additionally, we deliver a complete workflow described in SOPs which are customized to your quality management system and back up mandatory documentation. You benefit from application-specific workflows that combine engineering and medical know-how.

Regulatory data

Kumovis provides a complete set of regulatory data tailored to the cranial implant solution. These data include machine qualification as well as biological and mechanical validation for the cranial plate design envelope. Kumovis covers, among others, cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), implantation (ISO 10993-6), as well as chemical characterization and toxicological risk assessment (ISO 10993-18). You benefit from a predefined regulatory pathway for FDA and MDR markets and can bypass time-consuming QM procedures and save money by using Kumovis’ regulatory data.

Click on the hotspots above, and explore how hardware, process and workflow as well as regulatory data work together at Kumovis