It is estimated that there are approximately 500,000 people admitted to hospital every year across Europe, who have suffered some bone, joint, maxillofacial trauma or degenerative diseases that requires surgical attention using a customised implant, while 2.4 million people are injured or disabled each year by road traffic accidents in Europe.

The research and development work to be undertaken in ImplantDirect will help and support a consortium of SMEs to form a supply-chain approach, which will be able to manufacture patient specific implants and reduce the current lead-time from 4-6 weeks to 7 days. This will involve using CT-scanning to determine and optimise the design of the proposed implant(s) and fixation(s) required.

Also, in order to manufacture the personalised implants; the Rapid Manufacturing (RM) technology of Selective Laser Melting (SLM) will be used for reducing the build time for the implants and post-processing will ensure the required quality and accuracy.

Rapid Manufacturing technology – SLM 

Rapid Manufacturing is a technique of fabricating parts by an additive method. A 3D model generated in a CAD system is sliced into 2D profile by the software in the SLM machine. The sliced-layers of the model are then added one layer at a time onto the build platform by the SLM machine until a 3D part is produced.

Schematic of the Selective Laser Melting process (SLM)

Customised, patient-specific implants, with the natural ability to fit the patient’s anatomy, can reduce the operation time by 40%, and more importantly;

  • Reduce pain
  • Reduce tissue damage
  • Reduce removal of healthy bone
  • Eliminate the need for bone grafting
  • Promote more effective planning of implantation surgery
  • Reduce patient recovery period
  • Provide a longer lasting implant solution

While the technology is available and can deliver the well-recognised benefits of using personalised implants, the number of clinical cases is still limited. The main reasons are the complexity of the delivery process, the high cost of implants and the lack of human and technological resources in the area of biomodelling in hospitals. Especially, the multidisciplinary collaboration among radiologists, surgeons, and biomedical engineers, which is always needed during the design and manufacturing steps of a personalised implant but can also be time consuming and costly. In addition, the optimal solutions for investment of hardware and software are not readily available.

ImplantDirect will focus on the fastest and largest growing area of the medical implant market, maxillofacial (trauma) and load bearing in order to develop a cost effective, quicker manufacturing route for the individual needs of patients, aiming to improve the quality of the implant and effectively improve quality of life for the patient, and to reduce the medical care costs e.g. less revisions, less surgery time, less recovery time, etc. Once established the ImplantDirect supply-chain will also aim to penetrate into the load bearing (potentially hip, hand and knee) implant market.