Beijing AK Medical Co., Ltd. (AK Medical) has been adopting metal additive manufacturing for healthcare applications since 2009. As the first company to receive certificates for its 3D printed devices from the CFDA (China Food and Drug Administration), more than 5,000 AM orthopaedic implants have been successfully issued to patients including the world’s first customised artificial elbow joints and artificial hip system. These implants are manufactured using Arcam’s Electron Beam Melting (EBM) technology, specifically the Arcam Q10, which has been developed for the cost efficient production of complex, custom medical devices. TCT spoke to Mr. Zhijiang Li, President and CEO of AK Medical about the challenges of clinical certification in additive manufacturing and how 3D technologies are fast becoming an essential tool for the medical industry. 

Many metal AM technologies have appeared on the market in recent years, why is Arcam’s Electron Beam Melting process so well-suited to this application?

There are three main considerations. The EBM 3D printing process happens in a high vacuum environment, which effectively avoids the invasion and pollution of other gas impurities. That is very important for orthopaedic implants. The build process of EBM keeps at constant high temperature (500~700C°). It is beneficial to release the internal stress of material and not only ensure the strength but also increase the efficiency. This new manufacturing technology can also provide satisfactory technical support services.

Comparing with prior S12 and A series machine, the Q10 is more convenient for this operation. It has a new cathode with new material, which prolongs its lifetime. It is much more suitable for long build times and large parts. The electron beam spot diameter is reduced to 0.10mm, and the scanning layer thickness can reach to 0.05mm. As a result, the surface fineness of parts has improved and overall, has improved both efficiency and quality.

How does additive manufacturing for this application benefit the end-user?

The application of additive manufacture in the field of orthopaedic implants has the advantage that traditional technology does not have;

  •  It provides accurate 3D models for doctors and patients. It can be used for doctor-patient interaction, preoperative planning, surgical simulation, and accurate implantation;

  • l  Metal 3D printing technology can create a three-dimensional porous structure similar to trabecular bone, which can help to establish the blood supply and is beneficial to the ingrowth and fusion of bone cells.

AK Medical achieved the first CFDA approval for an AM implant in China - was that a challenging process?

Getting CFDA certification was a huge and difficult challenge for AK medical. Our R&D, production, quality control, clinical team and medical experts worked together, after 7 years of hard work, through a large number of careful and rigorous experimental study and have collected lots of data from physical and chemical characteristics of materials, animal experiments, process parameters, quality control, technical requirements, and so on. The most important thing is that we went through a large number of clinical trials, and finally got the approval of CFDA. More than 5,000 implants supplied by our company have been implanted. Now we are working on CE and FDA certificates.

How has this approval changed your business? Is implementing AM becoming easier now that it is being more widely recognised?

CFDA certification is an affirmation of our company's many years’ efforts, and thus gained more recognition from medical community and social public. But this did not make the application of this technology become simple and easy. Through study and practice, we continue to increase our knowledge of this technology, and also continue to consciously improve work standards and quality requirements, to improve the safety and effectiveness of medical instruments.

What do you believe are the biggest challenges in adopting AM for production purposes in the medical sector? How can they be overcome?

  • The lack of relevant laws and regulations;

  •  Formulation of relevant standards;

  •  Strictly control of related enterprises, for avoiding blindly and low quality following up

  • The lack of qualified medical interaction talents

The medical field is one of the most interesting application areas for AM, do you think 3D printing has become an essential tool for the medical industry?

Although the application of additive manufacture in medical field has only a few years’ history, it has shown its wide range of applications and good results, which has brought enormous economic and social benefits. I think the application of additive manufacturing in the medical field has just started. There is a huge potential for the future, with the combination of additive manufacture manufacturing technology and biological material technology, digital technology, artificial intelligence and so on, it will bring great changes and even revolutions in different medical fields.

Source:TCT Magazine