Even though China 3D prints thousands of orthopedic implants, mainly in titanium, personalized orthopedics and interbody spinal fusion devices made with 3D printing are still relatively new there and elsewhere. Medical 3D printing service Huaxiang Group has now received Category 3 medical device clearance from China’s National Medical Products Administration for its Porous Spine Fusion Cages.
Developed by Dr. Wang Wenjun, the cages have been tested in 108 patients across five hospitals before receiving approvals. The devices are to be used for conditions such as degenerative disk disease, spinal tuberculosis, and trauma. Printed on a Farsoon FS121M, the structures have lattice structures, customizable pore size, custom porosity and are meant to mimic the modulus trabecular bone, as well. This makes the implants analogous to NuVasive’s Modulus spinal cages. Other spinal cages on the market include those by CoreLink, CaptivaSpine, Osseus, EIT, Johnson and Johnson’s DePuy, and, of course, Striker.
Given the country’s strong 3D printing focus as a key part of the nation’s strategic development focus, China is quite late to the party in titanium spinal implants. What we are seeing, however, is that, bit-by-bit, the 3D printing industry is developing from being one of the manufacturing technologies for medical implants to the default technology in certain use cases. One of those use cases is spine and interbody fusion devices in particular. In this area most of the major players have turned to 3D printing to get a cheaper and, at the same time, higher-performing solution that also can be engineered to match the body better. Slowly but surely, over the course of thirty years, we are going from a novelty to a necessity for the implants market.
For Huaxiang and Farsoon, this is a milestone and they are playing their part in China’s 13th Five-Year Plan, which includes a goal to “extend the application of total 3D printing solutions for advanced medical devices including medical-grade material, 3D printing machines, design software, medical device development & clinical verification and medical supply chains.” This effort is lead by a consortium that includes: Shanghai Jiaotong University’s Ninth People’s Hospital, the Chinese Academy of Sciences Institute of Metal Research, South China University of Technology, Sichuan University, Xi’an Jiaotong University, Shanghai Institute of Ceramics, Hubei University, Central South University, Farsoon Technologies and Huaxiang Group. The Chinese government is clearly investing a lot of money in creating all of the necessary tools that China needs to become a leader in the medical space.
The global medical devices market has traditionally been dominated by a few leading medical device firms, most of them American. A high tech precision design and development game, it has considerable barriers to entry. Lawsuits may cost millions dollars and any mistake is close to catastrophic. A tight grasp of material science, design, software, the human body and many cross-influencing factors is required, as well as many millions of dollars to obtain regulatory approvals. Doctors are likely to trust those that they have for decades and track records mean a lot when a failure may severely impact the patient, hospital, surgeon and manufacturing firm. Medical devices have been a rapidly growing market and are set to continue to grow quickly. People are living longer and more people in developing countries are able to afford these types of surgeries. More active lifestyles and higher expectations, as well as obesity, all contribute to a huge anticipated demand in medical device growth.
By fundamentally investing in developing and rolling out titanium orthopedic implants in China, the country will be able to advance into this difficult but expanding high-margins market. At the same time, it will save itself considerable costs in the decades to come if it implements its own devices. Implants, then, could be lower cost for Chinese consumers, insurers, and the government, while helping maintain a more active and rewarding lifestyle and stave off knock-on health problems for an aging populace.
The return on investment for this must be incredible for the government. And the long-term big goal would be to go global, for the developing world, or for everyone, to make China a global orthopedics and medical device player. Given the resources that the Chinese government has and the progress that they are making, we can only accept that China has a role to play in the global device market. How big will this role be? That is for the market to decide.
For the longest time, the focus has only been on OECD country populations and premium solutions for only these. But, with millions more across the globe likely to benefit from interbody fusion devices as well as TKA and other procedures, device manufacturers could do much more to cater to those populations. Countries with many millions of people, such as India, the Philippines, Indonesia and Brazil are barely catered to by most multinationals. They could do more to engage doctors and regulatory authorities there.
At the same time, paradoxically, in a market best served by the best of the best, perhaps a less expensive brand would also go far? Similar to Volkswagen’s segmentation and branding efforts with VW, Audi, Porsche, etc., a medical device company could offer different products at different price points. Another possibly interesting option would be to promote flights to and surgeries in countries that are low in cost but high in quality of care in order to extend market dominance from those territories into developing countries. In plastic surgery for example, South Korea offers several medical visas aimed in part to entice people from the region to come to its leading elective surgery clinics. Indeed, when I last stayed in Seoul, I walked through an entire part of Gagnam devoted to plastic surgery. My nearby hotel was an interesting experience, as many other guests were extensively bandaged and puttered about recovering before returning to their respective nations. Could a similar market be created in order to make Stryker and Johnson & Johnson’s implants become branded in the consumer mind, aspirational even, and accessible through travel to a convenient country? I’d suggest hotels with lots of ramps.
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