Akesailong: Empowering Personalized Surgery with 3D Printing to Eliminate Surgical Blind Spots

2018 has passed. It was an eventful year for the medical device industry. At the end of the year, many people were concerned about policy uncertainty. After 2018, with the implementation of the “4+7” centralized drug procurement program and the nationwide rollout of online listing-based procurement, it has become clear that price reduction and cost control are the overarching themes. However, another trend worth closer attention is the national government’s measures to encourage innovation.

If price reductions are akin to a rigorous selection process where survival is uncertain regardless of one’s response, the inevitable will eventually come. Meanwhile, innovation in medical devices remains a long-standing challenge for the development of domestically produced medical devices in China. The government has also introduced multiple measures to encourage innovation in medical devices, aiming to achieve import substitution at an early date.

In the innovation of medical devices, 3D printing can be said to have injected a shot in the arm into the development of domestically produced medical devices. The research and development of high-performance medical devices is one of the ten key areas in the "13th Five-Year Plan," and the R&D of personalized medical devices will be at the forefront of high-performance medical device development. And 3D printing is precisely what can achieve breakthroughs in personalized medical devices.

Among the few domestic companies dedicated to 3D printing applications in healthcare, Excellent focuses on biomedicine and regenerative engineering of human tissues and organs, providing personalized precision surgical solutions. How does Excellent’s 3D printing technology assist surgeons during operations? And how does it integrate 3D printing with the research and development of personalized medical devices? At the “Top 100 Future Healthcare Companies” forum, VCBeat conducted an exclusive interview with Zhao Xiaowen, Chairman and Researcher at Excellent.

Mr. Zhao Xiaowen Delivers a Speech at the “Top 100 Future Healthcare Companies” BIN/NGS Frontier Forum

When Excellent was first established, prior to the involvement of professional investors, all initial investments were funded with its own capital. Entering the 3D printing industry is no easy task; achieving product commercialization in the 3D printing stage requires overcoming technical limitations, material constraints, and data bottlenecks. Nevertheless, Excellent chose to focus on 3D-printed orthopedic consumables, as 3D printing represents a significant breakthrough for orthopedic surgeries, whether in the preoperative, intraoperative, or postoperative phases.

Currently, Excellent has four main product lines: models, navigation templates, personalized implants, and biological scaffolds. 3D-printed medical additive manufacturing can be widely applied in clinical settings, especially in surgery and areas related to the skeletal system. Therefore, the clinical application scenarios of Excellent's products include not only orthopedics but also implantable materials for cranio-maxillofacial regions. In addition, with its biological scaffolds, Excellent’s products can be extensively used in various fields such as regenerative medicine, drug development, and new research projects.

3D-printed models are primarily used in preoperative planning, enabling the creation of personalized 3D-printed surgical models based on MR data, rapid reconstruction of 3D models, and high-precision 1:1 simulation of bone models.

For physicians, this facilitates more effective communication with patients regarding their condition and enables preoperative simulation and rehearsal. Taking hip arthroplasty as an example, surgeons can directly perform key procedures on the model, including acetabular identification, localization of the acetabular center of rotation, acetabular measurement and reaming, femoral neck osteotomy, femoral isthmus medullary canal measurement, and femoral osteotomy.

Previously, orthopedic surgeons could only rely on experience to “process” data in two dimensions; however, Excellent can now reconstruct data, produce 3D models, and print 3D models within 24 hours.

During surgery, Excellent also offers navigation template solutions for interventional procedures. Taking pedicle screw fixation in spinal surgery as an example, Excellent can reconstruct a 1:1 scale model of the patient’s spine based on individual data and design customized navigation templates. These templates ensure a more precise fit between the spine and the contact surface of the navigation guide, thereby reducing surgical errors and lowering overall procedural costs.

The application of 3D-printed surgical guides in hip replacement surgery can assist surgeons in rapidly determining acetabular positioning, reaming size, depth, and angle, as well as the entry point, angle, and length of acetabular screws. This facilitates precise surgical planning, reduces surgical trauma, shortens operative time, improves the success rate of complex total hip arthroplasty, and lowers the failure rate of high-difficulty total hip arthroplasty.

The use of navigation boards not only improves surgical precision but also reduces the difficulty of orthopedic surgeries, offering significant potential in complex procedures and primary care applications.

In terms of personalized implants, "custom-made" solutions based on patient data have been achieved.

Bringing these visions to reality first requires interdisciplinary backgrounds and team support. Especially in the medical field, safety and efficacy are non-negotiable bottom lines.

Zhao Xiaowen stated to VCBeat, “To truly achieve personalized custom additive manufacturing, interdisciplinary research spanning clinical practice, biomechanics, biology, anatomy, and materials science is required. Our team covered all these fields from its early formation, with nearly 20 researchers alone. Such a startup team is unique and irreplicable, which ensures that our products and technology maintain a certain lead both domestically and internationally.”

In the field of 3D printing applications in healthcare, China has already seen multiple successful cases. At Xiangya Hospital, artificial joint replacement surgeries combining MR technology and 3D printing have been successfully performed. In terms of medical applications, the development trend of 3D printing in the healthcare industry can be divided into five stages: from non-living objects to simple life-like features, active tissues, complex tissue organs, and ultimately achieving the printing of complete living organisms. Although each stage builds upon the previous one, every phase requires significant technological breakthroughs.

“Bone necrosis is not necessarily limited to the joints or spine; it can result from trauma, tumors, acquired conditions, or congenital diseases that cause damage to the skeletal system, leading to significant bone loss after necrosis. Traditional machining methods cannot fabricate such complex architectures. They merely provide simple fixation and connection for damaged or defective bone areas to meet mechanical strength requirements, but fail to reflect the interaction between the implant and tissue—specifically, affinity, biocompatibility, and particularly issues at the hard tissue interface,” stated Zhao Xiaowen. “Therefore, additive manufacturing can fulfill this mission by constructing complex implants layer by layer and point by point, thereby truly achieving perfect morphological restoration and functional reconstruction.”

At the “Top 100 Future Healthcare” conference, Zhao Xiaowen provided a detailed explanation of the essence and mechanisms of medical additive manufacturing: “After an implant is placed in the human body, as a foreign object, it first recruits a large amount of adhesive proteins on its surface, which activates signaling pathways. If these signaling pathways are appropriate, they will induce a proper inflammatory response. However, if the foreign object triggers excessive inflammation, it can lead to biofilm formation, preventing integration with surrounding tissue. This may result in clinical failure, reducing the expected service life of implants from ten years to merely three to five years, with complications such as loosening and fracture. Inflammation can also cause bone resorption. Therefore, effective integration at the implant–tissue interface after implantation can stimulate the regeneration of native tissue.”

Excellent aims to leverage additive manufacturing to achieve construction at the tissue level. If 3D-printed models involve knowledge of anatomy, materials science, and mathematics, then analysis at the tissue level pertains to the interactions between cells, as well as between cells and tissues. Only through quantification can targeted repair and reconstruction of tissues be achieved.

“After analyzing at the tissue level, we design personalized implants that are 3D-printed to achieve perfect morphological repair and reconstruction of tissues. Particularly in the area of personalized cranio-maxillofacial implant restoration, there is virtually a gap in China. The volume of cranio-maxillofacial surgeries in the United States reaches 20 million cases, according to data published by the American Association of Oral and Maxillofacial Surgeons, whereas China lacks authoritative data in this regard.” Zhao Xiaowen pointed out that there remains significant unmet demand in the field of personalized cranio-maxillofacial restoration.

Currently, leveraging its technology for the analysis and construction of trabecular bone-inspired biomimetic microstructures, Excellent has conducted extensive experimental research on additively manufactured implants. Using complex computational simulations, the company has investigated the quantitative relationships between tissue integration and nutrient transport. Zhao Xiaowen stated, “We reconstruct and analyze different tissues, performing quantification at the tissue level, and ultimately apply biomimetic design to the lesion sites. Upon implantation, in addition to morphological restoration, the interface features capillary network formation and regeneration of new tissue cells, thereby achieving ultimate integration between tissues. Follow-up observations at 24 months revealed favorable tissue ingrowth.”

Excellent not only boasts its own interdisciplinary R&D team but also collaborates with top-tier universities both in China and abroad on early-stage research, positioning itself at the forefront of global innovation in medical additive manufacturing and active materials.

Excellent has achieved breakthroughs in the R&D of personalized medical devices by leveraging 3D printing technology that developed in parallel with international advancements. It is poised to realize the transformation of 3D printing from virtual digital design models to physical reality. Established in 2005, Excellent has undergone more than a decade of development, demonstrating its progress in achieving the industrial commercialization of 3D printing.

Zhao Xiaowen also shared her outlook with VCBeat: “Although 3D printing still has much room for improvement, it can address many problems and pain points in healthcare, holding significant potential for future development.”