Interviewee of this issue: Zhao Xiaowen, Founder of Shenzhen Aikesailong Technology Co., Ltd.
Time: 10:00–11:00 AM, January 22, 2015
Host: Yuan Lin, VCBeat
Background: Axcelon is currently focused on digital orthopedics, leveraging 3D printing technology to provide technical support to clinicians and develop novel therapeutic approaches. The company is deeply involved in surgical projects and aims to enhance treatment outcomes through the power of technology and big data.
I. Consumers of 3D Printing Technology
1. Who ultimately bears the cost of applying this technology in the medical field? Is any of the cost passed on to patients during the process?
Zhao: At present, medical institutions bear the cost, although a portion of it is passed on to others. We will change this situation in the future, as surgical costs are decreasing.
2. You’re in medical device procurement, right? Are your clients the orthopedics department or the procurement department at hospitals?
Zhao: Procured as a technical solution. Primarily adopted by the department, with procurement covering the cost.
II. Specific Applications of Printing Technology in Hospitals
1. How to Explain Highly Invasive Procedures?
Zhao: High-level involvement means participation across the preoperative, intraoperative, and postoperative phases. This includes preoperative simulation, intraoperative navigation, and postoperative outcome analysis. The entire process, including patient scanning, is conducted within the hospital. Meanwhile, postoperative outcome analysis is not currently available to end-users; results are stored on both the hospital’s servers and our own.
2. Are hospitals willing to share their data with you? There should be a confidentiality agreement, right?
Zhao: In response to this issue, hospitals are indeed willing to share their data with us, as we are providing technical services to assist physicians.
3. This technology addresses the issue of leg fractures requiring amputation; now, bone replacement suffices. Hospitals provide data and procure customized materials.
Zhao: The scenario you described is not a simple question; it requires a multidimensional analysis. Factors such as the severity of the injury, the extent of tissue damage, the necessity and method of amputation, and whether localized or extensive reconstructive surgery is needed must all be considered. Therefore, there is no single, straightforward answer. However, this technology will inevitably reduce the harm inflicted on patients.
4. Are you medical materials? Can they be directly implanted into the human body? How long is the service life after implantation? Is replacement never required?
Zhao: It can be implanted into the human body. The duration of its presence in the body varies from person to person and should be evaluated by the device manufacturer and physicians based on individual patient data. It can be considered a permanent implant, but it is also removable.
5. Do you perform preoperative model simulations before developing solutions? What was the status quo prior to your involvement in this field, and what specific problems have you addressed since entering it?
Zhao: As you mentioned, prior to the intervention, we were not involved; however, post-intervention, it became evident that physicians required our assistance in addressing intraoperative challenges. For instance, providing three-dimensional axial views, precise localization, and angle guidance has proven highly effective in reducing surgical risks, increasing the success rate by more than 30%, as supported by research reports from Army Medical University. More importantly, it has reduced surgical time by nearly half, which is significantly beneficial for patients. In the past, surgeons were unable to visualize certain critical areas and had to rely on tactile sensation for neurovascular separation. Nearly all cases of 3D printing reported online in China are supported by us.
6. Could you briefly introduce its integration with the extension of bone tumors?
Zhao: Resection of osteochondroma at the proximal right humerus; this is the actual resection plan for the case. As shown in the figure:
III. Printing Cycle and Materials
1. How long is the cycle from data acquisition to successful printing?
Zhao: We currently maintain an average control time of 24 hours.
2. Has the 3D-printed product obtained registration approval for market launch, or is it still undergoing clinical trials?
Zhao: We are not a medical device distributor; do not register.
3. What materials are they made of? Are the printed products themselves intended for use as consumables?
Zhao: Titanium alloys and others. First, the surgical plan, accompanied by a physical model.
IV. Core Values and Advantages
1. How to respond to subsequent competition and imitation? Where does the core advantage lie?
Zhao: Competition and imitation are unavoidable if others are willing to invest time and money. Our advantage lies in our database and talent, which constitute our core competitiveness. Since our inception, we have achieved significant technological innovations, driving our continuous progress. As shown in the figure below, automatic generation is now possible. This structure was generated using big data from XX cases with extensive trauma and lesions. As the data volume increases, this skeletal model will become increasingly comprehensive.
2. This technology means that each hospital needs to be equipped with a 3D scanner, but the printer is located at your facility?
A: Actually, it is not necessary. CT and MRI data are already available from the scans. We only require the CT data, as we are highly proficient in design and printing.
V. Big Data in Orthopedics
1. How do you plan to leverage big data in the field of orthopedics?
Zhao: Our current priority is to conduct data mining. We have also carried out some intriguing explorations, such as analyzing the bone structure of Han Chinese individuals. In fact, these efforts are also based on big data.
2. Is the current skeletal model populated with case data? In actual clinical practice, is the design of patient-specific 3D-printed bone implants based on normal skeletal morphology, using the deviation between the patient’s skeletal anatomy and the normal skeletal model as a reference?
Zhao: In practical applications, we always prioritize the patient. This diagram illustrates our preparatory work, which is primarily based on extensive data. We are currently engaged in data mining; after accumulating a substantial volume of data, we will leverage these aggregated datasets for new initiatives, such as commanding surgical robots.
3. On Command-Controlled Surgical Robots
Zhao: We have also identified certain directions. After a CT scan assesses the patient’s current bone injury status, big data analytics are used to determine the optimal 3D morphology for the affected bone segment. This 3D model is then fabricated via 3D printing. Upon completion of the printing process, and guided by CT or MRI findings, surgeons are advised on the optimal surgical approach angle to avoid critical blood vessels and nerves, thereby facilitating precise bone placement.
4. What does intelligent analysis analyze?
Zhao: The concept for intelligent analysis is as follows: pathological confirmation, protocol matching, and then generation of workflows, device workflows, etc. We have only studied French surgical robots, and French experts hope that we can generate instructions. Let’s give it a try.
VI. Operational Promotion Model and Future Development Directions
1. In your collaboration with the department, how is work coordination and collaboration managed? Is it necessary to assign personnel to be stationed on-site at the department? How are communication continuity and timeliness ensured?
Zhao: We provide training first, followed by complimentary support, and then the department directors and hospital presidents come on board. In essence, our promotion strategy is rooted in our confidence in our technology. This technology genuinely benefits both hospitals and patients. Our task is to refine the technology to the highest standard and increase its visibility among healthcare professionals. Once they understand its value, hospitals will naturally adopt our technical support services.
2. What are the future development directions?
Zhao: Currently, we are developing 2D-to-3D solid modeling solutions. Telemedicine is our future direction. With our solutions and under the remote guidance of our experts, physicians in county-level and small-city hospitals can provide patients with localized treatment.
(The above content was compiled by VCBeat.)
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