I. Industry Risk Analysis

(1) Policy Risk

Currently, the medical CyberKnife industry faces dual risks during the policy formulation and adjustment periods. In the early stage of policy – making, the vague approval standards increase the compliance costs for enterprises (such as the extended clinical trial cycle). In the mid – implementation stage, the trend of medical insurance cost control may compress the equipment procurement budget. In the policy effect evaluation stage, if the clinical data fails to meet expectations, there is a risk of restricted use or product recall. At the end of the policy cycle, if the local pilot promotion fails, there is a risk of a decline in procurement subsidies. Entrepreneurs need to be vigilant about the differences in the approval scales of medical equipment configuration licenses in different regions, the tendency of DRGs payment reform to exclude high – priced equipment, and the increased market access threshold caused by the compliance review of technological patents under the import substitution policy.

(2) Economic Risk

During the economic downturn cycle, the medical CyberKnife industry faces multiple pressures. The procurement demand for high – end equipment is delayed due to the tightened hospital budgets. The financing cost rises with interest rate fluctuations, and the pay – back period for equipment is prolonged. In an inflationary environment, the import cost of core components increases, and the stability of the supply chain decreases. In some regions, medical investment has shifted to basic equipment, and the adjustment of government procurement priorities increases the risk of market contraction. Entrepreneurs need to establish a dynamic risk – resistance mechanism to balance high R & D investment and cash flow.

(3) Social Risk

The medical CyberKnife industry faces social risks caused by generational consumption differences. The elderly group has limited acceptance of high – priced precision radiotherapy due to insufficient medical insurance coverage and traditional medical concepts. Although the young middle – class pursues technological innovation, their payment ability fluctuates significantly under the pressure of economic downturn, which may weaken the market penetration rate of high – end equipment. The differentiation of generational consumption ability between regions exacerbates the contradiction of resource allocation. The concentration of equipment in developed areas may lead to public doubts about medical fairness, while in third – and fourth – tier cities, it is difficult to form effective demand due to the payment gap. In addition, the increased vigilance of the youth group against over – medical treatment may give rise to social disputes over the “technological over – supply” of high – end equipment, resulting in tightened policies or a decline in public trust.

(4) Legal Risk

In the control environment, the registration and approval process for medical equipment is complex (China implements the strictest approval for Class III medical devices, and the clinical trial cycle for CyberKnife usually lasts 3 – 5 years). Entrepreneurs are prone to miss the market window period due to approval delays. In terms of risk assessment, intellectual property disputes occur frequently (multinational enterprises’ patent barriers cover 70% of the core component technologies), and there is a risk of high – value infringement compensation. In control activities, the product quality traceability system has strict requirements (production data needs to be completely preserved for more than 15 years), and violations may lead to the revocation of the license. In information communication, the radiation safety standards are updated frequently (the new version GBZ 121 – 2023 in 2023 has raised the dose control requirements), and enterprises face the risk of lagging behind in compliance. In the monitoring link, there is a risk of liability for data leakage in patient privacy data protection (which needs to comply with both the “Personal Information Protection Law” and HIPAA standards).

II. Entrepreneurship Guide

(1) Suggestions on Entrepreneurial Opportunities

Focus on the pain points of precise treatment. Promote modular CyberKnife equipment in specialized hospitals in second – and third – tier cities, combine the policy dividends of domestic substitution with the trend of technology sinking, and use the financial leasing model to lower the procurement threshold for hospitals. Develop a cloud – based intelligent collaboration platform for complex surgeries, integrating the expert resources of top – tier hospitals and local medical institutions to form a joint treatment network. Iteratively optimize clinical data through the AI dose planning system, jointly develop insurance products for the efficacy of tumor radiotherapy with commercial insurance companies, and establish a revenue – sharing mechanism linking equipment utilization with patient treatment efficacy.

(2) Suggestions on Entrepreneurial Resources

Entrepreneurs need to focus on integrating resources in three aspects. On the technology side, cooperate with top – tier hospitals and research institutions for clinical verification to quickly obtain treatment data and optimize algorithms. In terms of funds, apply for government subsidies through the “High – end Medical Device Innovation Special Project” and simultaneously introduce industrial capital with medical channel resources. In the supply chain, identify alternative suppliers for German precision guide rails and Japanese image detectors and establish at least two backup plans. Regarding policy resources, communicate with the Technology Review Center of the National Health Commission in advance, use the green channel to accelerate the approval of Class III licenses, and reserve overseas registration specialists familiar with FDA certification to meet the needs of going global.

(3) Suggestions on Entrepreneurial Teams

The entrepreneurial team in the medical CyberKnife industry needs to build a composite core team. The founder should have both experience in medical equipment R & D and the ability to integrate clinical resources, accompanied by at least one regulatory expert proficient in the registration process of Class III medical devices (familiar with the NMPA/FDA certification system), one clinical promotion supervisor with experience in cooperation with the radiotherapy department of top – tier hospitals, and one medical AI algorithm engineer (focusing on breaking through real – time image – guided technology). In the early stage of the team, a full – time position for the medical device quality management system should be established, and operators with experience in clinical trial management of large – scale medical equipment should be arranged. For equity distribution, a 15% – 20% flexible pool should be reserved to attract high – end technical talents with the qualification of radiation physicists or a background in medical linear accelerator R & D.

(4) Suggestions on Entrepreneurial Risks

Entrepreneurs in the medical CyberKnife industry need to focus on the risk management and control of technology R & D. First, cooperate with top – tier hospitals to accumulate clinical trial data and simultaneously apply for the NMPA Class III medical device certification. Establish a professional medical – engineering cross – functional team to ensure that product iteration meets the needs of clinical precision radiotherapy. During the market promotion stage, adopt the “equipment placement + service revenue – sharing” model to lower the procurement threshold for medical institutions and bind with leading tumor hospitals to form a demonstration effect. In the supply chain, select military – grade precision component suppliers and establish a spare parts warehouse to prevent the risk of being “strangled” in the import substitution process. Focus on the areas of rigid indications covered by medical insurance, prepare price approval materials in advance for provincial tenders, and avoid the risk of payment policy changes.