I. Industry Risk Analysis

(1) Policy Risk

As the policy lifecycle enters the adjustment and optimization stage, the in vitro diagnostic industry faces the risk of intensive policy iterations: The scope of the volume-based procurement policy continues to expand, putting pressure on the price system and causing the gross profit margin to decline; after the upgrade of the medical device registrant system, enterprises need to assume full-cycle quality responsibilities, leading to a sharp increase in compliance costs; under the dynamic adjustment mechanism of the clinical test item catalog, product access faces the pressure of frequent technological iterations; during the promotion of hierarchical diagnosis and treatment, there are deviations in the implementation of regional policies, and there is a market penetration risk in channel sinking. At the same time, there is a possibility of a contraction in policy dividends in the special approval channel for innovative medical devices, and there is a risk of mismatch between the R & D investment made in advance and the subsequent review standards.

(2) Economic Risk

The in vitro diagnostic industry currently faces multiple risks brought about by economic cycle fluctuations: During the economic downturn, the government’s financial pressure increases, resulting in a reduction in public health expenditures. The tender and procurement cycle of public medical institutions is prolonged, and the budget is compressed, directly impacting the sales volume of mid – and low – end products; in the cold winter of capital, financing in the biomedical field has tightened, and start – up enterprises face the risk of a broken capital chain in promoting R & D pipelines and commercializing products; the reconstruction of the global supply chain combined with inflationary pressure has led to a 20 – 30% increase in the import cost of key raw materials, squeezing the gross profit margin of enterprises; after the industry enters the mature stage, leading enterprises accelerate market clearance through price wars (the price of some reagents has dropped by up to 40%), and new entrants face the dual pressures of existing channel barriers and high certification costs.

(3) Social Risk

The in vitro diagnostic industry faces a significant risk of generational consumption fragmentation. Young people prefer the convenience of instant home – testing products, while the middle – aged and elderly groups have a path dependence on traditional medical institution testing services. Emerging POCT (Point – of – Care Testing) products face the risk of a user group gap; Generation Z consumers pay more attention to the intelligent linkage between test data and health management apps, while the traditional distributor system cannot support the premium of digital services. Enterprises need to bear the double pressure of intelligent R & D investment and offline channel costs; under the medical insurance cost – control policy, the prices of basic testing items continue to decline, but the new generation of consumers are willing to pay high prices for self – paid items such as early cancer screening. The business structure faces the risk of operational imbalance due to the generational inversion of payment ability.

(4) Legal Risk

Entrepreneurs in the in vitro diagnostic industry face multiple legal risks: The product registration and approval process is complex and the standards are dynamically adjusted. Delays in product listing may occur due to untimely compliance; data privacy protection regulations are strict. Sample collection and test result storage need to be strictly encrypted. Violations will face high fines and civil compensation; the intellectual property protection system is imperfect. Core technologies are prone to infringement, and the cost of safeguarding rights is high; advertising and promotion are strictly restricted by the “Measures for the Administration of Medical Advertisements”. Improper expression of efficacy can easily trigger administrative penalties; the “Regulations on the Supervision and Administration of Medical Devices” strengthen the quality traceability mechanism. Medical accidents caused by testing errors will directly hold enterprises civilly and criminally liable.

II. Entrepreneurship Guide

(1) Suggestions on Entrepreneurial Opportunities

Currently, entrepreneurial opportunities in the in vitro diagnostic industry are concentrated in three areas: home self – testing (such as chronic disease monitoring kits), precision medicine – supporting testing (early cancer screening gene testing reagents), and AI – assisted diagnosis systems (automated pathological image analysis software). Entrepreneurs can develop miniaturized POCT devices, personalized testing packages, and digital reporting platforms, focus on the direction of domestic substitution to avoid the patent barriers of imported reagents, combine the hierarchical diagnosis and treatment policy to penetrate the county – level market, cooperate with third – party medical laboratories through the LDT model to enter the clinical scenario, and simultaneously layout the pet diagnosis blue – ocean market to establish a differentiated advantage.

(2) Suggestions on Entrepreneurial Resources

Entrepreneurs in the in vitro diagnostic industry should prioritize the integration of technology R & D resources (obtain patent authorization by cooperating with university laboratories), supply chain resources (sign long – term price – locking agreements with raw material suppliers), and clinical trial resources (build sample libraries jointly with regional top – tier hospitals). Solve the initial capital pressure by applying for IVD special industrial funds and government innovation subsidies. Focus on connecting with CRO service agencies with medical device registration experience to accelerate the product listing process. At the same time, use the open interfaces of AI – assisted diagnosis platforms to quickly build digital solutions. Pay attention to obtaining the latest industry standard dynamics through industry associations and participating in the regional testing center equipment sharing plan to reduce costs.

(3) Suggestions on Entrepreneurial Teams

Entrepreneurs in the in vitro diagnostic industry should form an interdisciplinary core team. Technical partners need to have a background in biomedicine, reagent R & D, or equipment engineering, and at least include members with more than 10 years of experience in IVD product development; allocate full – time registration and regulatory experts to track the dynamics of NMPA (especially pay attention to the new classification regulations for AI – assisted diagnostic equipment in 2023). Market partners need to have both hospital channel resources and the ability to interpret medical insurance policies; adopt a dual – leadership system of “technology + clinical”, invite experts at the level of the director of the laboratory department of top – tier hospitals as an advisory team, and simultaneously establish a talent pool with overseas backgrounds to cope with the CE certification reform; the team must ensure that more than 30% of its members have practical experience in the GMP system, conduct regular compliance training on the LDT model, and the core management layer needs to reserve a 15% – 20% equity pool to meet the needs of channel team reconstruction brought about by the volume – based procurement policy.

(4) Suggestions on Entrepreneurial Risks

Entrepreneurs in the in vitro diagnostic industry need to prioritize the establishment of compliance barriers, plan product registration and certification in advance (such as NMPA, FDA), and hire professional regulatory teams to avoid the risk of approval delays; focus on differentiated niche markets (such as POCT, early cancer screening) to avoid direct competition with giants in the red – ocean markets such as biochemical diagnosis; share R & D costs through strategic cooperation, conduct real – world research jointly with hospitals and third – party laboratories to reduce the capital and time costs in the clinical verification stage; establish a dual – backup mechanism for the raw material supply chain, and lock in domestic substitution solutions in advance for imported materials such as key enzymes, antigens, and antibodies; use AI – assisted diagnosis technology to develop an intelligent reporting system, and avoid the price – war trap through value – added services.