1. Industry Risk Analysis

(1) Policy Risk

Currently, the ophthalmic OTC device industry faces dual risks in policy formulation and implementation: During the policy – making period, the state is gradually tightening the classification and supervision requirements for medical devices. If entrepreneurs fail to keep track of the revision trends of the “Regulations on the Supervision and Administration of Medical Devices” in a timely manner, they may face the waste of R & D investment caused by the upgrade of product registration standards. At the policy implementation level, there are differences in the inspection standards for the advertising compliance of products such as optometers and vision training devices in different regions, and there is a risk of products being removed from the market due to sudden law – enforcement actions. The update cycle of industry standards is accelerating (such as the new standard for contact lens fitting in 2023), forcing enterprises to continuously invest in compliance transformation. Moreover, the penetration of the medical insurance cost – control policy into the consumer medical field may compress the terminal price space of OTC devices, directly affecting product pricing strategies and profit models.

(2) Economic Risk

In the economic downturn cycle, the ophthalmic OTC device industry is squeezed by both weak demand and a tightened financing environment. The decrease in consumers’ disposable income leads to a lower willingness to purchase mid – and high – end devices, and mid – and low – end products are caught in a price war due to severe homogenization. The upstream raw materials are affected by the fluctuations of the global supply chain, and the inflation pressure drives up the production cost. Meanwhile, the terminal sales are squeezed by the medical insurance cost – control and centralized procurement policies, compressing the bargaining space and the enterprise profits. In the current capital winter, the financing cycle of start – up enterprises is lengthened, the cash flow is under pressure, the investment in technology iteration and market education is forced to shrink, and the industry reshuffle is accelerating.

(3) Social Risk

The ophthalmic OTC device industry faces a significant risk of generational consumption gap. Millennial and Generation Z consumers are more reliant on digital diagnosis and treatment and professional brand endorsements, and they have low trust in traditional OTC products and weak repurchase willingness. Although the silver – haired group has stable demand, they are highly price – sensitive and their consumption decisions are easily affected by the fluctuations of medical insurance policies. At the same time, there is a gap in the value perception of “home eye health” among different generations. The younger generation pursues immediate efficacy and intelligent experience, while the middle – aged and elderly groups focus more on the cost – effectiveness of basic functions. The soaring market education cost makes it difficult for emerging brands to form cross – generational user stickiness.

(4) Legal Risk

As entrepreneurs, the current legal risks in the ophthalmic OTC device industry are mainly concentrated in compliance and liability: The registration and filing process of medical devices is complex and the policies are dynamically adjusted (such as the new regulations of the National Medical Products Administration in 2024 requiring stricter clinical evaluation for Class II medical devices). Start – up enterprises are prone to step on approval landmines. Advertising is strictly restricted by the “Regulations on the Supervision and Administration of Medical Devices”, and common efficacy expressions such as “relieving eye fatigue” may easily constitute false advertising. If the eye health data collected by the devices fails to meet the requirements of the “Personal Information Protection Law” for explicit consent and desensitization, it will trigger high – amount fines. In addition, the industry has dense patent barriers, and a slight similarity in the appearance or technical solutions of competing products may lead to intellectual property litigation.

2. Entrepreneurship Guide

(1) Suggestions on Entrepreneurial Opportunities

Entrepreneurial opportunities in the ophthalmic OTC device industry are concentrated in the home – based and intelligent vision health management track. By combining consumer medical care with hardware innovation, portable AI vision detectors (such as home optometry devices), intelligent eye – protection training devices (equipped with VR/AR technology), and data – based eye health monitoring systems (linked to medical institutions) can be developed. Priority should be given to targeting precise demand scenarios such as children’s myopia prevention and control and early screening of cataracts in the elderly. Products should be distributed through both online malls and community pharmacies, and the application for inclusion in the medical insurance device catalog should be combined to accelerate the entry of products into hospitals. Attention should be paid to avoiding the risks associated with the registration cycle of Class II medical devices, and the dual dividend window of the upgrade of grass – roots medical equipment and the upgrade of home health consumption should be seized.

(2) Suggestions on Entrepreneurial Resources

Entrepreneurs in the ophthalmic OTC device industry should focus on the efficiency of resource integration: First, cooperate with enterprises with medical device production qualifications for OEM manufacturing to reduce heavy – asset investment. Second, jointly establish clinical data verification channels with ophthalmic hospitals and optometry centers to solve the pain point of the credibility of home – use devices. Third, utilize the resources of pharmaceutical e – commerce platforms such as JD Health and Ali Health to quickly open up online distribution channels and avoid the channel barriers of traditional medical device enterprises. Fourth, access the local medical insurance chronic disease management platform resources to strive for the inclusion of home eye health monitoring devices in the medical insurance catalog. Fifth, obtain seed users and initial funds through intelligent hardware crowdfunding platforms and simultaneously accumulate product iteration data.

(3) Suggestions on Entrepreneurial Teams

The entrepreneurial team of ophthalmic OTC devices should first form an interdisciplinary core team, with a focus on including medical device R & D experts, registration and regulatory experts, and channel operation talents. The founder needs to ensure that the team has three key capabilities: First, master the registration and application process of Class II medical devices and be familiar with the norms of clinical trial design. Second, have experience in optical biological measurement or vision correction technology R & D and be able to quickly complete product engineering. Third, have the ability to integrate pharmacy/e – commerce channel resources. It is recommended to adopt a “technology + business dual – drive” structure. The technology partner should have a working background in Class III medical device enterprises, and the business partner should lead the establishment of a promotion system for “out – of – hospital sales + home self – inspection” scenarios. The team should allocate a full – time quality supervisor to control the nodes of ISO13485 system certification to avoid missing the market window period due to registration delays.

(4) Suggestions on Entrepreneurial Risks

Entrepreneurs in the ophthalmic OTC device industry should first ensure that their products comply with the latest regulations of the National Medical Products Administration and establish a dynamic policy tracking mechanism to deal with compliance risks. They should choose niche markets such as home vision correction or adolescent myopia monitoring, create differentiated products through portable design and AI – assisted film reading functions, and avoid competing in the high – end hospital market. They should adopt a modular development process, verify the accuracy of the core algorithm in stages, and apply for utility model patent protection. They should sign step – by – step procurement agreements with more than three component suppliers and give priority to domestic substitution solutions to reduce the risk of cost fluctuations. They should apply for science and technology subsidies for small, medium and micro – enterprises, and use the OEM manufacturing model at the initial stage to reduce the pressure of asset investment. They should install a local encrypted storage module and turn off non – essential data upload functions by default to avoid privacy risks. They should jointly carry out free screening activities with community clinics to quickly accumulate more than 500 cases of clinical data to assist product iteration and simultaneously promote the certification of Class II medical devices to shorten the market – entry cycle.