Joint research and development, bringing medical innovation to the market in 8 months
2024-04-15

In February 2022, a long-term customer approached us to seek the feasibility of joint research and development of minimally invasive ophthalmic surgical instruments. The client expected that through cooperation between the two parties, a product concept sketch would be turned into a mass-run product on the market within 8 months. This means that in just 8 months, in addition to helping customers turn sketches into products, we also had to complete many time-consuming and difficult tasks such as product feature and function verification, key process verification, sterilization verification, shelf life testing...etc.  Even so, in the face of customers' trust and expectations, and adhering to the belief that customers come first, we resolutely took over the task.

At the beginning of the project, relying on the high-precision processing capabilities of femtosecond laser cutting machine and Swiss 7-axis machine, we successfully completed the micron-level product characteristics envisioned by the customer on a minimally invasive tool blade, which size is a few tenths of a millimeter. A KEYENCE laser scanner was used to scan and measure this feature via non-contact method, thereby confirmed the stability in mass production processes.Finally, the customer's concept sketch was turned into mass production in a very short period of time and finally converted to standard process drawings.

At the same time, taking advantage of the deep vertical integration of various manufacturing processes in the factory, the development of the laser welding process verification of the device, mold developments of injection parts, automatic equipment for two-color pad printing, and verification solutions for sterilization packaging are also being carried out simultaneously in the factory. No need to resort to any external resources, and the product development progress is advancing at a rocket speed. In May 2022, we assisted the customer to complete the development of such an innovative minimally invasive device successfully. This device includes ultra-high-precision machining, Laser welding, clean injection molding, clean assembly and various complex processes.  All the product characteristics imagined by the customer at the beginning of the project fully became the truth.  

Moreover, based on our rich experience in medical device development and project management, we deeply understand that in order to achieve this time target, the most time-consuming verification work must be carried out in advance. As early as the initial stage of process qualification, we planned in advance and prepared equivalent samples required for various verifications, initiated sterilization verification within the time window, and assisted customers in providing various required U.S. FDA applications on time. Company's internal resources like engineering, material, R&D, process, quality control, and document control departments are coordinated to ensure that all progress is completed as planned. At the same time, we have established a very timely communication mechanism with our customers the same time as project kick-off. In addition to weekly meetings, each technical team communicates with customers in the United States almost every day, ensuring that all questions are answered and can be solved in time.

In early August, the minimally invasive device successfully completed its first clinical operation, officially announcing the success of the research and development of the project! At the same time, because the mass production of the production process was well planned in the early stages of research and development, the factory quickly increased production capacity in the two months from August to October, and successfully filled up the product after Oct in 2022. The customer's hub warehouse began to distribute goods normally to all relevant medical institutions in the United States.

In this way, within 8 months, we successfully turned a sketch of an innovative device into a professional device in the hands of thousands of clinicians. Faced with praise from customers, we firmly believe that as long as we adhere to the concept of putting customers first. By leveraging our vertically integrated manufacturing advantages, we will surely create greater value for more customers.