China News Service, Beijing, October 9. Title: Private enterprises attack brain pacemaker: explore the "small universe" and break the "monopoly"
Author Ren Dehui
Brain pacemaker therapy is widely used to treat neurological diseases such as Parkinson's, and related products have been monopolized by foreign medical device giants for a long time. Nowadays, when you walk into the lobby of Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as Pinchi Medical), the two rows of domestically produced brain pacemakers on the wall are like a "history of evolution", silently telling the day and night of batches of R&D personnel working hard on key problems.
Recently, Hao Hongwei, general manager of Pinchi Medical and deputy director of the National Engineering Research Center for Neuromodulation, was interviewed and explained the innovation path of private enterprises behind the introduction of this technological product into thousands of households.
Explore the mind
The human brain is like a "small universe", full of complex signals and noise. As an invasive brain-computer interface device, the brain pacemaker needs to lock abnormal signals in the brain, and then stimulate and adjust them through electrodes to improve symptoms such as movement disorders.
"If the patient dares to insert wires and electrodes into the brain, do you dare?"
The Pinchi Medical team has been deeply involved in brain pacemakers for more than ten years. From research and development, clinical to mass production, we must ask ourselves this question every step forward.
"Safety is the lifeline of invasive devices." Hao Hongwei said that the team initially focused on known problems such as rejection reactions and electromagnetic interference; considering that subsequent adjustments to the equipment would increase risks, they strived for "one implantation and long-term operation" to ensure the durability and stability of each component.
"The hardest thing is to break the unknown." Hao Hongwei recalled that before the product was put into clinical use, the team conducted countless deductions and experiments. "We have done everything we can and thought about everything we can think of. We just don't know what will happen if we put it on people."
In 2009, Pinchi Medical took a key step towards clinical practice. At that time, the equipment consisted of dozens of processing techniques, hundreds of parts and thousands of control documents. It suddenly broke into the "Made in China" position in the brain pacemaker market that had been monopolized by foreign giants.
Jump over the chasm
A "feed-through connector" the size of a fingernail can not only transmit electrical signals stably, but also strictly isolate the equipment from the internal environment, which is the key to ensuring the long-term operation of the equipment. From metals, glass to ceramic alloys, it took the company three years to find materials with suitable properties and that could be standardized for production.
Similar technical difficulties abound. The high R&D investment and long payback cycle make the industrialization of brain pacemakers a natural chasm.
"Innovation is the foundation for the survival of enterprises and the prerequisite for development." Hao Hongwei said that innovation in the field of brain-computer interface must be implemented in clinical scenarios and truly solve problems for patients.
Charging and temperature control avoid the risk of burns, remote program control enables remote follow-up visits, and it is compatible with MRI examinations to facilitate patient treatment... Over the years, Pinchi Medical has promoted products from "usable" to "easy to use", and has continued to iteratively upgrade.
"It is not easy to build a prototype, but it is even harder to build a hundred or ten thousand units." Hao Hongwei said frankly that in order to match the precision manufacturing needs brought about by technological upgrades, the company has built an integrated "industry-university-research-application" platform and established a comprehensive team across multiple disciplines such as materials, medicine, and mechanical engineering to accelerate the transformation of scientific and technological achievements.
In recent years, Pinchi Medical's core product lines have entered overseas markets and have successively launched surgical promotions in Europe, Asia, South America and other places.
"Relying on the huge demand in the Chinese market, we have formed a complete product sequence and replicable solutions, which can be flexibly promoted according to the medical level and patient conditions in different countries." Hao Hongwei said.
Touch the future
In January this year, Pinchi Medical’s smart manufacturing factory in Nantong, Jiangsu Province started operation. Neuromodulation technology is taking root on the basis of advanced manufacturing infrastructure and is accelerating towards millions of households.
"Our market demand and manufacturing capabilities have reached this stage." Hao Hongwei said that last year, the company's products had served more than 10,000 families and were at a critical node for large-scale mass production and inclusive technology.
While the scale is increasing, product iteration continues. The company implants intelligent algorithms into devices to achieve a leap from one-way control to two-way control, getting rid of dependence on preset parameters, sensing the patient's brain status in real time and responding to treatment needs independently.
"Artificial intelligence (AI) has become inseparable from us." Hao Hongwei said that with the rapid development of China's AI industry, related technologies are not only applied to the product side, but also deeply involved in pathological research, product design and other aspects, fully releasing the value of massive data behind test iteration and clinical diagnosis.
"Clinical research shows that everyone's brain signals are unique, and cross-individual research is a must-answer; at the same time, the mechanisms of many brain diseases still need to be revealed." Hao Hongwei said, "The development of brain-computer interfaces requires the support of the 'trinity' of neuroscience, engineering science, and chip software, which is also our main direction in the future."
