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Homegrown company brings innovation to medical device industry

chinadaily.com.cn | Updated: Apr 3, 2019 L M S

At an industry conference on medical devices in 2017, many industry entrepreneurs remarked that there is no innovation in orthopedic instruments now, but one entrepreneur proved them wrong.

He is Zhang Lin, general manager of Goosun Bio. The enterprise led by Zhang is listed as a Zhongguancun frontier technology company.

Zhang Lin, doctor of Tsinghua University, is the general manager of Goosun Biotechnology. [Photo provided to chinadaily.com.cn]

Founded in 2011, Beijing Goosun Biotechnology Company is mainly engaged in the research, development and production of ceramic hip prostheses for surgical implantation. It has mastered the most advanced manufacturing technology in this field and is about to enter the mass-production stage.

In the 1990s, China hadn't mastered artificial joint technology, the key to which is the ceramic material of the femoral head which is the core of joint rotation.

This requires the ceramic femoral head to resist impact and wear. In order to solve this problem, Tsinghua University Professor Tian Jiemo and other domestic academicians started research into suitable ceramic materials for hip joints.

The exploration was long and hard. It was not until 2000 that China made samples of ceramic hip prostheses; it then gradually improved its manufacturing technology. As investment had arrived to industrialize ceramic hip prostheses by 2011, a medical startup was founded.

Zhang explained that they set up the firm for two reasons.

First, China's artificial hip joint market was monopolized by foreign countries. In the implanted hip joint market, although the price of domestically produced products was one quarter of imported products, their sales volume was only one third of the imports’.

That's because the artificial hip joints produced in China 10 or 20 years ago were mainly made by imitating foreign technology, and lack of core technology resulted in poor quality.

"Second, I had visited a number of private medical device manufacturers, the processing methods of which were unhygienic and old-fashioned. We decided to offer safe, effective and inexpensive products for patients," Zhang explained.

Goosun Bio is a technology-driven company that specializes in the development of orthopedic medical devices. [Photo provided to chinadaily.com.cn]

From the establishment of the company in 2011 to now, they have conducted a lot of research and numbers of tests and experiments, with countless failures.

Zhang recalled, “Sometimes, we made a batch of samples of ceramic femoral heads, but seven or eight ceramic balls were cracked among the finished products. In such cases, we did experiments around the clock to find the problem”.

“For us, the most difficult part is the detection and clinical stages. Each test takes half a year or even a year. But we have to wait; these convincing data are necessary,” Zhang noted.

As different test results show, the ceramic femoral head made by Goosun has superior qualities.

There are three criteria for evaluating ceramic balls: the degree of wear, the degree of compression and impact toughness. Goosun’s ceramic ball wears at a rate of about 0.6 mg per million rotations, and the best ceramic ball in the market wears about 5 mg per million.

This proves that Goosun's products can be implanted in the human body for up to 20 years or longer without replacement.

Besides, Goosun's ceramic balls can withstand weights of from 7 to 10 tons, while imported products can only withstand a static pressure of 5 tons.

If Goosun’s ceramic balls fall from the second floor, they won't break. Their impact toughness is about twice that of foreign products.

Since last year, Goosun have been searching for patients in clinical trials in different cities across the country, implanting products of the company and observing their clinical symptoms.

The results are positive, and the patients who underwent surgeries gave fairly good feedback.

A senior resident in Beijing could only lie on her bed before undergoing surgery; now she can look after her grandson and dances on the square every day.

Another old man is an inheritor of an intangible cultural heritage. Having given an interview on CCTV after regaining his health, he happily shared the video with Goosun Bio.

“We’re very pleased to see that our products can better their lives and our efforts over the last seven years were not wasted,” Zhang noted.

With core technologies in hand, the cost of Goosun’s products is greatly reduced. Their price will be set as one third of imported products, but their performance is much better than their competitors’.

It is hoped that China’s medical device industry can move forward with more core technologies developed by Chinese firms.