Nanjing Shuangwei Biomedical Technology Co., Ltd. (hereinafter referred to as "Shuangwei Biology") was founded in 2001. It focuses on four series of products: safe blood transfusion equipment, bone injury and trauma burn equipment, anesthesia first aid equipment, and urinary equipment. Research and development, production, sales and service of new disposable medical consumables.

In 2016, the company's main business income was 65.13 million yuan, taxes were 7.92 million yuan, and there were more than 240 employees.

The product sales network covers all provinces and cities in China, and is exported to more than 20 countries in Europe, South America, Asia and Africa. The main product "disposable white blood cell filtration and blood transfusion equipment" has become a benchmark product in the domestic industry and has entered the world's advanced ranks. Sunway Biology is currently the only enterprise in China that can export this product in batches.

In this issue, we have the honor to interview Mr. Xiao Guofeng, the general manager of Shuangwei Biology, to decipher the growth gene of this innovative medical device enterprise for 16 years.

Xiao Guofeng, General Manager of Shuangwei Biology

All we can do is catch up"

In 1993, Nanjing Shuangwei Industrial Company signed a cooperation agreement with Nanjing Red Cross Blood Center to jointly develop an erythrocyte white filter blood transfusion device. The following year, the results of the national invention patent, and two years later for clinical trials.

In 1999, the two sides cooperated in the research and development of the white platelet filter, which filled the domestic gap, and the product technology innovation was highly recognized by the international blood transfusion community.

By 2001, Nanjing Shuangwei Biomedical Technology Co., Ltd. was formally established, which opened a new era of research and development and production of new disposable medical consumables for Shuangwei biology.

Despite a certain scale, the eyes of Sunway people have never relaxed to the highest international level.

Xiao Guofeng said--

"At that time, the white blood cell filtration rate of our products had reached 99.3 percent, but once we know that the international companies have reached 99.99 percent. The only thing we can do is to catch up."

Sunway products: whole blood type leukocyte filter

From 2001 to 2006, for five years, every 0.01 per cent improvement was cheered.

However, when they finally reached the technological highland of "99.9%", Shuangwei people did not dare to stop for a moment-to set off again towards the higher goal of "99.99%!

For eight years, Shuangwei people worked hard and worked hard, and finally turned the white blood cell filtration and blood transfusion equipment into a "trump card product" that meets international standards, becoming the only industry pioneer in China that can meet the "4 9" standards, and successfully opened the country. Go to the world.

In the next step, Shuangwei people have not stopped in the journey of "99.999%" international top level.

At the beginning of a small workshop, now has begun to take shape. In addition to all domestic provinces and cities, the company's products are also exported to Europe, South America, Asia and Africa more than 20 countries.

Sunway Biological Plant

The "initial heart" of the enterprise-the focus on innovative disposable medical devices, has never changed.

"In our business, we must be 'professional, focused and attentive. 'There are too many things to make money outside. If you want to do everything, you can't do anything well."

"In the genes of Sunway biology, there is never a lack of the spirit of' innovation"

Due to the pedigree of scientific research institutes, the genes of Sunway Biology never lack the spirit of "innovation. In addition to the main product "white blood cell filtration and blood transfusion equipment", Shuangwei Biology has continuously highlighted the research and development of innovative medical devices.

"Polymer fixed bandage" is the "star product" of Sunway Bio ". It is a glass fiber polymer material, soft, water 5-8 minutes can be cured, the strength is 20 times that of ordinary gypsum, the weight is only 1/5, and good air permeability, not afraid of water. More importantly, its X-ray transmittance is 100 per cent, and patients no longer have to go through the toss of "knocking off and then hitting the plaster again.

Sunway products: polymer fixed bandage

"Wound closed negative pressure drainage suit" is also a beautiful achievement of Sunway biology. Previous negative pressure drainage materials are made of chemical sponges as raw materials, which are easy to dry and harden, and tissue fragments and necrotic tissues of the patient's wound surface will block micropores and drainage channels, thus greatly affecting the therapeutic effect.

Sunway Bio creatively customized natural porous fiber plants as raw materials, and put them into use after special treatment. It has good negative pressure capacity, smoother drainage, and reduced the pain of patients to a greater extent. This technology has also applied for international patents.

Sunway products: wound closed negative pressure drainage suit

Such examples are not numerous.

For Sunway Biology, innovation is by no means a slogan, but a continuous process. In addition to its own R & D investment, Sunway Biology has also fully introduced and relied on external scientific research forces, and has maintained long-term close cooperative relations with many domestic universities and medical institutions such as Nanjing University of Aeronautics and Astronautics, Provincial and Municipal Blood Center, Nanjing Military General Manager, etc., and successfully built production. University-research integrated medical product research and development platform, specializing in the research and development of new high-tech medical devices.

Sunway products: disposable high negative pressure drainage suit

With the help of strong scientific research power, Sunway Biology has successively obtained 29 patents and won the "first new medical device" in many medical device application fields ".

"I am not usually nervous, but this time, I am really nervous."

In March this year, Shuangwei Biology received an audit notice from Brazil's ANVISA (National Health Supervision Bureau) through the Ministry of Foreign Affairs and the Food and Drug Administration.

Brazil is the largest medical device market in South America, and its ANVISA audit is also recognized as the "most stringent audit system", and the one-time pass rate is only 60%. If it fails to pass, the company will suffer a "heavy blow"-it will stop selling for at least two years and will be "publicized" on Brazil's official website ". By then, I'm afraid the entire South American market will be in trouble.

Due to the different laws and regulations in Brazil and China, Xiao Guofeng is not only worried about the different understanding of the laws and regulations, but also afraid of communication problems with ANVISA, which will affect the audit results.

"I am generally not nervous, but this time, I am really nervous."

On the basis of the daily high-standard quality system, the company has carried out more stringent and meticulous self-examination against ANVISA standards one by one, and even the turf has been resurfaced one by one.

From checking records, on-site inspections to interview questions, the expert group strictly reviews design and development, process verification, document control, and after-sales service for research and development, procurement, production, and sales.

In the end, Brazilian experts believe that the quality system of Nanjing Shuangwei Biomedical Technology Co., Ltd. is safe and effective, fully meets the requirements of GMP, and passes the audit at one time.

This is another affirmation of the effective operation of Sunway's biological product quality management system, which has successfully stabilized the Brazilian and South American markets and effectively enhanced the international reputation of Sunway's brand.

At present, the company has a 10,000-level laboratory and a 100,000-level purification workshop established in accordance with the "Medical Device Production Quality Management Regulations", and has established a complete quality management system based on ISO9001 and ISO13485 international standards, and obtained EU CE certification in 2002.

"We are not afraid of employees to be highly paid, as long as they have the ability"

The competition of enterprises is the competition of talents. Adhering to the talent concept of "knowing and making good use of people, making the best use of their talents, growing together and sharing achievements", Shuangwei biology pays attention to personnel training and the maintenance of employees' interests.

The recruitment policy of Sunway Biology is to "reduce talents without sticking to one pattern", encourage enterprises to recommend outstanding talents, select talents from colleges and universities and social elites, and build a systematic talent training mechanism to provide talent guarantee for the sustainable development of enterprises.

Xiao Guofeng said with a smile that "employees are not afraid of high salaries, as long as employees have the ability", constantly improving the performance appraisal and salary and welfare system, improving employee satisfaction, and allowing truly capable employees to take root in Shuangwei.

Corporate culture activities

Talents are recruited, through various forms of internal training, external training for technical improvement and policy and regulation learning, convenient and fast online learning platform, etc., multi-channel targeted training for different positions to help talents adapt and grow, and jointly realize the company and employees Value.

At the same time, the company also builds an internal training team and an internal transfer mechanism for out-of-home training to ensure the optimal allocation of resources.

There are opportunities, platforms, growth and belonging. The stability of Shuangwei biological talent team has given the enterprise the foundation and confidence for real development.

"The growth of the enterprise means market recognition, but also means" responsibility on the shoulder"

Sunway Biological Hall

Integrity, for a pharmaceutical company, often has a more important significance.

"In the final analysis, medical care is an ethical industry, where conscience comes first and product quality comes first. Without this foundation, no matter how big or strong an enterprise is, it won't go far."

It is precisely because of adhering to this belief that Sunway Biology strictly abides by every law, regulation and policy issued by the state, and carries out subtle, specific and strict quality control on the enterprise. "every action must be strictly in place."

Once in the registration process of a new product, clinical verification was required, and the agency that the market could undertake hospital clinical verification said, "Give it to us and package it." Money can be spent, but Xiao Guofeng is not at ease. He honestly did three years of clinical verification in the hospital and grasped all the data and feedback.

In the dictionary of Shuangwei people, there is no "make do". As long as the problem is found, it will be rectified at all costs. The data is unstable and the product will never flow to the market.

The growth of enterprises means market recognition, but also means "responsibility on the shoulder". When natural disasters and social accidents occur, the medical equipment donated by Sunway Biology is always sent to the disaster area as soon as possible.

"These medical devices are our best products and are what the victims can use. We are very willing to do our part when you need them, and it's a little bit of our social responsibility as a business."

Since its establishment, Sunway Biology has been recognized as a high-tech enterprise and has remained so far. Since 2005, the company has been recognized as an "excellent enterprise with integrity" by Jiangsu Food and Drug Administration for five consecutive sessions, and it is also the only enterprise in Nanjing that has been recognized for five consecutive sessions. In 2008, the company was rated as a "contract-abiding and credit-honoring" unit by the Nanjing Municipal People's Government.

A few days ago, Shuangwei Biology has invested 0.198 billion yuan in the western district of Yaogu (industrial zone) to prepare for the construction of a new research and development and production base project of nearly 30,000 square meters.

The project is planned to have a research and development center, a production workshop, an auxiliary utility system and other auxiliary facilities. After completion, it will greatly increase the production capacity of various products, with an annual output of 10 million sets of new safe blood transfusion equipment series, 5 million sets of new first aid equipment, and 3 million sets of orthopedic external care equipment.

After the completion of the renderings

In 2018, each monomer will be completed and put into use. With the help of the new carrier, on the fertile soil of Nanjing Biomedical Valley, Sunway Biology will once again achieve a new take-off in the continuation and growth of corporate DNA.

　　“

More than ten years ago, Shuangwei was first

Accompany Xiao Guofeng to move into the office together

And a small pot of green

And ten years later

This pot of green roses is still luxuriant and verdant--

Just like the first heart that Sunway people have never forgotten.

As in the past ten years

The journey of Sunway Biology is far and far away, and it is hard to forge ahead!

　　”