In 2014, Xia Min, deputy chief physician of the Department of Anesthesiology of Anhui Provincial Hospital, decided to start a business, along with Fa Xiaowuzhou, who also studied medicine.
Sell real estate, register a company, specialize in the innovative transformation of airway products.
At that time, it was the 10th year that Xia Min had entered the Anhui Provincial Hospital. Previously, after 3 years of surgical rotation, he was admitted to the Department of Anesthesiology in 2008. In his spare time, he made targeted improvements to the medical devices he used every day, including nursing devices, airway management tools for anesthesia, etc., and also applied for patents for some of the improved designs.
At that time, China's surgical technology and instruments had basically achieved international standards, but the development of anesthesia technology and anesthesia instruments was relatively lagging behind. In the case of difficult endotracheal intubation, for example, doctors even need to perform on their knees.
"Poor tools" is one of the reasons why Xia Min has innovated in medicine, but the main reason is the "mission" of the doctors.
"Medical devices, if not doctors to do innovation, then who will do innovation?" 」 Xia Min said in an interview with the health community.
In Xia Min's view, only doctors know best what doctors need, what patients need, and what are the clinical pain points, "You let others change (instruments), he doesn't know how to change them."
This is Xia Min's original intention of innovation and entrepreneurship, but entrepreneurship is far from being as simple as imagined. Even if you already have multiple patents, it is not easy to convert patents into products (samples) and then convert products into commodities. Xia Min admitted that too many "pits" fell along the way.
Xia Min, deputy chief physician of the Department of Anesthesiology of Anhui Provincial Hospital
The past self, the future self to the pit
The first pit is the "patent pit". The time is pulled to 2016, when Xia Min has been in business for 2 years, but the company still does not have any products.
The reason for this lies in patent rights.
As early as 2012, Xia Min applied for a patent called "Weak Stimulation Bionic Oropharyngeal Ventilation". Combined with oropharyngeal anatomical features, the patent is a redesign of a traditional product to reduce damage and irritation to patients during intubation.
Xia Min believes that this device is very worthy of clinical promotion and use, so as soon as the drawings are drawn, they applied for a patent early, completely without considering whether the irregular core involved in the product can be mass-produced.
As it turned out, it really couldn't. Although it is true that complex cavity morphology can be printed when making sample models and the application of 3D printing technology, it is more economical and feasible to produce traditional molds on a large scale.
However, the mold process does not achieve the irregular design in Xia Min's drawings.
You can only change drawings. Through repeated discussion and modification with the master of the mold factory, the final version can realize the production of the design drawing, but this version is far from the version that Xia Min originally applied for a patent, and the original patent right cannot protect the current product design.
Xia Min had to reapply for a new patent, but encountered new problems. According to Article 22 of the Patent Law, "inventions and utility models for which patent rights are granted shall be novel, inventive and practical". The so-called novelty means that the invention or utility model is not part of the prior art, nor has any unit or individual applied to the Patent Administration Department under the State Council for the same invention or utility model before and obtained disclosure.
Xia Min's situation is precisely the "loss of novelty", because he himself has applied for a patent before, and the technology is a public technology and can no longer be patented.
"It's equivalent to the patent in front of you, and you block the patent in the back." Xia Min said.
What to do? It is certainly not possible not to apply for a patent. Through repeated communication with the patent examiner of the Patent Office of the State Intellectual Property Office, he finally got the "new" patent rights, but the precious 5 years have passed.
Where to be soft? Where should it be hard? Only doctors know
The second pit is the "prototype pit". Xia Min does not have any engineering background, which is related to China's medical education system.
As we all know, if Chinese high school students are admitted to medical school, they need to go through "5+3+X" (that is, 5 years of undergraduate education in clinical medicine + 3 years of standardized training for resident physicians + 2 to 4 years of standardized training for specialists) before they can become a doctor. In this at least 8-year medical study, it does not involve other disciplines such as engineering and materials science.
The knowledge structure was "single", which made Xia Min suffer a big loss.
"The first product made a total of 6 sets of molds, and the first 5 sets could not be used." Xia Min said that the mold master is designed according to the product structure, and the reason why the mold made by the master cannot meet the requirements of combining with the human body is because the master does not know which places need to be soft, which places need to be harder, and which places cannot have burrs - these are all clinicians will understand.
How to cross this "combination of medical and industrial" has become another problem facing Xia Min. At the time, he didn't know that there was another profession called "mechanical engineer" that could solve such problems. He had to learn the mold knowledge on his own, and then communicate with the master, how to open the mold, how to divide the mold, how to put the front mold, how to put the back mold...
"If you don't have this [engineering] knowledge base yourself, if you don't have any knowledge, it's actually very difficult to make a medical product." Xia Min frankly said that this is one of the difficulties for doctors to transform the results of medical innovation.
It is in the repeated communication, modification, and remake of molds, not only time is lost, but money is also, and these sets of small molds alone cost Xia Min hundreds of thousands of yuan.
Those who didn't think of it at first
Key things to regret afterwards
After going through the "patent pit" and "prototype pit", finally in 2017, the airway products developed by Xia Min are expected to be put on the market for production.
This involves a very practical question: what kind of medical device products should be declared?
According to the "Regulations on the Supervision and Administration of Medical Devices", according to the degree of risk, the state implements classified management of medical devices: the first class of medical devices has a low degree of risk and implements product filing management, and the second class (medium risk) and the third class (higher risk) medical devices implement product registration management.
"At that time, our product could make both first-class declarations and second-class declarations in accordance with the regulations, and in order to shorten the product listing cycle, we declared a class of medical devices." Xia Min said.
As it turned out, this was another decision that Xia Min regretted.
It is true that the product was quickly put into production, but the fee was a big problem.
At this stage, there are two main ways for Chinese medical institutions to manage the price of medical devices:
First, planted (placed) medical devices and a small number of special materials are allowed to charge patients separately outside the medical service project;
The second is low-value health materials, as part of the cost of medical services, included in the package of medical service projects, not separately priced.
Obviously, the products declared by Xia Min as a class of medical devices should be managed in the second way.
Patients cannot be charged without being charged separately. For hospitals, it can only be counted as department cost procurement, which makes it difficult for products to open up the market.
Xia Min reflected that if you do some market research and evaluation as early as the beginning of product design, then you can avoid this tricky situation - for example, the product can be called "oropharyngeal ventilation", or "tracheal intubation fixator", which name is better, more conducive to the later market sales, need to do a good job of evaluation in the early stage.
For medical innovation and entrepreneurship, it is not enough to achieve the combination of medical and industrial work, but also to combine "business". "Not only to consider product design, but also to consider the business model, profit model, and even health insurance payment method." Xia Min was well aware of this.
Doctors run the risk of ruining their businesses
Compared with Xia Min, Ouyang Chenxi, deputy chief physician of the Vascular Center of Fuwai Hospital of the Chinese Academy of Medical Sciences, started his business earlier.
As early as 2009, when Ouyang Chenxi was still working in Wuhan Union Hospital, he set up a biotechnology company. In 2014, the company's research and development of products "small caliber artificial blood vessels" to achieve mass production, followed by in 2015 by the investment institution "blessing", got 20 million yuan A round of financing.
In the same year, Ouyang Chenxi was transferred to Fuwai Hospital, and in addition to his duties as a physician, he also served as the deputy director of the Achievement Transformation Center of Fuwai Hospital, responsible for the transformation of the hospital's achievements.
In the eyes of the outside world, Ouyang Chenxi's entrepreneurial experience is smooth, but in an interview with the health industry, he said that "doctors have the risk of ruining their businesses".
Ouyang Chenxi, deputy director of the Achievement Transformation Center and deputy chief physician of the Vascular Center of Fuwai Hospital of the Chinese Academy of Medical Sciences
"If scientific research fails, the state will not force you to return the money (scientific research fund), and no one will force you to sell the house to pay back the money, but as a business, it is likely that the money invested in it will be completely "adrift"." Ouyang Chenxi said.
In his view, the biggest risk that entrepreneurship needs to face is "bank loan breaks".
Although in recent years, in order to alleviate the financing difficulties and expensive problems of private enterprises, the state has introduced a series of policies, especially in 2018, the Banking and Insurance Regulatory Commission proposed to initially consider the loans to private enterprises to achieve the goal of "one-two-five" (that is, in the new corporate loans, large banks to private enterprises loans are not less than 1/3, small and medium-sized banks are not less than 2/3, and strive for 3 years later, the proportion of banking loans to private enterprises to new corporate loans is not less than 50%).
However, in reality, there is still a phenomenon that some banks "stop lending, suppress lending, draw loans, and cut off loans" to small and medium-sized enterprises and private enterprises.
"You pay back the money first, you can lend it again soon" is a common phrase used by bank loan officers. After listening to this sentence, some entrepreneurs will choose to borrow bridge funds from financial institutions such as small loan companies, pawn shops, financial leasing, private equity funds, etc., to pay off the old with the new, and the annualized interest rate of such loans is usually extremely high, and some even reach more than 30%.
"If the bank doesn't renew your loan, how will you repay the money you owe to the loan shark?" Ouyang Chenxi stressed that doctors must avoid falling into this financing trap when starting a business, which is "very dangerous".
Great rebellion? How can doctors in the system get into business?
Although he is often referred to as the "old" person in the doctor's entrepreneurial circle, in fact, Ouyang Chenxi did not think of starting a business at the beginning.
As a closed disciple of Academician Qiu Fazu, a chinese surgical giant, for a long time in the early stage, Ouyang Chenxi's focus was on "scientific research".
In 2003, after Ouyang Chenxi returned from studying in Germany and worked in the Department of Vascular Surgery of Wuhan Union Medical College Hospital, he chose "artificial blood vessels" as his scientific research direction.
Artificial blood vessels can be used for the treatment of a variety of vascular diseases, when the blood vessels in a certain part of the human body appear aging, embolism or damage, etc., can not normal blood supply, it can be removed and replaced with artificial blood vessels. As early as the 1950s, artificial blood vessels have been successfully developed and clinically applied, and by the beginning of the 21st century, artificial blood vessels with a diameter greater than 6 mm have been popularized, but the development of small-caliber blood vessels smaller than 6 mm is still an international problem.
In 2008, the small-caliber artificial blood vessel developed by Ouyang Chenxi's team won the "Second Prize of National Technological Invention". When he was recognized at the national level, he slowly felt that scientific research had achieved "head", but at the same time he also found that even if scientific research achieved "head", the industrialization results were still zero, because the invention and creation of the laboratory could not be directly applied to people.
"Only by translating [patents] into products can we truly benefit patients." Ouyang Chenxi decided to start a business.
At that time, national and local governments had taken the introduction of overseas scientific and technological talents as an important measure to seek development and promote innovation-driven, and support policies were introduced one after another. For example, in 2009, Guangdong Province funded up to $100 million to introduce innovative research teams.
Wuhan has also introduced relevant support policies. The first venture capital Ouyang Chenxi received came from the "3551 Optics Valley Talent Program".
However, contrary to the government's supportive attitude, universities and hospitals at that time did not recognize doctors' entrepreneurship.
"They think you're a big rebel." Ouyang Chenxi said.
"How can a doctor in the system be in business?" This was the prevailing mindset at the time. In the view of the leaders of scientific research institutes, the road of industrialization completely deviates from the path of scholars and the path of doctors.
However, what makes Ouyang Chenxi feel fortunate is that due to the government's funding, although the hospital did not express support for its entrepreneurship, it did not strongly oppose it.
Sources | the health community
Written by | Shen Mengxia