1. The status of the Chinese human factor industry
With the Chinese human factors engineering industry in its infancy, there are many medical device companies in China that do not fully understand human factors and its application. When Auxergo entered the Chinese market in 2017 we received good feedback, but most medical device companies had little knowledge of the area until we spoke with them. There are a few Chinese medical and pharmaceutical companies taking the lead who are willing to cooperate with human factors specialists to improve their products. However, most companies are still running with “a wait-and-see” approach, and some prefer to build their own teams with no relevant knowledge and experience to run human factors studies in a short period of time, which is not an advisable. It is hoped that the non-standardization and a recognition of the need for professionalism will gradually improve with the promulgation of new Chinese human factors regulations. The new regulations, and an increasing awareness in this field, should help persuade companies of the importance of human factors services. On the other hand, because of the booming international medical device market, Chinese companies will need to be in line with international human factors regulations and standards to take to full advantage. This gives international human factors companies an opportunity to enter the market and provide their services to Chinese medical device companies. To succeed, Chinese companies must be willing to pay and work with third party human factors specialists on their devices.
2. Industry threshold-professional technical requirements
With human factors being in the early stages in China, there are very few specialists in the field. Those who do work on human factors did not specialise in that area and rather came to it from being educated and employed in areas such as regulations, engineering, design, user experience, or interaction design. There are very few who have obtained a human factors degree or have much direct experience, and training has usually come in the form of reading books, reading the relevant regulations, or taking a training course. Even the national third-party approval agencies and the Chinese National Medical Products Administration (NMPA) do not yet have human factors specialists. To help with this, as a human factors specialist, we supported the NMPA in completing and developing Chinese human factors regulations for medical devices last year. There is also a shortage of human factors specialists in foreign companies in China, where most of the Chinese human factors work is led and executed by the European and American headquarter teams, and the local Chinese teams only play a supporting role. This working model leads to gaps in areas such as language, culture, and teamwork.
As we can see, the current technical standards for Chinese human factors engineers are low and confusing, with even the national third-party approval agencies and NMPA not being clear on how to effectively implement human factors engineering in the Chinese market. Therefore, China does not have an established foothold in this field, resulting in a great opportunity for international human factors companies to enter and take the lead. However, it is foreseeable that the status quo will gradually improve as the industry continues to mature.
3. Future development of this industry
Human factors engineering and usability are vital to the development of the medical device industry, whether it is in the Chinese market or globally. The recent change in China is clearly driven by the need to improve standards, and the internationalisation of market regulations. Auxergo is excited to help international human factors companies enter the Chinese market and work with them to take advantage of this promising opportunity.