{"id":5664523,"date":"2018-08-10T12:00:26","date_gmt":"2018-08-10T04:00:26","guid":{"rendered":"https:\/\/beluntech.com\/?p=5664523"},"modified":"2025-10-22T14:55:42","modified_gmt":"2025-10-22T06:55:42","slug":"belun-brings-ai-to-wearable-healthcare-devices","status":"publish","type":"post","link":"https:\/\/beluntech.com\/zh\/posts\/2018\/08\/belun-brings-ai-to-wearable-healthcare-devices\/","title":{"rendered":"Belun brings AI to wearable healthcare devices"},"content":{"rendered":"

10 August 2018
\nEJ Insight
\nFull link<\/a><\/p>\n

Belun brings AI to wearable healthcare devices<\/h3>\n

\"Belun<\/p>\n

<\/div>\n

Belun CEO Lydia Leung said the company has received practical support from the HKSTP in the development and marketing of Belun Ring. Photo: Belun, HKEJ<\/p>\n

Wearable devices such as fitness trackers and\u00a0smartwatches\u00a0are gaining popularity in the global market. Hong Kong\u00a0startup\u00a0Belun Technology has developed the Belun Ring, a medical-grade wearable device that is certified by the US Food and Drug Administration. Leveraging on artificial intelligence (AI) technology, the device enables users to analyze sleep quality as well as the risk of potentially serious disorders such as obstructive sleep apnea.<\/p>\n

Belun chief executive Lydia Leung recently sat down with the Hong Kong Economic Journal to share her entrepreneurial experiences and her company\u2019s innovative ideas.<\/p>\n

HKEJ:<\/strong>\u00a0As a biotech firm and an\u00a0incubatee\u00a0under the Hong Kong Science and Technology Park\u2019s (HKSTP) Incu-Tech Programme, can you explain Belun\u2019s business development?<\/p>\n

Leung:<\/strong>\u00a0Founded in 2016, Belun Technology is headquartered at the Hong Kong Science Park. We now have 16 employees and nine of them are research and development (R&D) staff. We are committed to developing medical-grade wearable devices for healthcare professionals in order to assist hospitals in making health risk assessments by collecting data from patients.<\/p>\n

Since the establishment of the company, our products have successfully passed R&D and clinical\u00a0tests,\u00a0and obtained the USFDA certification in\u00a0May\u00a0this year. We have established the foundation of the company, and for the next step, we are planning to recruit marketing and customer service professionals.<\/p>\n

Q:<\/strong>\u00a0Is it difficult to apply for USFDA certification? How can it help in the firm\u2019s development?<\/p>\n

A:<\/strong>\u00a0The FDA has strict regulatory measures and procedures. Applicants must first pass the ISO 13485, the medical device quality management system certification and submit detailed documents and supplementary materials.<\/p>\n

Companies need to get fully prepared before submitting the application to the FDA. First of all, researchers must thoroughly understand FDA\u2019s regulatory standards so that the products they design can meet the standards and get the ISO 13485 certification. Finally, when they submit the product plan to the authorities, they need good communication and collaboration during the process.<\/p>\n

With our product, medical personnel can make use of the data collected by the devices, such as heart rate and blood oxygen parameters, to evaluate and diagnose the patient\u2019s condition. We introduced the product to the market last year. However, at that time, they were not yet certified by the FDA and that affected the market adoption of the product.<\/p>\n

Q:<\/strong>\u00a0Have you considered entering the mainland market and applying for certification from the China Food and Drug Administration (CFDA)? What is the difference between the two application procedures?<\/p>\n

A:<\/strong>\u00a0The threshold for application of CFDA certificates for the China market is relatively higher. Applicants must set up a domestic company with their own production lines. The documents required by the CFDA are roughly the same as those asked by the FDA. However, for startups, having a self-owned production brings a high challenge on cost control. So at Belun, we plan to get the FDA certification first, and then we would think about applying for CFDA certification to enter the China market after we have obtained a domestic partner.<\/p>\n

Q:<\/strong>\u00a0How does Belun Technology attract investors\u2019 financial backing?<\/p>\n

A:<\/strong>\u00a0In the early stage of the development of biotech firms, there were only some basic product prototypes. If the company cannot obtain any certification for its products, and there is no previous reference to their technical achievements, it is difficult for investors to assess the risk of investing in it.<\/p>\n

Simply put, biotech investors must focus on measuring the corporate risk, business model, and the company\u2019s valuation before they make the investment decision. Take the development of botulinum toxin (BOTOX) as an example. It is originally a medical product for the treatment of nerves. But later, it was able to attract investors to invest at a high premium as it was transformed and applied in the beauty field, creating a new business model and market value.<\/p>\n

We did face challenges in financing. When we don\u2019t have any certification for our product, investors will question when they will pass the FDA certification. Last year, we finally got the investors\u2019 support in our seed round, and the raised capital has supported our operation and development.<\/p>\n

For now, as the product has obtained the ISO 13485 and the FDA certification successfully, these qualifications help close our series A funding round.<\/p>\n

Q:<\/strong>\u00a0As an incubatee in HKSTP\u2019s Incu-Tech Programme, what kind of support do they provide?<\/p>\n

A:<\/strong>\u00a0HKSTP does provide a lot of practical support to us, such as offering a relatively low rent for our office and a laboratory for product testing, which solves the space problem for us, so that we can have a better control of our operating costs.<\/p>\n

In addition, HKSTP has expanded our media exposure, and introduced investors to us, laying the foundation for the company to expand overseas. They also offer us a chance to attend\u00a0at\u00a0the global stage of startups\u00a0of\u00a0consumer technologies, the International Consumer Electronics Show (CES) in the US.<\/p>\n

In addition, HKSTP contacts local government agencies and the social welfare sector, allowing us to promote our technology projects targeting the elderly population, which will be a great opportunity for us to reach potential buyers.<\/p>\n

This article appeared in the Hong Kong Economic Journal on Aug 10<\/em><\/p>\n

Translation by Ben Ng<\/em><\/p>","protected":false},"excerpt":{"rendered":"

10 August 2018 EJ Insight Full link Belun brings AI to wearable healthcare devices Belun CEO Lydia Leung said the company has received practical support from the HKSTP in the development and marketing of Belun Ring. Photo: Belun, HKEJ Wearable devices such as fitness trackers and\u00a0smartwatches\u00a0are gaining popularity in the global market. Hong Kong\u00a0startup\u00a0Belun Technology […]<\/p>","protected":false},"author":2,"featured_media":5666275,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"footnotes":""},"categories":[79],"tags":[55],"class_list":["post-5664523","post","type-post","status-publish","format-gallery","has-post-thumbnail","hentry","category-featured-in-media","tag-belun-ring","post_format-post-format-gallery"],"_links":{"self":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5664523","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/comments?post=5664523"}],"version-history":[{"count":4,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5664523\/revisions"}],"predecessor-version":[{"id":5666292,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5664523\/revisions\/5666292"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/media\/5666275"}],"wp:attachment":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/media?parent=5664523"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/categories?post=5664523"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/tags?post=5664523"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}