Healthcare

A medical device is: any instrument, apparatus, appliance, software, material or other article that is used alone or in combination, including software specifically for diagnostic or therapeutic purposes, that the manufacturer intends for use in human beings. Such devices are used for: Diagnosis, prevention, monitoring, treatment, or alleviation of disease Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap Investigation, replacement, or modification of the anatomy or of a physiological process Control of conception                                                                                     (EU definition) Design and manufacture of medical devices require highly inter-disciplinary technologies that combine clinical medicine, electro-mechanics, electronics, mechanical engineering, and optical science....

Medical device market is increasingly turning oligopolistic.  Large corporations continue to expand their product portfolios through acquisition of other companies and increasingly dominate the market. Most small companies with potential are acquired in their growth stage. On the supplier side, competition is largely two-tiered: large corporations able to make large investments in R&D, and smaller enterprises with highly advanced but narrow technology.

The article suggests that medical device industry, particularly in telemedicine, is mired in excessive regulations.  Several aspects of regulatory environment in Korea present challenges for local companies.  First, companies are compelled to use cloud services instead of better ones provided by Amazon, Google, etc. Second, the government takes too long in approving innovative devices.  Third, lack of clear guideline in classification of certain devices such as smartphone apps for blood sugar management. You can find the article here.