The discovery of a medical device goes way back to 7000 BC when Neolithic dentists used flint-tipped drills and bowstrings. Many studies and medical literature also indicate the presence and usage of many types of medical devices during the time of ancient Rome.
In the United States, it was regulated in 1938 when Congress passed the Federal Food, Drug, and Cosmetic Act (FD&C) by which FDA has now had an authority to oversee the safety of food, drugs, medical devices, and cosmetics.
Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States.
The US is the largest market in the medical device industry of the world. At $156 billion in 2019, and is expected to reach $208 billion by 2023. The US medical device market represents 40% of the global market. Next, it is followed by Europe (25%), Japan (15%), and the rest of the world (20%).
The industry accounts for approximately 300K jobs and more than 80% of the US medical device companies have fewer than 50 employees. Most of these companies are startups with little or no revenue but with high innovation quotient. Compare to other industries viz. automotive, defense, and telecom, the medical device companies spend on average 7% of their revenue on R&D.
Besides, a drastic change is going on with the entrance of small and mid-size players and other industries as software, now, play a big part in medical devices.
Companies now focus more on manufacturing portable devices which are directly used by an end-user. In addition, companies coming from the lifestyle market like Apple and Fitbit try to gain a big portion of the market, using design and a bucket full of attractive features.
From 2007, the medical device industry in the US recorded a 50% increase in patent filings. There are almost 26 sub-technological areas in the medical device technologies and most of them recorded little to no growth in patent filing activity.
Patent filings in wearable medical devices, diagnosis and imaging devices, surgical devices, however, have climbed. The areas of monitoring/tracking devices and surgical devices saw almost 100% jump in patent filings in the course of the last 10 years thanks to foreign corporations like Philips and Covidien LP.
The wireless medical devices have seen a jump of more than 200% in patent filings since 2007.
Analysis By: Vipin Singh, Marketing