Coronavirus has obviously had far reaching impacts on healthcare, including medical device innovation. The implementation of telemedicine and remote diagnostic tools have both been accelerated and are growing exponentially. There’s also been an increase in investment, and investment requirements, in devices which protect against aerosolized pathogens. However, many of the upcoming areas of opportunity in medical device innovation are independent of COVID-19.
One of the big advances in medical devices are hybrid devices. Hybrid devices count as medical devices under both CE and US marks, even though they are typically some form of drug delivery. A good example of this is a stent called a drug-eluting stent. This is a device that is placed in the body and then slowly releases the relevant drug into the patients system.
Machine learning, big data, AI, etc. is getting very close to the point of having digital models of organs and even full human subsystems. It's not quite there yet, but it’s very, very close.
The FDA and the European CE mark agencies are moving in the direction of requiring a digital model of the medical devices so that they can be put into human simulations. Initially, this adds some costs and changes to business processes. But the flipside is that, as these models become better, the ability to innovate using AI, software, or CAD techniques really accelerates. So there's a huge opportunity here for companies that are moving in this direction.
The robotisation of medicine is primarily in the area of telemedicine, remote robotic surgery and such. There is some other work ongoing in robotics and robotic medicine but I think that's still nascent as the European population has not aged enough yet. Much of the effort in robotic medicine is in the area of patient assist. That does include artificial limbs – that is a stably evolving field. The area where Japan in particular leads the EU is in robotic companions that are “intelligent enough” to provide automated warning to authorities as well as providing “companionship” to the single elderly who have more limited mobility.
Finally, there are huge opportunities in rapid DNA/RNA testing, diagnosis and personalised medicine. The best example of this is PCR testing that is being done for COVID. Computers can do this testing, making it so prevalent that you can literally walk into a pharmacy which will have one of those devices on site and you can get tested right away. There are regulatory hurdles that these devices need to overcome. With COVID in particular the accuracy and efficacy questions have to be quickly proven. There is an opportunity here though that is perversely created by the well publicised Theranos failure. Startups in this area are likely to be undervalued until they actually ship a product. At which point their valuation is likely to jump to normal market levels.
There’s also DNA and RNA based synthesis. Craig Venter, who ran the project that first sequenced the human genome, has essentially invented a DNA printer. You can basically type in a string and it will synthesise either the DNA or the RNA that you want. You can then take an existing cell, take the nucleus out of that cell, insert the synthesised DNA, and the cell continues to live. This is really bleeding edge stuff. It’s one of those areas where, once the idea has been shown to work, and after the commercialisation of it, the acceleration of it is very rapid.
It’s still early days in this area, which means it probably requires 10-15 years for development. While this doesn’t tie to liquidity timelines it might be of interest to investors, and also something to start getting expertise in because it’s coming down the track.
There are some really exciting developments but some can also be a little scary.
For example, the epithelial stem cells, which are the stem cells of your skin, have been shown to be at least pluripotent. Pluripotent means that you can theoretically grow any organ in the body from them. In mice these same stem cells have been shown to be totipotent. Totipotent means that you can take a stem cell, hit it with some hormones, and put it inside a womb, and it gestates into a full mouse. Theoretically you could combine this with the 3D printing of DNA and then the idea of an “Ubermensch” is not that far away from being reality.
International as well as EU and US domestic laws prohibit testing of human totipotency. So there are not only ethical but legal barriers to this. It is, though, important to understand where this might/could lead. Particularly in parts of the world where the rule of law is not followed as scrupulously.