1Mby1M Virtual Accelerator Investor Forum: With Rajeev Singh-Morales, Founder and Managing Partner at Alma Mundi Ventures (Part 4)

Sramana Mitra: When it comes to some of the patient monitoring stuff, which is a very active category, all applications of information technology, especially the AI algorithm in drug discovery, how do you view the role of FDA or an equivalent regulatory body?

Rajeev Singh-Morales: I’ll be very candid. I’m not an expert on FDA or the equivalent in Europe. We are working with a company that has developed a technology for the diagnosis of sleep apnea. In today’s world if you’re told by your primary care physician that you might have sleep apnea, you have to go to a clinic.

They developed a technology where you put a quarter-sized plastic device on your neck. While you sleep, it reads the breathing signals and downloads it on your phone. In the morning, you have your diagnosis. It’s much more accurate than existing technologies. It’s a wearable.

Sramana Mitra: Does that require regulatory approval?

Rajeev Singh-Morales: Yes. We are going through the approval process here. It has been approved in Europe. It’s a non-invasive device so the burden of proof is lower. FDA and the regulating body in Europe are looking for innovative solutions. It’s very clear that they have more and more experience and you can directly see the correlation. As we see more and more technologies, the regulators will become more agile.

Sramana Mitra: In this company that you have invested in, it sounds like they’ve already got regulatory approval in Europe. They’re still waiting for approval in the US. As an investor, how do you view regulatory risk? Did this company come to you with the Europe regulatory approval?

Rajeev Singh-Morales: What we saw in this company was a very novel technology that was underpinned by an incredibly qualified academic. It does what is says on the box. The question then would be just going through the process. There are other technologies where it has a hypothesis. You have to prove that it does that.

In our case, we were pretty sure that the technology worked. All we needed to do was demonstrate it in a medical trial in the UK. The results turned out to be as we thought. That doesn’t mean that we’ll invest in any technology that requires FDA because it’s a long process. You do need some very specialized skills. Unless we believe that it’s a no-brainer that the underlying technology works, we’re generally not going to invest.

Sramana Mitra: You’re going to need to find investors who are comfortable taking on the regulatory risk. It is a reality. In those kinds of products, that is a reality. It does require a certain kind of investor. In every case, I talk about investor-entrepreneur fit. As an entrepreneur, your entrepreneurship thesis and the investor’s investment thesis have to match up.

Thank you for your time.

This segment is part 4 in the series : 1Mby1M Virtual Accelerator Investor Forum: With Rajeev Singh-Morales, Founder and Managing Partner at Alma Mundi Ventures
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