By: BrainQ team
Quality of life is a value at the forefront of innovation. The growth of cutting edge technology is allowing for breakthroughs in the rehabilitation and recovery of those who would otherwise face a much more challenging path following disease. But, in order to successfully implement the medical products revolutionizing treatments, the industry cannot work alone.
Digital health and brain-computer interface technologies (BCI) being developed by innovative MedTech companies require the oversight of regulatory bodies, but the unknowns of the niche products cause challenges in its exploration and distribution. Due to the upsurge in novel solutions of MedTech companies, regulatory guidance is needed from the get-go to partner with these companies to ensure that they can reach their potential in the market under regulatory guidelines. The FDA has taken strides in recent years to partner with MedTech companies by implementing new programs such as the Breakthrough Device Program, a track that BrainQ is one of many companies to have pursued, but this is just the beginning.
To dive deeper into this topic, we sat down with the talented Giovanni Lauricella, otherwise known as “Mister MedTech”, and Global Vice President of the Mullings Group, to tackle our burning questions about the evolving MedTech industry. Giovanni shares his unique perspective on what we and other MedTech innovators can expect to see in this developing landscape.
The FDA has become an integral part of the industry in recent years as the MedTech industry continues to make notable advancements. What is the reason behind this shift?
There have been significant changes in the FDA. Professionals who are originally from the MedTech industry are joining the FDA, and can be called the “agents of innovation”. They have experienced the technology and innovation gap, alongside regulation, and they’re proactively reaching out to early-stage startups to create programs specifically tailored to those unique technologies being developed.
It’s a pivotal time right now between innovation and the FDA. For a long time the FDA was considered by many to be more red tape. There was a disconnect that stemmed from not having industry insight or feeling the frustration that comes from regulatory roadblock within innovation. For the first time they’re offering to partner early on with innovators and opening pathways of communication to follow new companies in their journey and to create guidelines for novel technologies together.
Do you think that this shift will impact the regulatory process for MedTech companies?
We're at a point right now where the FDA is becoming a true partner of the industry, but we’re never going to remove barriers such as safety and efficacy, nor should we. The one baseline that won’t change is the purpose of regulation. The purpose of how we develop medical innovation will not be compromised to solve healthcare and medical solutions. It’s all based on evidence-based safety and efficacy. As long as the industry is continuing to innovate and create solutions that will not harm people along the way, there will be a continuous partnership between regulatory bodies and industry.
By working with the FDA and taking advantage of the regulatory body, partnership early on can enable you to have very clear guidance, teamwork, and insights to be able to develop your technology according to their regulations. We’ve seen this with significant innovation in the areas of BCI and digital health solutions.
How did the regulatory bodies come to accept BCI and digital health technologies?
To begin, let’s explain a bit about BCI. Brain computer interface technologies include noninvasive and invasive definitions. Simply, BCI technologies utilize the brain to control an external source. The FDA’s definition of BCI is synonymous with paralysis solutions. BCI can be used as either a marketing tool like bioelectronic medicine has been, or you can look at it as a very clear definition by using the FDA guidelines.
When BCI companies such as industry leaders Neuralink and Synchron started to become big, it created the “Stephen Hawking” effect. You have people who are paralyzed or have their quality of life significantly lessened due to physical impairment, yet their brains continue to function and they continue to seek solutions for recovery.
So how do you have a massive paralysis market and not have innovation that’s going to allow people access to the technologies that could offer improved quality of life?
Once it was acknowledged that there is a need and a market to create that innovation, BCI and digital health technologies became more accepted by the FDA. Knowing that the FDA did not have the resources to regulate that innovation properly at the time, the need for the FDA to create such documents and guidelines became imminent.
Is it limiting for the MedTech industry to take the route of regulation?
To illustrate, take a look at BCI as an example. The innovation that’s non-regulated, like the noninvasive consumer style brain-computer interface solutions, such as OpenBCI, don’t really have safety concerns. These are consumer products with a low barrier of entry without a lot of competition. However, if you add a regulated component you’re automatically adding value to that technology because there’s already a barrier of entry to competitors.
If products are not creating clinical outcomes, it’s likely the market will either disappear or it’ll be very short lived. A product that’s a game changer for the paralysis market, for example a next generation Stephen Hawking BCI that will allow paralyzed patients to regain the ability to walk or to write an email with their brains, would have medical application and have no choice but to go through a regulatory body.
A non-regulated product just has a low barrier of entry and a lot more competition to be able to prove what it’s doing. To have something regulated takes more time and money, and the barrier becomes creating the body of evidence to demonstrate what the product will be doing, whether it drives clinical outcomes, etc. Ultimately, if there’s regulation it takes more time and money.
How did the Covid-19 pandemic accelerate the regulatory path for digital health solutions?
Digital health has been around for years, but despite innovation in the field being expedited due to Corona, it’s still the wild west in terms of regulation. The timeline to solve problems became shortened and more efficient markets had to be created in a less amount of time.
When we say digital health we’re talking about wearables, machine learning, AI, every facet you can imagine right now. So you have this massive flock of innovation on the topic of digital health but you don’t have major success stories yet to act as benchmarks for market entry post-Corona. This is because regulatory bodies only now have the ability to put together resources for appropriate regulation of digital health. Ultimately at this stage, as market clarifications occur alongside regulations to support innovation, we can expect to see a dynamic digital health market in about five years instead of 15 years from now.
What is the biggest challenge in bringing digital health solutions to market now?
The biggest challenge in digital health is defining whether the solution is creating clinical outcomes or just creating a whole bunch of data, and ultimately defining who’s paying for it. That’s a big topic of conversation in digital health in general. Just because we can create it and regulate it doesn’t mean we know who will pay for it.
I don’t think this is unique to digital health either, but rather a stereotypical situation that happens in any wide open market that’s ripe for innovation. Digital health has been around for years and even though there’s a big push for digital health, it’s still the wild west.
If no one is paying for it then is there a market for it?
I think that as we have more acquisitions, a more educated industry, more solutions on reimbursement, and definitions as to whether a solution is focused on data collection or whether it’s really solving clinical outcomes then we’ll have a more efficient digital health market.
What measures can help ensure a more effective digital health market down the road following the surge of innovative solutions?
Right now we’re still in the early days and everyone can create a digital health platform or product. This is due to the fact that there is a safety component to these products which has a low barrier to entry. There is a lot of digital health that isn’t regulated. There’s an idea that if you can create tech that isn’t regulated it will allow you to get to the market quicker and that it will be less expensive.
So why not try to avoid being regulated if you don’t have to? But then, is it really solving a clinical outcome or is it more of a consumer product? It’s a different world.
Regulations will make the market more efficient. There’s a lot of innovation that’s being developed right now that will die off because there’s not an appropriate market. The biggest challenge in digital health is curating a defined market. But I think once we have more acquisitions, a more educated industry, solutions for reimbursement, and better definitions in regards to data vs solving clinical outcomes, we’ll have a more efficient digital health market.
The views and opinions expressed in the interview portion of this article belong solely to Giovanni Lauricella and do not necessarily represent the views of BrainQ.