Empowering Innovation With Regulation: Interview with Giovanni Lauricella, “Mister MedTech”

Advancing Quality of Life Through Innovation and Regulation

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. 

The Role of Regulation in Digital Health and BCI

Digital health and brain-computer interface technologies (BCI) being developed by innovative MedTech companies require the oversight of regulatory bodies, but the unknowns of these niche products cause challenges in their exploration and distribution.

Due to the upsurge in novel solutions by MedTech companies, regulatory guidance is needed from the outset to ensure these companies can reach their potential under established 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 BRAIN.Q is one of many companies to have pursued—but this is just the beginning.

A Conversation with Giovanni Lauricella (“Mister MedTech”)

To dive deeper into this topic, we sat down with Giovanni Lauricella, Global Vice President of the Mullings Group and widely known as “Mister MedTech,” to tackle key 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: The New Partners of Innovation

Why Is the FDA Playing a Bigger Role?

"The FDA has become an integral part of the industry in recent years as the MedTech field continues to make notable advancements."

"There have been significant changes within the FDA itself. Professionals originally from the MedTech industry are now joining the agency and can be seen as “agents of innovation.” They’ve experienced both the innovation gap and the regulatory challenges firsthand, and they’re now proactively reaching out to early-stage startups to co-create programs tailored to these emerging technologies."

"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."

Impact on the Regulatory Process

A True Partnership in Development

"We're at a point where the FDA is becoming a true partner of the industry—but safety and efficacy will always remain non-negotiable. The purpose of regulation is to protect patients while enabling progress. That mission isn’t going away.

“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 early, companies can gain clear guidance, valuable insights, and a collaborative process that aligns their development roadmap with compliance from the start."

The FDA’s Acceptance of BCI and Digital Health

Understanding BCI Technologies

"To begin, let’s explain a bit about BCI. Brain-computer interface technologies include both noninvasive and invasive types. Simply put, BCI technologies use brain signals to control external systems."

"The FDA’s current definition of BCI largely aligns with paralysis solutions. BCI can be seen either as a consumer-focused tool—like bioelectronic wellness devices—or as a regulated medical product, depending on how it’s positioned and evaluated."

The “Stephen Hawking Effect”

"When leading BCI companies like Neuralink and Synchron entered the scene, they brought public and regulatory attention to a key gap: millions of people with paralysis and no viable solutions. Their brains remain active, but their quality of life suffers due to physical limitations."

"This shift helped trigger regulatory acceptance of BCI technologies. Once the FDA acknowledged both the medical need and the market opportunity, it became clear that they had to develop specific guidelines to support the safe development of these technologies."

Is Regulation a Limiting Path for MedTech?

The Value of Regulated vs. Non-Regulated Products

"To illustrate, take BCI as an example again."

• "Non-regulated BCI solutions, like consumer-grade OpenBCI headsets, typically pose little risk. They are easier and cheaper to launch but may have limited credibility or staying power."
• "Regulated solutions, on the other hand, offer higher market defensibility and greater long-term value, especially when focused on real clinical outcomes."

“If you add a regulated component, you’re automatically adding value… because there’s already a barrier of entry to competitors.”

Clinical Outcomes Are the Ultimate Differentiator

"If a product isn’t demonstrating clear, clinical outcomes, it may vanish from the market. For example, a next-generation Stephen Hawking-style BCI that enables paralyzed individuals to walk or type an email would need to be regulated because it has true medical application."

"That said, pursuing regulation requires more time, more capital, and a robust body of evidence to support claims. That’s the tradeoff—but also the opportunity for meaningful, long-term impact."

The Impact of the COVID-19 Pandemic on the Digital Health Regulatory Landscape

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 COVID-19, 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 less 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 in digital health, but you don’t have major success stories yet to act as benchmarks for market entry post-COVID."

"This is because regulatory bodies are only now beginning to build the infrastructure and resources needed to appropriately regulate digital health. Ultimately, as market clarifications evolve alongside supportive regulations, we can expect to see a dynamic digital health market in about five years instead of fifteen."

What Is the Biggest Challenge in Bringing Digital Health Solutions to Market?

"The biggest challenge in digital health is defining whether the solution is actually creating clinical outcomes or simply generating large amounts of data—and ultimately, identifying who’s paying for it."

"This isn’t unique to digital health; it’s a classic issue in any wide-open, innovation-rich market. While there’s a big push for digital health, it’s still developing into a mature, structured sector."

If no one is paying for it, is there truly a market?

"The key lies in developing reimbursement strategies, defining the product’s true impact (clinical vs. data-driven), and educating the ecosystem. As we see more acquisitions, regulatory clarity, and viable reimbursement models, the market will stabilize and grow."

What Measures Can Help Ensure a More Effective Digital Health Market?

"Right now, we’re still in the early days. Nearly anyone can create a digital health platform or product, especially because these technologies often pose fewer safety risks and therefore avoid heavy regulation."

"This low barrier to entry means many developers choose not to pursue regulation, which helps them move faster and spend less—but it also raises the question:"

Is the product solving a real medical need, or is it just another consumer gadget?

"Without regulation, many of these products may never survive long-term. Regulations can bring structure, trust, and validation to the industry."

The Way Forward

"To ensure a more effective market, we need:"

• "More acquisitions that validate successful business models"
• "A more educated industry that understands the reimbursement landscape"
• "Clearer definitions of whether a product is just collecting data or producing measurable outcomes"
• "Regulatory clarity to guide innovation responsibly"

"With these in place, digital health will move from early chaos to lasting impact."

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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 BRAIN.Q.