In this Speaker Spotlight, Guillaume Blivet, Co-Founder & Chief Innovation Officer at REGEnLIFE, will give a preview of his upcoming session at the European Medical Device Summit titled "Innovation Spotlight: Driving Breakthroughs in Medical Device Development."
My journey into the medical device world wasn’t just a career choice; it was a mission to challenge conventional thinking and redefine how we approach brain health.
My background spans nearly two decades across public health, medical technology, and executive leadership, graduated with an Executive MBA and a Master’s in Public Health. But beyond business, I immersed myself in scientific research, working with physicists, engineers, neuroscientists, neurologists, etc. I was lucky enough to be mentored by a renowned neurologist, Prof. Jacques Touchon. This scientific journey has led to international recognition, allowing me to contribute to leading conferences and scientific journals in neuroscience, Alzheimer’s research, and biophotonics.
As the co-founder and Chief Innovation Officer at REGEnLIFE, I’ve spearheaded the development of the first medical device to target the brain and gut for neurological diseases treatment. Utilizing photonic emission for non-invasive brain-gut stimulation, this breakthrough challenges conventional treatment paradigms and opens new avenues in neurostimulation, photobiomodulation, and therapeutics development involving the brain-gut-microbiota axis. From conceptualizing the technology to leading clinical trials and navigating the rigorous MDR regulatory landscape, I’ve been at the forefront of turning this vision into reality. Today, I’m proud to say, with our team and stakeholders, we’re closer than ever to bringing this innovation to market, offering hope to millions of patients and their families.
At REGEnLIFE, we don’t just develop medical devices—we challenge the status quo of brain health. My role is to bridge the gap between visionary ideas and real-world impact, ensuring that innovation translates into tangible improvements in patient lives.
In the field of neurotechnologies, balancing innovation, facilitating access, especially when patient risk is limited, with regulatory and compliance requirements in the medical device industry is not just a challenge… it’s a necessity! Patients urgently need innovation not only for their own brain health but also to build a smarter, stronger, and more resilient society. When we talk about brain health, we’re not just addressing a medical issue; we’re shaping the future of human potential.
This year at Davos, during the World Economic Forum, I joined critical discussions at the Mental Health Day at the Social Innovation House and at the Davos Alzheimer’s Collaborative at the Brain House. It was a turning point—brain health emerged as a top global priority. Beyond healthcare, we must consider the brain economy: a world where citizens maintain long-lasting, high-functioning cognitive abilities means a workforce that thrives, contributes, and continues to innovate. A healthier brain is not just a personal advantage; it’s an economic and societal imperative.
To achieve this, we must unlock innovation and rethink how we integrate and evaluate new medical technologies. Safe, well-tolerated, and promising solutions – especially those like non-invasive brain stimulation – should not face unnecessary barriers to adoption. Instead, we need pragmatic and feasible pathways that allow groundbreaking innovations to transform healthcare efficiently. This means fostering new clinical practices, reimagining how we assess emerging technologies, and accelerating patient access to efficient solutions.
As technology advances, the line between medical and non-medical devices is fading, especially with the rise of data-collecting technologies, including mobile apps, AI powered solutions, and wearables. This presents new ethical challenges, especially for neurotech, around privacy, security, and responsible use. The key question is: How do we ensure safe, ethical, and equitable access to innovation while maintaining regulatory rigor?
Globally, there is a need to rethink how we evaluate, adopt, and integrate innovative medical devices. Regulatory pathways should be adaptive, ensuring that safe, promising innovations reach patients without unnecessary delays. At the same time, ethical frameworks must protect patient rights, data integrity, and equitable access.
Innovation and regulation should not be at odds. When done right, they work together to ensure that the best, safest, and most effective breakthroughs reach the people who need them most, helping individuals, economies, and societies thrive.
"Beyond healthcare, we must consider the brain economy: a world where citizens maintain long-lasting, high-functioning cognitive abilities means a workforce that thrives, contributes, and continues to innovate. A healthier brain is not just a personal advantage; it’s an economic and societal imperative."
A key challenge is balancing regulatory compliance with design flexibility, ensuring that feedback-driven changes do not delay approvals or increase costs. Additionally, we work closely with clinical trial investigators to ensure diversity in patient inclusion, with proportional representation across gender, age, and socioeconomic backgrounds. By analyzing outcomes by gender, we will be able to identify specific responses to our therapeutic approach and refine our device accordingly. Especially for Alzheimer’s disease where women have a higher prevalence of Alzheimer's compared to men.
Despite these challenges, we remain committed to enhancing usability, improving treatment outcomes, and ensuring our devices meet real-world patient needs effectively.
At REGEnLIFE, as a medical device company, certified ISO 13485, we maintain a regulatory watch to stay ahead of evolving regulatory requirements. We rigorously follow EU MDR regulations with the aim to bring our medical devices to the EU market while ensuring compliance with the highest safety and efficacy standards. Regarding the FDA, we are actively planning a strategic roadmap to prepare for future development in the US market over the coming years.
By anticipating regulatory changes and integrating them into our innovation process, we aim to accelerate patient access to breakthrough neurotechnology.
Beyond the current EU MDR, we are looking forward to regulatory advancements tailored to neurotechnologies, aimed at fostering innovation and streamlining clinical evaluation. These developments are waited, especially for therapeutic neurotech, to facilitate market authorization while enhancing post-market follow-up through more robust clinical data. This evolution could and should be guided by the European Charter for the Responsible Development of Neurotechnologies, an initiative led by the European Brain Council.
In medical device development, sustainability is increasingly important as it helps reduce the environmental impact.
Our medical device has a very low energy consumption, reducing emissions. Unlike pharmaceutical treatments that can leave chemical residues and contaminate water, our device as a treatment uses safe and non-ionizing radiation, avoiding pollutant emissions and preserving ecosystems.
There are, of course, challenges to be met in terms of device design, materials, and electronics. Since the beginning, we focus on designing products that are modular, extending their lifespan and minimizing the need for replacements.
We more and more prioritize the use of biocompatible and recyclable materials. This reduces the amount of waste generated during manufacturing and enhances the recyclability of devices at the end of their lifecycle.
Because we plan to commercialize our first medical device in early 2026, we will opt for eco-friendly packaging with the aim of minimizing packaging materials, opting for reusable, recyclable, or biodegradable alternatives to reduce single-use plastic and packaging waste.
We also plan to anticipate the end-of-life management by establishing take-back programs and recycling initiatives for devices after use, ensuring that they are properly disposed of or repurposed, helps reduce environmental harm and promotes a circular economy.
We are also becoming more and more selective by partnering with suppliers who also commit to sustainable practices.
To develop the science on our technology and to evaluate our devices, we have developed several research partnerships with universities, research centers, and hospitals.
One of our devices, for the treatment of acute concussion symptoms, targets the brain only. However, for Alzheimer’s disease and other neurological conditions under development, our technology is designed to stimulate both the brain and the gut. In our preclinical studies on Alzheimer’s and depression, we have observed a more effective therapeutic response with combined brain-gut stimulation compared to brain-only or gut-only approaches. Additionally, our research has indicated measurable effects on gut microbiota.
This multimodal approach is more efficient, cost-effective, and faster to evaluate at the preclinical level. In our ongoing clinical development for Alzheimer’s, we are currently assessing our non-invasive brain-gut stimulation device in a randomized, double-blind study. As pioneers in this innovative therapeutic strategy, we are initially focused on demonstrating clinical efficacy with a standardized treatment approach. Following CE marking, our device will become more accessible for broader research applications. This will also allow us to gradually move towards personalized approaches.
Which aspect of the European Medical Device Summit are you most looking forward to?
I'm most looking forward to discussions on prototyping and risk mitigation, particularly how early and frequent iterations can align with regulatory expectations while optimizing cost control. I'm also eager to explore insights on discussions in terms of business economics for a successful commercial rollout.
Beyond that, I’m excited to connect with industry peers, share experiences, and learn from others to drive innovation in medical device development.
We are incredibly grateful to Guillaume Blivet, Co-Founder and Chief Innovations Officer at REGEnLIFE, for taking the time to share his insights ahead of his upcoming session, "Innovation Spotlight: Driving Breakthroughs in Medical Device Development," at the European Medical Device Summit. His perspectives, both here and at the event, will be invaluable in advancing innovation within the MedTech industry.