Epilepsy therapy innovations start with an idea. So how does it go from that to a device that can be safely used in patients? In this episode of Seizure Diaries, our conversation is centered around the medical device regulatory process, offering a behind-the-scenes look at how safety, evidence, and patient protection guide every step of development.

​​Joining the conversation is Tim Marjenin, Vice President and Head of Neurology Regulatory Affairs at MCRA. Drawing on his experience at the U.S. Food and Drug Administration, he shares insight into the regulatory landscape and how it intersects with clinical research.

Listeners are introduced to the structure of medical device regulation in the United States, including how laws, FDA regulations, and guidance documents shape the pathway for bringing new technologies to market. The discussion explains device classifications, the unique Humanitarian Device Exemption pathway, and the collaborative relationship between companies, regulators, and clinical experts. Together, these elements illustrate the extensive planning, testing, and documentation required to demonstrate that a device is safe and effective.

Key takeaways emphasize the central role of risk-benefit evaluation, the multidisciplinary teams involved in reviewing devices, and the importance of communication and transparency, especially for families considering participation in clinical trials.

The episode highlights how rigorous oversight and thoughtful decision-making aim to ensure that new therapies are developed responsibly while maintaining a strong focus on patient well-being.

Listeners will hear:

• How a medical device moves from concept to regulatory approval

• The role of Congress, the FDA, and guidance documents in device oversight

• Differences between device classes and what they mean for safety requirements

• What the Humanitarian Device Exemption pathway is and when it's used

• How FDA review teams evaluate safety, effectiveness, and risk-benefit balance

• Why strong communication between companies, regulators, and families matters

• Considerations for parents and caregivers when evaluating clinical trial participation

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

This episode focuses on clinical experience and research insights. While no specific studies were cited, the organizations and technologies below provide helpful context for listeners who want to learn more.

Resources mentioned in this episode:

• MCRA

• FDA | Medical Devices

• FDA | CDRH

• FDA | FD&C Act

• iqvia.com

What does it take to move epilepsy care forward, from understanding the brain's biomarkers to developing therapies that could change patients' lives? In this episode of Seizure Diaries, our conversation explores the intersection of clinical care, research, and engineering innovation through the work of neurologist and researcher Dr. Greg Worrell and his long-standing collaboration with Cadence Neuroscience. Together, they discuss how scientific curiosity and patient-centered care are driving new possibilities in epilepsy treatment.

Listeners gain background on the unique challenges of epilepsy, particularly drug-resistant epilepsy, where traditional medications may not provide adequate seizure control. The discussion highlights the role of Mayo Clinic's research environment, advances in neuromodulation, and the importance of identifying measurable brain biomarkers to guide therapy. The episode also traces the origins of biomarker targeted stimulation and the collaborative work that continues to shape emerging technologies.

Key takeaways center on how innovation happens in real clinical settings, the value of cross-disciplinary collaboration, and the growing potential of data, sensing technology, and personalized treatment approaches. The conversation reinforces a central theme: progress in epilepsy care depends on combining engineering advances with deep clinical insight and a sustained focus on improving quality of life for patients.

Listeners will hear:

• An overview of the challenges in treating drug-resistant epilepsyHow neuromodulation works and why biomarkers matter

• The role of Mayo Clinic's research culture in advancing therapies

• The origin story of biomarker targeted stimulation

• Real-world patient impacts and success stories

• Future directions in sensing technology, data, and personalized care

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

This episode focuses on clinical experience and research insights. While no specific studies were cited, the organizations and technologies below provide helpful context for listeners who want to learn more.

Resources mentioned in this episode:

• www.mayoclinic.org/departments-centers/neurology

• neurovista.us

• www.mayoclinic.org/biographies/worrell-gregory

Today's conversation centers on when cutting-edge neuromodulation meets compassionate, team-based pediatric care. In this episode, the Seizure Diaries hosts welcome Dr. Scott Perry, Director of the Jane and John Justin Institute for Mind Health at Cook Children's Hospital, for a deep dive into the evolving world of epilepsy surgery, neuromodulation, and patient-centered decision-making.

Learn how Dr. Perry and his team are helping families navigate complex diagnoses, evaluate treatment options, and harness technology to improve outcomes.

Dr. Perry shares his professional journey from aspiring astronaut to leading pediatric neurologist, offering insight into the multidisciplinary approach that powers Cook Children's Neuroscience Center. He discusses how collaboration across neurology, psychology, psychiatry, developmental pediatrics, and rehabilitation supports holistic care, and why big data and collaborative research networks like the Pediatric Epilepsy Research Consortium are shaping the future of epilepsy treatment.

Through stories and statistics, Dr. Perry explains how earlier surgical referrals, detailed evaluations, and the rise of stereo EEG (SEEG) are changing what's possible for children with intractable epilepsy.

Listeners will hear:

• How neuromodulation, epilepsy surgery, and genetic insights intersect in pediatric care

• The critical role of parents and caregivers in informed decision-making

• The value of individualized treatment

• Ongoing efforts to shorten the path from diagnosis to intervention

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

Resources & Links Mentioned in This Episode

• cookchildrens.org/services/neurosciences

• perc-epilepsy.org

• childneurologyfoundation.org