Conference Day 1


9:25 am Chair’s Opening Remarks

A Regulatory Perspective: Establishing Clear Expectations & Advancing Towards a Standardized Approach

9:30 am Overview of CDRH & Regulatory Pathways to Provide Novel Neuromodulation & Physical Medicine Devices to Patients

  • Vivek Pinto Director, Division of Neuromodulation and Physical Medicine Devices, FDA


• Understanding the time during device development to engage with the agency

• Ensuring productive interactions with review teams

• Learning current agency programs intended to ensure patients have access to high-quality, safe, and effective medical devices

10:00 am Industry Perspective on the Optimal Strategies to Streamline the Submission Process


  • How and when to approach regulatory bodies?
  • Do’s and Don’ts in your development and regulatory process
  • How to choose which submission type is the best first step

10:30 am Safety Vs Risk: Developing Neuromodulation Devices While Considering Cost-Benefit Analysis


  • Understanding the varying approaches in demonstrating safety and efficacy?
  • What is the true risk and how could it be better managed?
  • Discussing the steps towards approaching CMS

11:00 am Speed Networking & Morning Break


This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the bioelectric medicine world and establish meaningful business relationships

12:00 pm Panel Discussion: A Comparison of EU & US Regulations to Move Towards Global Harmonization

  • Mary McNamara-Cullinane Vice President of Regulatory Affairs, ClearPoint Neuro Inc.
  • Greg Alden Chief Executive Officer, Diagnostic Biochips Inc.
  • Vivek Pinto Director, Division of Neuromodulation and Physical Medicine Devices, FDA


  • Shedding a light on the differences between global agencies and how devices are regulated
  • Is it better to have a greater burden on technologies considering their influence on the nervous system?
  • Delving into the pros and cons of each to adopt a standardized approach

12:30 pm Demonstrating the Benefits of Using Bioelectric Medicine Over Conventional Procedures to Reduce Patient Resistance

  • Alex Yeh Founder, Chief Technology Officer & Vice President Research and Development, NeuSpera


  • Delving into product differentiation – safety profile and efficacy
  • How to package this to present to patients and physicians?
  • Discussing the traction from patients to validate the initial thesis of differentiation to drive greater patient adoption

1:00 pm Lunch Break & Networking

Overcoming Funding Challenges & Current Resistance To Device Adoption to Increase Implementation in Hospitals, Outpatients & Clinics

2:00 pm Uniting Government, Industry & Academia to Strategize Methods in Advancing Bioelectric Medicine Through Funding Initiatives

  • Imran Eba Partner, Action Potential Learning LLC


  • What is the status of the scientific community?
  • What do government agencies need to see?
  • How can funding initiatives be optimized?

2:30 pm The Total Product Lifecycle (TPLC) Advisory Program (TAP): Piloting a New Approach


  • Understanding the TAP pilot, which offers proactive and strategic engagement with deep Medtech industry expertise
  • Discussing the TAP pilot processes, which includes a new paradigm of speed and collaboration
  • Learning how CDRH is pursuing our public health mission by accelerating patient access to innovation

3:00 pm Afternoon Break & Networking

3:30 pm Reviewing Currently Approved & Adopted Devices to Identify Ways for Bioelectric Medicine to be Used as a Main Therapy


  • How does the adoption of invasive and non-invasive devices differ?
  • Bringing in the voice of the patient and what they’d be encouraged by
  • Uniting to make bioelectric medicine routine therapy rather than a last resort  

4:00 pm New Therapeutic Modality: Unique Challenges & Opportunities


  • Funding early innovation through government partnership and investment
  • The emergence of non-invasive bio-ultrasonic therapy for treatment of chronic diseases
  • Bringing novel technology into the realm of healthcare

4:30 pm Chair’s Closing Remarks

4:45 pm Poster Session


After the formal presentations have finished, the learning and networking carries on. The Poster Session is allows you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session, posters will be presented on the very latest insights in developing and commercializing the next generation of neuromodulation devices.