Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Participated over $100 Million financing in medical device investment

Investments include multiple exits to IPO + top medical device companies (e.g. Stryker)

Co-founder, DexSono Medical

Specialties:
- 28 years experience in Medical Device field.
- Complex AIMD System Engineering
- Domestic and International Standards: 13485, 14971, 60601-X, 10974, 62304, FDA CFRs
- International Project Team Management
- Over 10 years served as Management Representative and General Manager of Quality

General:
- Electrical Engineering: Electrical Hardware Design / Component & Circuit Identification / PCB Layout & Design / Vendor Identification / ISO13485 Vendor Audit & Approvals
- Project Management: Intradivisional Team Management / International Team Management / Class I to Class III Projects
- Process Development IQ/OQ/PQ
- Site Operations Management: Personnel Management / Forecast / Budget / Spend Management / Lean Manufacturing Structure / Resource Allocation / Shift Structure / OSHA Compliance

Goal: To manage a forward thinking, technologically advanced company and/or R&D group, whose goal is to create and market safe and effective medical devices for those in the greatest need for improvement of their quality of life.

Nada joined Experien Group (now Veranex) in 2017 after working 12 years at the FDA’s Center for Devices and Radiological Health (CDRH). Since 2010 she had been a CDRH senior science health advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to the FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at the FDA, Nada led postmarket investigations for OB-GYN devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices, and metal-on-metal hip implants, and she applies this knowledge to help companies effectively manage postmarket requirements.

At Veranex, Nada helps medical device and combination product manufacturers generate regulatory/clinical road maps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones. Nada’s primary functions include:

• Product information review and strategic regulatory/clinical assessment to devise long-term program and actionable milestones toward U.S. commercialization
• Pre-submission support and FDA communication, including product positioning for device testing and clinical studies, including patient preference testing
• U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, de novos, HUD/HDEs, 513(g)s, etc.)
• Postmarket compliance advisory services
• Veranex and client company representative at industry meetings and symposia, presenting as speaker or panelist to societies, universities, and public/private consortiums

Past companies and experience
Nada initiated her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for first-of-kind (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE, and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and agency programs for the advancement of the FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program, and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection, and she was the CDRH liaison and subject matter expert to the FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH).

Education
Nada holds a B.E. and an M.S. in biomedical materials science and engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).