This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at firstname.lastname@example.org.
Nada began her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation in 2004 and led FDA review teams for first-of-kind devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE, and two novel neurological stent HDEs. As a Senior Science Health Advisor at CDRH, Nada led cross-Center programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative.
Tell us a little bit about your time at FDA.
During my tenure at FDA I had the good fortune of holding a variety of roles. I started my journey as a Lead Scientific Reviewer in the Plastic and Reconstructive Surgery Branch (PRSB) in the Office of Device Evaluation (ODE) at CDRH. After four years, I transitioned to the Office of the Center Director (OCD) and served as a Network Leader to establish consistent business practices for planning, managing, and organizing surveillance of medical devices to enhance premarket and postmarket safety. In my final role at FDA, as a Senior Science Health Advisor, I ran the development, implementation, and assessment of cross-Center and Agency policies and public health programs for the advancement of public health. I advised on projects related to strategic outreach and collaboration efforts, all while consulting and collaborating with stakeholders to ensure that premarket, postmarket, scientific, and compliance initiatives aligned with FDA’s mission.
What trait(s) do you think helped you be a successful regulator at FDA?
Team work, flexibility, and collaboration are key. In addition, keeping patient needs and improved health outcomes at the forefront of regulatory decision making is critical to being successful at FDA. I found it very worthwhile to take time at the start of each project to clearly ‘define the problem’ and determine where we wanted to go. Pre-work on goals and objectives paid dividends in the end as we developed and implemented strategies and solutions. I believe effectiveness is vital to all work products. Efficiency is good to shoot for, but ultimately, we should all strive to achieve an effective outcome for whatever it was we are trying to address.
What are you doing now?
I am currently the Chief Strategy Officer for Experien Group, a full-service medical device consulting firm based in Silicon Valley and San Diego. We offer support in regulatory affairs, quality systems, pre-clinical and clinical research, data management and reimbursement. In my role I provide high-level strategic direction and executive oversight for the development of regulatory and clinical strategies for medical devices and combination products. We guide and help companies at every stage in order for them to focus on executable programs throughout the total product life cycle—from early product development through post-market compliance.
What's something that you learned from FDA that helped you in your current position?
FDA is not an obstacle that companies must overcome or get through. FDA’S role is to help companies have the best product; one that is safe and effective for its intended use and remains so once it is on the market. It is best to consider FDA reviewers and management as a critical part of your team and take a more collaborative approach in your dealings with them from the very start. Partnership is key!
What do you think is a common misconception about FDA?
Industry may fear FDA and/or think that FDA wants to make things challenging for a sponsor or manufacturer. This is simply not true. FDA is there to help facilitate the journey to get a safe and effective product to market and to patients in need. I think it is important to view the interactive reviews and additional questions as a conduit to making your product the best version to truly improve health outcomes.
What do you think is a common misconception about your current industry?
A common misconception is that ‘one size fit’s all’ in navigating a regulatory path; and that is simply not the case. Companies should be open to exploring new ways and creative strategies – don’t box yourself in! I strongly recommend that medical device developers and manufactures (regardless of whether early stage startups, well established traditional device companies, or some of the emerging novel digital technologies developers), always answer a key question:
“What is the clinical problem my device or technology is addressing?”
They should then identify their long-term goals to most effectively develop a roadmap for the total product life cycle. Keep patients as the vanguard of the mission, and consider all stakeholder's needs throughout the product development stages.
What is some advice you can give to a person interested in regulatory affairs?
If you are a curious person who enjoys solving complex challenges, developing solutions, addressing problems proactively, and enjoy a relatively fast-changing field, then don’t hesitate to explore the world of regulatory and medical devices. You won’t be disappointed.
More about Nada Hanafi, MSc, MPH
Nada's work, both at FDA and in her current role, has a strong focus on women-specific diseases and indications. While at the Agency, she served as the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and Office of Minority Health (OMH) to evaluate research proposals and intramural grant applications.
Nada also had the opportunity of detailing as Lead International Policy Analyst at the Center for Tobacco Products (CTP) within OCD, where she helped develop an international strategic plan. She represented CTP in multilateral conferences and interagency working groups to develop regulatory partnerships and mutually beneficial information exchange for internal policy development and decision making.
For more information about Nada and her colleagues’ work at Experien Group, please visit the following link: http://experiengroup.com/team/