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Career Catalyst | De-Risking MedTech: Building FDA- and Investor-Ready Development Plans
Bringing a MedTech innovation to market requires more than breakthrough science, it demands a development strategy that withstands both FDA scrutiny and investor diligence. Too often, early-stage companies face preventable delays, costly rework, or failed studies because critical risks weren’t addressed upfront.
This Career Catalyst session Dr. Tamara C. Baynham and Paris McKenzie will unpack what “de-risking” truly means in practice. Attendees will gain insight into the regulatory, clinical, and strategic decisions that determine whether a product accelerates toward approval or stalls under pressure. From designing capital-efficient milestones to avoiding common early-stage missteps, this program will equip MedTech innovators with practical strategies to build smarter, more resilient development plans.
Whether preparing for FDA engagement, fundraising, or commercialization, this session will provide a roadmap for reducing uncertainty and strengthening long-term success.
Key Takeaways:
What “de-risking” really means: The most common regulatory and clinical risks that derail timelines, reduce valuation, or kill deals.
Designing capital-efficient milestones: How to structure development phases that satisfy both FDA requirements and investor expectations.
Early decisions that matter most: The strategic choices that prevent delays, rework, and failed studies down the line.
Who Should Attend
Clinical & Regulatory Leaders
Product Development Managers
Program Managers
Professionals transitioning into regulatory or clinical strategy roles
Operators preparing to move into leadership positions
Scientists seeking broader understanding of commercialization pathways
Venture capital associates
Startup advisors evaluating development risk
Anyone interested in learning more about MedTech
About the Speaker
Tamara C. Baynham, PhD
Dr. Tamara C. Baynham is a biomedical engineer, innovator, entrepreneur, and mentor with more than two decades of leadership in the medical device industry. She earned her B.E. in Biomedical and Electrical Engineering from Vanderbilt University and her M.S. and Ph.D. in Biomedical Engineering from the University of Alabama at Birmingham.
Her career spans research and development, intellectual property strategy, and clinical and regulatory science, with contributions to innovations in neuromodulation and cardiovascular therapies. Dr. Baynham is a registered patent agent with the United States Patent and Trademark Office and holds 50 U.S. patents focused on advancing technologies that improve patient outcomes.
In 2013, she founded Ingenuity Medical Device Research, LLC, where she advises emerging medical device companies on intellectual property development, clinical and regulatory strategy, and medical writing. Dr. Baynham also mentors innovators through Vanderbilt University’s Wond’ry Innovation Center and the MIT LinQ Catalyst Program and serves on the NIH NIBIB Advisory Council. She was named a Fellow of the Biomedical Engineering Society in 2023.
About the Host
Paris McKenzie
Paris is a multidisciplinary leader whose work bridges beauty, biotechnology, and fabrication with uncommon depth and resolve. Born in Brooklyn, New York to Jamaican parents, she relocated to Maryland alone at 17 to pursue college after graduating high school early. She currently serves as a Biotechnology Support Technician and Manufacturing Technician II at Longeviti Neuro Solutions, where she supports medical device manufacturing and cross-functional technical workflows, translating complex systems into precise, real-world outcomes.
Before entering the medical device industry, Paris built and scaled businesses in the beauty sector, earning national recognition for her work and vision. Her story and impact have been featured by Teen Vogue, People Magazine, The New York Post, Fox Business, and more. Rather than abandoning that world, she carried its lessons forward, demonstrating that creativity and scientific rigor are not contradictions, but complementary forms of discipline.
Her academic journey reflects the same refusal to quit. After mental health struggles early in college, resulting in a 0.38 GPA, Paris rebuilt her footing and ultimately earned her bachelor’s degree in Interdisciplinary Health and Human Sciences on time, completing an accelerated 43 credits in a single semester. Now rooted in biomanufacturing, she is committed to widening access to pathways she once had to discover alone. Through leadership, mentorship, and education, Paris works to ensure others, especially young people, know that industries like biomanufacturing exist, and that they never have to shrink themselves to fit one box to belong.
About the Program
Career Catalyst
Career Catalyst is BioBuzz’s flagship weekly virtual series connecting life sciences professionals with experts and actionable insights. The program runs every Tuesday @ 12 PM EST for approximately 45 minutes:
20-minute expert presentation
25-minute live, open Q&A
Sessions rotate through four thematic tracks with new experts each week, ensuring content stays relevant for life sciences professionals at every career stage. Each track is community-led and hosted by our Career Community Ambassadors.
Tracks include:
➡️ Career Navigation — Networking, skill-building, and strategies to advance your career across all life sciences disciplines. Hosted by Crystal Richards, Principal & Owner, MindsparQ.
➡️ Research — Deep dives on research and opportunities shaping the life sciences ecosystem and their relevance to your professional growth. Hosted by Gautam Kumar, Postdoctoral Candidate, NIH, NIDA
➡️ Biomanufacturing — Insights into the backbone of biotech success, shaping the industry and your career. Hosted by Paris McKenzie, Manufacturing Technician, Longeviti Neuro Solutions.
➡️ CQV & Validation — Insights into compliance, quality systems, and operational standards that underpin high-performing life sciences organizations and support your professional growth. Hosted by Kayla Britt, Founder & Principal Consultant, Britt Biocomputing.
Sponsors
Bio-Trac
With over 30 years of expertise, Bio-Trac® workshops have trained more than 17,000 scientists and engaged 300 scientist instructors. Designed by active researchers and open to the scientific community, these workshops equip bench and research scientists with the latest lab techniques and provide training on cutting-edge biotechnology advancements to a global audience across all biotech sectors.
Workforce Genetics
Workforce Genetics (WGx) is a premier recruiting firm serving the life sciences, MedTech, and healthcare sectors, supporting companies from startup to commercial. The firm delivers transformative talent strategies through retained and executive search, contingent search, and outsourced talent acquisition.
Important Information
BioBuzz's Career Catalyst sessions are intended to provide insights, guidance, and support for professionals navigating their careers. These sessions are not a platform for selling services, recruitment pitches, or business solicitations. They are designed for job seekers and those looking to make connections and build community.
Please be respectful of fellow participants and help ensure this remains a valuable, trusted resource for all.
Participants who engage in solicitation, promotional activity, or behavior that disrupts the intent of the session will be asked to leave.
Repeated or serious violations may result in removal from the session and exclusion from future Career Catalyst events.
Want to be an expert guest?
If you’re interested in sharing your knowledge with the BioBuzz community, get in touch via hello [@] biobuzz.io.