About SpiralMed
Experience
Gina M. Nagvajara, Ph.D. has 25 years of experience in the medical device industry, including experience in Research and Development, Regulatory Affairs, Product Development and Patent Portfolio Management. Dr. Nagvajara holds 9 U.S. Patents and multiple foreign counterparts related to orthopaedic and spine biomaterials and implants; and is licensed to practice patent law before the United States Patent and Trademark Office (USPTO).
Dr. Nagvajara received her Bachelor of Arts/Bachelor of Engineering degrees from Dartmouth College (Hanover, NH) and MS/PhD degrees in Biomedical Engineering from Drexel University (Philadelphia, PA). Much of her training and early experience has been in the Orthopaedic and Spine arena, but more recently, she has worked with a variety of products, including General Surgery products such as surgical meshes, surgical hemostats, and lasers; Gastroenterology/Urology catheters; and devices that utilize sensors and software.
Approach
Services include an attentive consult to help clients- individuals, start-ups and large companies, achieve their goals. Dr. Nagvajara has a wide variety of experiences including, but not limited to:
- Providing strategic Regulatory Guidance
- FDA filings
- Pre-clinical protocol development and testing including biomechanical testing
- Drafting manuscripts, reports, SOPs and Quality and Regulatory documents
- Grant Management
- ISO 10993 strategy and testing
- Post-approval Marketing Material Review
- Clinical Study Auditing
- Patent searching and patent application drafting
Courses, Certifications and Licenses
- NIH Office of Extramural Research- Protecting Human Research Participants (Aug, 2018)
- RAPS IDE Webcast Module I: IDE Introduction and Basics (Sept, 2003)
- RAPS IDE Webcast Module II: Planning Ahead for the IDE-Clinical Study Design and Design Controls (Sept, 2003)
- RAPS IDE Webcast Module III: IDE Considerations- Managing the Study and Interacting with FDA (Oct, 2003)
- NAMSA Developments in Medical Device Testing (Sept, 2003)
- SoCRA FDA Clinical Trial Requirements, Regulations, Compliance and GCP (FDA and Society of Clinical Research Associates (SoCRA) Co-Sponsored Conference (June, 2003))
- The Center for Professional Advancement: The Institute for Applied Pharmaceutical Sciences- Auditing & Inspecting Pre-clinical Research for GLP Compliance (Sept, 2000)
- Registered U.S. Patent Agent (USPTO) (Feb, 1994)
Example Projects
- Contracted by a Fortune 500 Company that was not in the Medical Device industry, but who had developed technology that could be used in a variety of medical applications: researched various Regulatory Pathways, participated in weekly calls with Management and provided multiple Regulatory Guidance Memoranda
- Contracted by a Start-Up Medical Device Company to summarize extensive amount of pre-clinical data in formal reports to be controlled in MasterControl; and worked with team members to draft manuscripts for publication
- Hired by Start-up Medical Device Company to fulfill Regulatory Affairs role: assisted with Special 510(k) filing and Post-Marketing activities
- Hired by NIH Phase I Grant Awardees to be their Project Manager: worked with vendor to complete design revisions on the device, conducted Clinical Usability Testing, helped navigate the Regulatory Pathway, selected and validated an eQMS, and helped manage the Financials associated with the Grant
- Contracted by Company to conduct a Screening Audit of its Post-Marketing Clinical Study and Routine Audit of its CRO per 21 CFR 50, 54, 56, 812.119, 45CFR 160 and 164; delivered findings in an Audit Report and presented findings to Executive Management
Affiliations
Dr. Nagvajara is a member of the Regulatory Affairs Professionals Society (RAPS), Orthopaedic Research Society (ORS) and the Society For Biomaterials (SFB) and serves as the Board Chair for Next Level Sports in Ardmore, PA.
Dr. Nagvajara leverages her many business relationships to help support her clients and compliment her know-how.