Thomas E. Claiborne, PhD, RAC

Leading US corporate RA teams.

Managing RA teams for dV5, SP, and Ion platforms.

Leading and advising on regulatory strategy for our products.

Responsible for US regulatory strategy guidance and premarket submission support. (IDE, 510(k), Presubmission) Contributor to US regulatory policy development and consensus standards support. (Advamed, MDMA, IEC, ISO)

Responsible for corporate regulatory compliance and strategy related to FDA. Duties include: • Management of devices regulated under 21 CFR 872, e.g. robot-assisted dental surgery devices • Responsible for FDA submissions: o Premarket Notifications: 510(k) o Clinical studies: IDE o Pre-submissions (Qsub) o Classification requests 513(g) & (f) • Responsible for postmarket reporting, registrations, and fees: o Facility Registration o User Fees o UDI/GUDID o MDR o Recalls/Corrections/Removals • Marketing support o Responsible for on label marketing and promotional material • Quality Assurance Support o Assist with compliance to 21 CFR 820 o Contributor to process improvements o Author of SOPs and Policy documents o Signature authority • R&D Support o Plan and prepare protocols for premarket verification and validation o Contribute to risk management (ISO 14971) o Ensure compliance with applicable consensus standards (e.g. electrical safety, EMC, software) o Responsible for marketing decisions (e.g. letter-to-file v. 510(k) design or label changes) • Hiring and supervision of direct report

• Premarket review of devices regulated under 21 CFR 876, 878, 874, and 888, e.g. robotically assisted surgical devices (RASD) and other powered devices (510(k), IDE, Q-Sub, 513(g), PMA Supplement) • Primary Liaison / Technical Expert for AAMI/ISO/IEC Surgical Robotics Committee JWG-35 & ISO TC299 JWG5 Medical Robotics, co-author of IEC 80601-2-77 (FDA-recognized) • Member of the FDA Early Feasibility Clinical Study Committee • Member of the FDA Real World Evidence- Informed Consent Subgroup • Premarket review of Robotically-Assisted Surgical Devices (RASD) o Co-author of RASD guidance/policy documents • Co-author of White Paper and MC for Public Workshop - Robotically-Assisted Surgical Devices: Challenges and Opportunities, July 27-28, 2015 • Contributor to Intramural Research in OSEL

-Transcatheter aortic valve replacement (TAVR) biomechanics research and medical device development. -Planned, initiated and led an interdisciplinary IRB-approved clinical-biomedical engineering research study involving the Heart Institute and Dept. of Biomedical Engineering. -Directed the work of two BME graduate students and one medical student. -Collaborated with Depts. of Radiology and Pathology. 21 CFR Part 50 compliant. [R&D, IRB, Supervise, Mentor, Lead, Publish, Grants, Public Speaking]

-Responsible for mentoring/supervising graduate and undergraduate students, project/budget management, purchasing, vendors, data analysis (SPSS), communicating results, and independent research. -Wrote grant applications for NIH and AHA. Investigated transcatheter aortic valve replacement (TAVR) biomechanics by creating patient-pathology-specific numerical models for evaluating realistic device performance. -IRB-approved and 21 CFR Part 50 compliant. [R&D, Publish, Public Speaking, Presentations, Mentor, Grants, IRB]

-Co-founded the company based on novel technology that I co-invented. Established a fully operational C-Corp licensed in New York. -Awarded $100k in seed funding from State and Private support. -Wrote and submitted two SBIR Phase I grant applications. -Gained entry into Start-Up NY program and the Long Island High Technology Incubator (LIHTI). -Negotiated options for intellectual property from three institutions. -Directed the activities of four R&D interns. -Produced two additional new IP disclosures. -Collaborated with industrial partners for prototyping. -Performed market analysis and IP freedom to operate analysis. -Wrote business, operational, and R&D plans. -Created and managed the operating budget. -Followed 21 CFR part 820, and NYS and Delaware corporate and labor laws. [Start-up, Funding, Business Plan, Budget, R&D, Lead, Supervise, Vision, Direct]

-Responsible for analyzing, processing and reporting on customer product complaints in compliance with 21 CFR 820.198, performing internal and supplier quality audits in compliance with 21 CFR 820.22, and risk analysis according to ISO 14971. -Supported sustaining engineering. -ASQ Quality Auditor Training ISO 13485.

Responsible for the design, specification, purchase and IQ, OQ, PQ of new manufacturing and packaging equipment for latex-based medical devices under 21 CFR Part 820. [manufacturing, specifications, IQ, OQ, PQ, tooling, die]

Cardio-thoracic surgery scrub tech

Decorated with honorable discharge, Gulf War Era veteran, surgery scrub tech in multiple specialties including cardio-thoracic.

Minor in Biomedical Engineering