Academic Credentials
  • Ph.D., Biomedical Engineering, Tulane University, 1996
  • M.S., Biomedical Engineering, Tulane University, 1992
  • B.S., Biomedical Engineering, Tulane University, 1990
Licenses & Certifications
  • Certified ISO 13485 Lead Auditor
  • ISO 14971:2019 - Application of risk management to medical devices
  • Regulatory Affairs Certification (RAC: Devices)
  • Regulatory Affairs Certification (RAC: US)
Additional Education & Training
  • Leading Strategic Growth, Columbia Business School, Executive Education ExecOnline, June 2021
Academic Appointments
  • Research Assistant Professor, School of Biomedical Engineering, Science and Health Systems at Drexel University, Philadelphia
  • Previous Academic Appointments
  • Adjunct Professor in the Department of Mechanical Engineering at Temple University, Philadelphia
  • Visiting Lecturer in Mechanical and Aerospace Engineering at Princeton University, 2000-2006
  • Adjunct Assistant Professor in the Department of Biomedical Engineering at Tulane University, New Orleans
Professional Honors
  • American Association of University Women (AAUW) Selected Professions Fellow
  • National Science Foundation Minority Graduate Fellow
  • Sigma Xi (Scientific Research Society)
  • Alpha Eta Mu Beta (Biomedical Engineering Honor Society)
  • Tau Beta Pi
  • 2000 Harold Levey Award (Tulane School of Engineering: In recognition of professional achievement to an alum)
Professional Affiliations
  • Regulatory Affairs Professionals Society (member)
  • Women in Bio (member Philadelphia Chapter)
  • MedTech Women (member)
  • ChIPs® (Chiefs in Intellectual Property) (member)
  • Medical Device Innovation Consortium (MDIC), Case for Quality
  • Food and Drug Law Institute (Corporate Member), 2020 & 2021 Annual Meeting Planning Committee, 2023 Enforcement, Compliance and Litigation Planning Committee
  • Orthopaedic Research Society (member)
  • ASTM International (member), Subcommittees F04.25: Spinal Devices, F04.15: Material Test Methods, F04.18: Device Retrieval Analysis
  • Life Sciences PA (Corporate Member), 2019 Life Sciences Future, MedTech Planning Committee
  • The Forum of Executive Women (member), 2021 DEI Committee
  • Philadelphia Biotechnology & Medical Device Seminar Series, Co-Founder 2004
Languages
  • Spanish

Marta Villarraga, Ph.D., RAC, is a principal in Exponent's Biomedical Engineering & Sciences practice with over 25 years of experience in medical device consulting. She specializes in evaluating device performance across the product lifecycle, regulatory strategy, compliance, quality control, and life sciences due diligence across various medical device types, including general surgery, orthopedic, spine, women's health, and diagnostics.

Dr. Villarraga has provided technical support for regulatory submissions, risk management, postmarketing surveillance, product development, and government investigations. She has conducted failure analyses, root-cause analyses, and compliance evaluations related to medical device recalls. She has also served as an expert witness in product liability, intellectual property, contract disputes, trade secret, and arbitration matters involving medical devices.

Dr. Villarraga's research experience and interests include spine biomechanics; implant and tissue retrieval analysis, including the use of microscopic (SEM) and tissue analysis techniques (ICP, histology); use of animal models for evaluating orthopedic/spinal device performance; and the use of experimental and finite element stress analysis techniques to characterize the mechanical behavior of bone, other biological structures, and orthopedic/spinal implant devices. She has been a reviewer for the Journal of Biomechanical Engineering, Clinical Orthopedics and Related Research, Clinical Biomechanics, Clinical Neurology and Neurosurgery, Journal of Engineering in Medicine, and the Journal of Biomedical Materials Research.

Medical device total product lifecycle consulting

Dr. Villarraga advises MedTech clients on technical and regulatory issues throughout the total product lifecycle. This has included working with client teams during risk management file development and developing and conducting medical device performance evaluations during pre- and postmarket stages, as well as assessments related to quality and compliance requirements.

Medical device performance evaluation

Dr. Villarraga has expertise in developing unique methodologies for evaluating medical device performance during the premarketing and postmarketing stages. These evaluations have included assessments used as part of verification and validation and in support of durability and/or reliability studies, utilizing industry standards as guides or developing unique methodologies when necessary. She has experience with orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, and diagnostic medical devices.

Medical device regulatory strategy and compliance

As a Regulatory Affairs Certified (RAC-US, Devices) professional, Dr. Villarraga uses her knowledge and experience with U.S. Food and Drug Administration regulations and the EU Medical Deice Regulation (EU MDR) requirements to develop regulatory strategies for novel products, contribute to or prepare regulatory submissions, interact with regulatory bodies, and support identifying, developing, and justifying technical evaluations for premarket assessments and postmarket compliance matters. Additionally, as a certified lead ISO 13485 auditor, she is able to leverage her experience to address regulatory and compliance issues that may arise during the total product development cycle, including internal audits and regulatory body inspections.

Medical device quality control

Dr. Villarraga has experience in identifying scientifically justifiable methodologies for assessment of quality control issues as applied to medical devices, combination products, and pharmaceuticals, medical device quality systems compliance (gap analysis), contamination, manufacturing compliance, and finished device evaluations.

Life sciences due diligence

Dr. Villarraga has provided technical and regulatory expertise as part of due diligence efforts associated with potential acquisitions. These efforts have leveraged the multidisciplinary expertise of Exponent colleagues while providing targeted technical and regulatory perspective from her decades of consulting with medical device clients. 

Recent Projects