Joseph (Joe) Carraway, DVM, MS

Dr. Joe Carraway has over 29 years of experience in medical device development and testing and over 43 years’ experience in clinical medicine and surgery, biomedical science, and testing procedures. He has been with NAMSA for 29+ years, focused on medical devices testing and evaluation, covering a wide range of therapeutic areas. Dr. Carraway has a Doctor of Veterinary Medicine (DVM) from Mississippi State University and a Master of Science (MS) degree from Ohio State University.

Prior to joining NAMSA in 1996, he was in private veterinary practice in Mississippi before joining the military (US Army) and serving in Florida, Greece, and Germany. He left the military in 1993 to complete a post-doc research program in laboratory animal medicine and research at OSU. At NAMSA, he has been the Supervisor for Special Studies, Manager of In Vitro Toxicology, Director of Toxicology, and Scientific Director for Laboratory Services.

Dr. Carraway is actively involved in standards development in ISO and ASTM. He serves as the Convenor for 10993/TC194 – Biological Evaluation Medical Devices, Working Group 7 (WG7) – Systemic Toxicity and is a US expert for WGs 10 – Implantation, WG3 – Animal Welfare, WG7 – Systemic Toxicity, WG8 – Irritation & Sensitization, WG9 – Effects on Blood, and WG12 – Sample preparation.

CORE COMPETENCIES

• Scientific resource for all NAMSA biocompatibility and preclinical laboratories for testing medical devices
• Serves as company expert in troubleshooting unexpected or failing laboratory results
• Oversees and performs preclinical studies and safety evaluations for medical devices and combination products for worldwide regulatory submissions
• Served as a surgeon for various soft tissue, orthopedic, ocular, cranial, and cardiovascular surgeries
• Assists in the development, design and execution of medical product testing plans for a wide range of medical devices from concept to final product
• Oversees pathology evaluations for wide range of studies and regularly consults with study pathologists and Sponsor to relate the significance of pathology findings
• Serves as expert in biocompatibility testing and representative in the ISO 10993/TC194 working groups developing device testing standards
• Supports multiple U.S. Food and Drug Administration (FDA) pre-submission meetings to assist in answering preclinical study design questions
• Acts as expert in the areas of preclinical study design for regulatory submission for multiple device and combination product types, including but not limited to: bone void fillers, and dental , dermal void fillers, dural repair materials, anti-adhesions products, ocular devices, and cardiovascular devices
• Serves as an experienced leader for medical device testing plan development, covering both efficacy and safety testing as required by regulatory agencies
• Responsible for the implementation and application of standards and guidelines to meet the requirements for U.S. FDA Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) device and tissue regulations
  • Directly involved in the design and development of NAMSA animal testing facility in Ohio implemented programs and obtained American Association for Accreditation of Laboratory Animal Care (AAALAC) certifications for these operations

RECENT PROJECTS

• Dental membranes and bone void fillers to address the FDA Guidance documents
• Laparoscopic stapling instruments for abdominal and thoracic use
• Dural repair materials for dural replacement and sealant use
• Anti-adhesion materials for prevention of post-operative adhesions
• Various hemostatic materials for internal and external use
• Various bone void fillers for general use, spinal fusion, dental, and cranial use

PUBLICATIONS

1. de Jong WH, Carraway JW, Liu C, Fan C, Liu J, Turley AP, Rollins TS, Coleman KP. The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results. Toxicology in Vitro, Volume 69, 2020, Article 104916.
2. de Jong WH, Carraway JW, and Geertsma RE. In vivo and in vitro testing for biological safety evaluations of biomaterials and medical devices in Biocompatibility and performance of medical devices (Boutrand JP, Ed.) 2nd edition, Woodhead Publishing Limited, Cambridge, UK. 2020, pp 123-166.
3. Kerecman Myers D, Goldberg AM, Poth A, Wolf MF, Carraway J, McKim J, Coleman KP, Hutchinson R, Brown R, Krug HF, Bahinski A, Hartung T. From in vivo to in vitro: The medical device testing paradigm shift. ALTEX. 2017;34(4):479-500.
4. Gazda LS, Vinerean HV, Laramore MA, Hall RD, Carraway JW, and Smith BH. No Evidence of Viral Transmission following Long-Term Implantation of Agarose Encapsulated Porcine Islets in Diabetic Dogs. Journal of Diabetes Research, Volume 2014 (2014), Article ID 727483, 11 pages, Published 9 June 2014.
5. Gazda LS, Vinerean HV, Laramore MA, Hall RD, Carraway JW, and Smith BH. Pravastatin Improves Glucose Regulation and Biocompatibility of Agarose Encapsulated Porcine Islets following Transplantation into Pancreatectomized Dogs. Journal of Diabetes Research. Volume 2014 (2014), Article ID 405362, 10 pages, Published 19 May 2014.
6. Carraway JW and Daniel EM. Study Design and Methodologies for Study of Ocular Medical Devices in Ocular Pharmacology and Toxicology (Gilger BC, Ed.), Springer Science+Business Media (Humana Press), New York, NY. 2013, pp 243-265.
7. de Jong WH, Carraway JW, and Geertsma RE. In vivo and in vitro testing for biological safety evaluations of biomaterials and medical devices in Biocompatibility and performance of medical devices (Boutrand JP, Ed.), Woodhead Publishing Limited, Cambridge, UK. 2012, pp 120-158.
8. Carraway JW, Kent D, Young K, Cole A, Friedman R, Ward KR. Comparison of a new mineral based hemostatic agent to a commercially available granular zeolite agent for hemostasis in a swine model of lethal extremity arterial hemorrhage. Resuscitation. 2008 Aug;78(2):230-5.
9. Carraway J, Ghosh C. The Challenge to Global Acceptance of Part 3 of ISO 10993. Medical Device Technology. June 2006, p 16-18.
10. Carraway JW; Park S; McCune SA; Holycross BJ; Radin MJ. Comparison of irbesartan with captopril effects on cardiac hypertrophy and gene expression in heart failure-prone male SHHF/ Mcc-facp rats. J Cardiovasc Pharmacol 33(3):451-460, 1999.

PRESENTATIONS

1. Biocompatibility testing for medical devices. University of Toledo, Bioengineering Senior Design II, October 2, 2024.
2. Challenges of testing soluble medical devices. Monthly FDA Veterinary Rounds (White Oak), Silver Springs, MD, February 21, 2024.
3. Overview of the biocompatibility assessment of medical devices. National Capital Area Chapter (NCAC) of the Society of Toxicology (SOT) and the FDA Center for Food Additive Safety Joint Fall Symposium, College Park, MD, November 2, 2023.
4. Biocompatibility testing for medical devices. Purdue University, BME 561 (undergraduate and graduate classes), October 30, 2023.
5. Biocompatibility testing for medical devices. Purdue University, BME 561 (undergraduate and graduate classes), October 31, 2022.
6. Pre-clinical testing requirements for medical devices. Michigan Society of Toxicology Fall Meeting, Mattawan, MI, September 25, 2015.
7. Overview of ISO 10993. 3. Tissue Response to Implanted Active Medical Devices Meeting, Herndon, Virginia, May 9-10, 2014.
8. Currently used in vivo testing methods. CAAT Sponsored – In Vitro Medical Device Testing Meeting, Johns Hopkins University, Baltimore MD, December 10-11, 2013.
9. Biocompatibility and Performance of Medical Devices symposiums (NAMSA sponsored) in London (Feb 12-14, 2013) and again in Minneapolis (May 14-16, 2013).
10. Basic Testing Requirements: ISO and FDA. 32nd Annual Meeting of the American College of Toxicology, Phoenix, AZ, November 6-9, 2011.
11. Preclinical Testing for Combination Products. 2010 RAPS Annual Conference & Exhibition, San Jose, CA; October 24-27, 2010.
12. Streamlining the Process for Preclinical Testing of Orthopedic Medical Devices, 2nd Annual Orthopaedic Design & Technology Conference and Expo, Fort Wayne, IN, October 29-31, 2007.
13. Preclinical Biocompatibility Evaluation, 2nd Annual Orthopaedic Manufacturing & Technology Exposition and Conference, Chicago, IL, June 21-22, 2006.
14. Preclinical Risk Management Analysis and Device-Tissue Interactions: Material Characterization, Toxicology and Biocompatibility Considerations.  Drug Information Association (DIA) Seminar – Medical Device Development Lifecycle from Concept to Market: Strategies to Maximize Success. San Francisco, CA, February 23-26, 2003.
15. Various NAMSA Seminars on Safety Evaluation of Medical Devices and ISO 10993 Testing Requirements. 1-2 seminars per year, various locations, 2000 to present.
16. Use of Analgesics in Laboratory Animals. Ohio Forum on Issues in Animal Research at The Ohio State University. June 8, 2000.
17. Medical Devices – Following ISO Procedures to Satisfy the FDA: Trends in Genotoxicity Testing and Surgical Implantation Procedures. Henry Stewart Conference Studies. Philadelphia, PA, December 6, 1999.
18. Achieving ISO 9000 Certification in an Animal Care and use Program. 49th Annual AALAS Convention. Cincinnati, Ohio, October 19, 1998.
19. Principles of Aseptic Surgery. 48th Annual AALAS Convention. Anaheim, California, November 19, 1997.
20. Comparison of Irbesartan to Captopril in Heart Failure Prone Male SHHF/Mcc-facp Rats. Annual College of Veterinary Medicine, Advances in Veterinary Medicine Research Day, The Ohio State University. February 21, 1996.
21. Canine Leishmaniasis. Central Europe Continuing Education Seminars, Ramstein Air Base, Germany, December 1990.
22. Status of Dairy Facilities in Bahrain, Oman and United Arab Emirates. Annual International Veterinary Continuing Education Conf., Sonhofen, Germany, October 1989.

ABSTRACTS

1. McCune, SA, Carraway JW, Radin MJ, Holycross BJ: Comparison of Irbesartan to Captopril in Heart Failure Prone Male SHHF/Mcc-facp Rats. Abstracts of Scientific Papers Presented at Sixteenth Scientific Meeting of the International Society of Hypertension, June 1996.
2. Holycross BJ, McCune SA, Hoepf T, Carraway JW, Radin MJ: Role of Obesity and Gender in Regulating Responsiveness to Irbesartan, Captopril and Angiotensin II in a Hypertensive Rat Model (SHHF/Mcc-facp). Abstracts of Scientific Papers Presented at the Eleventh Scientific Meeting of the American Society of Hypertension, May 1996.