Thomas Herbst Email & Phone Number

Maple Grove, Mn

Major responsibilities in this position include:Planning and refining study specific endpoints used to assess the response at the device-tissue interface to allow safety assessments prior to submission.Advising on GLP study design and mentoring study directors. Perform GLP and non-GLP pathology analysis on device studies including cardiac stents, pacing leads, defib leads, peripheral stents and aneurysm coils. Teaching internal classes for engineers and scientists on medical device pathology. Maintaining contract pathologist resources for peak workloads and for continued outside expert input for regulatory submissions. Integration of BSC-Guidant cardiac rhythm device pathology needs.Directing GO or NO GO recommendations regarding device safety as assessed in BSC preclinical studies.Conduct pathologic analysis on complaint specimens (MDR) where pathology analysis may add significant content to our understanding of failure processes. Interface with regulatory bodies for device submissions.

Pathology support position within the preclinical division of BSC. The position involves morphologic interpretation and reporting on medical device preclinical animal studies. Implant histopathology and clinical pathology as well as scanning electron microscopy are used to assess device performance and local tissue responses. In addition to the pathology services, the position involves interaction with discovery teams (R&D) on forward thinking device design and testing strategy.

Facility director with oversight of preclinical safety/toxicology testing at AppTec. Participation in business development projects, novel device study designs and custom technology transfers. For non-compendial studies, advise clients on study design and endpoint determinations and interface with the FDA in support of client submissions and proposals. Review of "positive" test results in preclinical studies and making recommendations for appropriate course of action. Managing a staff of technicians, research associates, study directors, two veterinarians and a pathologist. Reviewed policies and budgets and wrote SOP's and report templates. Performed ongoing technical training in areas of medical device biocompatibility testing. Functioned as study director on hundreds of GLP preclinical safety studies (implantation, sensitization, irritation . ) for ISO, EPA, USP, EU and FDA compliant requirements for clients in the medical device, pharmaceutical and biotechnology arenas. Member of several AAMI/ISO technical committees

Worked initially as study pathologist for 5 years in preclinical medical device investigations. This included work on central and peripheral vascular grafts, dialysis grafts, intracardiac and pericardial membranes, sutures, soft tissue patches for hernia repairs, anti-adhesion studies, antimicrobial treated implants, pacing catheters as well as plastic and reconstructive implants. Spent 3 years as the principal pathologist for a specialized group within Gore doing discovery work on combination medical devices; ePTFE isolation chambers containing genetically engineered cells and/or primary tissues such as islets, for the treatment of specific single gene genetic diseases with a primary focus on type I diabetes. In addition to device pathology focus at Gore, gave technical and marketing presentations to surgeons and clinical scientists and gave in-house lectures in medical device pathology and immunology. Wrote technical documents in support of 510K submissions to the FDA. Chaired the Animal Care and Use Committee. Managed the histology and implantology group within Gore Hybrid Technologies and at Gore Medical Products Marketing Division I performed post-explant failure analysis on regular and MDR explanted returned clinical device specimens. Over 8 years have written reports for surgeons on many hundreds of explanted medical devices and/or portions of devices removed from humans.; Lectures and labs in microbiology, cell biology, immunology, biochemistry, electron microscopy and research methodology/techniques. Established the tissue culture laboratory. Obtained NSF funding.

Mpls, Mn

Tenure-track faculty position in the Biology Dept teaching upper division courses and labs in immunology, microbiology, biochemistry, cell biology and research methodology.

Human Clinical Cytogenetics

Ph.D., Pathobiology

Ph.D. minor in microbiology

Ph.D., Pathobiology

Ph.D. Pathobiology; Ph.D

Ms, Electron Microscopy

*MS degree not completed; left early to start Ph.D. program at U of M; completed all required classwork and summer internship in electron.

B.S, Natural Science