• Medical Lasers: operation, applications, and safety

Professional Summary

Manage North American accounts and resolve regulatory, engineering and training issues related to medical laser research, development and clinical use. Provide support for FDA approved drug and medical device clinical trials, PMA, NDA & 510K submissions, medical staff training and regulatory approval processes.

Experience

• Support North American NIH sponsored PDT research and FDA approved clinical trials on behalf of universities, pharmaceutical and medical device manufacturing industries.
• North American clinical and technical support specialist for the Phase III, multi-center clinical trials of a light activated photosensitizer (Photofrin & Foscan) and investigational instrumentation used in the treatment of cancer. Efforts contributed to the FDA approval and clinical use of drug (Photofrin®) and ancillary instrumentation used for the treatment of lung cancer, esophageal cancer and Barrett's Esophagus.
• Supported the set-up, operation, instrumentation and application of >15,000 clinical and surgical laser procedures utilizing advanced instrumentation involving all medical and surgical specialties.
• Establish institutional laser safety policies, perform audits, prepare pre & post injury hazard analysis reports and develop accredited staff training programs in compliance with local, state or federal regulations.
• Saved health care organizations several hundred thousand dollars annually by maintaining and repairing state-of-the art medical equipment, advanced laser & electro-optic systems and ancillary instrumentation in lieu of costly service and maintenance options.
• Proficient in the use of analytical, diagnostic and scientific instrumentation and service software.
• Evaluate customer requirements for capital equipment purchases and repairs, complete system upgrades, retrofits and calibrations that meet and exceed customer expectations.

Employment

Axcan Pharma, Birmingham, AL (Consultant & contract employee) 2003-Present ~North American PDT Clinical, Regulatory, Engineering Support & Speakers Bureau Support medical centers and university hospitals in the clinical application of FDA approved light-activated drug and devices for treatment of lung & esophageal cancer, esophageal Barrett’s (high grade dysplasia [HGD]) and Phase III clinical trials (cholangiocarcinoma, head & neck, metastatic chest wall, etc.). Clinical and engineering support for OEM partners in the development of light sources, fiber optics, balloon catheters and endoscopic instrumentation.

Diomed Inc., Andover, MA 2000-2003~North American Customer Support Manager~Manage, support and train North American physicians, medical staff, independent sales representatives and strategic partners for United Kingdom based medical laser manufacturer. Technical and clinical support for surgical, vascular and oncology procedures involving medical lasers and ancillary instrumentation.

Allina Health System, Minneapolis, MN 1990-2000~Medical Laser Application Specialist~Technical/clinical support for all surgical, cardiovascular, endoscopic, minimally invasive and outpatient laser procedures and NIH sponsored research projects. Medical staff trainer and institution Laser Safety Officer. Saved several hundred thousand dollars annually by maintaining and repairing state-of-the art medical equipment, advanced laser & electro-optic systems and ancillary instrumentation in lieu of costly service and maintenance options.

Johnson & Johnson, Raritan, NJ (Photomedica Inc.) 1985-2000 North American Clinical Support Manager Clinical/engineering support for Phase III multi-centered clinical trials of light activated drug for treatment of lung, esophageal and urinary bladder cancer. Assist/support clinical investigators in all aspects of information gathering for the device portion of Investigational New Drug (IND) and New Drug Application (NDA) required FDA submissions.

Education

• Electronics & Laser Electro Optics Technology 1990-1995~Minnesota State Licensed Instructor (VT File #5709)~Hennepin Technical College, MN
• Laser/Electro-Optic Technology 1984~AAS Degree, Northcentral Technical College, Wausau, WI
• Marketing 1980~AAS Degree, Northcentral Technical College, Wausau, WI

Memberships

• Laser Institute of America (1999-present)
• Board Certified Laser Safety Officer (2002-present)
• American Society for Laser Medicine and Surgery (1985-present)
• American National Standards Institute (ANSI) Z136.3 Subcommittee (1999-present)

Clinical, Regulatory & Engineering Support

• Development of Photofrin® and ancillary instrumentation for the treatment of cancer and esophageal Barrett’s/ High Grade Dysplasia (HGD) at university hospitals throughout United States, Canada and Spain
• National Institute of Health (NIH) sponsored research projects of Photodynamic Therapy (PDT) conducted by Advanced Photodynamic Technologies, Inc., Minneapolis, MN
• Contract regulatory and engineering support for Axcan Scandipharm Inc., Diomed Inc., Vascular Solutions Inc., Narco Medical Services, Laserman Inc., TransOne Mobile Technologies, Medical Alliance & University of Minnesota College of Veterinary Sciences

Published

• Photodynamic Therapy to the Oral Cavity, Tongue & Larynx: a Canine Normal Tissue Tolerance Study (Lasers in Medical Science 1995, 10:13-18) co-author
• Laser Safety During Laparoscopy Procedure (Volume 6, Number 1, January 1998) Laser Institute of America Newsletter
• Photodynamic Therapy: A Guide to Instrumentation and Dosimetry Calculations and Surgical Lasers: A Technology Review (Volume 10, Number 3, 1996), Minimally Invasive Surgical Nursing Journal
• Laser Technology: The Basics and Beyond, (Volume 9, Number 2, 1995)
• Minimally Invasive Surgical Nursing Journal~~Effect of Low-Dose Argon Irradiation on Rate of Wound Closure (Lasers in Surgery and Medicine 5:607-614, 1985) co-author

Invited Faculty/Instructor

Endobronchial Photodynamic Therapy: “Hands-On” Training for Clinicians, Roswell Park Cancer Institute, Buffalo, NY. 2004~

Photodynamic Therapy physician training programs for Barrett’s HGD & Esophageal Cancer, University of Tennessee/Thompson Cancer Survivor Center. 2000-present

Physician’s Forum on Photodynamic Therapy, Health Education Technologies (HET): New York, NY. 1997-1998

Medical Laser Safety Training: Rockwell Laser Industries, Cincinnati, OH. 1994

Medical Lasers & Safety: Engineering Technology Institute, Waco, TX. 1990-1991

Holmium Laser Arthroscopy Seminar & Current Trends in Photodynamic Therapy, Coherent Medical Group: Miller-Dwan Hospital, Duluth, MN. 1997

Medical Laser Training for Physicians: Laser Center, Abbott Northwestern Hospital, Minneapolis, MN 1988-2000

Advanced Endoscopic Surgery for the Gynecologist: University of Missouri-Kansas City, School of Medicine, Kansas City, MO. 1990

Medical Laser Training for Physicians: Laser Center, Grant Hospital, Columbus, OH. 1982-1985

Laser Nurse Training: Laser Institute of America, Orlando, FL. 1983

Laser Training Programs Developed & Presented~Medical Laser Safety Update Training (8 hrs): Community Memorial Hospital, Oconto Falls, WI on behalf of the Laser Institute of America, February 2005

Axcan-Photofrin® North American Technical Sales Representatives, Marina Del Rey, CA, October, 2003

Advanced Medical Laser Hazard Analysis: International Laser Safety Conference 1999 sponsored by the Laser Institute of America (LIA), Orlando, FL

OR Laser Safety Training: West Health, AMC-Hastings, Allina Health System, Mayo Clinics (Rochester, MN, Jacksonville, FL, & Scottsdale, AZ)

Fairview/University Health System, Maplewood Surgery Center, Barnes-Jewish Hospital and others, 1988-present

Advanced Medical Laser Hazard Analysis: 5th annual meeting of the North Central Biomedical Association (NCBA), Breezy Point, MN 1998

Advanced Medical Laser Technology courses (40 hrs/ea): Fairview/University Hospital, November 1997 & January 1999, and Fairview Southdale Hospital, March & May 2000 and June 2003, CM Points issued by the Board of Laser Safety

Industrial Laser Safety Audit & Employee Training: ADC Telecommunications, Minneapolis, MN. October 1997 & January 2000

Electronics & Laser Electro-Optics Technology course (40 hrs/semester-accredited): Hennepin Technical College, Licensed by the Minnesota State Board of Vocational Technical Education, 1990-1995

Biomedical Applications of Lasers courses (30 hrs/quarter): Laser Center of Abbott Northwestern Hospital, Minneapolis, MN 1989-2000

Biomedical Laser Maintenance and Operation courses (16 hrs/ea): Laser Center of Abbott Northwestern Hospital, Minneapolis, MN. 1989-2000

Laser Safety in the Operating Room: Minnesota Association of Nurse Anesthetist’s (MANA) annual meeting, October 1997

Laser Physics, Dosimetry and Safety: Allegheny General Hospital (Pittsburgh, PA) program on "Current Trends in Photodynamic Therapy", September 1997

Laser Technology: The Basics and Beyond: 15th annual meeting of the American Society for Laser Medicine & Surgery (ASLMS), San Diego, CA. 1995

The Role of the Biomedical Laser Specialist: 11th annual meeting of the American Society for Laser Medicine and Surgery, San Diego, CA. 1991

Medical Laser Safety: 30th annual meeting of the Association for the Advancement of Medical Instrumentation (AAMI), Anaheim, CA. 1995 & Tampa, FL 2005

Non-Ionizing Radiation and Laser Safety Workshop: Midwest Center for Occupational Health & Safety, Minneapolis, MN. 1993-1994

Medical Laser Operation, Safety & Maintenance: North Central Biomedical Association (NCBA), Minneapolis, MN. 1994 & 1996