Expert in Medical Technology
Expert is experienced in guiding medical device clients with software and hardware requirements. The FDA requirements for validation of software products and the maintenance of development records are quite stringent. Medical device companies need to know these requirements early in their development planning to avoid costly delays.
Expert is well versed in requirements for verification and validation testing for stability and integrity of biomaterials. The testing, selection, qualification, and processing of these materials is critical to developing a safe device that will pass FDA and international regulatory review. Expert knows the ins and outs of ISO 10993 and other international testing requirements.
Expert is knowledgeable in the areas of specialized packaging materials, clean room technique (manufacturing), and sterilization procedures. Although not an "expert" in any one particular area, Expert is skilled in integrating clean room requirements, product requirements, manufacturer limitations, and OSR. Expert aids clients in identifying key clean room resources.
These devices require a full appreciation of the materials, manufacturing, clinical evaluation, and FDA application procedures, as well as reliability and retrieval issues. This is a highly developed field with extremely rigid FDA requirements and user expectations. Expert has a comprehensive working knowledge in this area, and can assist in avoiding common problems in new product development, or mature product management.
Expert has more than a decade of experience with providing submissions and supplements for a variety of devices. Her background includes a broad range of device categories and specializes in helping clients prepare submissions and all supporting documentation.
Expert has been instrumental in defining the clinical protocols and establishing clinical centers for testing materials and implants. Expert knows the requirements and regulations for testing new medical devices prior to approval. She works with clients to design clinical trials, monitor studies, and develop clinical assessment strategies to support regulatory submission.
Combination drugs and devices and biologics and devices require specialized strategic planning early in product development. It is critical to the medical device manufacturer that they understand the complexity of the submissions for these types of products. Combination products can be as simple as a drug on a catheter or as complex as an in-vitro diagnostic that involves a biologic, drug, and biomaterial medical device. Expert is proficient in the submission of combination products and can aid clients with early strategic planning.
Expert has been instrumental in defining the clinical protocols and establishing clinical centers for testing dental materials and dental implants. Furthermore, she is knowledgeable about FDA regulations for these devices and their biomaterials testing requirements.
Expert has developed a hazard analysis and risk assessment report template and spreadsheet that features many of the attributes of a failure modes and effects analysis spreadsheet, but which compiles with EN 1441 for risk analysis. This procedure, report template, and hazard analysis spreadsheet is well tested through numerous FDA submissions. Expert's skill in organizing hazard analysis teams within client companies and training client companies on the methodology have proven effective in early project planning and design control and review.
Expert may consult nationally and internationally, and is also local to the following cities: Minneapolis, Minnesota - Saint Paul, Minnesota - Rochester, Minnesota - Burnsville, Minnesota - Saint Cloud, Minnesota - Eden Prairie, Minnesota - Minnetonka, Minnesota - Eau Claire, Wisconsin
|Year: 1981||Degree: MS||Subject: Biomedical and Mechanical Engineering||Institution: University of Minnesota|
|Year: 1974||Degree: BS||Subject: Biomedical and Mechanical Engineering||Institution: University of Kentucky|
|Years: 1987 to Present||Employer: Undisclosed||Title: President||Department:||Responsibilities: Established in 1987, provides regulatory and clinical consulting, as well as contract technical management to emerging medical product programs. Services include engineering and process analysis, clinical/regulatory affairs consulting, and medical product new-business assessment.|
|Years: 2018 to Present||Employer: Undisclosed||Title: ADJUNCT PROFESSOR OF BIOMEDICAL ENGINEERING||Department:||Responsibilities: Curriculum consulting and ad-hoc teaching|
|Years: 1989 to 1997||Employer: Boston Scientific||Title: Consultant||Department: Guidant||Responsibilities:|
|Years: 1984 to 1987||Employer: Possis Medical, Inc.||Title: Vice President of Research and Development, Vice President of Product Assurance||Department: Product Assurance||Responsibilities: Responsible for identifying new business opportunities; including establishment of alternative biomaterial partner-company to graft project and new product opportunities. Reported to CEO of Possis/PMI and President of PMI and Board of Directors. Responsible for development of new vascular graft program; including successful joint venture negotiations with major medical firm. Developed polyurethane microfiber and ePTFE grafts. Designed and developed unique mock-circulatory loop. Directed regulatory approval and animal research. Established product assurance department/materials qualification and testing capabilities. Reported to CEO of Possis/PMI and President/GM of PMI.|
|Years: 1983 to 1984||Employer: Kolff Medical, Inc.||Title: Director of Regulatory Affairs and Quality Assurance||Department:||Responsibilities: Responsible for clinical programs and regulatory submissions of JARVIK-7 artificial heart and cochlear prosthesis. Instituted GMP and GLP programs. Coordinated artificial heart training program for surgeons. Analyzed failure of the Shiley heart valves. Qualified use of Medtronic valve. Planned and budgeted contract animal implant studies, biocompatibility and physical testing for 5-year program. Assisted in taking the company through first public stock offering. Reported to President/CEO (R. Jarvik) and Vice-president/COO.|
|Years: 1974 to 1983||Employer: 3M Health Care Group||Title: Senior Research Engineer||Department:||Responsibilities: Responsible for new product development and new technology assessment/acquisition teams. Successfully acquired and integrated first implantable products: silicone hydrocephalic shunt, intraocular lens, mammary prosthesis, cardiac assist products, collagen products, new vascular and dental prosthetic materials. Developed patented disposable wound drainage system, non-woven vascular prosthesis, and implantable magnetic material. Assessed percutaneous access technology/market potential. Lead for acquisition of bone growth stimulator and bone growth materials. Reported to Technical Director; major acquisitions, reported directly to Division Vice-president.|
|Associations / Societies|
|The American Institute for Medical and Biological Engineering (AIMBE)-FELLOW
Society For Biomaterials:
Former Editor of Biomaterials Forum.
Council member 1981-2000.
Nominated for President
Journal of Biomedical Materials Research, editorial review board.
Numerous committees and Special Interest Groups
Association for the Advancement of Medical Instrumention (AAMI)
American Society for Testing Materials (ASTM):- F-4 Committee (medical device standards)
Regulatory Affairs Professional Society (RAPS
Retired Memberships-Held More than 10 years
Biomedical Engineering Society
Academy of Surgical Research-
International and American Society for Artificial Internal Organs
|Licenses / Certifications|
|Expert is a certified Regulatory Affairs Consultant (RAC) through the Regulatory Affairs Professional Association (RAP).|
|College of Engineering Dean’s Advisory Committee, University of Kentucky
Biomedical Engineering Department, University of Kentucky
(Formerly)-Biomedical Engineering Center, University of Minnesota
|Awards / Recognition|
|Outstanding Contribution to the Healthcare Industry, Medical Alley
C. William Hall Award for Service to the Society For Biomaterials
Hall of Distinction, University of Kentucky, College of Engineering
|Publications and Patents Summary|
| Expert has contributed to such publications as The Validation Consultant and Medical Device and Diagnostic Magazine.
Patents: 2 (US)