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 Expert  713381

Expert in Medical Technology

Available for your Consulting and Expert Witness Needs

Minnesota (MN)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements (QSR) and compliance issues such as recalls, corrections, complaints, and medical device reporting (MDR).

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.


biomedical device design review


Food and Drug Administration compliance


FDA medical device regulation


Food and Drug Administration regulation


investigational medical device exemption regulation




biocompatible material


bioimplantable material


implantable device


polymer biocompatibility


medical device manufacturing


medical device packaging material


medical product packaging process


medical sterilization


surgical implant device


medical device premarket approval


medical device reporting


premarket approval assessment


clinical protocol


clinical trial design


Medical Device Reporting regulation


clinical trial


biologic (product)


dental material

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.

medical device hazard analysis

Show Secondary and Basic Areas of Expertise
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;  and Eau Claire, Wisconsin.

Often requested
with this expert:

Medical Products Packaging: FDA Package Validation,...
Biomaterials and Product Development R&D for Orthopedic,...
FDA Regulations, Labeling and Compliance; Medical Devices,...
Medical Device Design and Manufacture

Year   Degree   Subject   Institution  
1981   MS   Biomedical and Mechanical Engineering   University of Minnesota  
1974   BS   Biomedical and Mechanical Engineering   University of Kentucky  

Work History:
Years   Employer   Title  

1987 to






1987 to 1987


Possis Medical, Inc.


Vice President of New Ventures


1984 to 1987


Possis Medical, Inc.


Vice President of Research and Development, Vice President of Product Assurance


1983 to 1984


Kolff Medical, Inc.


Director of Regulatory Affairs and Quality Assurance


1974 to 1983


3M Health Care Group


Senior Research Engineer


Career Accomplishments:

Expert is a member of ASTM, the Association for the Advancement of Medical Instrumentation (AAMI), the Biomedical Engineering Society (BMES), the Institute of Environmental Science, the American Association for the Advancement of Science, the Regulatory Affairs Professional Society (RAPS), the Academy of Surgical Research, the American Society for Artificial Internal Organs (ASAIO), the Canadian Biomaterials Society, the Food and Drug Law Institute (FDLI), the Surfaces in Biomaterials Foundation, and the Medical Alley Association.


Expert is a certified Regulatory Affairs Consultant (RAC) through the Regulatory Affairs Professional Association (RAP).

Professional Appointments

Expert has served on the executive committee and in other leadership positions of the Society for Biomaterials since 1981 and is currently editor of the Society's newsletter: "Biomaterials Forum."


Expert is a recipient of the 1999 C. William Hall Award, in recognition of outstanding records in establishing, developing, maintaining, and promoting the objectives and goals of the Society for Biomaterials. In 1992, Expert was awarded Medical Alley's "Outstanding Contribution to the Health Care Industry."

Publications and Patents Summary

Expert has contributed to such publications as The Validation Consultant and Medical Device and Diagnostic Magazine.

Selected Publications and Publishers  
 - The Validation Consultant  
 - Medical Device and Diagnostic Magazine  

Consulting Services:
Recent Client Requests:
  • Expert in Addressing cytotoxicity results.
  • Biocompatibility expert for consulting on Biocompatibility of medical devices used in ophthalmic and ENT surgery.
  • Expert in Medical Devices Forum
  • FDA Expert needed to review packaging validation testing and provide assistance with FDA communications.
  • FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Biomedical engineer expert witness for consulting on Use of pre-filled diluent syringes in the Autoject device by an MS patient. The syringe broke when using the Autoject and caused injuries to our client.
  • Medical device expert catheter for consulting on Recalled Pain Pump (faulty battery); Recallled tubing (fractured).
  • Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
  • Expert statistician for consulting on clinical trial, reporting/publication of results.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language  

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has experience locating vendors of: Packaging and sterilization for medical devices Biocompatibility testing laboratories and animal study groups Materials suppliers for medical devices.


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