Clinical and Legal Nurse Expert Specializing in All Aspects of Medical Device Product Development and Liability

Expertise

• Product development expert in recognition of clinical problems that can generate important medical device solutions that meet or exceed sales expectation.
• Clinical Research Director for large Maternal Infant Care (MIC) Medical Device Business.
• Expert in developing claims and regulatory strategy for product development.
• Patient safety and clinical risk assessment process for MIC portfolio.
• Risk assessment activities during product development.
• Planned and directed pre and post-market research projects with more than 60 studies completed or in progress.
• Over 15 years in research protocols development, budget and, managed annual research budget for profit and loss.
• Product validation exercises as part of design controls process, submittal of appropriate IDE, 510K, or PMA applications.
• Member of the executive management team in lean initiatives at profit and loss level resulting in the enhancement of understanding internal systems, achieved and changes made to move unproductive efforts into productive work output.
• Worked with product management, downstream marketing, and clinical application teams to develop appropriate, standardized training materials for internal customers to support strategic product launches.
• Development of innovative, professional medical and clinical educational tools for external customers to support product launch.
• Cultivated and supported key global relationships through development of advisory boards counsels at individual and clinical association level.
• Expert witness in medical device liability cases to determine use/misuse, product design forensic analysis, product installation/training issues as part of legal expert opinion development.

Experience

Undisclosed Company, President, 2010 - Present

• Provides the skills of the industry leader in working collaboratively with clinical customers and medical device manufacturers to benchmark work flow and clinical data.
• This ethnographic, immersion approach allows for identification of solvable, clinically relevant problems.
• Provides rich opportunities for implement improved patient outcomes and the ability to turn data into evidence-based process or product solutions to important clinical problems that meet sales goals.
• Over 15 years expert witness/advisory experience to work with the legal community on medical device liability issues function versus malfunction (hospital, industry, and consumer dimensions) to determine product liability issues. Plaintiff/defense cases considered.
• Cases reviewed for product design use/misuse/regulatory clearance issues, clinician use/misuse issues, and hospital liability and training issues.

GE Healthcare, Maternal Infant Care, Laurel, MD, 1995 - 2010

• Providing support in various positions: Manager, Clinical Research and Special Projects (Giraffe OmniBed, Panda iRes and Giraffe Warmers).
• Lead clinical and evidence generation strategy for MIC medical device business within GE Healthcare's $17 billion portfolio.
• Lead patient safety and clinical risk assessment processes for MIC portfolio as part of regulatory team.
• Supported clinical affairs support and risk assessment activities during product development and post-market product surveillance to meet regulatory compliance demands.
• Planned and directed pre- and post-market research projects with over 60 studies completed.
• Developed and managed annual research budget for profit and loss.
• Directed product validation, as part of design controls process.
• Assisted regulatory team in submittal of appropriate IDE, 510K, PMA applications.
• Participated as a member of the executive management team in Lean initiatives at profit and loss level. As a result of this effort, enhanced understanding of internal systems achieved and changes made to move unproductive efforts into productive work.
• Worked with product management, downstream marketing, and clinical application teams to develop appropriate, standardized training materials for internal customers.
• Lead multiple advisory panels across functional clinical care areas; act as key liaison to clinical leaders around the world.
• Lead in development of professional medical and clinical educational tools for external customers to support product launch.
• Cultivated and supported key global relationships through development of advisory boards counsels at individual and clinical association level.

Christiana Care Health System, Neonatology, Newark, DE, Senior NNP, 1985 - Present

• Deliver comprehensive, family-centered healthcare to sick, convalescing, and healthy infants.
• Perform approved medical procedures under the supervision of an attending neonatologist.
• Case manages select neonates using the nursing clinical model of assessment, planning, teaching, and evaluation.
• Facilitate educational efforts to improve outcomes across various collaborative practice groups.

Honors & Publications

Credentials

• Post Masters' Neonatal Nurse Practitioner, Georgetown University Hospital
• Board certified Neonatal Nurse Practitioner
• Outstanding Research Submission - NANN
• Distinguished Service Award - NANN
• Outstanding Alumnus - University of Delaware
• Delaware Nurse of the Year
• Highest Score on NAACOG NNP/Clinician Certification Exam
• Registered Nurse with Highest Graduating GPA - Widener

Academic and Professional Affiliations

• National Association of Neonatal Nurses president, (President to over 40,000 neonatal nurses)
• Society of Clinical Research Associates
• Association of Clinical Research Professionals
• National Perinatal Association
• American Society of Association Executive
• Delaware Nurses' Association
• Maryland Nurses' Association
• American Nurses' Association
• American College of Nurse Practitioners
• Delaware Valley Association of Neonatal Nurses
• National Association of Neonatal Nurses
• Sigma Theta Tau
• Association of Women's Health, Obstetric, and Neonatal Nurses

Awards

• Clinical technical advisor to 3 product teams receiving Medical Design Excellence Award (MDEA), from Canon Communications.

Publications and Patents

• Author of Over 20, book chapters, articles and publications.
• 4 U.S. patents.

Education

• Ph.D. Physiology, University of Maryland at Baltimore, MD
• M.S.N. Clinical Nurse Specialist, University of DE, Newark, DE
• B.S.N. Nursing, Widener University, Chester, PA