Biomedical Engineering Medical Device Design Development Expert Witness

Expert Witness No.815

Texas

Summary of Expertise

Biomedical Engineering; Medical Device Design, Medical Device Development

Expert 815 has been responsible for developing over 200 commercially viable medical products, ranging from surgical instruments to surgical implants.  His area of greatest concentration has been in minimally invasive surgery and least invasive surgery (MIS/LIS) instruments.  These instruments have been powered by hand, laser, pneumatics, hydraulics and electricity.  He has worked on the development of these products from concept through manufacture.  Many of these devices have been done in collaboration with internationally known medical professionals.

Medical Device Manufacture

In the area of medical device manufacturing Expert 815 has devised the means to manufacture, purchased tooling and equipment, secured outside vendors, and/or supervised Quality Control for a diverse list of medical products.  He has worked with laser catheters, arthroscopy shavers, forceps, scissors, ophthalmic products, surgical drapes, needle free injection systems, limb positioners and numerous other devices.

ISO 9001;  Good Manufacturing Practices (GMP)

He has been highly successful at establishing procedures for control of medical product development that meet the requirements set forth by GMP and ISO 9001 design control.  He has devoted considerable attention to ensuring that these systems are simple, easy to adhere to and require minimal paper work.

Bio-compatible Material

Because of his background in biomedical engineering, Expert 815 has become familiar with the bio-compatible, non-toxic, non-pyrogenic, and non-mutagenic requirements of medical products and components.  He is knowledgeable of how certain material properties can change due to certain sterilization processes. 

He understands how proper selection of materials is crucial to the approval process and as a result has helped speed product to market in a timely fashion.  He has worked with metals, plastics, ceramics, composites, woven and non-woven materials.  He is also familiar with adhesives and fibers used in medical products.

Disposable Medical Products

Expert 815 has dealt with high and low volume disposable medical device design, development and manufacture.  Having worked with such items as arthroscopy shaver blades, knives, laser catheters and surgical drapes he understands how such devices must be designed to be fully functional for single use applications without compromising the original intent or the product or the patients safety.  He has extensive knowledge of the varied usage environments as well as materials, manufacturing techniques and processes.

Reusable Medical Devices

Due to the rising costs of disposable medical products, there has been a renewed interest in reusable and multi-use instruments.  Expert 815 understands that multi-use instruments must be more robust than their disposable counterparts so to deal with the harsher environments of multiple usage, cleanings, sterilizations and in some cases, poor care by untrained or non-conscientious workers.  Expert 815 has designed, developed, and manufactured instruments that have been reliable, yet affordable, for several companies.  He has also designed and built custom instrumentation for unique surgical procedures.

Minimally Invasive Surgery Instrumentation

Over the past 20+ years Expert 815 has developed MIS and LIS instrumentation for arthroscopy, ENT, general surgery, ophthalmic, neurosurgery, urology, laparoscopy, GYN and esthetic surgical applications.

Experience

1994- Present, RWJ & Associates ,President

2000- Present, Equidyne Systems, Director of Operations

1998-2000, Kera Vision Inc., Director of Instruments

1990-1995, Laserscope, San Jose, CA, Director- Surgical Instruments Engineering

1987-1990, Baxter Edwards Orthopaedic Division, Tustin, CA, Director of Engineering

1986-1987, Precision Surgical Instruments, Richmond, VA, Manager of Engineering

1977-1986, Richards Medical Co., Memphis, TN, Manager, Product Development

Education

1981 - B.Sc. Degree, Mechanical Engineering
Memphis State University

1977 - A.S. Degree, Mech. Engr. Technology
State Technical Institute

1971 - B.A. Degree, Philosophy and Sociology
University of Mississippi

1969 - Estudios Hispanicos
Universidad de Barcelona

Continuing Education

1995 - ISO Lead Auditor Training, BSA

1988 - Manufacturing Management, Stanford University

1983 - Project Management, University of Tennessee

1982 - Management Development, Dale Carnegie & Associates

1982 - Supervision of Scientists, Engineers and Technical Staff, American Management Association

1981- 1995 - Numerous Surgical Technique Training Courses, CMA credits

Professional Memberships

The Orthopaedic Research Society

SPIE

The Society for Biomaterials

The Society for Testing and Materials

Patents

Data Available upon Request