October 23, 2007
RJLG Experts Exhibit Spinal Implant Services at NASS
Company uses ASTM F-1877 as standard practice for particle characterization
RJ Lee Group's (RJLG) medical device experts exhibited at the 22nd Annual Meeting of the North American Spine Society (NASS) in Austin, Texas, October 23-27, 2007, at the Austin Convention Center.
Wear fatigue and debris characterization is one of the services that our medical device experts provide, using a variety of analytical techniques, including Computer-Controlled Scanning Electron Microscopy (CCSEM), Raman microscopy, polarized light microscopy, and FTIR. We employ ASTM Test Method F 1877, which encompasses a series of procedures (including optical microscopy, SEM and energy dispersive X-ray (EDS) analysis) for characterization of the morphology, quantity, size, and size distribution of particles produced by wear test machines, total joint simulation systems, and abrasion testing. Additional medical device laboratory services include contamination identification, high resolution SEM imaging, particle sizing / characterization, technical support of FDA submittals, forensic defect analysis, device cleanliness assessments and litigation support services.
RJLG has consistently demonstrated the ability to provide the highest quality particulate analysis of wear debris from tested spinal implant assemblies, and has directly contributed to several successful applications for FDA approval. The ability to analyze such a high number of particles in such a short amount of time through the use of computer controlled SEM techniques reduces assumptions about how representative a given sample is, and provides the customer with a much higher level of confidence in the data. Furthermore, RJLG has forged a collaborative relationship with Lisa Ferrara of OrthoKinetic Technologies, LLC, one of the leading biomechanical engineers in the field of spinal implants specializing in FDA submittals, which will help to provide our clients the highest level of support when seeking FDA approval.
RJLG's Director of Biomedical Services, Steve Schlaegle created
a Medical Device Task Team composed of staff dedicated to
developing the Company's customer base within the Medical Device
community. In particular, the Team is focused on capitalizing on
the recent successes of RJLG in the medical implant field and the
high customer satisfaction associated with those accomplishments.
Members include Tricia Egry (Corporate Marketing), Jerome Schafer
(Corporate Sales), Dr. Matt Perricone (Technical Consulting
Services), and Tricia Wood(FDA Interactions).
Since its inception in 1980, RJLG has prided itself on the ability
to provide timely, customer-centric technical services. Our experts
simplify the complex through a thorough understanding of problems
and using applied sciences to solve them. This focus and
determination, in an ever-changing corporate environment, has
allowed the Company to brand itself as the expert in materials
characterization. In serving the health care industry, the Greene
County, PA, facility has expanded its laboratory capabilities to
include biomedical and pharmaceutical and biotechnology services.
As well, the New York office will continue to be involved with
Hospital / Clean Room Consulting (USP 797).
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