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DESIGN OF MEDICAL DEVICES: A LIFE CYCLE APPROACH

Award Information

Agency:
National Science Foundation
Branch:
N/A
Award ID:
27503
Program Year/Program:
1994 / SBIR
Agency Tracking Number:
27503
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
BERTEC CORPORATION
6171 HUNTLEY RD, STE J COLUMBUS, OH 43229-1047
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 1994
Title: DESIGN OF MEDICAL DEVICES: A LIFE CYCLE APPROACH
Agency: NSF
Contract: N/A
Award Amount: $65,000.00
 

Abstract:

LIFE CYCLE DESIGN (LCD) CAN BE DEFINED AS THE INCORPORATION OF VARIOUS VALUES SUCH AS MANUFACTURABILITY, RELIABILITY, SERVICEABILITY, RECYCLABILITY, DISPOSABILITY, AND FUNCTIONALITY OF A PRODUCT IN THE EARLY STAGES OF DESIGN. WHEN APPLIED, CURRENT ADVANCEMENTS IN THE AREA OF LCD HAVE SIGNIFICANTLY ENHANCED THE DESIGN, DEVELOPMENT, AND QUALITY OF PRODUCTS. THE MEDICAL DEVICE INDUSTRY HAS NOT FULLY UTILIZED THESE TECHNIQUES. THE APPROVAL AND USE OF MEDICAL DEVICES ARE REGULATED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION. RECENT LEGISLATION, SUCH AS THE SAFE MEDICAL DEVICE ACT OF 1990 AND ITS 1992 AMENDMENTS, HAVE HAD AN IMPACT ON HOW SUCH DEVICES ARE DESIGNED AND MANUFACTURED. A SIGNIFICANT PERCENTAGE OF A COMPANY'S RESOURCES AND EFFORTS IS COMMITTED TO COMPLYING WITH A MULTITUDE OF REGULATIONS DURING THE DESIGN OF A MEDICAL DEVICE. THIS IS A TREMENDOUS BURDEN ON SMALL BUSINESSES. RESEARCHERS HAVE IDENTIFIED A NEED FOR A MEDICAL DEVICE DESIGN GUIDE THAT INCORPORATES COMPLIANCE WITH FEDERAL REGULATIONS WHILE UTILIZING STATE-OF-THE-ART LCD TECHNOLOGY. A FEASIBILITY STUDY IS BEING PERFORMED TO ASSESS THE POSSIBILITY OF SUCH A GUIDE. THE POTENTIAL BENEFITS AND COMMERCIAL REWARDS FOR SUCH A DESIGN TOOL ARE VAST.

Principal Investigator:

Scott Z Barnes
6144212803

Business Contact:

Small Business Information at Submission:

Bertec Corp.
819 Loch Lomond Ln Worthington, OH 43085

EIN/Tax ID:
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No