Software
PDM Software Tracks Product Development Process
Helps device manufacturers meet design control requirements
Workgroup Technology Corp. (Lexington, MA) has developed a tool that provides medical device manufacturers with complete product data management (PDM) capabilities, enabling them to meet regulatory requirements. The CMS 7.0 software package manages the actual work outputs--or deliverables--of product managers, change coordinators, engineers, and other professionals throughout the product life cycle. It provides vault and version control, file security, product structure management, configuration management, process management, information distribution, viewing, and integration with desktop applications.
The software is particularly useful for medical device manufacturers trying to implement ISO 9000, QS-9000, FDA's quality system regulation, and the European Medical Devices Directive. CMS 7.0 makes this easier by modeling and institutionalizing processes, maintaining complete audit trails, and keeping process and product information tightly coupled.
Conventional PDM has focused only on managing information once engineering has released it, and has not significantly affected the front end of the development cycle. Likewise, conventional work flow technology has not been effective in automating product development because its rigid task-based approach does not accommodate the creative and iterative engineering process.
CMS 7.0 provides real-time visibility into the state of completion of deliverables, as well as any dependencies a deliverable may have on others. Features include stage-based process modeling, process synchronization, real-time project tracking, project and deliverable reuse, and enterprise-distributed vault.
For more information, contact Workgroup Technology Corp. at 617/674-2000.
New Equipment
Cutting Machine Designed for Processing Medical Tubing
Available with an optional solvent dispenser
For more information, contact TechnoMed at 603/893-6765.
Adhesives
Polyurethane Tape Provides a Breathable Contamination Barrier
For wound-care dressings and securing devices to skin
A polyurethane medical tape from 3M Medical Specialties (St. Paul, MN) comprises a 0.8-mil semipermeable film coated with a hypoallergenic, nonlatex, pressure-sensitive acrylate adhesive on one side that gently yet securely adheres to the skin. The 3M 9841 tape is suitable for medical products where breathability, long-term adhesion, and conformability are required.
The transparent tape enables complete visual monitoring of the wound without disturbing or removing the dressing. Acting as a liquid and microorganism barrier, the tape protects skin from outside contaminants, like bacteria and body fluids, and promotes quick healing. The waterproof, washable surface enables users to bathe and swim while wearing the tape, and the tape's breathability lets oxygen in and moisture vapor out, promoting normal skin function and extending wear time.
Because the adhesive is gentle to the skin and contains no rubber ingredients, it is suitable for neonatal and geriatric skin types and can be worn for extended periods with minimal risk of irritation. The flat profile conforms to irregular body contours.
Compatible with EtO and gamma sterilization methods, the tape is suitable for such applications as wound-care dressings, burn care, IV tube attachments, ostomy product attachments, and securing of devices to the skin.
For more information, contact 3M Medical Specialties at 800/228-3957.
