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PDM Software Tracks Product Development Process

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.

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New Equipment

Cutting Machine Designed for Processing Medical Tubing

Available with an optional solvent dispenser

A benchtop Programmable cutting machine has been developed by TechnoMed Inc. (Salem, NH) for use with medical tubing. The Readycut machine features an optional internal system that dispenses solvent onto the tubing for immediate assembly. When the operator's hand interrupts a photosensor, the prewetted tubing is automatically released.

The Readycut machine is particularly well suited for manufacturing tubing sets where cut-length precision, cut accuracy, and the quantity of solvent dispensed are critical. Cut lengths can vary from 2 to 390 in. in 0.04-in. increments, with average repeatability of ±2%, depending on the tubing material used. Outside diameters from 1.57 to 3.89 in. can be accommodated.

Fifty different production cycles can be stored in the system's memory, offering flexibility and repeatability. An in-progress counter displays the actual number of sequences or steps completed and the preset quantity per batch. An uncoiling system and tubing reel holder are also included.

In addition to the Readycut, TechnoMed also offers the Technocut and Rotocut tubing-cutting machines as well as various other types of assembly and testing equipment for medical product manufacturers. All tubing-cutting machines are CE marked, microprocessor controlled, and cleanroom compatible. The company also supplies medical-grade components and subassemblies used in the manufacture of dialysis, IV therapy, infusion, nutrition, and cardiosurgery tubing sets and assemblies.

For more information, contact TechnoMed at 603/893-6765.

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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.

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