PRODUCT UPDATE
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SolidWorks
A design bureau that believes new product development works best when you attempt to cohesively link users, markets, and technology contributed to the development of a nonsurgical skin cancer treatment product. By using SolidWorks (Concord, MA, USA) software to its full potential, Lucid Innovation Group (Manchester, UK) was able to rapidly develop a commercially viable product.
Leveraging research showing that a combination of medication and exposure to light-emitting diodes (LEDs) can effectively treat nonmelanoma skin conditions, Photo Therapeutics (Altrincham, Cheshire, UK) set out to build a device harnessing that technology. The firm contracted Lucid to turn the concept into a marketable product.
Lucid solicited input from doctors, clinicians, marketing professionals, and patients on the product’s functional requirements. That data were translated into rough sketches that led to the creation of 3-D models of the Omnilux device using SolidWorks.
In building solid models to troubleshoot such issues as part interference, the design team made use of the software’s surfacing capabilities to produce the device’s sweeping shape. The CosmosXpress design validation tool helped to ensure that the device’s articulated arm, which holds the LED light source, would be sufficiently lightweight yet durable enough to stand up to constant use and cost-effective to manufacture.
The Omnilux went from concept to shipped product in 10 months. Currently, there are more than 2000 units in use worldwide.
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IQMS
Designed to replace paper-based device history records (DHRs) and to provide complete traceability, a DHR module links to a company’s enterprise resource planning (ERP) software to produce total visibility and control over the manufacturing process. The EnterpriseIQ ERP platform and DHR module allow medical device OEMs to eliminate expensive and time-consuming paper-based tracking systems, streamline product development, and ensure compliance, according to IQMS (Paso Robles, CA, USA).
The DHR module uses Web-based workflow tools and e-mail to connect business systems. For example, each person in a workgroup is simultaneously notified of change orders via e-mail. Once notified, each one can click on the provided link and approve changes with an electronic signature. A user-friendly interface helps operators to follow proper procedures. The software supplier has also developed a Quality Medical module for its ERP system. The module provides OEMs with tools to ensure that they are in compliance with ISO 13485 and ISO 9001, as well as US FDA regulatory requirements.
MasterControl Inc.
A new version of an integrated quality management suite of software will be released during the fourth quarter of 2006. Developed by MasterControl Inc. (Salt Lake City, UT, USA), the software is designed to help companies achieve continuous compliance with US FDA regulations, ISO standards, the Sarbanes-Oxley act, and other regulatory requirements. Version 6 features six new modules as well as hundreds of enhancements, according to the firm.
The new modules will allow companies to integrate existing electronic records with the MasterControl applications, to establish enterprise-wide connectivity while ensuring that business units are able to manage their own processes, and to monitor quality-related events and tasks in real time. In addition, a new Toolkit module enables integration of the MasterControl quality management software with existing enterprise resource planning, customer resource management, and other systems. Two more modules are designed to streamline management of the different phases of document-based or process-oriented projects, and to transfer the operational qualification documentation as part of an overall validation effort.
The MasterControl suite is built around a so-called continuous validation approach. This reduces the time and cost involved in system validation and minimizes the risks inherent in project implementation, thereby facilitating the validation of software upgrades.
Sparta Systems Europe
Enterprise quality and regulatory management software is described as a Web-based system that facilitates compliance with US FDA 21 CFR parts 11, 808, 812, and 820, and international quality system requirements. TrackWise software from Sparta Systems Europe (Ramat Gan, Israel) manages and tracks all compliance needs across the manufacturing, quality assurance, engineering, and product surveillance departments.
The software platform is completely configurable. It allows companies to manage the full range of business processes on standard architecture without purchasing application modules.
Vigilance and other reporting requirements are satisfied by means of automated workflow, rules enforcement, and report generation. The system provides ad hoc query capabilities, dynamic reporting to provide users with current information, and an array of other features.
Camstar
Manufacturing execution and quality management software is designed to manage, monitor, and synchronize manufacturing activities across globally distributed plants and integrate them in real time with core business processes. Camstar (Charlotte, NC, USA) offers one such package that is created specifically for medical device manufacturers.
Powered by the company’s InSite enterprise manufacturing and quality system, the medical device suite provides real-time data validation and analysis, a structured device master record, and a self-auditing device history record.
Manufacturing controls help to eliminate scrap, rework, paperwork errors, and redundant checks. The Web-accessible program gathers and stores data that production, quality, engineering, and management can use to rapidly resolve issues.
Abrevity
Life sciences organizations generate more data than most other vertical markets, according to a software developer located in California’s Silicon Valley. In particular, the use of laboratory instruments to analyze cellular and molecular mechanisms and to conduct clinical research generates huge amounts of data. The BioData Extraction module offered by Abrevity (San Jose, CA, USA) is designed to facilitate analysis, compliance, security, and information value management for companies working within this sector.
The software leverages patent-pending SLICE technology, which the company claims is more efficient than traditional methods for extracting and managing data involving laboratory instrument files. It can be installed in minutes.
The data model is described as an alternative to relational database or enterprise search technologies. It looks inside instrument files to extract target data and to tag the files with new metadata for classification purposes and to allow for policy-based management. According to the firm, the system also enables users to classify files based on the value they have to the business.
Pilgrim Software Inc.
A company that provides enterprise compliance and quality management software offers modules designed specifically for medical device manufacturers. The Web-based packages from Pilgrim Software Inc. (Tampa, FL, USA) are intended to help medical device companies ensure product safety and regulatory compliance, reduce manufacturing costs, and improve customer satisfaction.
The company’s Compliance Platform offers a fully integrated solution for internal and external assessments, nonconformance management, customer complaints, document management and SOP enforcement, employee qualification and certification, and equipment management.
The company’s products comply with US FDA’s 21 CFR Part 11 and help to ensure that regulatory and product safety requirements are fully met across the enterprise.
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Dyadem International Ltd.
Enterprise-ready software for fault-tree analysis uses a top-down approach to analyze events and potential product failures before they occur. FTA-Pro from Dyadem International Ltd. (Richmond Hill, ON, Canada) features an intuitive graphical user interface that enables analysts to save time on development and editing and to concentrate on system improvements. The system can reduce fault-tree development time by up to 80% when existing failure mode and effects analysis data are used, and by about 30% if they are developed from scratch.
The company also offers a configurable, knowledge-based risk management tool. FMEA-Med 7 helps device manufacturers verify that risk management is properly implemented in all stages of the design and manufacturing processes.
Brooks Software
A comprehensive suite of software applications for med-tech manufacturers is designed to be a complete regulatory process management and compliance system. The Medic suite from Brooks Software (Feldkirchen, Germany) provides a risk management and mitigation benefit by enabling manufacturers to control all critical data across operational and divisional units of their businesses.
Providing real-time applications and services, the software package addresses design, manufacturing, quality, traceability, and regulatory requirements in a linked fashion. Specific modules can be integrated as business needs grow to require them. The suite is based on a manufacturing compliance framework module using service-oriented architecture that connects the other modules, and connects those with legacy applications.
