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Below is a sampling of our many customer success stories.
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Select by Customer: |
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| Displaying Industry: Medical Device |
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 | Medical Device Manufacturer Streamlines Product Design and Manufacturing Processes and Shortens New Product Development Timelines for Light-based Aesthetic and Medical Treatment Systems | | Industry | | Medical Device - Light-based Aesthetic Treatment Systems | | | | Overview | Cynosure was looking to streamline their product design and manufacturing processes in order to shorten new product development timelines and ease collaboration with suppliers. They needed to implement technology that provided a centralized location to store product documentation such as bill of materials (BOMs) and design drawings, in addition to automate the processing of engineering change orders (ECOs). Cynosure wanted the ability to import SolidWorks software files and OrCAD BOMs in addition to the ability to upload data to both their existing and future ERP systems. Easy export of information into common formats such as Excel spreadsheets and BOM comparison functionality were important features. Enabling secure access to product information for key suppliers and contract manufacturers were also fundamental requirements.
Cynosure selected Omnify Software due to Omnify's ease of use, powerful data sharing capabilities, and affordable cost. Omnify's unique ability to directly integrate with SolidWorks and Cadence® OrCAD® Capture CIS have helped to greatly decrease the time required for documenting change as well as significantly increase the quality and accuracy of product data. | | | | Return on Investment | | • | Data validation and error checking earlier in the design cycle | | • | Decreased engineering change cycles through direct integration with their engineering tools | | • | Improved data integrity | | • | Decreased time spent searching for information | | • | Reduced product redundancies | | • | Shortened product development time | | • | Shortened time-to-market | | • | Quick implementation | | • | Easy to use |
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 | Pathway Medical Technologies Engineers More Products and Eases Audit Processes | | Industry | | Endovascular treatments for Peripheral Arterial Disease (PAD) | | | | Overview | Pathway Medical Technologies was using a paper-based system for managing all of its product documentation, part drawings and engineering changes. The company utilized a room that housed all of the paper procedures and hard drawings with a checkout system similar to a library. The company wanted to bring in a PLM system to streamline the entire engineering change process, implement better security with document vaulting, improve Bill of Material (BOM) management, and make product information (drawings, blueprints, revisions, and supporting materials) easily yet securely accessible to appropriate team members.
Pathway selected the Empower PLM solution from Omnify Software because of its ease of use, fast deployment time and low cost. Document control, engineering change, BOM and regulatory conformance processes are now managed via the Empower PLM system. All departments that have governing procedures are using the system including: design engineering, quality, regulatory, manufacturing engineering, purchasing operations, and even facilities management. Any changes made to any procedures are performed and managed within Empower PLM.
As a medical device manufacturer, Empower PLM product features such as Quality Management, for documenting and tracking all non-conformances and customer complaints, and Training Management, to automate the management of all internal and external training, address the companies’ need to comply with ISO quality management system requirements.
Managing compliance data with Empower PLM has simplified Pathway's audit process, making it much easier to show auditors how product information is accessed and tracked online and prove the audit trail of activity for documentation as well as get requested documents much faster than through their previous paper-based vault system. | | | | Return on Investment | | • | Affordable, easy to use, quick to implement system for start-up | | • | Ability to engineer more products with resource time-savings | | • | Streamline entire engineering change process | | • | Eliminate tedious paper-based, hard copy system | | • | Centralized and secure product information | | • | Ease ISO compliance audits/processes | | • | Compliance with quality system requirements | | • | Integration with Exact MAX ERP system | | • | Single system for product data, quality and training management |
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 | Leader in Innovative Technologies for the Cardiac and Vascular Markets Automates Engineering Change and Training Processes for Continuous Improvement and FDA/ISO Compliance | | Industry | | Medical Aesthetics | | | | Overview | The company was managing product data with a homegrown system developed in an Access database that required a great deal of manual intervention and paper processes. If someone changed a Quality document they would have to print it out, pull out the old document from a folder, put in the new version and then walk around from person to person for sign-off. This setup did not have the necessary tracking for who was actually trained on a certain procedure, who signed off on an Engineering Change Order (ECO), or when items were signed-off. In addition, it did not allow PLC to capture employee product knowledge so if anyone left the company they took that knowledge with them.
PLC was looking to replace the homegrown database with a solution that would allow Documentation Control to keep ECOs moving through an automated system rather than a ‘walking system’ where they had to physically walk from person to person for sign-off. In addition, being in a highly regulated industry required PLC to set up more formal, automated processes. | | | | Return on Investment | | • | Meet stringent FDA and ISO compliance requirements | | • | Improve ECO and Training process efficiencies | | • | Substantial labor savings due to automated processes | | • | Significant cut in change approval to production time |
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 | Solta Medical Meets Stringent FDA Compliance Requirements for Class II Medical Device Product | | Industry | | Medical Aesthetics | | | | Overview | The Thermage solution from Solta Medical is a Class II medical device and therefore is required to meet stringent Food and Drug Administration (FDA) compliance requirements. Solta Medical must have a proper document structure in place to show the history of how a product was built, with signed and dated documents.
Solta Medical wanted a central and secure location for all Thermage product data to be vaulted so that they could easily track, manage and find information. They also wanted to implement a system that would support better compliance and manufacturing processes. | | | | Return on Investment | | • | Meet stringent FDA compliance requirements (21 CFR part 11) | | • | Able to complete Software Validation in short timeframe | | • | Eliminate waste in manually searching for product information | | • | Easy to use solution/Fast user adoption for existing and new staff | | • | Superior customer support |
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 | Hot Medical Device Start-up Prepared for Growth and Compliance | | Industry | | Medical Device | | | | Overview | Vessix Vascular is a privately-held, venture-backed company developing novel radiofrequency balloon catheter technology directed towards a variety of clinical applications including the treatment of medication resistant hypertension via percutaneous renal denervation, and peripheral in-stent restenosis.
Comprised of a group of individuals with previous experience at successful medical device companies, one of their first priorities was to formalize their product development processes to prepare for their market introduction, successfully meet regulatory guidelines and implement best practices early on.
Vessix selected the Empower PLM solution because it met their needs as a small start-up with an easy to use and configure system and also delivered the features they needed for controlled product development processes to meet compliance requirements. The scalability of Empower PLM ensured Vessix that they would be able to continue to use the tool as the company grew. | | | | Return on Investment | | • | Implement product development best practices early on | | • | Affordable, scalable and robust PLM solution for start-up | | • | Time to process ECOs is transparent | | • | Simplified audit processes/meet compliance requirements | | • | Dynamic vendor management provides visibility into all vendor associated parts and assemblies | | • | More efficient machine calibration and preventive maintenance process |
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