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Product Lifecycle Management (PLM) Solutions

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Below is a sampling of our many customer success stories.
Medical Device Manufacturer Streamlines Product Design and Manufacturing Processes and Shortens New Product Development Timelines for Light-based Aesthetic and Medical Treatment Systems
Medical Device - Light-based Aesthetic Treatment Systems
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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Centralized and Automated Development Processes Get Accolades from ISO Auditor
Medical Device-Cell Purification Systems
Cytonome develops, manufactures and markets the most advanced, highest quality cell purification systems available worldwide for BioMedicine, BioIndustry, and BioScience.

They have an innovative focus to developing new products, where engineering develops concepts in parallel with manufacturing during the prototype phase. More efficient communication between these departments was the drive to adopt a PLM system. The company was managing product development with tools that did not communicate with each other. Information had to be manually entered into separate systems which took up valuable employee time, introduced costly human data entry errors and resulted in systems containing incorrect or out-of-date information.

Cytonome was also preparing for their International Organization for Standardization (ISO) certification and needed to have formal processes in place to demonstrate proper management, tracking and reporting of product development and manufacturing procedures and information.

“Our overall product development processes are faster and more efficient due to the time savings and improved data accuracy we have realized by implementing Omnify Empower as our central product information management system,” stated Heather Kiessling, Chief Financial Officer for Cytonome. “The most significant business benefit of using Omnify Empower is the real time global updates among engineering, purchasing and manufacturing that we did not have before.”
Return on Investment
 • First ISO audit resulted in zero findings and accolades from auditor
 • Achieved goal of real time information sharing among engineering, purchasing and manufacturing
 • Able to eliminate errors associated with manual processes
 • Direct integration with SOLIDWORKS
 • Direct integration with Expandable ERP
 • Gained faster and more efficient product development processes
 • Now manage product, quality and training information in a single/central system
 • Ease of use facilitated adoption across the company
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LoneStar Heart, Inc.
Efficiencies in Product Development Processes Result in Estimated $80,000 in Savings
Medical Device-Cardiac Restorative Therapies
LoneStar Heart was looking to gain efficiencies in product design and development by replacing their paper-based document control processes with an electronic system. As a developmental stage start-up, they wanted a cost-effective, cloud-based solution that would scale as the company grew. To meet Food and Drug Administration (FDA) requirements, the solution also had to adhere to FDA 21 CFR Part 11 guidelines for electronic records and electronic signatures and with plans to allow external partners such as consultants, development partners and suppliers access to necessary documentation, they wanted customizable role-based user access controls.

LoneStar Heart is using the Empower PLM system to manage product Bill of Materials (BOMs), Engineering Change Orders (ECOs) and Documents as well as Training records. Centralized information and automated processes helped to reduce ECO cycle time, enable faster communications with suppliers and development partners, and make compliance with regulatory requirements much easier resulting in $60,000-$80,000 in cost-savings in the first year of deployment.

“We selected Omnify Empower because we found that there are very few cloud/hosted PLM systems out there that are cost-effective while ensuring that there are no compromises on features and controls required for meeting regulatory requirements," stated Manoj Raghuraman, Program Director, Algisyl for LoneStar Heart, Inc.
Return on Investment
 • Cost-effective, cloud-based, scalable solution
 • $60,000 - $80,000 in savings in the first year of deployment
 • Faster communication with suppliers and partners
 • Reduced Engineering Change Order cycle time
 • Adhere to 21 CFR Part 11 compliance for electronic records
 • Easier to meet compliance with centralized information
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RenalGuard (Formerly PLC Medical Systems, Inc.)
Leader in Innovative Technologies for the Cardiac and Vascular Markets Automates Engineering Change and Training Processes for Continuous Improvement and FDA/ISO Compliance
Medical Device-Technologies for the Cardiac and Vascular Markets
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/RenalGuard to capture employee product knowledge so if anyone left the company they took that knowledge with them.

PLC/RenalGuard 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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Seahorse Bioscience
Medical Device-Biological Research and Drug Discover Products
Serving the life sciences industry since 2001, Seahorse Bioscience provides industry-leading analytical instruments, biomanufacturing systems and consumable labware products for biological research and drug discovery.

Seahorse Bioscience was managing product development with paper-based processes. Information such as part numbers and Engineering Change Orders (ECOs) were processed using Excel spreadsheets. This eventually became inefficient, risky and laborious. In addition, the company had two corporate divisions. With the data spillover that can result from any collaborative work
between multiple corporate divisions, a Product Lifecycle Management (PLM) system became a necessity in order to centralize and control information.

The company’s primary goal was to find a means to centralize and automate their document control tasks. They wanted to have one corporate source for part number generation, ECO generation and tracking, and a secure corporate repository for design/product data with automated revision control.
Return on Investment
 • Replace error-prone Excel-based part generation and ECO processes
 • Keep product data for two corporate divisions in sync
 • Eliminate issues with misplaced or forgotten ECOs
 • Eliminate purchasing out-of-rev parts and assemblies
 • Guarantee vendors are using the latest revision
 • Streamline design and manufacturing information
 • Integration with corporate ERP system, Infor Syteline
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Solta Medical, Inc.
Solta Medical Meets Stringent FDA Compliance Requirements for Class II Medical Device Product
Medical Device-Medical Aesthetics
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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