PLM automates medical design & manufacture processes

Synaptive, a medical device maker based in Toronto, Canada, has experienced an exceptionally aggressive and steep growth rate in response to market demand. Along with resource growth, Synaptive has gone through complete design, development, and transfer-to-manufacturing iterations for a number of medical device products. As company personnel and products grew, the mix of paper and software solutions for product development proved inadequate. The company needed to migrate to a software-only, integrated solution that provided the flexibility, visibility, control, and regulatory compliance required.

Company officials reviewed several solutions to address their needs. Initially they looked for an enterprise resource planning (ERP) system that could do it all but found that such a product didn’t exist. A recommendation from one of the ERP vendors prompted them to investigate Omnify Software’s product lifecycle management (PLM ) solution that integrates with ERP and met Synaptive’s requirements.

“We evaluated Omnify along with four other solutions,” states Arie Henkin, a quality systems lead at Synaptive Medical who led the software implementation. “Based on ease of integration, ease of configuration, feature list, and price, we chose Omnify Empower.”

The implementation process was straightforward. As a 40-person company at the time with limited IT resources, Synaptive chose to deploy the system in a hosted environment. A team of two was able to implement the solution in less than three months. A detailed plan was made for a module rollout. The system’s flexibility spurred an interest in implementing more than just core functionality of part data, bill of material, engineering change, and document management.

“Once the plan was made, it was a matter of familiarizing ourselves with the tool, performing data scrubs, setting up workflows, and importing data into the newly created system,” Henkin says. “Apart from tool validation – a must-have in the medical device industry – a rigorous training process was undertaken that involved everyone in the company.”

Omnify Empower has improved the speed of approvals, visibility, and productivity. Using its flexible workflow engine has helped make a variety of business processes electronic. As employees familiarized themselves with the software’s features, they started pushing for paper-based processes not originally considered to be migrated into the system.

“We are currently in the process of extending Omnify yet again, this time by implementing a module that will allow two-way communication between Omnify and our ERP software. This should improve the speed of implementing change orders and the generation of purchase orders by piping information directly from Omnify into the ERP, and will allow other information, such as costing, to be sent into Omnify,” Henkin explains.

Today, Synaptive Medical has more than 100 Omnify Empower users, a testimonial to the system’s ability to scale with its customers and integrate into employees’ workdays.

Omnify Software

www.omnifysoft.com

Synaptive Medical

www.synaptivemedical.com