Synaptive offers case study on PLM to automate medical device product development.
Synaptive is a medical device maker based out of Toronto, Canada. Their BrightMatter Neurosurgery products offer state-of-the-art equipment, advanced surgical visualization, and cohesive informatics. Through partnerships with neurosurgeons, radiologists, and healthcare facilities, they integrate these technologies in a way that is clinically relevant, cost effective, and above all, centered on improving patient care. From automated surgical positioning systems to neurosurgical imaging, optics and information science, Synaptive Medical delivers the systems and equipment required to fully focus on what matters most: the patient.
In recent years, Synaptive 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 the company grew (in personnel and products), it was becoming obvious that the existing mixed paper and software solution for product development processes was inadequate. There was a need to migrate to a software-only, integrated solution that provided the flexibility, visibility, control, and regulatory compliance required for a growing medical device company.
The company reviewed several solutions to address their needs. Initially they looked for an ERP (Enterprise Resource Planning) 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 as a solution that can integrate well with ERP and meet Synaptive’s requirements. “We evaluated Omnify along with four other solutions,” stated Arie Henkin, a Quality Systems Lead at Synaptive Medical, who led the implementation of Omnify Empower. “Based on ease of integration, ease of configuration, feature list, and price, we chose Omnify Empower.”
The implementation process for Omnify was straight-forward. As a small company with limited IT resources, Synaptive chose to deploy the system in a hosted environment. The company was 40 people at the time, and a team of two was able to implement the solution in less than three months. A detailed plan was made for module roll-out; due to the flexibility of the system there was a desire to implement 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,” stated Mr. Henkin. “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 subsequently productivity. Utilizing its flexible workflow engine has helped to make a variety of business processes electronic. As employees familiarized themselves with the features in Omnify Empower, they started pushing for other paper-based processes (which were not originally in-scope, and which were not originally contemplated to be handled by Omnify) to be migrated into Omnify. An example of this is a Purchase Request process to allow employees to submit requests to the Buyer Group for initiating Purchase Orders (for prototype, evaluation, and miscellaneous purchases). Approving is performed in Omnify Empower by routing the Purchase Request, based on project and cost, to the appropriate approval level.
The improvements don’t stop there: “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,” said Mr. Henkin.
Today, Synaptive Medical has more than 100 Omnify Empower users, which validates the system’s ability to scale with its customers. Omnify Empower is integrated into the daily life of employees. Whether raising a non-conformance in production, creating a change order in engineering, or opening a corrective action in quality, employees know that the answer to “where can I find….?” is “Omnify.”
Synaptive Medical
synaptivemedical.com
