Medical device makers may put innovation on the back burner in light of the ever-increasing numbers of government regulations.
Some device makers simply don’t have time to come up with new and better designs and to ensure those designs meet all regulatory requirements.
But executives at Osstem Implant, which makes various dental implants, sought a way to balance regulation with innovation, said Tae-Yong Kim, head of the company’s information system management team. Osstem Implant’s products include implants that attach to weakened bones, more mainstream implants, and bone regenerative material, used when a patient has lost bone for implant attachment.
Because the company submits quality assurance information to regulatory organizations like the U.S. Food and Drug Administration, that QA data needs to be closely monitored in house, Kim said.
But executives also wanted to manage unique device identifiers (UDI) and design changes on the same digital platform used for quality assurance.
The FDA-established UDI system identifies medical devices throughout their distribution and use. The label of most devices includes UDI in human- and machine-readable form.
With those goals in mind, the dental implant company recently implemented the “License to Cure for Medical Device” software from Dassault Systèmes. The platform holds promise for the sought-for integration, as it brings traditionally disconnected processes and data together within one system, Kim said.
The solution offers a collaborative, end-to-end, traceable, and compliant product development process directly linked to quality and regulatory information. All from a single source of information, said Jean Colombel, vice president life sciences industry, Dassault Systèmes.
This end-to-end product development process minimizes time to market and regulatory overhead, Kim said.
“We selected (the software) to help us better manage regulatory activities and new product development as we expand internationally and must meet different market requirements,” Kim said. “We can improve product development and project management efficiency and streamline the regulatory filing process for our dental implant solutions.”
In the case of the device maker, regulatory information is included on the platform, meaning engineers can check for potential compliance issues within their designs and employees who oversee regulatory issues can also ensure designs comply with requirements, Colombel said.
The Dassault product is based on the company’s 3DExperience Platform, which provides 3D design, analysis, simulation, and intelligence software across company departments that might include sales, marketing, and engineering. Through its use, designers can share ideas across the company and those in sales and marketing can suggest changes and give feedback.
Medical device makes need a single environment to manage all aspects of their business, including the innovation process. Successful device makers jumpstart projects by using customer feedback along with supplier or internal best practices. They treat regulatory compliance as an asset in the development process, rather than a requirement, according to a Dassault Systèmes statement.
In other words, when compliance and innovation become complementary, rather than conflicting, processes the business’s bottom line stands to gain.
Filed Under: 3D CAD World