Review process sped from 5 days to 5 minutes

Hyper-growth med device manufacturer needs scalable solution to improve compliance within processes

As a medical device manufacturer, deploying a dedicated, scalable quality management system was essential to maintaining compliance across the product lifecycle as the company continued to scale both their workforce and product portfolio. Supporting a remote workforce made their paper-based change approval process all the more challenging. “Because of how quickly we are growing, we knew we needed a system that was configurable, scalable and could provide guidance going forward,” said Donielle Baudin, Director of Quality at Imperative Care. “We needed a way to improve compliance within our processes across the board."

Paper-based quality management makes it challenging to integrate quality with the design and development phase. Without having clear insight into quality issues during the design phase, engineers risk the possibility of designing products with components that may have been associated with a quality incident or complaint. “We realized that we needed to be able to track product and component problems all the way back to the PLM structure. We needed to be able to see if an item has been related to any quality incidents before it made its way into the next part,” said Baudin. With their homegrown system, engineers had to actively seek the information in a spreadsheet instead of having it readily available during the design phase, leading to longer development times and potential missed opportunities to improve quality. Imperative Care quickly discovered their previous method for tracking CAPAs and NCMRs was an inefficient way to get their products to market. “We really needed that closed-loop between PLM and QMS,” Baudin added.

“We would be in a world of hurt if we didn’t have Propel. The platform has enabled us to stay in business during a critical time as we make products for emergency care patients.”

^{Donielle Boudin, Director of Quality at Imperative Care}

The paper-based process also made it more challenging and time-consuming to collaborate across teams and projects. “We have employees who are offsite and getting signatures from them was very difficult,” said Baudin. “For changes or approvals everyone had to pass around paper or share spreadsheets,” she added. “It was very inefficient.”

In order to increase efficiency, collaborate effectively, manage quality and get their products to market faster, Imperative Care needed a cloud-native solution that combined product lifecycle management and quality management in one platform that enabled their team remote access from anywhere in the world.

PLM and QMS in one unified platform for full visibility into real-time quality issues

Propel provides Imperative Care with a closed-loop PLM and QMS solution from design to final product in one single cloud-native platform used by the entire organization. Propel is the hub for all product data and quality information, complete with dashboards, reporting, approvals, workflows, change orders, contextual collaboration, training records and more. “By having PLM and QMS together in one system, we now have immediate visual access and a hyperlink into what problems might exist,” said Baudin.

With product lifecycle management and quality management in one unified platform, their engineers have full visibility into any quality issues in real time. They also have complete PLM functionality and the ability to tie the bill of materials (BOM) to their quality records for future product iterations. “With Propel, we can easily track quality issues from finished goods and ensure they are addressed during the design phase of future versions,” said Baudin. “We are able to quickly analyze the data in front of us and examine if it’s a single incident, multi-incident or specific to a particular size or component,” she added. “Now I can monitor quality much more closely and more rapidly instead of spending time looking at a spreadsheet for those answers.”

Propel delivers a cloud-native platform that enables complete remote access of the product lifecycle from any device or region. All communication, product updates, changes and approvals are now completed within the platform without the need for physical paperwork. Imperative Care no longer has to distribute paper documents or a spreadsheet file as part of their product development process. “It’s great because it’s all done electronically now. We no longer have to make copies or spend our time filing,” said Baudin. “The fact that we can remote access any document or any piece of information from our quality system worldwide is tremendous.”

Propel delivers faster time to market, streamlined processes and global remote access

Propel’s comprehensive dashboards and reports have enabled Imperative Care to spend less time on administrative work and more time creating life-changing products for their customers. “At a moment’s notice, we can see the pulse of where our quality system lies. My management review process has gone from five days of data crunching and analyzing graphs and spreadsheets to a 5-minute report and I’m done,” said Baudin.

The modern and user-friendly interface has also enabled Imperative Care to quickly onboard and ramp their employees. “We were able to launch over 100 people in the first week,” said Baudin. “The user interface is modern and consistent, making it a lot easier and faster for our employees to learn and use.” The easy-to-use interface helps Imperative Care ensure simple onboarding and training, and preserve knowledge continuity going forward as their workforce evolves.

The ease-of-use has been especially helpful in training Imperative Care employees on critical, time-sensitive updates and documentation. “Before Propel we used an Excel spreadsheet for our manufacturing operators, which wasn’t entirely accurate in recording training assignments because it relied on the individual to fill it out,” said Baudin. “But with Propel, the first thing an employee sees in the platform are any open training assignments they need to complete,” continued Baudin. “The visibility into who has and hasn’t completed training has been extremely helpful for us. We no longer need to log into another platform to manage and track training compliance. It’s all there in Propel,” she added.

By decreasing the time spent on change approvals, Imperative Care has been able to get their products to market faster. “We’ve drastically reduced cycle times for change reviews. In our old system, reviews were done in series so person A looked at it then person B and then person C. With Propel, everyone can view them in parallel. Release activity has gone from a 20 to 30-minute process per document to 3 mouse clicks and we’re done, and the product is released,” said Baudin.

Because Propel is a cloud-native platform, Imperative Care is able to access their product information from anywhere in the world. “With Propel we’re able to work remotely from anywhere. Plus, as we continue to grow as a business, we are able to rapidly onboard employees and bring them into the same processes quickly,” said Baudin. Like many organizations, Imperative Care recently experienced the need for remote access during the COVID-19 shelter-in-place restrictions in Santa Clara County. “We would be in a world of hurt if we didn’t have Propel. The platform has enabled us to stay in business during a critical time as we make products for emergency care patients,” said Baudin.

Propel’s closed-loop platform helps Imperative Care get their products to market faster, maximize customer satisfaction and safety, and maintain compliance across any regulatory environment. Imperative Care is able to address stroke care needs by utilizing a cloud-native, closed-loop platform for the entire product lifecycle. “Because everything is done in one platform we don’t have to spend time hunting for information,” said Baudin. “Now, we can actually focus on day-to-day business needs and future strategy.”