Innokas, a responsive and adaptive technology partner, collaborated with Sartorius, a global leader in Liquid Handling and In-Vitro Diagnostic (IVD) devices, on a significant project. This endeavor focused on developing a digital solution for production testing for Sartorius' Picus® 2 Electronic Pipette. Despite encountering tight schedules, technological complexities, and coordination challenges, Innokas demonstrated agility and commitment to delivering a high-quality solution. This case study illustrates how Innokas navigated various obstacles, including adapting to evolving project requirements, implementing strict security measures, and overcoming architectural transitions, to successfully deploy a functional product on time and ensure timely production ramp-up. 

Background and project kickoff  

  

Sartorius, founded in 1870, is a long-standing German-based global development and manufacturing company specializing in Liquid Handling and In-Vitro Diagnostic (IDV) devices. Their product, the Picus® 2 Electronic Pipette, offers reliable and ergonomic pipetting suitable for both novice and experienced lab workers. With mobile connectivity via the Sartorius Pipetting app, users can streamline workflows, access advanced settings effortlessly, and ensure readily available software updates. The app also allows users to configure the pipette and program sequences into it according to their needs.  

Innokas was tasked to digitalize production testing phase for Picus® 2 Electronic Pipette via a software solution. The project was immediately on a tight schedule; Innokas was asked to join the effort in November 2022 while the product had to be test-ready in March, so the production ramp-up could begin in May as scheduled in the roadmap.  

“We had good experiences about co-operation with Innokas based on our previous projects,” explains Mikko Turunen from Sartorius on why Innokas was chosen as the partner company for the development of the tester. Trust in successful delivery had already been established at that point.

Technical solution overview and technical infrastructure  

  

Innokas answered the need, and the project was initiated swiftly. The solution was to be a system accessible via browsers on the factory floor that would collect manufacturing data and provide calibration information for production line devices under test. Technology (stack) choice is Microsoft .NET based web application running on-prem servers, with Azure cloud service deployed for authentication and delivering firmware images. The system was developed and deployed using the customer’s tools and systems, adhering to the high-standard security rules set by Bundesamt für Sicherheit in der Informationstechnik (BSI), the Federal Cyber Security Authority in Germany.  

  
Software requirement specification and medical software development checklist  

  

Innokas followed established practices audited by the customer for software requirement specification. While the solution didn't demand all requirements of the medical software lifecycle standard as being the production testing software, Innokas employed relevant practices from their medical software development checklist: applying templates, establishing software architecture, thorough documentation, and verification planning. Additionally, Innokas provided testing and verification expertise, along with UX design for tester interface development. 

Coordinating software development with product development  

  

Some of the most significant challenges lay in coordinating the software development with the ongoing product development of the device firmware itself. The software team had to consistently adapt to changes in the device's hardware and firmware, given that its specifications were still undefined, and the software was tailored specifically for the product. The developers worked with weekly “snapshots” of the products' current state. Additionally, managing the diverse array of demands from various multicultural stakeholders within the organization introduced further complexity to the process.  

Adding to the challenge, the web server was not hosted on a readily accessible cloud service, but rather on the customer's on-prem servers in Germany, which necessitated access policies granted by the customer. In practice, this required the use of Sartorius specific computers and secure encrypted connections to access the server and deploy solutions. The strict cybersecurity dictated a lot of the projects pacing.   

Successful deployment and pilot series testing  

  

Despite the challenges, Innokas demonstrated flexibility in adapting to both the project requirements and the technological aspects. Innokas engineers participated in on-site verification at the Sartorius Kajaani factory, ensuring that all components functioned as intended. They were readily available to address any issues and enhance usability.   

“This testing equipment and application is an important part of the manufacturing chain of the new Picus®2 pipette,” Mikko remarks. “In focus of the new product implementation in manufacturing and a market launch in scheduled time, it was necessary to have the new tester developed simultaneous with the Picus®2 development and the tester being verified before the first production runs,” he adds.  

This case highlights Innokas' capacity to adapt proactively and responsively to evolving customer needs, even within time sensitive projects. An instance of this was seen in December 2022 when the project shifted from a desktop application to a web server client which necessitated a significant change in the solution's architecture. Despite the challenge posed by late-stage overhaul, Innokas successfully delivered a functional product on time. Pilot series testing commenced in March as scheduled, with the basic software functionality ready. As the production volume ramped up, a production testing system was deployed on the customer’s servers in Germany.  

If you have a need for similar adaptive agility in your upcoming or ongoing project, don't hesitate to turn to us. Innokas stands ready to support you in product development, manufacturing, digital solutions and quality assurance according to your needs. Submit a contact form below.