Developing Medical Device Simulators for the World’s No. 1 Pharmaceutical Сompany

Summary

Industry: Biotech
Headquarters: Basel, Switzerland
Partnership period: May 2019 – Ongoing
Team size: 15 experts
Software product: Medical device simulators
Expertise delivered: Dedicated Development Team, Java Development Services, Quality Assurance.

Challenge

Our client Roche is a Basel-, Switzerland-headquartered pharmaceutical and BioTech multinational, the history of which spans more than 126 years. They are the world’s #1 pharmaceutical company and a leading provider of cancer treatments globally. Roche employs more than 100,000 people in 150 countries.

At the time prior to the project’s start, the client required technical assistance in several important areas. We became the provider of choice for the project through a referral by one of Roche’s technical officers, who had previously worked for a major eCommerce client of ours and recommended us as a competent and reliable provider of bespoke software.

The primary area in which our client needed assistance was developing software for Roche’s DNA-sequencing machine, responsible for analyzing multiple DNA samples concurrently. When a person takes a blood test in a lab, the related data is added to a system called Connecting Software. The obtained DNA sample is then added to a DNA-sequencing machine to conduct the DNA-sequencing process. Next, the sequenced DNA samples are transferred to other machines to be further analyzed automatically, or to doctors and scientists, who analyze them manually.

Whenever a new API is added to the system’s embedded software to enable its interactions with the controlling software, our team tests whether it works properly and determines the adjustments to be made to the system’s software or hardware for achieving the maximum efficiency of interactions between them. However, not all the testing can be performed on a real machine for the risk of getting it damaged.
In addition to the testing of Roche’s DNA-sequencing machine and developing the related simulator software, our experts are also engaged in several more activities as part of the сlient’s in-house team. In particular, such activities include migrating tests from the legacy testing framework to the new one and helping further enhance the product.

Solution

At first, the project team we provided was composed of only 2 experts. In the spring of 2020, this initial team was significantly expanded and kept on gradually growing afterward. By April 2022, SPD Group’s project team had grown to include 15 experts.

As of February, 2023, 10 members of our project team were involved in testing the client’s software and developing medical device simulators for their DNA-sequencing machines engaged in Nanopore DNA sequencing. Two of our experts are working on the Connecting Software system. Two of our developers – a Java developer and a frontend developer – are also engaged in software development, while two more of our experts are working on converting tests from the client’s legacy framework to the one that was chosen as a replacement. We also have a Product Owner, who works on adding new features to the product.

The remote testing of the client’s embedded software posed a significant challenge from the very beginning. Our team in Ukraine had to have a person in a laboratory monitor the machine’s response to certain actions and send reports to the testing team. This approach had remained productive for a while but shortly became inconvenient as the team grew.

In order to optimize the process, the on-site Senior Software Engineering Manager installed a number of webcams on the machine and launched online streaming. This allowed our team to see how the machine was responding to changes in the software, as well as to run tests at any time of the day. This solution has helped us turn the problem of the 10-hour time difference into an advantage, enabling our team to perform testing even when the on-site team is not working. Additionally, we’ve adjusted the Agile processes in our teams to make our regular meetings maximally productive and exclude the people who are not required on the calls.

Testing any newly added software has been made a great deal more difficult by the risk of getting the client’s hardware damaged as a result of some incompatibilities between this hardware and the new features. Moreover, automated and manual testing on a real machine can cause damage to both the machine in its own right and the DNA material.

To eliminate the testing-related risks, we have developed medical device stimulators (also referred to as “stubs”). This software emulates the interactions between any newly developed functionality and the hardware of the DNA-sequencing machine, and allows virtually testing the features being added. Furthermore, our custom-developed stubs also help achieve time savings for the entire client’s organization. These stubs can be reused by other 6 or 7 teams at Roche in order to test some other software on other similar machines. Our stubs have project-specific logic for a particular sequencer, so they can be widely reused by other teams.

In addition to the Simulator Software, our team has also delivered a Software Quality Assurance (SQA) Dashboard.

The application allows monitoring the testing progress by collecting and storing testing reports for multiple projects. It includes such parameters as time, the reasons for test failures, the number of failed tests, and so on. This dashboard can be used for any project at Roche. The dashboard has been in use by 7 Roche’s teams.

It should also be noted that the need to use a client-defined technology stack that had been used before we embarked on the project has taken us an additional effort. Besides, the testing-related information being distributed across multiple data sources constituted yet another challenge we’ve successfully solved.

Technology Solution

• Spring Boot
• Angular
• Java 8
• GCP
• MySQL
• Git
• Auth0

Methodology, Tools:

• Kanban
• CI/CD

Result

As of February, 2023, SPD Group’s project team has been working on Roche’s project for more than 3.5 years.

The COVID-19 pandemic-related lockdown slowed down the project’s progress, limiting our experts’ on-site access to the California-based laboratories. Currently, the project is actively under development. The members of our project team continue to provide automated and manual testing services, develop simulator software, perform business analysis, analyze the related documentation, and expand the solution’s Software Quality Assurance dashboard.

We have managed to dramatically reduce the possibility of Roche’s DNA-sequencing hardware and software suffering damages during the testing of edge cases, and have thus safeguarded and enhanced one of their major business processes.
When run on the client‘s actual hardware, some of the automated tests our experts have created ensure 3x-4x time savings as compared with manual testing.