Medical software engineering for leading provider of LIMS immunodiagnostic solution
A large percentage of the world’s blood tests are done using the company’s laboratory equipment. Our medical software engineering team are instrumental in the development of the company’s QIMS system for the quality control of their immunodiagnostic production.
In brief
Challenge
Update and take over the management of the inhouse developed QIMS system. Run DevOps, including development of new functionality in accordance with standards such as IEC 62304 and FDA Title 21 CFR Part 11 regulations.
Solution
Our Application Lifecycle Management Service for medical devices, provides an experienced team to develop and maintain QIMS, while handling any software issues from a global user base.
How we did it
We analyzed the company’s existing and future needs. A core medical software engineering team with relevant regulatory and standards competence was assembled, with the option to bring in other technology expertise when needed.
Benefits
The company’s IT costs have been reduced. QIMS updates and new releases are launched faster and issues are resolved quickly. Additionally, with the transition to a more robust platform, new capabilities can be introduced.
About the client
The world’s leading provider of immunodiagnostic solutions offers blood test systems to support clinical diagnosis and monitoring of allergies, asthma and autoimmune diseases.
Medical software engineering for leading life science company
A large percentage of the world’s blood tests are done on the life science company’s laboratory equipment. A single machine can handle up to 40,000 tests a day. The company’s inhouse LIMS software development team developed their own laboratory information management system (LIMS). This is a core monitoring and quality assurance component of the business offering, handling many of the internal workflows for processing tests and evaluating results.
As technology has advanced and regulations have become more complex, the life science company has had to allocate more and more resources to IT – often from multiple external consulting companies. In order to focus on its core competence of immunodiagnostics, the company began a search for a new long-term medical engineering software partner to develop and manage their QIMS system, which ensures the quality control of their immunodiagnostic production..
A highly regulated market
In the highly regulated healthcare industry, companies can be severely penalized when software isn’t up to standard. Therefore, choosing the right medical software engineering partner is business critical. They opted for Data Ductus’s Application Lifecycle Management Service for Life Sciences, which included administration, implementation and development of QIMS, as well as updating and streamlining the service within the regulatory framework.
A dedicated team of medical software engineers
With the parameters set, an extensive analysis of existing needs as well as the company’s IT roadmap for the coming years was undertaken. A dedicated team of medical software engineers with relevant experience from IEC 62366, IEC 62304, ISO 14971, ISO 13485 and MDD 93/42/EEC (now replaced by 2017/745) and FDA Title 21 CFR Part 11 was assigned to the case with the option of bringing in other domain and/or technology expertise when needed.
To ensure a smooth transition, the Data Ductus team spent three months onsite with the existing QIMS team before assuming responsibility for the product. This included development, management and handling of software issues from the global user base. Since transition, Data Ductus has delivered four new releases into production.
Lower Costs and Faster Releases
The tight collaboration between the product owner and the QIMS team at Data Ductus ensures any third line support issues are quickly resolved. Data Ductus Software developers and the company’s Product Development team are also aligned when it comes to updates, new versions and the general direction of QIMS. Releases are now delivered on schedule, while maintenance costs remain within budget. Additionally, whenever new capabilities require additional competencies, specialist Data Ductus medical software engineers can be drafted into the process to ensure a smooth delivery.
“Since we took over QIMS, the life science company’s IT costs have been reduced, launch times are quicker and software issues are resolved faster,” says Amin Gholiha, Business Developer, Data Ductus.” They can now concentrate on what they’re best at, immunodiagnostics, and we handle IT, which is our core expertise.”