Pharma
& Life Science

We fooster the patient empowerment by delivering innovative and secure software solutions. This enables personalised medicine while streamlining the manufacturing processes through data-driven solutions based on AI and ML.

Pharmaceutical and life sciences industries are taking advantage of the digitalisation to become closer to the patient and offer them personalised treatments. In a digitalised medicine lifecycle, large amounts of data are generated leading to challenges in data storage, harmonisation, exploitation and presentation.

Our specialists at ERNI are experts in the handling and analysis of large amounts of data. We start with the harmonisation and centralisation of data streams. Using various technologies and tools, from machine learning and AI to data science, we analyse your data and prepare it visually for interpretation. Combined with our pharmaceutical and life sciences industry expertise, we create solutions that exceed your and your patients’ expectations.

What we do

Software engineering in the health sector

The high regulations in the healthcare sector have an impact on the software solutions used. The development, operation and maintenance of medical software solutions are becoming increasingly demanding. If you want to remain competitive, you have to develop and implement solutions in ever shorter innovation cycles and integrate them into other systems. At the same time, requirements are increasing. More than ever, product development depends on multidisciplinary expertise and agile processes.

The healthcare environment holds many special features. Even at the design stage of a new medical device, the intended application and target markets of the product must be clear. These are prerequisites for the precise description of the requirements. Precise analysis and requirements engineering methods are of high relevance for software engineering. The RE specialists at ERNI combine strong methodological knowledge with knowledge of healthcare requirements.

For the approval of a software solution in the medical field, a complete documentation of the development history is necessary. The traceability of tests at all stages, as well as their relation to the requirements, are critical. The handling of product risks also plays a central role. The integrity of patients, users and the environment is always paramount. Our test experts are aware of the risks and know that only high test coverage can prove that the final product will function correctly without causing harm.

Connected devices in the diagnostic environment

Process automatisation is becoming a key factor to streamline the efficiency of laboratories and hospitals, which, at the same time, is enabling fastest and more reliable results to boost patients caring.

In this context, interoperability plays a key role to ensure and optimise the communications between laboratory instruments, Point of Care devices, Middlewares, LIS and Electronic Health Records. It is becoming even more critical as new and more diverse devices are being introduced to the environment (e.g. Medical Robots). Enabling them to interact with the rest of the system components is key for its success.

ERNI specialists in medical device interoperability are able to design robust and optimised communication systems, using protocols such as HL7 FHIR, ASTM, POCT1a, and designing IoT solutions to empower patient centric approaches.

Connected devices in the health sector

Precision medicine is based on collecting data over the patient’s lifecycle to enable tailored treatment plans for individual patients. The benefits of personalised medicine are many, ranging from improving diagnostic accuracy to identifying the best treatment option for a patient based on their characteristics, to targeted therapy that increases the likelihood of successful treatments, reduces side effects, allows for better disease prevention, and most importantly, increases patient engagement, reduces healthcare costs, and also promotes research and innovation.

In this context, the performance and connectivity of sensors and the data platforms used are highly regulated. In addition, creating smooth systems able to collect, process and leverage the data in a safety and efficient way is key for its success.

A sensitive issue are devices for end users. After all, they collect and analyse the data required for diagnosis, predicting the course of an illness and for supporting the patient. The use of well-designed wearables, mobile apps, software solutions and smartphones noticeably improve current products in this area. With a proper design, it is possible to become able to place independent, end-to-end solutions on the market in short development cycles. In this sense, telemedicine and wearable devices connected to the global network known as the Internet of Things and provide communication channels for healthcare professionals, will enable more elements of care to be delivered remotely.

The solution should be built using established development processes and constantly monitored during operation. Our specialist data experts help you identify untapped opportunities, enabling you to unleash the full potential of the data you collect.

GAP-Analysis of your medical product

Modern and powerful information technologies ensure maximum data security. And are thus becoming increasingly important, especially in the healthcare sector. The complex and high regulatory requirements change continuously. In order to maintain the desired scope of services, we support you with a GAP-Analysis.

With a GAP-Analysis, we compare the performance of your processes, your products or your services with defined targets. This is of particular relevance in the healthcare sector, where the expected use must be defined even before the product is developed. Thus, with a gap analysis, we can show which measures need to be taken in order to meet these targets, which are defined very early on.

Improvement measures can be lean and efficient solutions, cost optimisation, enhanced transparency or even better communication at the interfaces between business and technology. Thus, with our support, you unlock the strategic potential and innovation opportunity to offer stable and attractive services and solutions.