Digitalization of IVD Kits and Instruments

by | 01. 07. 2024 | Software Development

Reading Time: 9 minutes

The digitalization of operations is transforming the scientific landscape. In many cases, laboratories still rely on manual methods for data collection, analysis, and management, often leading to inefficiencies, errors, and increased costs.

Data is highly valued today, especially with new technologies, like AI models, that can turn large amounts of seemingly useless data into highly valuable insights. We often say, “Data is the new gold.” However, to make use of the data, it is necessary to digitalize. Many laboratory kits and instrument providers neglect the importance of software or rely on third-party software to integrate with it.

In this blog article, we will explore the market, explain why it’s important for kit and instrument manufacturers to provide software with their products, which types of software they can provide, and describe how to approach in-vitro diagnostic (IVD) software development.

Market overview

The rapid growth in the pharmaceutical and biotechnology industries, along with the expanding healthcare sector, are expected to fuel market growth. When it comes to IVD laboratory kits and instruments, the increasing demand for effective disease diagnosis will further expand future growth. According to the European Commission, 70% of all clinical decisions are made using IVD devices.

The global IVD market’s revenue was estimated to be $85.2 billion in 2024 and is poised to reach $119.4 billion by 2029, growing at a CAGR of 6.9% from 2024 to 2029 (source: MarketsandMarkets).

The increasing demand for IVD products is due to the rapid growth of the population globally and the prevalence of age-associated diseases. Also, many developing countries are expected to grow very much, especially India, China, Turkey, Russia, and Mexico, due to high disease prevalence, large patient population, improved healthcare structure, and growing medical tourism in these countries, especially for tropical diseases (source: MarketsandMarkets).

Additionally, many industries are obliged to follow stricter regulations every year. The same goes for IVD regulation (IVDR), which requires many new and existing IVD products to be certified, even though they previously didn’t need to.

With increasing market growth, regulatory requirements, and greater emphasis on efficiency and safety, automation plays a crucial role, and software is a critical component of every automated system.

According to a report by MarketsandMarkets, the global automation market’s revenue was estimated to be worth $5.1 billion in 2022 and is poised to reach $7.1 billion by 2028, growing at a CAGR of 5.8% from 2022 to 2028. This growth is fueled by integrating software solutions with laboratory equipment and laboratory kits, enabling seamless data management and integrations, enhanced analytical capabilities, and improved compliance with regulatory standards.

Why is offering software along with your IVD product important?

Providing tailored software solutions with your laboratory kit or instrument products will bring you and your customer many benefits:

    Brand recognition

    By providing end-to-end workflow to your customers, you will further establish your product or company brand as a go-to solution for the end-users. This will make your company less vulnerable to competition.

    Upsell potential

    Additionally, software can promote product upsell and can help you understand use-cases and user behaviour and ultimately expand intended purpose to other areas when possible. This will significantly boost your sales.

    IP ownership

    If you decide to develop your own software and/or device, you will usually own the IP. This will give you the freedom to expand and upgrade the product. This will also add to your overall company valuation.

    Efficiency and productivity for your customers

    Software provided with your products will streamline laboratory workflows, automate data collection and analysis, and provide real-time access. This will minimize human input, thus significantly improving productivity and quality. If your customers consider efficiency and productivity as critical KPIs, they will be more likely to buy a complete solution in which case they can also rely on the support in case of malfunction.

    User experience

    Users will have a much better experience if digital solutions meet your product and end-users’ needs. Off-the-shelf software solutions might be less expensive to implement at first but may lack the critical functionalities that your users need. This means that you will need to reach an agreement with the OEM partner to develop the missing functionalities or make necessary adjustments. An important topic is also licencing agreement, which defines your right to modify and distribute the software. Depending on your business model, developing on your own or taking an out-of-the-box solution is viable; however, make sure that the user experience meets your customers’ needs. If not, your potential customers will likely decide on a competitor’s product.

    Seamless data flow and integrations

    Software tailored to your products will ensure that the data generated is in a standardized format that is easily readable by the software and by other systems, such as Laboratory Information Management Systems (LIMS), Laboratory Information Systems (LIS), or Electronic Laboratory Notebooks (ELN). Since laboratories are usually a complex ecosystem of various hardware and software solutions, the availability of APIs that can connect your solution with a central software platform is a must.

    Enhanced analytical capabilities

    Software solutions often include advanced analytical tools that provide deeper insights into experimental data. These include capabilities for complex statistical analysis, data visualization, and integration with other data sources. Furthermore, machine learning algorithms can learn from the data and provide more accurate results or predict new outcomes based on historical data, which optimizes laboratory processes and reduces costs in terms of time and resources.

    Data management and integrity

    Digital systems offer robust data management capabilities, including secure storage, easy retrieval, and efficient data sharing. This ensures data integrity and traceability, which are essential for regulatory compliance and collaborative research efforts.

    Regulatory compliance

    Many industries, especially pharmaceuticals and biotechnology, need to meet regulatory requirements. Software facilitates compliance by providing 21 CFR Part 11 features like audit trails, authentication, electronic signatures, etc., making it much easier for your customer to comply with various regulation requirements like IVD regulation (IVDR).

    Enhanced collaboration

    The software will serve as a centralized platform for storing and accessing data. This will ensure your customers have a single source to perform tasks, collaborate, and access the data.

    Types of software for IVD kits or instruments

    You can provide many types of software with your laboratory kits or instruments. Let’s look at some typical examples:

    • Laboratory middleware is software that integrates multiple laboratory devices into one system to standardize all data. It acts as an intermediary layer that facilitates communication and data exchange between various laboratory instruments and other software systems, like LIMS or ELN.
    • Data analysis software will provide your end users with statistical analysis tools and data visualization capabilities to support them with data interpretation. Additionally, it can also provide visualization and reporting capabilities with advanced data visualization tools and customizable report generation.
    • Instrument control software is designed to control and monitor instruments and automatically provide relevant information about them in real time. Users can manage condition parameters, set alert thresholds, and manage calibration and maintenance notifications. This will enhance precise and consistent operations, instrument performance, and longevity.
    • A laboratory execution system (LES) is used to support the execution of processes according to standard operating procedures (SOPs). This is useful, especially when complex workflows are required to perform analyses, which will reduce manual errors and increase efficiency and accuracy.
    • Laboratory information management software (LIMS) enables sample tracking and management, centralized data management, workflow automation, inventory management, analysis and reporting, and many other functionalities to streamline laboratory operations, mainly in regulated environments. LIMS system with specific chromatography features is Chromatography Data Management Systems (CDMS).
    • Electronic laboratory notebook (ELN)provides digital record-keeping of experiments and observations, protocols creation and experiment management, central data management, inventory management, and some other functionalities to streamline laboratory operations, mainly in a non-regulated environment.
    • Training and support software will help end users with interactive tutorials and user guides, create support tickets, provide support feedback, and notify them with updates and maintenance notifications. This will ensure the software remains up-to-date and functional.

    You are not limited to offering a single type of software or functionality. Instead, consider combining multiple functionalities to cover various laboratory needs. Start by deploying a minimal viable product (MVP) with essential features and add additional features later as needed. This approach prevents investment in unnecessary features that may not be crucial; you will enter the market much faster and gain valuable insights from end users about which additional functionalities to implement.

    Approach to IVD software development

    Software development is a complex multiphase process that involves different people and tasks. Especially if you aim to produce IVD-ready software, the process is even more complex and requires additional experience in regulation. IVDR does not specifically describe the software development workflow to follow, but it does provide some harmonized standards that are recommended to practice and will ensure you comply with the regulation. Those are:

    • ISO 13485: Quality management system for MD (and IVD)
    • ISO 14971: Risk management system for MD (and IVD)
    • IEC 62304: Software development lifecycle for MD (and IVD)

     In IVD software development, those standards, especially IEC 62304, clearly describe each phase of the process. It establishes a framework for the software development lifecycle (SDLC) process necessary for the safe design, development, and maintenance of (in-vitro) medical device software.

    Here is an overview of the IEC 62304 standard on how to approach the SDLC process:

    You can read more about the standards, regulation and software development lifecycle (SDLC) process in our blog articles: Digitalization – Understanding Standards, Regulations, and Guidelines and IVD Medical Device Software Development and Regulations.

    IVD software documentation

    For the IVD-ready software, comprehensive documentation is crucial to ensure regulatory compliance. Besides the software development plan and specifications described above, you will also need to prepare various risk management documentation, verification and testing plans, reports, log of software of unknown provenance (SOUP), version description document, software configuration management plan, maintenance plan and post-market surveillance plan and report. Additionally, IVD requires traceability, meaning you establish a documented connection between different stages of the SDLC so that everything is linked to the original source.

    Proper documentation is essential for audit trails, enabling traceability of all changes and decisions made throughout the development lifecycle. Additionally, thorough documentation supports the validation process, confirming that the software meets its intended use and performs reliably and safely under expected conditions.

    You can learn more about IVD documentation by watching our webinar, How to Approach IVD Software Development.

    Case study – GeneFirst

    One of the many software products BioSistemika developed for various instrument and laboratory kit providers was software for a molecular diagnostic company, GeneFirst.

    GeneFirst offers respiratory kits for the identification of multiple concurrent respiratory pathogens, including SARS-CoV-2. Their kits are based on the innovative Multiplex Probe Amplification (MPA) technology to perform multiplex qPCR assays, allowing for simultaneous detection and differentiation of up to seven respiratory pathogens per fluorescence channel.

    The initial software provided by GeneFirst was designed for the R&D environment, so it could not be used in clinical settings as it was not IVD compliant. Therefore, BioSistemika provided help with life science, software development, and IVD regulatory knowledge and expertise to develop IVD-ready software with all required functionalities and documentation.

    The product was an automated, high-throughput data analysis software solution for the fast diagnosis of multiple viral and bacterial respiratory pathogens in clinical settings. It enables automatic analysis of qPCR data obtained with GeneFirst kits, verification of analyzed results, and reporting to the Laboratory Information System (LIS). Additionally, we developed a research-use-only (RUO) configuration for the non-regulated market, providing a more detailed insight into analyzed results.

    You can learn more about the software development for this project in our case study: Development of IVD and RUO analytical software.

    Conclusion

    • There is a growing demand for in-vitro (IVD) products like instruments and laboratory kits in the healthcare and diagnostic market.
    • With increasing market growth, regulatory requirements, and greater emphasis on efficiency and safety, automation plays a crucial role, and software is a critical component of every automated system.
    • Providing tailored software solutions with IVD products will enhance efficiency, productivity, user experience, and analytical capabilities, provide specific workflows, and ensure regulatory compliance.
    • There are different software functionalities to provide with your IVD products, for example, automated data entry and analysis, integration, instrument control and monitoring, reporting, and workflow management.
    • IEC 62304 standard describes how to approach the software development lifecycle (SDLC) in accordance with IVD regulation. Additionally, ISO 13485 and ISO 14971 provide great frameworks for IVD software documentation and QMS processes.
    • For IVD-ready software, comprehensive documentation and traceability are crucial to ensure regulatory compliance.

    Ready to start your next project? Discover how our expertise can help you succeed.

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