5 Reasons Why The In-House Development Of IVD Software Often Backfires

With the use of software in the IVD space, we are able to digitise measurements, share results, process data, and create workflows for remote care and monitoring, which is pivotal in the future of digital healthcare. If you are using IVD software, it is very likely that you'll need a cloud solution for storage, managing your processes, and computing results. Developing such a system in-house has risks and can backfire.

Below, we are going to explain why this happens. Although it may seem like a good idea to develop your own software in-house, we will explore why it is fundamental to have a tried-and-tested medical BaaS at the basis of your product.

Increased time to market

Developing IVD software in-house takes a lot of time. Not only do you need to program the backend from scratch, but you also need to make sure that the software is compliant to the various data regulations. The process of becoming compliant to these regulations is time-consuming, and often ends up delaying the time it takes to get the product to market.

It is essential for IVD software to be IVDR compliant. This new regulation, which came into force on 26 May 2017 and will be in effect as of May 2022, is much more stringent than the previous In Vitro Diagnostic Directive (IVDD). All IVDs manufactured with a CE mark will be affected by the IVDR and its corresponding new risk classification. Using our medical BaaS will relieve the pressure of meeting these regulations of this big upcoming change.

Extra Horizon has a strong regulatory foundation. We have all the company-level certifications you, as a digital medical solution company, would dream of (ISO13485:2016, ISO27001:2017, ISO27701:2019 and so on). Our medical BaaS is also the perfect fit regarding the GDPR and HIPAA data protection laws. On a product and process level, the Extra Horizon medical BaaS helps to enable our customers to achieve CE (MDR, IVDR), FDA, TGA and other local approvals. As a result, this drastically reduces the time it takes to get to market, as there are less issues within the regulatory compliance space.

Additionally, using our medical BaaS will save time on finding and educating an entire team to produce the software in-house. Recruiting and training a team of skilled developers takes up a lot of valuable time. Therefore, using a readily-available medical BaaS, such as Extra Horizon’s, saves precious time and gets the product to market much quicker.

High and unexpected costs

Although getting into the market in time is very important, having a cost-efficient solution, especially in the early stages, is very important as well. Developing IVD software in-house can often result in unpredictable and unexpected costs. This is because in-house software is not always able to cope effectively with unexpected issues. If you make wrong decisions in the start of your IVDR journey, it might become a very expensive ordeal in the end.

High quality IVD software can usually compensate for any potential system malfunctions. If the IVD software is built in a flexible and sophisticated way, such as by using a medical BaaS like ours, the system should be able to deal with these issues by itself. However, if the software cannot cope, additional costs can be incurred from the additional error handling.

Therefore, leveraging a tried and tested medical BaaS, as opposed to building one from scratch in-house, will reduce these unexpected costs and help you stay within your budget. When using Extra Horizon’s BaaS, you pay a fixed monthly license fee, so the costs are predictable and there are no hidden surprises.

Lack of thorough documentation

As well as keeping the budget under control when developing IVD software, it is extremely important to keep a meticulous documentation record. This is very important for adhering to the In Vitro Medical Devices Regulation (IVDR), for which all technical documentation is required. 

Also, should a data breach occur, keeping a detailed log of everything enables you to see the exact extent of the damage. The documentation will allow you to see the cause of the breach, whether that be simply an error made by an employee, or a hacker who managed to access the backend. 

Therefore, in-house development of IVD can lead products to be more vulnerable to data breaches, and can make it hard to establish the reasons for a data breach. Thus, it is in the best interests of a company to use a sophisticated medical BaaS, like Extra Horizon, to make sure that everything is recorded properly.

Lack of scalability

In addition to keeping thorough documentation, it is important to keep up with the constantly-evolving healthcare industry and adapt to changing patient needs, as well as the increased usage of medical applications. Therefore, IVD software needs to evolve fast to keep up with the newest developments and increased user capacity. 



These updates and changes need to be made quickly and easily, in order to keep up with the fast-changing industry. In-house developed IVD software often lacks the flexibility to be scaled up and down as necessary, which means that developers will be forced to start from scratch again. By using a medical BaaS, software can be scaled up to address new trends and increased usage with relative ease, saving valuable time.

Updates are slower and it's more difficult to adapt to new challenges

Next to making sure your software can be scaled appropriately, it is extremely important that the software remains up to date and able to handle new challenges, as IVD software products normally stay on the market for a long time. Therefore, new processes and methods need to be continually incorporated as new best practices become available. If this does not happen, the software can become outdated very quickly.

With technological advancements taking place daily in the digital medical landscape, most medical solutions will need to be connected with electronic health records (EHR) at some point in time. Making sure that your cloud-based IVD solution can be compatible with HL7 (Health Level 7) and FHIR (Fast Healthcare Interoperability Resources) is, therefore, one of the key aspects not to overlook when building a future-proof and scalable solution.

The problem with in-house solutions is that they are generally made to fulfil just one purpose, and are therefore not very adaptable. This makes it hard to adapt the software to the ever-changing new best practices of the IVD space. By using Extra Horizon’s medical BaaS, you do not need to worry about software becoming outdated, as our backend is highly adaptable and updates are rolled out quickly and easily. 

To see for yourself how using Extra Horizon’s tried-and-tested medical BaaS can be the answer you need for your IVD software, contact us here.