5 questions to ask before building a medical software infrastructure

Connected devices, combination products, Software-as-a-Medical Device (SaMD), digital therapeutics, clinical decision-making solutions, … They all have at least two things in common: they are all evolving at rapid pace and they all need sophisticated infrastructure to ensure full regulatory compliance.

When it comes to delivering this digital health infrastructure, MedTech, IVD and pharmaceutical companies face two options: they can build it themselves or they can buy a pre-built solution. The decision becomes an especially relevant one when you look beyond a project’s research or pilot phase and start to focus on the go-2-market phase where regulatory approvals and international scaling are most critical.

That’s precisely when you need to consider what sets you apart and what your actual IP is. Is it your device, your algorithm, the mobile application or a mix? Most importantly, do you really want to re-invent the wheel in building your own infrastructure?

5 critical questions

As your idea or company grows, there are several such critical questions you should ask yourself when it comes to building your infrastructure:

How should we build our product? Do we have the right team in-house to set up, develop, maintain and scale global medical software and cloud infrastructure?

How can we reduce the time to market for my medical product?

How can we avoid trade-offs to ensure a future-proof setup that supports our evolving business requirements?

What is the best way to manage regulatory updates and submissions to maintain compliance?

How do we ensure the secure and compliant processing of sensitive data in every new region we move into?

When you dig deeper into these questions, it becomes clear that buying a pre-built platform is a smart and strategic move. As well as being more cost-effective, it mitigates your security, privacy, regulatory and technical debt risk!

Extra Horizon is the leading provider of globally regulated medical software infrastructure for Software as a Medical Device, pharma and MedTech suppliers. Every line of code in our platform is built to IEC62304 standards and managed via an ISO 13485:2016 certified medical quality management system. To guarantee the meticulous and fully compliant processing of sensitive (medical) data, we are also certified as a Cybersecurity Information Management System (ISO 27001:2017) and Privacy Information Management System (ISO 27701/2019). Once you decide to work with Extra Horizon, you can choose to “build it yourself” or rely on our support to maintain and scale your product while ensuring full compliance. 

Want to learn more about the many benefits of our world-leading platform? Contact us anytime!