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 share two commonalities: rapid evolution and the need for sophisticated infrastructure ensuring regulatory compliance.
When delivering digital health infrastructure, MedTech, IVD, and pharmaceutical companies face two options: build it themselves or purchase pre-built solutions. This decision becomes particularly critical when moving beyond research and pilot phases toward go-to-market stages prioritizing regulatory approvals and international scaling.
At this juncture, companies must evaluate what truly differentiates them and constitutes their actual intellectual property. Is it the device, algorithm, mobile application, or combination thereof? More importantly, is reinventing infrastructure a worthwhile investment?
5 critical questions
-
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?
Deeper examination reveals that purchasing a pre-built platform represents a strategic, cost-effective approach that mitigates security, privacy, regulatory, and technical debt risks.
Introducing the Extra Horizon solution
Extra Horizon provides globally regulated medical software infrastructure for SaMD, pharma, and MedTech suppliers. Every line of code follows IEC62304 standards and operates under an ISO 13485:2016 certified medical quality management system. The company maintains ISO 27001:2017 Cybersecurity Information Management System certification and ISO 27701:2019 Privacy Information Management System certification, guaranteeing compliant sensitive data processing. Organizations can choose independent development or leverage Extra Horizon’s support for maintenance, scaling, and full compliance assurance.