2025-10-24

After years of navigating the friction between innovation and oversight, global health technology is redefining its trajectory. Regulators around the globe are collaborating with innovators rather than remaining reactive. The end effect is a new stage of planned expansion that is empowering both new and existing businesses to grow clearly and at scale.

This transformation has been the result of sustained global collaboration and policy reform. International health authorities have worked collectively to bring transparency and uniformity to digital health regulations. The FDA has developed resources such as the AI-Enabled Medical Device List and guiding principles for change control and transparency in machine learning-enabled medical devices, offering greater visibility into how software systems are assessed in clinical care. These developments have made it possible for businesses to create AI-based decision-support tools and diagnostic systems with more predictable approval processes.

The 2023 National Medical Devices Policy in India has significantly increased the country's healthtech sector. Through improved quality systems, expedited certifications and support for domestic manufacturing, the policy seeks to increase the size of the nation's medical device industry from USD 11 billion to USD 50 billion by 2030. Similar initiatives have been seen in Southeast Asia and the European Union, where authorities are proactively coordinating innovation incentives with patient safety regulations.

This change in regulations is also impacting the investments in the healthcare sector. Investor interest in healthtech has started to rebound following a slowdown between 2022 and 2023, when funding dropped from almost USD 29 billion to about USD 10 billion. More than USD 10 billion was spent on global healthtech mergers and acquisitions in the first half of 2025, indicating a renewed desire for innovation that is carefully controlled. According to Grand View Research, the global digital health market is projected to grow from USD 288 billion in 2024 to almost USD 946 billion by 2030, driven by advances in telehealth, connected care and AI-enabled diagnostics.

Building scalable health technology products demands a different approach. Growth can no longer rely on speed alone; it must be rooted in design discipline and regulatory foresight. Compliance must be incorporated into all aspects of product development, from data management to system architecture, for businesses to be successful. To do this, regulatory awareness must be established in early design to guarantee that documentation, clinical validation and traceability are developed as part of the process rather than as an afterthought.

Another important component of scalability is interoperability. Today's healthtech companies must create products that can communicate with other hospitals, devices and insurance systems while adhering to stringent privacy regulations. Using frameworks like openEHR and HL7 FHIR makes it easier to get regulatory clearance in several areas and facilitates data exchange. However, adherence to privacy regulations like HIPAA in the US and new data protection frameworks in the EU and India guarantees that products can grow responsibly internationally.

Healthcare providers and pharmaceutical companies are more likely to partner with startups that exhibit clinical credibility, transparent data management and early alignment with global standards. A practical benchmark has been established for the concept of a minimum viable but compliant product. It guarantees that products can proceed to pilot programmes and marketing without encountering delays while undergoing regulatory evaluations.

In the future, collaboration is expected to guide the next phase of the development of digital health. Companies are developing platforms that combine analytics, monitoring and care delivery into a single ecosystem rather than developing discrete apps. With this strategy, data security and compliance are maintained while hospitals, payers and device manufacturers collaborate within common frameworks. Because new modules can be added without completely rebuilding the system, it also facilitates faster innovation through partnerships.

The goal of the post-regulatory boom is to move with direction instead of moving faster. In digital healthcare, trust is increasingly built on the harmony between innovation and compliance. Businesses that invest in quality, transparency and interoperability will be best positioned to expand in a global market that values accountability as much as innovation.

Ayush Jain is an accomplished tech entrepreneur, author and visionary leader driving digital transformation initiatives across industries. He is the CEO and co-founder of Mindbowser, an award-winning digital transformation services provider. A TEDx speaker, Jain is the author of the acclaimed book "The Zero Hiccup Way," a blueprint guiding aspiring entrepreneurs through the journey of building and scaling technology companies.