The Next Frontier in Medtech Innovation

Interoperability has long been a buzzword in medtech, but for most device developers, it still represents a hurdle rather than a competitive advantage. For decades, the medical device industry has made incremental progress, yet the lack of open, interoperable plug-and-play connectivity is slowing innovation, driving up integration costs, and keeping promising new products from going to market.

As device connectivity becomes central to remote monitoring, surgical robotics and hospital-at-home care models, the cost of device fragmentation is simply too high to ignore.

Implementation, Not Innovation, Is the Missing Link

Today, most devices require custom integrations or vendor-specific workarounds just to function in real-world care environments. Standards like HL7 Version 2, ISO/IEEE 11073, and HL7 FHIR have long existed to guide structured, consistent data exchange. However, what’s been missing is a consistent framework for adoption. Too often, efforts to implement these standards have been derailed by misaligned business drivers, unclear regulatory guidance, or the lack of cross-industry coordination.

To change that dynamic, HL7 has introduced the Device Interoperability FHIR Accelerator, an implementation-first initiative that brings together manufacturers, clinicians, developers and regulators. Rooted in the belief that community-driven collaboration is essential to make plug-and-play connectivity achievable, the accelerator focuses on operationalizing existing frameworks, making device interoperability not just possible, but practical and scalable in real-world clinical environments.

The Barrier to Entry for Medtech Innovators

The consequences of fragmented interoperability aren’t just technical; they’re strategic. For device developers, the absence of widely adopted, open standards means each integration becomes a custom project. Teams are forced to build bespoke APIs for every new hospital or EHR, often requiring direct coordination with IT departments, mapping teams, and internal informatics experts. This complexity creates operational drag and makes it difficult for smaller companies to compete or scale quickly. For device manufacturers, proprietary interfaces create barriers to widespread adoption.

Manufacturers spend over $430 million annually on redundant R&D efforts to make their products work with different EHRs. In an industry increasingly driven by speed-to-value, this lack of uniformity can be the difference between rapid adoption and commercial stagnation. And the burden doesn’t fall evenly; startups and smaller manufacturers often lack the internal expertise or capital to navigate this patchwork environment.

Plug-and-trust standards offer a way forward. By enabling interoperable devices to “speak” the same language from the outset, HL7’s approach lowers the barrier to entry, reduces onboarding complexity, and opens the market for agile, innovation-led companies to participate more fully.

Regulatory Alignment Is Within Reach

Interoperability is quickly becoming more than a market expectation; it’s a regulatory priority, with federal agencies like CMS and ONC mandating FHIR-based APIs as part of their broader strategy to improve health data exchange. The Interoperability and Prior Authorization Final Rule (CMS-0057-F) now requires payers to implement FHIR-based APIs, setting the stage for greater standardization across healthcare. Similarly, the Trusted Exchange Framework and Common Agreement (TEFCA) is expanding its interoperability requirements to support FHIR API exchanges, further aligning the industry toward a standardized approach.

The FDA has already recognized several of the ISO/IEEE 11073 “plug-and-trust” standards that underpin HL7’s accelerator work. Importantly, the Gemini SDPi+FHIR specification, which harmonizes HL7 FHIR with ISO/IEEE service-oriented device connectivity, is currently under FDA review. If recognized, it could become the first formal interoperability specification from either HL7 or IHE to receive that distinction.

This level of regulatory engagement matters. It signals that plug-and-trust is not just a forward-looking goal but a part of the present-day regulatory conversation.

In a time of increasing attention to real-time data exchange, device traceability, and system transparency, having interoperability “baked in” will be a differentiator. For early adopters, it may even create a strategic advantage when navigating regulatory pathways or payer contracts.

Built for the Future of Connected Care

HL7’s Fast Healthcare Interoperability Resources (FHIR) standard was designed for today’s increasingly decentralized care delivery environment. It supports mobile apps, cloud-based tools and APIs that extend far beyond the hospital setting. That flexibility is critical in a healthcare landscape where hospital-at-home programs, continuous monitoring, and edge computing are becoming the norm.

The HL7 Device Interoperability FHIR Accelerator initiative explicitly supports this vision. While the initiative addresses traditional acute care settings like ICUs and operating rooms, it also prioritizes the needs of consumer-grade and outpatient devices like wearables, home sensors and mobile diagnostic tools. These devices must connect not just to EHRs, but to the broader digital health ecosystem. Plug-and-trust standards make that connection possible. This broader scope reflects a core truth: if we want to empower care anywhere, we must design interoperability everywhere.

From Plug-and-Pray to Plug-and-Trust

Today’s device ecosystem is often described as “plug-and-pray,” a reflection of the uncertainty, inefficiency, and cost that plagues integration. Each new connection introduces risk. Each custom project demands resources that could be better spent on innovation.

By aligning existing standards with real-world implementation, the accelerator provides a practical, scalable model for building devices that work seamlessly in complex clinical environments. It also opens the door for innovation, extending what’s possible by lowering integration barriers and allowing developers to focus on advancing functionality rather than rebuilding infrastructure.

At a time when device developers are being asked to do more with less, and deliver greater safety, transparency and connectivity, plug-and-trust isn’t just an aspiration. It’s a necessary shift in how we build, test and deploy the medical technologies of tomorrow.

HL7 invites all interested stakeholders to become founding members of the Device Interoperability FHIR Accelerator and help drive the next era of medtech innovation. For more information, email to [email protected].

Dr. Charles Jaffe is CEO of HL7 International, where he leads the organization’s global mission to empower health data interoperability. Todd Cooper is HL7 Devices Evangelist and co-founder of the HL7-IHE Gemini Program, focusing on advancing medical device interoperability.