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This extract is from our recent whitepaper: From Medical Devices to Digital Health Ecosystems: Navigating the Complexities of Product Development. Featuring insights from Inspire, Natus, and S3 Connected Health, it delves into the transition that occurs when medtech companies advance along the value chain, evolving from creating standalone connected devices to providing integrated digital health solutions. It examines how this shift impacts physical device design, software architecture, and system integration, while also addressing the technical, operational, and regulatory considerations that arise throughout the process.
Designing a medical device for a digital health ecosystem requires more than just a mindset shift — it demands alignment between strategic vision and technical execution.
A hardware-first mindset drives standalone device development, focused on solving a specific clinical problem through a self-contained product, optimized for safety, efficacy, and regulatory compliance within a narrowly defined intended use. Many products will have at least basic connectivity, but may be limited to operational enhancement or limited data export.
Connected system thinking, by contrast, views the device as one component within a broader digital ecosystem. Designing for a connected ecosystem requires holistic thinking, encompassing not only medical functionality but also the real-world environment, user context, connectivity constraints, and the data lifecycle from capture and transmission to storage, interpretation, and action.
“One of the advantages of being device-only is that you can concentrate solely on the device's inputs and outputs. However, once you create an ecosystem, you need to be more aware of how it will be used, and with that knowledge comes responsibility.”
Justin Cambra, Formerly Senior Vice President, Software & Systems Development, iRhythm Technologies, Inc
In parallel with defining the core functionality of the device, it is essential to understand how the solution will fit within and add value to a connected healthcare ecosystem. Early architectural and integration decisions can determine whether the product becomes a standalone tool or a critical component of an ecosystem that enhances care quality and efficiency.
“Our core mission is to ensure the best possible patient experience, safety, and treatment efficacy. Naturally, the device is a critical part of that; it’s the closest touchpoint to the patient. But it's not the only lever we have to drive impact. We examine the entire ecosystem surrounding the therapy and evaluate potential solutions based on how effectively they address the pain points and opportunities we've identified. Then, we make strategic decisions at the system level, allocating resources where they’ll have the greatest impact, rather than defaulting to device-first thinking.”
Dave Dieken, VP of Product Development, Inspire Medical Systems
Connected system thinking starts with recognizing that a device’s value grows exponentially when it becomes an integral part of a wider healthcare ecosystem. At this stage, it’s essential to ask strategic questions that clarify the solution’s role, relationships, and requirements within that ecosystem, including:
- What is the primary setting of care for this solution: traditional environments, such as hospitals, outpatient clinics, and ambulatory centers, home, or is the solution with the patient continuously (on-the-go)? The answer affects everything from connectivity assumptions and user interface design to data security, remote monitoring capabilities, and regulatory classification.
- Who are the various users of the device, the overall solution, and its data, and what are their specific requirements? Understanding these items early shapes how the solution integrates into clinical workflows, determines the level and type of patient interaction (e.g., passive monitoring vs. active input), and defines how data will be collected, stored, shared, and transformed into actionable insights.
- Will the solution compete with, replace, or complement existing digital tools and services? A device that duplicates functionality already embedded in EHR platforms or remote monitoring systems may struggle to gain traction unless it offers a clearly differentiated clinical or economic benefit.
- How will the solution integrate into and interface with current clinical workflows, decision-support systems, and patient data ecosystems? Seamless interfacing and integration are critical for adoption. Solutions that create friction for clinicians or add to their workload struggle to secure adoption.
Strategic design choices made at this stage define the product’s architecture, data strategy, and user experience. Addressing them early ensures alignment between technical capabilities and market expectations; overlooking them risks costly delays, rework, and products that fail to deliver on their promise.
“It’s critical not to just start building without first defining the non-functional requirements, things like scalability, resilience, and interoperability, which are essential for long-term success. That approach has been central to our strategy. We make sure to clearly define what our architecture needs to support, and once those requirements are outlined, it often leads to insights that change or refine initial design assumptions.”
Dave Dieken, VP of Product Development, Inspire Medical Systems
If you haven’t already, you can access the full whitepaper for the complete insights here
Hear from industry leaders at Inspire, Natus, and S3 Connected Health as they provide practical guidance across the entire product lifecycle — from concept and design to development and ongoing management — to help teams build devices that thrive in today’s connected healthcare environment.
