Developing a connected medical device isn’t simply about adding connectivity to existing hardware. It requires a comprehensive transformation for medtech companies; developing devices that integrate seamlessly with healthcare systems, operate securely in real-world environments, meet regulatory requirements, and serve a diverse set of users, many of whom are not healthcare professionals.
In this article, we explore five challenges developers must address to bring connected medical devices successfully to market. From transitioning to service-oriented business models to securing market access and reimbursement, we outline the strategic considerations, regulatory complexities, and user-centered aspects shaping medtech innovation.
1. Transitioning from device-only to service-oriented models
Traditionally, medical devices were standalone products purchased, deployed, and used with little further involvement from the manufacturer. In a connected world, that model is rapidly becoming obsolete. With connected devices comes an expectation of ongoing service delivery, including device maintenance, software updates, data management, security monitoring, and user support.
This transition requires a fundamental change in mindset, focusing on long-term value creation through connected services rather than immediate returns from device sales. Such a shift involves developing new value propositions, forming cross-functional teams, investing in the necessary infrastructure, building the core capabilities to deliver these services, and potentially forming new partnerships
It is important to establish underlying frameworks that will provide the foundations to build, deploy, roll out, operate, and scale digital health services in a regulatory-compliant and cost-effective manner. Developers must be able to manage devices throughout their operational life remotely, provide over-the-air (OTA) software and firmware updates, monitor and respond to cybersecurity threats, and deliver customer support at scale. Equally important is a data strategy that defines why, what, and how data should be acquired, stored, processed, and utilized in a compliant and secure manner. Lastly, a full digital health technology stack must be designed that enables building multiple customized applications for end-users across multiple therapy areas in a regulatory-compliant, cost-effective manner.
2. Ensuring seamless integration with healthcare systems
To maximize the value of connected medical devices, it’s essential for them to integrate smoothly and reliably with existing healthcare infrastructures, such as Electronic Health Records (EHRs) and other clinical systems. In addition to ensuring current integration, developers must also consider future compatibility, allowing devices to adapt alongside the rapidly evolving landscape of healthcare IT.
A key factor in achieving this seamless integration is the adoption of standardized data formats and protocols. Developers can enhance communication with various healthcare systems and applications by developing devices that follow standards like HL7 and FHIR and creating robust APIs. From a developmental standpoint, aligning with international standards like AAMI/UL 2800 for interoperable device interfaces and ASTM guidelines can provide a solid foundation for safe and effective system integration.
Despite significant global initiatives aimed at standardizing healthcare data (such as the Patient-Centric Integrated Clinical Environment (ICE) and the FHIR interface linked to the US Core Data for Interoperability (USCDI)), real-world interoperability still faces challenges. Integration requirements often vary widely depending on local factors, including the architecture of healthcare systems, specific hospital networks, and unique IT setups.
By designing flexible data interfaces that are configurable and adaptable, developers can ensure that devices are ready for customization when they are implemented in real-world settings. This forward-thinking approach will significantly enhance the effectiveness of connected medical devices in improving healthcare delivery.
3. Addressing cybersecurity, data security, and privacy regulations
The collection and transmission of sensitive health data by connected devices raises significant security and privacy concerns. Developers must implement robust cybersecurity measures to protect against data breaches and unauthorized access. This includes encrypting data, securing communication channels, and ensuring compliance with relevant data protection regulations.
Connected medical devices must comply with stringent regulatory standards that vary across regions. Developers need to ensure their products meet requirements related to safety, efficacy, and data security. This includes adhering to standards like ISO 13485 for quality management and ISO 14971 for risk management.
Cybersecurity is an ongoing process that must start at the design stage of the device and digital health solution and continues throughout the entire product and service lifecycle. A one-time setup for cybersecurity, without a plan for ongoing monitoring, identifying, and addressing vulnerabilities and exploits, will no longer be approved by the regulators. Hospital systems are also increasingly mandating detailed information security agreements to ensure devices adhere to specific cybersecurity standards before they can be acquired. Cybersecurity must be integrated from the design stage and maintained throughout the entire product lifecycle. By integrating robust cybersecurity measures from the outset and maintaining them throughout the product lifecycle, manufacturers can create resilient solutions. They are also encouraged to regularly update software and firmware to address newly discovered vulnerabilities and improve their capacity to respond to and mitigate cybersecurity incidents swiftly.
4. Designing for non-clinical users
Developers must design devices that reflect the fact that increasingly, patients and caregivers, not just clinicians in hospital settings, are the primary users of connected medical devices. As a result, medtech companies must adopt a user-centered design approach that focuses on user needs, preferences, and capabilities in the design, deployment, and ongoing engagement strategies for their devices.
When designing medical devices for home use, developers must prioritize usability, safety, and adaptability to varied environments. Devices need to be intuitive and easy to operate by individuals with no medical training, including the elderly or those with limited mobility or health literacy.
Achieving this requires early-stage user research to understand day-to-day challenges and needs, followed by the application of behavioral science to promote ease of use and adherence. Intuitive interfaces, clear instructions, and built-in safeguards help minimize user error. Ongoing support, such as tutorials, helplines, or app-based guidance, is critical for confidence and sustained use. These efforts must be validated through human factors testing and refined through continuous user feedback. Together, they ensure not just safe use but long-term engagement and better outcomes across diverse care settings.
5. Market access and reimbursement
Unlike traditional medical devices that often follow well-established regulatory and payment pathways, connected solutions, particularly those involving digital services, face a fragmented and still-developing reimbursement landscape.
There is no global framework for market access and reimbursement – rather it remains an inherently local challenge, often influenced by national healthcare structures and regional payer systems, and developers must navigate variations in requirements, clinical evidence standards, and reimbursement mechanisms. Further complicating matters is the fact that digital health solutions are typically reimbursed as a bundle, together with the accompanying medical devices they support.
Developers must leverage the inherent capabilities of their solutions to help overcome these challenges. Their solutions can collect objective usage, adherence, and outcome data that demonstrate the value proposition, feasibility, and impact of the solution. Additionally, they can provide live access to this data and insights (at various levels of anonymization) to multiple stakeholders, such as payers, providers, prescribers and patients that enables building additional supplementary services that further add value to the original solutions.
Our recent whitepaper delves into the challenges medtech companies face and how to overcome them throughout the entire development lifecycle: from initial concept and strategy formulation, through to development and commercialization.
With insights from experts from S3 Connected Health, Blatchford, Olympus, and Smith + Nephew, you can download your free copy today below.
