Bringing a compliant, connected clinical app to market quickly can mean the difference between leading innovation and lagging behind. That’s where NEX for clinical apps comes in. Developed by Sequenex, NEX is a prebuilt, customizable and configurable software platform designed to streamline the development of clinical and connected medical apps.
With built-in BLE device integration, HIPAA-compliant data management, and rapid MVP deployment, NEX gives MedTech developers the tools they need to accelerate timelines, ensure regulatory readiness, and focus on delivering an innovative clinical app with real-world impact.
What Is NEX?
Sequenex is a trusted name in MedTech and SaMD development, known for helping companies build cutting-edge digital health platforms and connected medical devices. With deep expertise in diabetes care, biosensor technology, and BLE integration, Sequenex empowers device manufacturers, health systems, and digital health startups to bring innovative, compliant software products to life faster and more efficiently.
Now, we’ve taken that mission a step further with the launch of NEX—a powerful, prebuilt, and fully customizable software platform designed specifically for connected medical devices and clinical applications.
NEX for clinical apps offers a turnkey software foundation that dramatically reduces the time, cost, and complexity of developing BLE-integrated health solutions. Whether you’re building an app to support a CGM, blood pressure monitor, pulse oximeter, or any other biosensor-enabled device, NEX provides the secure infrastructure, mobile interfaces, and data pipelines needed to get up and running fast.
Built for both regulated and non-regulated use cases, NEX delivers a complete suite of tools tailored for healthcare and research institutions, including:
- Customizable mobile companion apps for iOS and Android
- Patient and Clinician Dashboards
- A customizable roles-based Admin Portal
- A HIPAA-compliant cloud backend
- Real-time data collection and BLE connectivity
- Required Regulatory Documentation (DHF)
By leveraging NEX for clinical apps, MedTech developers and clinical innovators can focus on clinical outcomes and product differentiation while Sequenex handles the technical complexity, compliance considerations, and interoperability challenges behind the scenes.
Why Use NEX for Clinic Apps?
In the competitive world of digital health and medical device innovation, speed, scalability, and compliance are everything. Traditional clinical app development is often slowed by regulatory hurdles, complex BLE integration, and resource-intensive builds. That’s where NEX for clinical apps delivers a game-changing advantage.
Designed specifically for MedTech and health tech developers, NEX empowers teams to build smarter, launch faster, and collect real-time clinical data without sacrificing quality or compliance.
Rapid Development Cycles
One of the most powerful benefits of using NEX for clinical apps is the platform’s ability to dramatically accelerate development timelines. With prebuilt mobile apps for iOS and Android, a secure cloud backend, and a fully functional admin portal, NEX gives developers a 80% head start right out of the gate.
Sequenex’s MVP-123 Program enables teams to launch minimum viable products (MVPs) in as little as three months, giving startups and established companies alike the speed they need to secure funding, begin trials, or meet tight go-to-market deadlines.
By removing the burden of building foundational architecture from scratch, NEX allows your development team to focus on innovation, clinical features, and user experience rather than infrastructure.
Rapid Data Collection
For clinical and connected health apps, real-time data collection is essential. NEX is engineered to seamlessly integrate with a wide range of BLE-connected medical devices, including CGMs, pulse oximeters, and blood pressure monitors. This allows your app to collect accurate, real-time health data from biosensors with minimal development effort.
NEX also supports:
- End-to-end encryption
- HIPAA-compliant data storage
- Real-time streaming and analytics
- Device and serial number tracking via the admin portal
Whether you’re conducting a clinical trial, building a remote patient monitoring system, or launching a consumer-facing wellness device, NEX ensures you can reliably capture and manage the data that matters most.
Customizability for Clinical Use Cases
Unlike rigid off-the-shelf platforms, NEX for clinical apps is fully customizable to fit your unique project requirements. Whether you’re building for a niche patient population, specific trial protocol, or health system workflow, NEX offers:
- Customizable UI/UX across mobile and web
- Configurable features and data dashboards
- Modular components for expanding functionality
- Flexible integration with external systems and EHRs
This adaptability makes NEX ideal for research institutions, MedTech startups, and clinical organizations that require tailored digital health solutions without reinventing the wheel.
Extra Benefits: Built-In Compliance and Interoperability
When developing software for connected medical devices, regulatory compliance and seamless system integration are critical. NEX for clinical apps was designed with these demands in mind, offering built-in tools and frameworks that help MedTech companies meet regulatory requirements while ensuring their devices and software communicate effortlessly.
ISO 13485 Certified QMS-Driven Development
Compliance is baked into the DNA of NEX. Developed under Sequenex’s ISO 13485 Certified Quality Management System (QMS), NEX follows industry-best practices for safety, risk management, and quality control throughout the software lifecycle. This ensures your clinical app meets the stringent regulatory expectations of the FDA and other global health authorities from day one.
Using NEX for clinical apps means your development process is aligned with regulatory standards from the start, saving you time, reducing risk, and eliminating costly rework later in the cycle.
Prebuilt Support for Design History Files and FDA Submissions
One of the most time-consuming aspects of bringing a medical app to market is building and maintaining the documentation required for FDA clearance or approval. NEX streamlines this process by supporting automated documentation workflows that generate key components of your Design History File (DHF).
This includes:
- Traceability of software requirements
- Version-controlled development artifacts
- Validation and verification evidence
- Risk analysis documentation
With these elements in place, you’re better positioned to pursue FDA 510(k), De Novo, or PMA submissions without scrambling to retroactively build a compliant paper trail.
End-to-End Interoperability for Connected Device Ecosystems
Modern clinical apps rarely operate in isolation. That’s why NEX for clinical apps was engineered for end-to-end interoperability with BLE-connected medical devices, cloud systems, and third-party data platforms. Whether you’re connecting to a CGM, wearable biosensor, or custom BLE hardware, NEX handles real-time data communication, storage, and processing with ease.
Built-in interoperability features include:
- Seamless BLE device pairing and data syncing
- API integrations for EHRs and cloud services
- Scalable architecture that adapts to multi-device environments
By enabling smooth communication across devices and systems, NEX empowers MedTech developers to build cohesive, reliable clinical solutions that are ready for real-world deployment.
Who Should Use NEX for Clinical Apps?
NEX for clinical apps provides a strategic advantage for organizations building innovative connected health solutions. Whether you’re a MedTech startup, hospital IT team, research institution, or contract developer, NEX provides a robust, compliant, and scalable foundation tailored to your specific needs.
Here’s how different organizations can benefit from using NEX.
Startups
Early-stage medical device companies often face limited technical resources and tight timelines. NEX solves both challenges by delivering a prebuilt, customizable platform that handles the complex work of mobile development, BLE integration, and regulatory compliance.
- Launch MVPs in under three months with the MVP-123 Program
- Avoid costly internal hires or long vendor engagements
- Quickly validate device functionality and data flows
- Focus on innovation and differentiation, not infrastructure
NEX empowers startups to get investor-ready and trial-ready fast.
Hospitals & Health System
As healthcare providers increasingly turn to remote monitoring and in-house innovation, NEX for clinical apps offers a scalable solution to build custom clinical apps without reinventing the wheel.
- Rapidly develop apps that integrate with patient-facing biosensors
- Deploy HIPAA-compliant solutions on your own infrastructure
- Customize features to match clinical workflows and staff needs
- Gain full control over patient data, security, and device management
NEX helps health systems accelerate digital transformation while ensuring safety, reliability, and compliance.
Academic Research
Academic and institutional research projects often require flexible, fast-to-deploy platforms that support custom study protocols and biosensor integrations. NEX is built for just that.
- Create study-ready apps with real-time BLE device data capture
- Easily adapt the platform to unique research requirements
- Enable secure, long-term data collection and analysis
- Streamline participant enrollment and remote monitoring
Whether you’re conducting pilot studies or multi-year longitudinal trials, NEX for clinical apps offers the adaptability and compliance needed in academic settings.
CDMOs & MedTech Contractors
Contract development and manufacturing organizations (CDMOs) and freelance MedTech developers need flexible, reusable solutions that meet diverse client needs. NEX delivers a plug-and-play foundation that can be rapidly customized and deployed across projects.
- Reuse a proven software core for faster client turnaround
- Offer value-added services with lower overhead
- Ensure regulatory compliance across varying device types
- Scale development capacity without increasing internal headcount
With NEX for clinical apps, contract developers can expand their offerings and deliver high-quality, connected medical software solutions faster and for a higher profit.
NEX Provides a Clear Advantage for Clinical Apps
Beyond its rapid development capabilities and customizable architecture, NEX for clinical apps offers a host of additional features that make it a uniquely powerful platform for building connected healthcare solutions. Whether you’re developing for regulated markets or internal research, NEX includes everything needed to ensure a secure, scalable, and compliant deployment right out of the box.
HIPAA-compliant hosting is available either through Sequenex-managed infrastructure or on your organization’s own servers, giving you full control over where and how your data is stored. This flexible hosting model is ideal for hospitals, research institutions, and startups navigating varied IT and privacy policies.
NEX also includes device tracking, secure backup and recovery protocols, and built-in audit trails to support traceability and accountability, critical features for any clinical-grade system.
Additionally, NEX supports continuous delivery and compliance, ensuring that software updates are seamlessly deployed while maintaining alignment with FDA and ISO standards. With integration-ready support for BLE-connected biosensors, NEX enables real-time data acquisition, syncing, and monitoring without the heavy lifting of developing custom communication layers or middleware.
Most importantly, NEX is designed to eliminate traditional regulatory and engineering burdens, empowering clinical innovators to focus on what truly matters: improving patient outcomes and advancing medical research.
Are you ready to accelerate your clinical app development?
Explore how Sequenex’s NEX platform can streamline your path from concept to compliant product. Or connect with us today to schedule a discovery call and learn how NEX for clinical apps can give your team the speed, confidence, and flexibility to lead in the connected health market.
