For Medtech

Product development for connected, in-hospital equipment

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Our multi-disciplinary team understand the complex technical, regulatory, and clinical aspects of medical device development, and what it takes to innovate and create next generation connected, in-hospital equipment.

With deep domain expertise in digital health, connectivity, communications, and end-to-end cyber security, we can accelerate device development, and ensure your device is safe and successfully integrated with hospital systems.

Our flexible approach, certified quality management system, and proven process allows us to take customers from concept, through development, and on to operation and lifecycle management.

We can be your end-to-end partner for device development

Full Product Development Lifecycle

Support for every stage, from concept and development, through to launch and operations

- Long term partnership for connected medical devices

- System development, prime contracting, end-to-end solution delivery

- Approach to address global healthcare markets

Team Collaboration and Cultural Fit

Way of working that matches medical device vendor’s work culture

- Open, transparent communication

- Focusing on trust and relationship

- Taking shared responsibility and ownership for ultimate program success

Agile for Regulated Devices

Compliant medical device design, development, and integration

- Compliance with core medical device development standards (IEC 62304, IEC 62366, IEC/EN 60601-1)

- Integrated, quality-driven development environment

- Robust, agile practices for medical device development

Clinical Engagement

Engagement with clinical stakeholders

- Understanding of clinical workflow and care pathways

- Integration with clinical systems and services

- Design of patient and clinical interactions

Multi- Technology Solution Stack

Technology stack that covers a wide spectrum of medical devices

- Electronics and embedded, mobile, enterprise and web development

- Use of modern technology frameworks and platforms to accelerate development

- Experience in software-as-a-service deployment and operations for SaMD

Connectivity and Integration

End-to-end connectivity framework for medical devices

- Connectivity design and back-end services

- Wide spectrum of wireless connectivity options for home and hospital settings

- Integration with hospital information systems

- Verification for market approval and service readiness

Cyber Security

Security by design

- Cyber security framework

- Safety, risk-based design, implementation, and verification

- On-going field monitoring

- Post-market surveillance

Regulatory Expertise

Proven processes and procedures to design, develop, and operate connected health solutions

- Robust eQMS certified against key standards for medical device industry (ISO 13485, ISO 14971, ISO 27001 Information Security Management System in the areas of support and delivery of cloud-based systems by Managed Service Operations business)

- Process framework for global patient data privacy

- Working towards DHF and Technical File regulatory submissions

“Working with our customers is about more than technological capability. Our teams integrate with your work culture, to deliver the best possible results and experience.

Our support doesn’t stop after development either; we offer secure device services throughout engineering, manufacturing and operations. This leads to a smoother, more cost-effective process to successfully bring a product to market.”

Derek Dwyer

VP Strategic Accounts

Case Study

Developing a connected drug delivery device and bespoke in-hospital connectivity solution

Read how S3 Connected Health designed and developed an FDA class II connected drug delivery device for use in hospital environments.

We created a bespoke solution that uses multiple connectivity options to securely transmit data from the in-hospital device to our customer, optimizing the supply chain for this medication and revolutionizing their business operating model.

Service capabilities

Requirements definition, software and systems architecture
Electronic and firmware design
Wireless communications and connectivity (antenna design, radio, and RF systems)
IEC 62304 compliant medical device software design, development, and integration

End-to-end cybersecurity and device management
Development of end-to-end integrated devices, mobile apps, portals, and cloud-based solutions
Medical device verification and validation

Certifications and regulatory compliance