For Medtech

Wearable and implantable medical device development

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Our team understand the challenges medtech companies face when developing a medical device; we’ve taken many clients successfully through the development process and we can do the same for you.

Using certified tools and processes, our experts will address performance and regulatory gaps and efficiently turn your concept into a marketable product.

We understand the journey from concept to market success

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Value

Time

Gaps in performance and regulatory maturity that prevent successful market launch of a scalable product

Device potential will not be realized if quality, regulatory and performance issues are not addressed

First Product Prototype

Pre-Clinical Validation

Regulatory, quality, and technical readiness assessment and critical fixes

- Holistic assessment

- Defining a realistic path to regulatory submission and market launch

- Readiness for Clinical Study/Trials: prioritization of key product requirements

- Addressing critical issues of first product prototype

Clinical Trials and Validation

Staged product development aligned to the needs of medtech companies

- Analysis of usability, performance, and product issues following clinical trial

- Refining product roadmap following clinical study to reach MVP for market launch of device

- Staged device development in accordance with regulatory and quality standards

- Performance validation and verification against user needs and UE/HFE

- DHF and preparation for first-time-right regulatory submission

Regulatory Approval and Market Launch

Post-market adjustment and preparing for scale

- Analysis of user feedback, fit with clinical practice, workflow integration, and patient experience

- Analysis of evidence requirements for reimbursement

- Alignment with stakeholder needs, assessing any regulatory impacts

- MVP roadmap and product refinement

- Feature and value development

- Go-to-market planning, optimization, and TFM

Commercialization and Market Penetration

"A quick time to market is particularly important for medtech companies focused on a single product, or teams responsible for delivering next-generation devices.

Our team of experts quickly assess potential technical or regulatory deficiencies in prototypes before designing a pragmatic development path to a robust and marketable product.”

Szymon Zysko

VP R&D

Case Study

NightBalance Lunoa

Design and development of a connected wearable device for POSA

For NightBalance Lunoa, S3 Connected Health designed and developed a next-generation sensor device with Bluetooth Low Energy (BLE) connectivity, including electronics (PCBA), firmware, mobile application for iOS and Android, and cloud-based portal.

Service capabilities

Gap analysis report, which forms the path to a robust and regulatory approved product
Electronic and firmware design from concept to “transfer to manufacture”
Medical device development in compliance with stringent regulatory requirements and processes
Creation of regulatory documentation from intended use to technical file and digital history file

IEC 62304-compliant medical device software design, development, and integration
Identification of IEC 62304 gaps
Wireless communications and antenna design
Software development of end-to-end integrated device, including mobile apps, portals, and cloud-based solutions
Managed service including cloud hosting, maintenance, and monitoring

Certifications and regulatory compliance