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
i
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
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Staged product development aligned to scale-ups' needs

- 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
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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 scale-up companies focused on a single product.

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-S3-Connected-Health
Szymon Zysko
Head of Services Delivery and Operations
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.

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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
  • IEC62304-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
BSI-Assurance-Mark-ISO-13485
ISO-60601Certification
IEC 62304 Certification