Accelerating Innovation: End-to-End Engineering from Concept to FDA-Cleared Wireless Patient Monitoring

A global MNC leader in patient Monitoring products and entering wireless patient monitoring devices segment with a NPI/NPD product.

No product in the wearable medical device segment. Need to develop one for a growing market in the US and EU region.
Novel medical device using wireless sensors, limited predicate devices
Large number of physiological parameters to be monitored in real-time, multiple product codes
Enhanced human factors engineering requirements, Single hand Docking mandatory
Cloud connect data in a secure way FDA 510(k) clearance mandatory

End-to-end medical device product development of FDA Class II device: wireless patient monitoring system
Medical grade app development along with a customized Docking Station for Hospital use
Compliant Product DHF, Cybersecurity and Safety RM, Usability study, human factors validation study
Comply with all certification standards and submissions
Wireless coexistence and Cybersecurity tests
FDA 510(k) submission (Ph-I)
Design Implementation of the iBSM app
Identification of a medical grade tab and enabling remote management of the same
Mechanical design of the docking station and the associated hardware electronics
Development and deployment of the associated cloud components to deliver the workflows
Risk management for product safety and security
Extensive Verification and Validation and generation of test reports
DHF, IFU labelling and Medical Device File readiness for submission leveraging iOrbit's ISO 13485 processes
Integrated testing of the product, including multi RF coexistence tests at TUV labs
Human Factor Engineering, human factor validation tests and usability testing
Design and development of product workflows and protocols
Completion of all statutory IEC 60601 and ISO tests to meet FDA consensus standards
3rd party medical device cybersecurity testing and certification of all components

Leveraging expertise in digital healthcare technology, iOrbit designed the iBSM product platform to meet the requirements of a wireless patient monitoring system
UX design and development of clinician-facing iBSM applications
Seamless integration of wearables with bedside monitors
Remote management of medical-grade tablets
Mechanical and hardware design of an elegant and ergonomic docking station
Cloud-connected medical device infrastructure design and workflow automation
Safety, risk, and cybersecurity compliance
Medical device verification and validation, usability, and human factors testing completed
DHF, IFU, labeling, and documentation as per iOrbit's ISO 13485 process framework
Third-party IEC/ISO testing and RF coexistence validation with TUV

First-in-Segment Wearable Solution: Delivered a novel wearable patient monitoring device for US and EU markets, addressing a major portfolio gap.
Regulatory Success: Achieved FDA 510(k) clearance (K243837) with full compliance to IEC/ISO, cybersecurity, usability, and RF coexistence standards.
Seamless Clinical Integration: Enabled interoperability of wearable sensors with bedside monitors, clinician apps, and medical-grade tablets.
Elegant & Practical Design: Developed an ergonomic single-hand docking station and robust hardware/software platform optimized for hospital workflows.
Cloud-Connected Ecosystem: Designed secure cloud infrastructure and workflow automation for real-time physiological parameter monitoring.
Patient Safety & Usability Validated: Completed rigorous Verification & Validation, Human Factors Engineering, and third-party cybersecurity testing.
End-to-End Ownership: Delivered the complete DHF, IFU, labeling, and submission documentation under iOrbit's ISO 13485 framework.