Integra Systems, Inc., validation and verification capabilities for wireless networks for healthcare and medical devices.
- Originated the first concept to demonstrate that real time patient monitoring traffic could be shared with an enterprise network. Took this from a concept to reality and validated and verified both quality of service and security on commercially available networks. Provided the testing required for regulatory approval and launched the design on an international basis.
- Brought in as a SME (Subject Matter Expert) to validate and verify the correct networking requirements for a medical device company that had an embedded wireless adapter as a part of their solution. Architected their internal network and design requirements. Wrote the test protocols, test plans, and conducted the testing for a FDA 510(k) submittal. Addressed concerns from the reviewer.
- Provided baseline R&D validation for BAN (Body Area Networks) http://www.fcc.gov/document/medical-body-area-networks for a medical device company.
- Authored test plans, protocols, and conducted the testing for multiple medical device companies that had a wireless component as a part of their enterprise solution. This enabled some of these companies to obtain the fastest FDA 510(k) approval in the history of the company.
- Authored test plans, protocols, and methodology for testing that is consistent with the FDA released guidance published in August 2013. This process has been used by multiple companies to meet these newly released requirements.
- Provided R&D design guidance for the use of an embedded ANT radio for a unique wireless medical device application. www.thisisant.com
- Provided R&D guidance for the use of LPBT http://www.bluetooth.com/Pages/Bluetooth-Smart.aspx and a GSM wireless patient monitoring application.
- Provided R&D guidance on the use or non-use of Wi-Fi Direct http://www.wi-fi.org/discover-wi-fi/wi-fi-direct and/or LPBT.
- Brought in as the SME to develop an initial prototype of a multi-faceted wireless medical device application that included Zigbee, http://www.zigbee.org/ GSM, http://en.wikipedia.org/wiki/GSM and software application development. Worked with testing houses for EMI, EMC, and FCC certifications.
- Worked with a company that has a commercially available multi-functional wireless networking appliance. Helped them to initiate the guidance to comply with the current MDDS ruling effective April 18, 2012 for Class I devices. This includes the guidance to initiate the requirements for a compliant Quality System.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/ucm251897.htm
- Provided forensic analysis on a WMTS http://www.fcc.gov/encyclopedia/wireless-medical-telemetry-service-wmts telemetry system that was experiencing extensive issues over a period of years. Established the root cause of issues, provided the correct documentation, and enabled an immediate resolution.
- Brought in as the SME for a classified government wireless project. Provided a design review to an in-effective wireless implementation for wireless voice over IP. Created the correct design, implemented the design, enabled the correct testing, with the result of the application performing as expected.
