The System provides many advantages to Medical Device and Drug Companies, primarily in the area of collecting, storing, and analyzing the data. While Device and Drug/Treatment trials are different, there are common elements that are envisioned to be supported by the System, which are mainly the same common elements that are used to care for patients, not in trials.

 

• It provides access to more and less expensive network connected home and clinical monitoring and test devices, that have higher availability and remote access for any support

• It provides recordable “Remote Presence” and/or “Telemedicine” to be able to provide treatments and follow-ups in more places at less cost

• Through Localization and Internationalization, it can create larger potential markets

• It provides Common Object Interfaces, Methods, Documentation, and Integration  to

  • Leverage off of the design, developing, documentation, and testing  the product (mainly for devices) prior to the trial at lower costs with fewer bugs (allowing device companies to concentrate on their device specific attributes)

  • design, develop, and get approval for methods and plans for the trials and the eventual certification (delta cert)

  • automatically collect Patient Data in a common format from a variety of sources (personal monitoring, home monitoring, patient input, and clinic/doctor/hospital monitoring and input), plus programmable alerts

  • collect detailed information (configuration, model, date of manufacture, errors, resets, upgrades, calibrations, etc.) about any Medical Devices (Monitoring, Test, Diagnosis, and Treatment) used in the trial plus remote access

  • provide a rich set of real-time, scheduled, and as needed analysis tools to analyze and correlate the data across one or more sources of data, plus threshold alerts

  • provide lower cost development and trials, to larger parts of the world, to potentially spur new products to rarer conditions

• It provides audit trails and verification of

  • when and what treatments have been given to a person

  • verification of prescribed treatments prior to being given (reduce mistakes)

  • verification of any incompatibilities in prescribed treatments

  • verification of collected data (source and time)

• It provides HIPAA Cloud Storage (and processing) to collect patient and device data for various canned and custom searches and correlation

• It provides the ability to get (and use prior) extensive baseline data about the patient prior to the trial, and automatically identify differences

• It provides Intelligent Adaptive Examination Decision Trees to help baseline and help to identify seemingly insignificant changes and issues, to see if they might correlate to larger issues, and can also have adjustments for regional issues

• After the trial, the data is still collected and can be used to correlate manufacturing batch or common issues over larger populations of individuals or devices over time

 

System Components:

• Smartphones, Tablets, and/or PCs with downloaded APPs  (and access to Cloud Data and Processing  through the APPs)

• Access to the Data and Processing Clouds, and the creation of different algorithms to perform real-time and longer term issue analysis

• Any required monitoring, test, and treatment Devices