DEVELOPMENT OF A HEALTH DATA MANAGEMENT SYSTEM

Client Profile: A Medical Device Company seeking to provide software technology for blood glucose measurements, insulin data and other diabetes related patient data management.

Technologies Used: Use Case Analysis, UML, Requirements Engineering, Model Maker, knowledge of Clinical Diagnostics Device functionality and interfaces, C/C++,.NET Framework, Delphi, SQL, and Mercury Quality Center.

Project Summary: The client needed a state-of-the-art web enabled health data management system in order to maintain their market leadership and provide their patients a system that efficiently tracks results and shares data with Healthcare Providers.  A comprehensive software requirements specification (SRS) document was required to support system development. The SRS is the primary reference for the development of the application design and contained an accurate and detailed description of system behavior. The SRS is also the primary source from which the Development Team produces a strategy for testing the end product. The development effort included a PC based client application and a backend database that communicates via a Web interface in order to share data among subscribers pursuant to HIPAA guidelines.

Working with the client, The Ashvins Group managed and directed the activities necessary to develop the application. These activities included many processes:

• Facilitated Use Case Analysis and Requirements Review Sessions. Clearly defined the requirements for the development of a multi-user intuitive application that includes a Windows based front end, with a web enabled back-end Host System. This application synchronizes data elements between the home user and the Healthcare Provider so that both have visibility to the same data. Data is uploaded directly from glucose-related medical devices to the Windows application to simplify data entry.



• Provided requirements that will ensure the application's enhanced flexibility and scalability for current and future technology.



• Developed the application in a phased approach based on the Rational Unified Process.



• Prepared, executed, and directed the software verification.



• Prepared documentation based on FDA Guidelines for application development and validation for Medical Devices.

The team based management approach incorporating both an Ashvins development team and a client project team greatly contributed to defining and developing an innovative, robust, and unique application.

WIRELESS INTEGRATION OF PORTABLE MEDICAL DEVICES USING BLUETOOTH TECHNOLOGIES

Client Profile: A global clinical and medical device company that develops personal and portable medical devices. The devices are Bluetooth enabled glucose meters for continuous glucose monitoring. Being one of the most versatile technologies in the wireless market, the Bluetooth technology was chosen by the client to address performance requirements specific to the medical application and because it is a particularly good fit use for models demanding high mobility, long battery life and limited infrastructure support.

Technologies Used: Visual C++, Bluetooth Technologies, UML, Broadcom Bluetooth Development Toolkit, Mercury Quality Center

Project Summary: Ashvins Group was contracted by the client to develop the wireless interface with the client’s medical devices that utilize Bluetooth technology. The interface is acting as the primary data extraction point from the system and acts as a source of device data upload for the client’s Data Management Solution.

The interface is architected around a core Bluetooth SPP communication engine developed in-house. This engine is wrapped into a data validation layer and all was integrated into a data management handler framework. The layer design of the interface provided data de-coupling and low risk upgrades. The Bluetooth communication layer can be easily upgraded to keep pace with the latest Bluetooth protocol developments. Thus, the engine was upgraded from the original Bluetooth 1.1 implementation to 1.2 and later to Bluetooth 2.0. The Bluetooth has proven itself to be a reliable and secure communication protocol.

The implementation of the Bluetooth protocol for the device communication gave the client an edge in the industry. It is clear that medical devices and medical data management products benefit from the advantages provided by wireless technologies.

BLACKBERRY PLATFORM:  HEALTH MANAGEMENT APPLICATION DEVELOPMENT

Client Profile: A Medical Device Company who markets a personal healthcare device to measure chronic condition levels seeking to develop a mobile phone application that can interface to the device and track/trend data

Technologies Used: Use Case Analysis, Human Factors Engineering, Requirements Engineering, Java ME, Bluetooth interface technology, knowledge of Medical Device functionality and interfaces, FDA Application Development /V&V Guidelines to support submission of 510K and HP Mercury Quality Center.

Project Summary: The project consisted of the development of a Health Management Application that will run on a BlackBerry mobile phone platform and interface wirelessly (Bluetooth) to personal medical devices collecting and displaying health management data for users.

The BlackBerry Health Management Application is a comprehensive clinical data management system allowing users of the medical device secure access to real-time information, trends (with graphical display) and system level alerts,  thereby maximizing efficiencies in the delivery of optimal health care.  Created in close collaboration with the medical device client, the result is a user-friendly, customizable interface that allows interaction with the system through point and click and free text entry.  The system includes automatic upload of critical medical data and device alarms/alerts so that the user is immediately notified of imminent health situations.  It provides users with intuitive usability at varying levels of functionality, based on the user’s needs and technical comfort.  Users are able to set target alerts for medical parameters and automatically send out SMS messages to healthcare providers or other contacts when parameters are in an alert zone.  The application also has a web-enabled interface that supports HIPAA compliant data sharing with healthcare providers. Through the BlackBerry Health Management Application, users have a secure, effective means of data management. Increased awareness of critical factors can lower a patient’s risk of complications in the management of chronic conditions.

INSULIN DELIVERY DEVICE:  REMOTE MONITORING AND HEALTH MANAGEMENT APPLICATION DEVELOPMENT

Client Profile: A Medical Device Company who markets an Insulin Delivery Device seeking to develop an application that can remotely monitor the device and track/trend data.

Technologies Used: Use Case Analysis, Requirements Engineering, Java ME, Bluetooth interface technology, knowledge of Medical Device functionality and interfaces, FDA Application Development /V&V Guidelines to support submission of 510K and HP Mercury Quality Center.

Project Summary: Ashvins' focus in this project was the development of a Windows based/ Web enabled application that will interface with the insulin delivery device to facilitate the tracking and trending of medical data.  Additionally, the application also facilitates sharing of data between patients and Healthcare Providers for remote monitoring.

• Data management application to support insulin delivery device users.



• Wireless connection to insulin delivery device and automatic device reading.



• Allows Healthcare Providers to view pump history, troubleshoot issues remotely and review data from users



• Extensible architecture to support future expansion.



• Intuitive GUI, complex reporting, configurable features.



• Overall the application enables patients to more effectively manage their disease and improves/increases efficiency of communications between patients and healthcare providers.

CLINICAL LABORATORY QUALITY CONTROL SYSTEM SUPPORTING GLOBAL CUSTOMER BASE

Client Profile: An industry leader in the field of clinical diagnostics who supplies clients with products and services that support laboratory Quality Control (QC) processes.

Technologies Used: C/C++, Oracle, Oracle Forms and Reports, PERL, PL/SQL, Korn Shell, OCR for Forms, Rightfax, Adobe, Crystal Reports, WinRunner and AIX.

Project Summary: Clinical laboratories are required by law to monitor and verify their data by using independent control samples to verify the validity of the patient results. The client requested the development of a web-based Quality Control/ Quality Assurance system consisting of a Windows based application, Web based interface and a central repository of data. The project was developed in phases beginning with the creation of the software requirements specifications for both the client and host applications. The client application standardizes the QC processes managed by the laboratory customers, and offers full CLIA documentation, comprehensive selection of QC Rules and immediately accessible data review reports. The system also included LIS/HIS interfaces to facilitate data submission, storage and management.

Laboratory QC Systems are regulated by the FDA. These regulations require proper documentation and testing prior to release. Testing protocols, test cases and validation documentation were developed to ensure FDA regulation compliance.

The entire system entails the acceptance of QC data via LIS/HIS interfaces, mail, fax, electronic data transfer and direct data submission via the Web based interface from the client application on a daily and/or monthly basis from labs around the world.  Mailed and faxed data is processed using Optical Character Recognition (OCR) technology and imported to the Oracle relational database.  Received data is stored in a central repository categorized by laboratory parameters. The data is analyzed for statistical validity and compared to other laboratories using similar test methodologies. Report pdf files are generated and are either printed for mailing or sent to users electronically. 

POINT OF CARE CLINICAL DIAGNOSTIC DEVICE:  DATA INTERFACE TO LIS/HIS

Client Profile: An established manufacturer of Point of Care reagents /device for clinical diagnostic testing.

Technologies Used: Requirements Engineering, Rational Unified Process, Computer Related Systems Validation (CRSV) Methods, Project Management Techniques

Project Summary: The client needed to identify and/or develop then validate an information management solution for their Point of Care device.  Ashvins’ role in the project was to determine if a commercial solution was available that could achieve the client’s data management requirements or if development of a custom solution was the optimal approach and then carry the project to implementation (with either a commercial system or a custom system).  The first step in the project was to establish a full set of software requirement specifications for the system.  The next step was to review commercially available solutions to determine if an existing solution could satisfy the requirements.  An essential requirement of the system was that data coming from the Point of Care device via automatic systems interface could be monitored and then data shared with the user’s LIS/HIS.   A commercially available solution was identified and Ashvins completed the validation of the interface and system.  Implementing a commercially available system was the most cost effective and efficient solution for the client.

REQUIREMENTS ENGINEERING, SYSTEM ARCHITECTURE /DESIGN FOR CLINICAL DIAGNOSTICS APPLICATION

Client Profile: An established manufacturer of clinical laboratory reagents and instrumentation for in vitro diagnostic testing.

Technologies Used: Rational Unified Process, Use Cases, UML, Mercury Interactive TestDirector/WinRunner.

Project Summary: To quickly develop requirement specifications and system design documentation for a critical laboratory software product. This comprehensive web-enabled system was essential for supporting improved Quality Control tests performance by their customers worldwide.

• Using best practice RUP processes and Use Case Analysis, The Ashvins Group produced a detailed Software Requirements Specification (SRS). This step established clear, detailed documentation of the system goals in order to manage and to achieve an effective and efficient software development process.



• Prepared complete Design and Architecture Documentation with GUI templates and model diagrams to aid accelerated implementation of the software coding and development.



• Provided independent Test Administration support including Quality Assurance planning, software test case development, system & integration testing, change control procedures, defect tracking and coordination of field beta testing.

MICROARRAY INSTRUMENTATION SOFTWARE

Client Profile: A biotech company developing new technology for the Life Science Industry.

Technologies Used: C#/C++,.NET Framework, XML, Mercury Quality Center / WinRunner

Project Summary: This client developed a microarray/bio-sensor instrument that is used to characterize molecular interactions and support the expanding field of Proteomics. Ashvins' focus in this project was the development of a Windows based graphical user interface to control and acquire data from the new instrument. The instrument is attached to a robot sample handler.  The application was required to manage the interaction of both the robot movements and instrument data capture procedures.

• Phase 1: Created a team consisting of members from the industrial design company, the biotech client and Ashvins to develop the Software Requirements Specification.



• Phase 2: Developed the Design and Architecture of the system utilizing established UML Best Practices.



• Phase 3: Implementation of the solution, testing/validation processes, change control procedures and defect tracking.

Throughout the life of the project, communication was critical since both the firmware for the instrument and the software was developed concurrently. Constant interaction between the biotech company, the industrial design company, and Ashvins ensured a successful project.  An application was developed with an easy to use graphical interface that allows a lab technician to learn and use the application in less than a day while orchestrating complex experiments in less time than competing systems.

OPEN SOURCE SOLUTION TO SUPPORT PROTEOMICS RESEARCH

Client Profile: A prominent Proteomics Research University whose focus is on the study of biomolecular interactions.

Technologies Used: JBoss (Java J2EE), Apache AXIS (SOAP)

Project Summary: The client manages an extensive database designed to store full descriptions of interactions, molecular complexes and pathways. The database stores variables such as small molecule biochemistry to signal transduction, which is abstracted in such a way that graph theory methods may be applied for data mining. The database is used to study networks of interactions, to map pathways across taxonomic branches and to generate information for kinetic simulations. A standard means of submitting data related to biomolecular interactions was vitally needed due to an anticipated large influx of interaction information from high-throughput proteomics efforts including detailed information about post-translational modifications from mass spectrometry.

Ashvins developed a custom open source solution that entailed web service API development. This involved creating independent application components and making them available for use across the Internet. Developers of Internet-based applications incorporate this service into their applications for the benefit of their end users in an unobtrusive and seamless implementation. This interface allows Integrated Development Environments (IDE) such as JBuilder and Delphi to generate a dynamic listing and access to the API utilizing the native SOAP services that are used to communicate and integrate with their internal applications. The API is made available to developers via a Web Service. The SOAP API provides a modular, more flexible, and higher-performing interface to increase the accessibility of the database.

CLINICAL DATA MANAGEMENT SYSTEM INTEGRATION

Client Profile: A growing biotechnology company seeking to improve clinical data management between internal clinical systems and contracted outside Clinical Research Organizations in order to accelerate the process of bringing new products to market.

Technologies Required for Implementation: RUP, Java, JSP, WebSphere, Oracle Clinical, Oracle Thesaurus Management System, SAS

Project Summary: The Ashvins Group was contracted to apply Systems Integration IT resources to maximize communications between different application programs, databases and systems. The project included:

• A user-friendly interface to facilitate the capture of data from clinical trials, the ability to set-up/track and manage Phase I-IV clinical studies, the ability to custom configure clinical studies based on the study/specifications and reports generated utilizing industry standard reporting tools.



• The system automated information flow and accessibility to data generated by multiple sites (even outside CRO's) through the use of the batch load function of Oracle Clinical, and synchronization to the web-based user interfaces.

The client was able to achieve immediate access to clinical research data through the use of the improved web-based system. The advanced data management system allows the client to dramatically improve overall management of the clinical trials process and additionally provides detailed documentation along the way.

DRUG DISCOVERY AND HTS PROCESS AUTOMATION

Client Profile: An emerging drug discovery company utilizing proprietary molecular interaction modeling and protein capture technologies.

Technologies Used: Java, J2EE, Apache, JBuilder, Oracle

Project Summary: Biotech client markets a proprietary process to model molecular interactions and capture proteins for drug discovery. The procedure is a time consuming manual process that involves many steps and several different chemical analyses. Individual phases of the process required scientists to program several robots and analytical instruments, each with different software packages. Both the development of the test methods and coordination of the instrumentation were very cumbersome. The client was seeking to automate the process, and create a High Throughput Screening application.

Ashvins was contracted to manage the requirements gathering and documentation, architect the automation application, and develop project schedules for the different phases of development. A team with members from Ashvins and the client developed a web based scheduling application that coordinated all the robotic movements and extracted the data from the different analytical instruments. The data acquired is stored in a central database where it is statistically analyzed and collated for reactivity. Experiments are batched ahead of time and processed throughout the day. The application monitors and provides instant feedback as to the status of the experiment via a secure web portal interface.

As a result, the client achieved a streamlined process and quadrupled their processing volume with fewer resources. Scientists are able to configure their experiments and monitor them remotely, even when off site.

WEB-BASED SYSTEM SOLUTION FOR RESEARCH GRANT MANAGEMENT

Client Profile: A large university medical school handling multiple research studies and grants.

Technologies Used: Rational Unified Process; Java; J2EE; Oracle; WebSphere; JSP

Project Summary: As a research university managing multiple research grants projects, the client found that each department would collect their results on multiple PC's using various software applications. This fragmentation of the data did not provide the university with the ability to access or link similar studies for further analytical review. The university contracted The Ashvins Group to conduct a thorough review of their current processes and to formulate a solution.

The Ashvins Group prepared a comprehensive list of recommendations that included the implementation of a large web-based system that tracks the state's primary health care network. The system was designed to identify and forecast the needs for preventative medical services and incorporate this knowledge into the student curriculum for predoctoral training in primary health care.

The Ashvins Group undertook an extensive data modeling endeavor for the system. The data model was realized into an Oracle database on the host server. Ashvins also implemented the application server portion of the project. We undertook conception and system requirements analysis using the Rational Unified Process, and then subsequent elaboration and construction phases of the project.

As a result, the university can formulate comparative studies of similar projects. Having one database has also minimized data entry as multiple users were previously entering like information into separate databases.

ERP INTERFACE / SYSTEM INTEGRATION

Client Profile: An established Clinical Diagnostics manufacturing company.

Technologies Used: Java, J2EE, WebSphere, PL/SQL, DB2, XML, Oracle

Project Summary: A Clinical Diagnostics company needed three large Enterprise Systems to share customer data to avoid redundant data entry and multiple customer records. All customers had records in (1) the ERP server running DB2, (2) the Quality Assurance Program (QAP) server running Oracle, and (3) in the Customer Call Management System. Each time a customer would call into the diagnostic company, the Customer Support and Services Group would need to access three different systems depending on the customer request, causing delays in response to the customer. In addition, customer records were being created in three different systems making the process prone to errors, adding redundant information that could not be easily updated or synchronized and contributing to overall process inefficiencies that frequently resulted in system application crashes.

The Ashvins Group developed an electronic data interface to integrate all three systems and developed a Graphical User Interface that performs all required functions to interact with the three systems. SQL modules were developed and integrated into the ERP System that would update the QAP System automatically. PL/SQL modules were added to the QAP database to accept the data update, automatically create a new record for the customer in the QAP database, and generate customer documentation. Custom SQL queries were developed for the Customer Management Database that would retrieve customer laboratory information and automatically fill in all the required fields for a customer record.

As a result of the new integrated application and comprehensive GUI, the Customer Support and Service Group was able to increase customer satisfaction by cutting the response time 75%. In addition, the most current information and data was immediately available and consistent between sources. Application crashes were no longer an issue and data entry was streamlined by eliminating data entry duplication. Data errors were significantly reduced and the process of customer data management enhanced.

SYSTEMS VALIDATION AND OPERATIONAL QUALIFICATION

Client Profile: A pharmaceutical manufacturing company implementing laboratory automation instrumentation to support production operations.

Technologies Used: FDA Regulations/Standards, IEEE Documentation Standards, Computer Related Systems Validation (CRSV) Methods, Project Management Techniques

Project Summary: The pharmaceutical manufacturing client recently started production in a new plant. Part of the production process included automated ELISA testing using a TECAN Genesis System and components. The Ashvins Group led the Operational Qualification (OQ) efforts for this important automation project. Operational Qualification is the process of demonstrating that an instrument system and associated software will function according to its specifications and requirements (including FDA regulations such as 21 CFR 11) in the selected environment.

Working with the client, The Ashvins Group prepared the OQ Validation Plan, assisted during the execution of the OQ protocols and prepared the Summary of Results. The client was able to capitalize on the Ashvins’ laboratory automation expertise, knowledge of FDA regulations and documentation skills to efficiently document and implement their new instrument system.

RETROSPECTIVE VALIDATION FOR CUSTOM APPLICATION

Client Profile: A bio-pharma company involved in drug discovery and moving into pharmaceutical manufacturing.

Technologies Used: RUP, IEEE Recommended Practice for Software Requirements Specifications, UML, and Rational Rose Modeling Tool.

Project Summary: The bio-pharma client was using a custom application to automate testing procedures and data analysis. The software had been developed in-house when the organization was a start-up biotech company. The client was fast moving toward commercialization of their first product and needed to have all applications documented and validated per FDA standards.

The Ashvins Group consulted with the client to understand the functional requirements associated with the custom application and to review all existing design and development documentation. By working both with the end-users of the application and with a running model of the application, The Ashvins Group developed a comprehensive Software Requirements Specification. From there, a Detailed Design Document was developed that included all existing functionality. Finally, the application was fully validated to provide sufficient documentation to support the continued use of the application in an FDA regulated environment. By creating “retrospective documentation” to support the application, the client was able to implement the existing software and use the software as a base-line to support continuing development efforts for the application.