Applied Sciences Group, Inc.

Ingestible Motility Pill 

Overview

Applied Sciences Group, Inc. has been under contract since 2005 to develop the software for an ingestible, wireless capsule that measures pressure, pH and temperature as it traverses the gastrointestinal tract.  The information is used to provide gastric emptying time, combined small and large bowel transit time, total transit time, pressure contraction patterns from the antrum and duodenum, and motility indices.  This capsule will aid in the diagnosis of Crone’s Disease, gastroparesis and irritable bowel syndrome and other chronic gastrointestinal ailments.

The single-use wireless capsule is swallowed by the patient.  The pill then periodically transmits data to a receiver worn by the patient while the pill is moving through the GI tract.  After the capsule has passed, the data from the receiver is downloaded into a program at the clinicians’ office, and the test results can be displayed and analyzed in both graphical and report formats at that time.

ASG has been involved in all development aspects of this project as well as product test development as it is manufactured.  This project has been ongoing since 2005 and has utilized several ASG engineers at multiple levels:

• Risk Assessment
• Design
• Code
• Test
• Integration
• Quality Measures and Support for FDA Audits
• Analysis
• Report Generation
• Manufacturing Test Development

The capsule and receiver software was written in embedded C, based on the embedded nature of these two devices.  The extensive analysis portion of this project, developed for use under the Windows operating system, was written entirely in the Microsoft Windows .net framework using Visual Basic.net and C#.net.  Additional simulation and modeling was developed using Matlab and C#, utilizing the National Instruments signal processing library.

This project required that engineers learn and understand basic human anatomy and physiology, learn the appropriate terminology, and work with client staff to move this project through the FDA regulatory process for eventual approval.  The first version of the capsule system was approved for clinical use in 2009.

This project continues to evolve as more versions of the capsule and additional analysis programs are being written and submitted to the FDA.

User graphics development and training documentation was critical in nature, as the clinicians utilizing the system had to be able to clearly monitor gastrointestinal data in order to provide accurate assessment of patients’ conditions.

Project Management

Virtually all of the initial development work required that ASG employees be sited at the client’s offices, in order to interact closely with the client’s staff.  For those ASG staff, client management provided direct oversight of ASG employees; with regular (weekly) status meetings attended by the ASG project manager.  The design and implementation of much of the analysis software took place at ASG, with direct staff oversight by the ASG project manager and status reporting to the client.  Generally, ASG and client project managers met regularly during the entire product development phase regardless of where ASG staff actually performed the work. 

FDA Guidance – Requirements, Design, Testing and Validation

For medical device development, ASG strictly follows FDA guidelines for software development.  ASG staff helped develop the documents associated with the initial FDA submittal; staff met regularly with the client during requirements development and were intimately involved in risk assessment, design, verification testing (and reporting) and validation testing (and reporting).  Software was documented and managed, with strict adherence to version controls.

Other ASG Resource Involvement

ASG was the go-to company that the client would approach when the client did not have the internal resources needed to address technical software and analysis issues.  Supplemental ASG resources focused into several major areas:

• ·         Capsule Communications:  Capsule battery size, and therefore power, was a limiting factor into the rate at which data could be transmitted to the receiver.  ASG developed the capsule data buffering logic, sleep algorithm and transmission protocols to conserve battery power while reliably moving the data from capsule to receiver.
• ·         Receiver Communications:  ASG utilized its USB driver development expertise to design, code and test the USB driver that the receiver used to deliver data to the PC.
• ·         Signal Analysis:  Post collection, the data is exceptionally noisy and – if simply displayed as raw data – any relevant patterns are hard to discern.  ASG was asked to provide signal processing expertise to convolve, filter and integrate the data in order to improve signal to noise ratios.
• ·         Graphical User Interface:  ASG provide much of the design guidance for a clean graphical interface used by the various analysis programs.

Outcomes

Two versions of the capsule have been submitted and approved by the FDA.  The manufacturing facility has also received FDA approval, and the capsule is now on the market.

Three ASG engineers have been included on several of the client’s patent submissions.

USB Development White Paper

ASG has developed a number of USB solutions for several clients.  USB drivers are typically developed and configured to run in either device (“gadget”) or host mode.  ASG has developed drivers for both modes of USB.

Customers’ Challenges

The typical client technology hurdle was to develop a custom driver to support a specific USB chip or processor with integrated USB interface in an embedded computer system.  Development of a USB driver is dependent on a number of factors, and less-common embedded platforms do not necessarily provide ideal USB solutions. Often, only templates and examples can be provided, and the developer must then modify whatever is available in order for the interface to operate correctly and efficiently on the specific platform.  Additionally, many clients do not have internal software development resources experienced in USB driver development.

Of great importance during the initial design phase is the selection of components that have been commonly used together. Ideally reference designs can be utilized, and device driver example code will be available. The ubiquity of USB has made debugging and testing the interface less demanding than many other technologies.  ASG’s experience, however, is that some unique combinations of hardware can lead to compatibility issues, race conditions and hardware interface problems that exacerbate what should be a simple integration problem. 

Our Solutions

ASG has developed significant internal expertise in USB driver development and implementation.  Several open-source drivers have been adapted and implemented in Linux based platforms including ARM, embedded x86 and Freescale Coldfire processors.  In embedded microcontroller applications, Interrupt Service Routine software and Interface routines have been developed to support an Atmel 8051 variant (c8051f32) with an integrated USB interface as a USB Device.  Other applications have included Windows CE, Windows and Linux operating systems, in which both USB Gadget and Host drivers have been successfully implemented.

Key Technologies

·        USB driver development

·        USB Host and USB Gadget mode

·        Linux, Windows CE, Windows operating systems.

Standalone Embedded Microcontroller Applications

Freescale Coldfire White Paper Overview

Applied Sciences Group (ASG) was contracted by an electronics manufacturer to develop the board support package (BSP) for a Freescale Coldfire-based single board computer.  The embedded Linux solution had to support multiple peripherals as well as a high-speed monitoring application running on top of the Linux operating system.

Customer’s Challenge

Our client had developed an embedded single board computer based on the Freeescale Coldfire MCF5484 CPU.  The board was to be utilized to support high-speed monitoring of data generated at semiconductor fabs during the manufacturing process.

The client needed to quickly develop a custom Linux-based board support package (BSP) for the single board computer.

Our Solution

Applied Sciences Group has extensive experience with both the Freescale Coldfire product line and embedded Linux.  Development of the SBC was straightforward, beginning with setting up RAM, setting up flash memory and modifying the Coldfire Linux Loader (CoLILO) bootloader to fit the client’s bootup requirements.  Once the boot process was stable, additional device drivers were written to support all peripherals and the embedded application sitting on top of the operating system.

Non-trivial peripheral support included development and integration of Ethernet, FLEXBUS, USB (as a host), DeviceNet, digital I/O and SPI drivers.

ASG utilized the GNU Compiler (GCC) and Freescale Linux Target Image Builder (LTIB) tools to build the BusyBox Linux image.  CoLILO was extensively upgraded to support field upgradeability, memory testing, Coldfire processor initialization and additional boot options.

Key Technologies

·        Motorola Freescale Coldfire Processor

·        Linux

·        Board Support Packages

·        Device Driver Development

·        CoLILO, GCC, LTIB

·        Serial, Ethernet, DeviceNet, SPI, FLEXBUS, USB Host

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