Intertech works with medical device companies to help them meet their most pressing engineering, regulatory, and project management challenges by:

• Complying with regulatory requirements of the FDA and other agencies for device design, development, and validation
• Balancing the interrelated challenges of time-to-market, development cost and product quality
• Launching trouble-free maintenance releases of existing products without impacting new product development schedules
• Validating design, development, production or quality system software

We help our clients overcome these challenges through a combination of high level consulting and training, or by our hands-on engineering services. Some of our clients have used us as a Center of Excellence for specific skills. Other clients outsource turn-key development to us or use us to supplement an in-house engineering team. Many companies come to us to help them get through a crisis related to a delayed or flawed design, or to advise them on a regulatory issue. When the crisis subsides, we work with them to address the weaknesses in their design process that contributed to the initial crisis.

Our goal is to save our clients money while keeping them in regulatory compliance with a robust, cost-effective design, development, and validation process.

Infant Auditory Emision Screener

Description of the Product:
This product is used for screening newborns for hearing deficits prior to discharge from the hospital. Features include: extremely simple UI, data storage, IR communications to PC capability, rapid printer/charger module.

Intertech’s Role in the Project:
Hardware Development – Participated in system level design, implementation and debug of screener and printer/charger module.
Software Development – Requirements definition, design, implementation, and debug of the platform software. Reviewer of application layer software.

Middle-Ear Analyzer

Description of the Product:
Presentation of controlled tone pairs and complex analysis of the sound reflected allows the instrument to calculate elasticity of the middle ear and allows the audiologist to infer the health of the inner ear.

Intertech’s Role in the Project:
Hardware Development – Complete development and layout of three boards, including audio analog and three microprocessors.
Software Development – Requirements definition, design, implementation and debug of product software. Reverse engineered features for predecessor device. Implemented new features. Software Verification & Validation – wrote and executed verification tests for system.

Membrane Immunoassay Sequencer

Description of the Product:
The membrane sequencer is a fast, reliable, fully automated, high throughput instrument capable of running and interpreting 28 samples in under 30 minutes. A sample is aspirated through a membrane on the principle that increasing the interaction of antibodies and antigens shortens the assay reaction time. The assay is carried out on a disease-specific membrane contained in a multi-channel cassette.

Intertech’s Role in the Project:
Hardware Development – Complete development and layout of digital interface circuitry.
Software Development – Requirements definition, design, implementation and debug of product software. Developed sequencing language that could be deterministically validated. Software Verification & Validation – wrote and executed verification tests for system.

Portable Organ Preservation System

Description of the Product:
The Portable Organ Preservation System enables the preservation, resuscitation and transport of organs in their functioning state for up to 24 hours and represents a potential breakthrough in the field of organ transplants.

Intertech’s Role in the Project:
Hardware Development – Complete development and layout of User Interface Module (UIM).
Software Development – Requirements definition, design, and implementation of UIM software. Requirements engineering and design of inter-processor communications protocols. Requirements definition, design, implementation and integration of Electronic Perfusion Device (EPD) host software.

Electrical Surgical Aid

Description of the Product:
Electrical stimulation of the cavernosal nerve during radical prostatectomy allows CaverMap to locate the nerve and aid surgeons in sparing the nerve and thus male sexual function.

Intertech’s Role in the Project
Software Development – Requirements definition, design, implementation and debug of product release software. Implemented new features. Software Verification & Validation – wrote and executed verification tests for system.

Excimer Laser System

Description of the Product:
The laser system was designed to simplify use of the laser. The Windows based upgrade made management of treatment data easier by delivering a range of valuable conveniences. The technology greatly extended capability and expanded digital connectivity, allowing users to reduce time spent on repetitive, time-consuming tasks freeing them to focus their time on value-added patient care.

Intertech’s Role in the Project
Software Development – Requirements definition, design, implementation and debug of product user interface software. Interfaced with client provided laser communication software. Software Verification & Validation – wrote and executed verification tests for system.

Insulin Pump

Description of Product:
The Insulin Pump helps children and adults with Type 1 and 2 Diabetes keep blood glucose under control.

Intertech’s Role in the Project:
Software Verification Testing - Software unit test planning, design and execution
Reviews – Requirements, design, source code.
Defect analysis and correction.

PCA Syringe Pump

Description of the Product:
Patient Controlled Analgesic (PCA) Pump – syringe pump used for pain therapy.

Intertech’s Role in the Project:
Requirements Management - Worked in collaboration with client to write and review software requirements
Planning – Verification and Validation Planning, Test Planning
Test Design and Execution – full responsibility for software Unit, Integration and System Testing

Defect and Issue Management :: Validation of Software Tools used in development

Pain Management System

Description of Product:
A customizable, ambulatory pain management drug delivery pump.

Intertech’s Role in the Project:
Requirements – Review of software requirements, development of GUI concept into detailed requirements.
Software Verification & Validation – full responsibility for system, integration, and unit level test procedure design and execution.
Defect and Issue Management – lead responsibility for reporting defects, and organizing cross functional meetings with client to prioritize and manage responses to defect reports.

Photometric Analyzer

Product Description: A Photometric analyzer for microplate based assays intended for use in diagnostic labs to duplicate manual analytical procedures. Automatically performs various steps including pipetting, washing, heating, and measuring color intensity according to the assays procedures provided by reagents’ manufacturers.

Intertech’s Role in the Project:
Documentation - Revised and augmented submission documentation Software Verification and Validation - conducted additional testing required for a FDA 510(k) submission.

Ultrasonic System

Product Description:
The Ultrasonic System uses energy in the form of ultrasonic vibration to weld sutures in a focused area. The ultrasonic energy is generated in the handpiece and is transferred to the sutures via a tuned wave guide producing the weld.

Intertech’s Role in the Project:
Software Test Design and Execution :: Requirements and Designs Review