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Medical Device Product Design and Prototype Development

Foster-Miller, Inc. offers 52 years of success in developing medical devices (Class I, II, and III/implanted) and manufacturing equipment for the Device and Pharmaceutical industries.  Core competencies include medical product development (electro-mechanical equipment, embedded/software-controlled systems and disposables), process and laboratory equipment/automation, innovative packaging, drug delivery systems, implantable and hand held instruments.  All development program documentation meets FDA QSR, as well as, ISO 13485 standards.  We specialize in innovative solutions to complex product and system requirements with attention to industrial design and manufacturability.  You will have access to over 260 experienced engineers with depth in design, development, testing and efficient transfer to manufacturing.

Our Clinical core competencies include:

• Cardiology
• Neurology
• Orthopedics
• Urology
• Endoscopy
• Wound Care
• Imaging
• Oncology
• Interventional Radiology 
 

Our Technical core competencies include:

• Medical device development
• Process development
• Innovative packaging solutions
• Drug delivery
• Implantable devices
• Hand held devices
• Pump design and development
• Automation (high speed, continuous motion, continuous process)
• Automated handling of small, fragile and limp components
• Automation (flexible, lean, non-synchronous transfer)
• Rotary molding
• Extrusion (conventional, single screw, twin screw, counter-rotating
• die for LCP's)
• Mechanisms
• Water jet and ultrasonic cutting
• Robotics
• Thermal engineering
• Vision systems
• Software development and validation
• Materials development (plastics, polymers, composites, ceramics,
• Phase transition gels, coatings)
• Design and development for new and next generation products

 
Our confidential client list includes almost every major U. S. medical device and pharmaceutical manufacturer, plus many smaller firms that hope to become major businesses.


Lab Automation

Foster-Miller serves the pharmaceutical and chemical industries with laboratory automation design services driven by integrated and comprehensive mechanical, electrical and software system development skills. While we begin with a thorough analysis of existing technologies in an effort to provide off-the-shelf solutions, our proven track record in engineering services complements our effort to provide innovative "systems" that meet the entire suite of requirements driving the design. We meet the needs of our customers with services that encompass all levels of systems, from stand-alone work cells to fully integrated enterprise solutions. When customer market applications require software, we use state-of-the-art technologies and follow a well-established SDLC.

Medical Devices/Diagnostic Instruments

Our medical device and diagnostic instrument clients demand fresh ideas, speed to market and a history of success. We combine these ideas with practical innovation and top technical talent to develop world-class products. Intellectual property developed for a client is transferred to the client and helps build strong, competitive positions. We form an integrated project team with our clients to use our strengths to greatly enhance product development and speed to market. Typically, we begin with user research that defines the market requirements and provides the basis for the technical requirements. We are experienced in both the development of medical products and design, build and installation of manufacturing systems. Because we are an independent engineering firm and not a contract manufacturer, we design products for the most appropriate manufacturing process from the beginning of the project, thus minimizing manufacturing development time and cost. We also offer business development services that include technology forecasting, technical due diligence and technology assessment.

Biomedical

Foster-Miller designs and develops a range of biomedical systems and equipment to address cutting edge issues facing the medical community. With clinical partners that include the Cleveland Clinic Foundation (CCF) and Tufts University, Foster-Miller has developed and tested advanced biomedical systems under grants from the National Institutes of Health and NASA. We take advantage of our experience in developing mechanical systems for DoD and commercial industry to engineer breakthrough concepts to meet biomedical needs.

Read more about our work in Pharmaceutical Technology Innovation.

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Project Examples

Bard Biopsy Tool
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BD-Logic Glucose Monitor
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Blood Pumps
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Bone Marrow Harvesting Device
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Implantable Intra-Cranial Pressure Sensor
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Insulin Injector Pen
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Lab Automation Software
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Lab Automation System
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Micromanipulator
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Foster-Miller, Inc. - QinetiQ North America | 350 Second Avenue, Waltham, MA 02451