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Medical Devices & Diagnostics

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which:

Is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, orIs intended to affect the structure or any function of the body of man or other animals,
Is intended to affect the structure or any function of the body of man or other animals,
Does not achieve its purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes (which would make it a drug).

IMPACT has expertise in the development, design, specification, and prototype manufacturing of medical devices and diagnostic tools. Our team can provide either expert support skills to your medical device design project, help troubleshoot design issues, or even provide full turn-key development, commercialization, and production capability.

Medical Devices

IMPACT has helped clients develop chemical-based surgical sealants, liver function diagnostic tests for third world applications, surgical suture aids, and orthopedic implant coating processes amongst other technologies. The team’s previous employment includes experience from leading medical device companies such as Becton Dickinson, Kontron, and Millipore.

Blood/Cell Processing

IMPACT also has world-class expertise in blood and cord blood processing technologies including FACS (Fluorescent Activated Cell Sorting), MACS (Magnetically Activated Cell Sorting), Centrifugation, Elutriation, Plasmapheresis, Leukocyte Reduction, Blood Oxygenation/De-oxygenation, Blood Warmers in microfluidic and bulk scales. IMPACT’s experience is based on the team’s previous employment with companies such as Haemonetics, Hemasure, ViaCell, ViaCord and New Health Sciences.

Diagnostics

IMPACT has assisted in the development and scale-up of in-vitro and in-vivo diagnostics devices. Expertise is applied toward sample preparation, rare cell enrichment, chemistry stabilization, materials of construction, jigs and fixtures and scale-up of manufacturing processes. The team’s previous employment includes experience from diagnostic companies such as, Living Microsystems, Arryx, DX Tech, Massachusetts General Hospital, Magellan and U.S. Genomics.

IMPACT utilized process modeling techniques to develop and optimize a difficult coating process for orthpaedic knee implants via controlled precipitation.

IMPACT helped develop and scale-up a process for producing an innovative surgical sealant technology based on isocyanoacrylic chemistry. The technology is used for skin closure from wounds or surgery.

IMPACT developed and wrote validation packages for a line of cytometry equipment (PCA, EasyCyte, EasyCyte mini, and ViaCount Assay) including IQ/OQ and PQ.

IMPACT helped with the initial modeling and design of a new packed red blood cell de-oxygenation technology, HemaNext®, for extending the storage life of the world blood supply.

IMPACT utilized our knowledge in particle technology, separations, and process/product design experience to develop an air sampling device for bio-weapons sensing under a HSARPA grant.

IMPACT helped redesign a portable device for testing lead level in blood focused on increasing assay sensitivity, decreasing variability, and preventing corrosion of key components.