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"I had the privilege of working for and with Jim in the forward looking application of effective infection control technologies applied to a wide variety of medical devices. His leadership drove technology development, vital product efficacy testing and key performance documentation in support of emerging regulatory requirements in the antimicrobial medical device field."

~ David Fink, Director of R&D, Kendall Healthcare Div., Covidien
Welcome to amxtek llc

AMxTek LLC is a combination product medical device consulting and IP development company. A combination product is a medical device that is part device and part drug or biologic. The CDRH branch of the FDA regulates such products, providing the product’s Primary Mode of Action [PMOA] remains that of a medical device.

AMxTek LLC currently provides combination product medical device Consulting Services in the following specialties:
> Antimicrobial Medical Devices
> Osteogenic Implants and Devices

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Consulting

AMxTek assists corporate clients in an array of front-end business development, technology due diligence, product development and regulatory affairs consulting activities associated with combination product medical devices. When business decisions need to be made regarding investment, technology selection, opportunity-cost and commercialization strategy, AMxTek provides critical third-party objectivity and expertise regarding combination product medical device business planning and implementation.
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IP Development

AMxTek LLC also develops Intellectual Property [IP] for business development and licensing opportunities, when and where technology and novelty can be brought to bear on unmet clinical needs. AMxTek concept development and IP secures early proprietary combination product market positions, creating discontinuities in traditional medical market segments, leveraging the unique utility and value proposition of such hybrid products. This affords AMxTek business development partners: i) proprietary combination products; ii) lower commercialization risk; and iii) reduced time to market.
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Technologies


With over 15 years of executive management experience as Vice President of R&D for two major hospital supply/medical device companies,
and as Vice President of Business Development for a development-stage orthobiologics company, AMxTek's principal - Jim Walls has been either directly responsible for, or contributed significantly to, the successful commercial development of the following Combination Product Medical Devices:
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