ABOUT
The Aspen Medical Risk Consutling Story
Richard Matt is the principle consultant at Aspen Risk Management Consulting. His background inclueds over 30 years of experience working in a wide variety of Class I, II, and III medical manufactuers, both therapeutic and diagnostic products, and every kind of combination product possible - even one product that was a combination device / drug / biologic in one.
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In this time, Richard observed the conflict between the importance of properly assessing benefit-risk (the 'apex' deliverable for any R&D organization, per Glaxo-Smith Kline) and common practices that lacked a systematic and objective approach. In response, he has developed a patent-pending method that enables modeling of patient benefit and risk at whatever level of complexity is reuqired to draw the proper conclusion and avoids the fatal error of converting risk levels to numbers.
Richard is excited about this method's incorporation of medical product risk metrics into the overall assessment of a product's benefit-risk balance and is currently working with FDA and the ISO technical committee on risk to establish the first ISO standard on assessing benefit-risk.
THE TEAM
Aspen Medical Risk Consulting is componsed of a group of senior consultants in the development and remediation of medial products. These consultants backgrounds range from Risk Management Specialists to Quality Engineers (both development and manufacturing), System Engineers, and Project Managers. What ties them all together is their commitment to quality and recognition of the central role that 'risk' plays in the decisions required in all phases of medical products.
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(Under construction - further details to follow)
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