Clinical Assessment

A Clinical Assessment is a critical component of the Marketing Report, (part of the Standard Development Process) to help determine the potential clinical adoption of an emerging medical technology or pharmaceutical. The Assessment is divided into two phases: The first phase includes more of a clinical overview of the standard of care and physician preferences for technological or pharmaceutical solution for clinical challenges. The second phase delves into the product specifications for the particular technology.

Phase one of the Clinical Assessment is an objective analysis of a minimum of 15 - 20 well aligned physicians and occasionally other healthcare professionals about the potential biomedical technology or pharmaceutical under consideration. It is critical to select the physician participants for this analysis based on their established expertise in the particular domain of the technology or pharmaceutical under consideration. Market preferences are determined by evaluating clinical need, the number and reasons patients are refractory to current treatments, understanding the trends in the patient care pathway, measuring the price sensitivity and objectively measuring the interest levels in a new concept. This analysis is used in the early stages to determine interest in the potential technology and assists in forecasting a technology's commercial success.

A wide range of questions should be identified and structured to obtain measurable preferences and understand market trends. Critical areas should be addressed from several vantage points, to ensure that one receives the definitive information. Robust documentation of the clinical preferences must be analyzed in depth to ensure that the each area is appropriately addressed.

If significant interest is established in the concept of a biomedical technology or pharmaceutical, robust evaluations of reimbursement and regulatory strategy need to also be addressed. If the outcomes of these processes are positive, Phase two of a Clinical Assessment seeks expanded market driven input for the development of the exact product specifications. It is critical to implement an iterative process for this development with continual input of the target market throughout the development. Phase two Phase two of the Clinical Assessment progresses to face-to-face meetings with eight to ten carefully selected clinicians with significant domain experience, usually selected from the physicians in Phase one discussions. Under non-disclosure, the technology is outlined and specific features and benefits are presented for input. Details are captured, and are integral to the development of the Marketing Requirement Specification (Product Development Process). Phase two Clinical Assessment is an iterative process where the information provided is used to support engineering development, and then followed with additional dialog to ensure that the product meets market expectations.