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MedRes Learning: Defining clinical needs in medical product development


In product development, especially in the field of medical devices, one of the pre-requisites for successful implementation is accurately characterizing a particular medical problem.

Often, the first phase of product development begins with intensive secondary research in order to investigate the existing problem that the product would provide a solution for, the market needs as well as the current scientific consensus. Secondary research comprises an extensive and detailed summary, collation, and/or synthesis of existing research materials. Research data from different sources such as peer-reviewed publications, textbooks, government published data, statistical databases, national organizations, or official medical websites are analyzed and reviewed thoroughly to reveal:

➡︎ Valuable background information on the medical problem;
➡︎ Currently existing solutions;
➡︎ Trends impacting the competitive landscape; and
➡︎ The exact market needs.

At MedRes, secondary research is included in the Stakeholder requirements documentation.

First, a detailed market problem and background consisting of extensive information about the medical condition in question are provided. This includes:

➡︎ Definition;
➡︎ Incidence;
➡︎ Prevalence;
➡︎ Current medical approaches and trends; and
➡︎ Possible shortcomings or unmet needs.

Then, upon scientific and market research, the solutions available today and trends impacting the field are explored to map out and capture the competitive landscape. Different or emerging techniques that have a scientific or clinical impact on the medical problem are examined thoroughly to have a profound knowledge of these areas. Furthermore, reviewing research materials discussing cost analysis or cost-effectivity regarding the currently dominating approaches could provide relevant information for not only future marketing strategies, but in early developmental phases as well. When comparing specific competitive products, a detailed description is required in order to aid product design as well as to receive a more accurate picture of the product’s potential advantages and disadvantages over the competition.