Clinical Rationale

Commercialization Process: Clinical Rationale


Clinical Rationale is the clinical justification for development of the technology based on opinion pieces from stakeholder groups, policies, standards, and published evidence of need and impact on people and society. A strong clinical rationale indicates that there is a need for the technology, and increases the likelihood of adoption, purchase and reimbursement by policy makers.

How this Milestone Reduces Project Risk

When there is a clinical need that a new technology addresses there is a greater probability that the healthcare professionals involved will prescribe or recommend the technology to their patients, bolstering the commercial success.

What to consider at this time

Who are the key opinion leaders, policy makers and regulators of the technology? Is there an identified need or call for the technology? Are there relevant clinical guidelines or standards? Is there evidence of the problem from published research?

Ready to start?

In this module you will learn how to:

  • Establish that the problem you are attempting to address is very important to the people who will use, buy, pay, or influence the adoption of new technology.
  • Create a clear argument supported by objective evidence.
Module Guide

Learn how to write a rationale statement in this guide.

Introduction to Clinical Rationale

This presentation outlines the major learning objectives and resources for composing a compelling rationale.

Healthcare Delivery Module

How does your technology fit within the clinical ecosystem?

Supplemental Reading

Take a deeper dive into how clinical rationale fits into your product evaluation strategy in this supplemental reading.

Literature Review Worksheet

Use this worksheet alongside the supplemental reading to document your literature searches.

Healthcare Delivery Worksheet

Lay out the patient care pathway relative to your technology.