Radiological computer-assisted triage and notification software is a form of image processing software. Based on computer-assisted image analysis done by the device, the device alerts a predefined list of doctors when time-sensitive radiological medical images are available for examination. Using the analysis of medical images obtained from radiological signal collection systems, radiological computer-assisted triage and notification software prioritizes and triages time-sensitive patient detection and diagnosis. However, it does not give information from the image analysis beyond triage and notice. Elexes worked with a medical equipment manufacturer with radiological triage software intended for the US market.

The Problem:

The company requested assistance in comprehending what is meant by clinical evaluation and testing criteria established by the FDA, as well as the players in the market with identical devices.

Approach & Solution:

Elexes further investigated the problem and had initial calls to ensure that both Elexes and the Client were aligned in terms of the next steps and approach. Elexes proposed the following after analyzing the manufacturer’s objectives and the available evidence:

1. Concerns in Clinical Study requirements
   • Performance Data Analysis

Elexes enabled the manufacturer to understand that clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data when the product is used as directed by the manufacturer. 

Elexes outlined to the manufacturer the sequential procedure (see following) to be followed to get clinical validation for the product.

Elexes explained that:

1. The manufacturer must ensure there is a valid clinical association between the product output and the targeted clinical condition.
2. Manufacturers should determine if their product correctly processes input data to generate accurate, reliable, and precise output data.
3. Finally, the manufacturer should make sure that the use of their product delivers accurate, reliable, and precise output data, achieving the intended purpose in the target population in the context of clinical care.

In order to ascertain the aforementioned statements, various studies can be conducted at different stages of product development and validation. When conducting studies, manufacturers should know what kind of studies may be classified as a significant risk vs. a non-significant risk and determine which one would need an IDE, so they are compliant to the regulatory requirements at all times. 

Elexes Team used the following flowchart to provide further clarification and insights on when an IDE will be needed. 

2. Competitor Analysis:

Using the analysis of medical pictures obtained from radiological signal collection systems, the device aids in prioritizing and triage of time-sensitive patient identification and diagnosis. Elexes investigated and prepared a competitor analysis (as per the Manufacturer’s requested format) and identified that there are over 40 such products currently in the market.

Key Takeaway:

• The manufacturer was able to understand the concepts around clinical study, and by involving further experts from the Elexes clinical team, the manufacturer successfully developed different clinical studies 
• Manufacturer obtained IDE approval from the FDA for the studies that needed such an approval, and the ones that did not need an IDE approval, the manufacturer was able to get a rationale in place by Elexes. This helped the manufacturer stay in compliance with the applicable requirements. 
• Manufacturer attained an in-depth understanding of the competitors and their corresponding intended use and differences w.r.t. the manufacturer’s product. This helped them develop a thorough project plan and testing plan to ensure that the product performs as good as or better than the competitors. 

The medical device manufacturer collaborated with Elexes possessing strong quality, regulatory, and project management experience, to successfully obtain the required information. Elexes answered all manufacturer’s questions within the allotted time span. All this aided the manufacturer to exactly anticipate the launch date.

The most crucial step in getting a product into the target market is to carry out effective regulatory due diligence and choose an acceptable approach. We encourage all companies to have a thorough understanding of the expectations before starting any form of execution. 

Would you like to place your device in the US market?

Elexes can be of assistance to you. Our hardworking team has years of experience in helping customers through this process. Please get in touch with us at jennifer@elexes.com so we can examine your equipment in accordance with FDA guidelines and walk you through the necessary steps further.