Formative and Summative Validation Testing for IVD & Life Sciences Devices
Formative and summative testing are important components of the overall user experience testing and human factors engineering (HFE) process. TE offers a full range of user experience testing services that allow manufacturers to bring their product to market in compliance with regulatory requirements and do so with confidence that they will be safe and effective.
A Well-Defined Process for IVD Formative Testing
Usability testing begins with planning and identifying typical users, the use environment, critical tasks that need to be performed and so on. Many people think of the next phase (formative testing) as a series of functional tests, but we see it as a structured process. Formative studies are intended to tease out problems early on when they are easier to fix. We conduct this formative testing using 15+ participants total but typically a handful of initial participants identify most issues. TE does all recruiting so we are able to tightly control who participates in tests.
Proven Expertise, From Concept to Market
Uncovering Critical Issues Early Saves You Money and Time
Our goal is to be so thorough during the formative testing phase that the summative testing phase will almost be a formality and should not reveal surprises.
We Evaluate the Total User Experience, Not Just the Device
- Display Interfaces
- Mechanical Controls
- Alerts and Alarms
- Product Labeling
- Instructions for Use
- Training Tools
Real World Testing Delivers a True Picture of Usability
With all usability projects we conduct, we aim to use or simulate the real environment in which your device will be used, be it a lab, field hospital or living room sofa. For instance, if you are creating an Dx instrument and associated consumable that may frequently be used by nurses in outdoor environments with excessive heat, humidity or space constraints, we will factor all of these into the plan and test accordingly.
In-house Prototyping Allows for Quick Adjustments
We have extensive in-house prototyping capabilities that allow us to conduct initial formative testing on whole assemblies or individual design components. We can then quickly make design adjustments, produce a new part, and test it again with users. This shortens your time to market.
Summative Validation Testing of Your Device
During the formative testing phase, we uncover issues that may pose a problem with the usability and fix them. With the final device form complete, we move on to conduct summative testing. Our goal here is not to learn something new. Rather, we want to demonstrate (validate) that your device, IFU, labeling and any training can be used and understood without any serious use errors. We do this through direct observation of device use, user interviews to assess task comprehension and qualitative assessments – all according to the plan. The final output is a detailed validation usability test report that becomes part of your technical documentation used to support your FDA or international regulatory submission.
