Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

A systematic approach to the Planck LFI end-to-end test and its application to the DPC Level 1 pipeline

The Level 1 of the Planck LFI Data Processing Centre (DPC) is devoted to the handling of the scientific and housekeeping telemetry. It is a critical component of the Planck ground segment which has to strictly commit to the project schedule to be ready for the launch and flight operations. In order to guarantee the quality necessary to achieve the objectives of the Planck mission, the design and development of the Level 1 software has followed the ESA Software Engineering Standards. A fundamental step in the software life cycle is the Verification and Validation of the software. The purpose of this work is to show an example of procedures, test development and analysis successfully applied to a key software project of an ESA mission. We present the end-to-end validation tests performed on the Level 1 of the LFI-DPC, by detailing the methods used and the results obtained. Different approaches have been used to test the scientific and housekeeping data processing. Scientific data processing has been tested by injecting signals with known properties directly into the acquisition electronics, in order to generate a test dataset of real telemetry data and reproduce as much as possible nominal conditions. For the HK telemetry processing, validation software have been developed to inject known parameter values into a set of real housekeeping packets and perform a comparison with the corresponding timelines generated by the Level 1. With the proposed validation and verification procedure, where the on-board and ground processing are viewed as a single pipeline, we demonstrated that the scientific and housekeeping processing of the Planck-LFI raw data is correct and meets the project requirements.Comment: 20 pages, 7 figures; this paper is part of the Prelaunch status LFI papers published on JINST: http://www.iop.org/EJ/journal/-page=extra.proc5/jins

NOViSE: a virtual natural orifice transluminal endoscopic surgery simulator

Purpose: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a novel technique in minimally invasive surgery whereby a flexible endoscope is inserted via a natural orifice to gain access to the abdominal cavity, leaving no external scars. This innovative use of flexible endoscopy creates many new challenges and is associated with a steep learning curve for clinicians. Methods: We developed NOViSE - the first force-feedback enabled virtual reality simulator for NOTES training supporting a flexible endoscope. The haptic device is custom built and the behaviour of the virtual flexible endoscope is based on an established theoretical framework – the Cosserat Theory of Elastic Rods. Results: We present the application of NOViSE to the simulation of a hybrid trans-gastric cholecystectomy procedure. Preliminary results of face, content and construct validation have previously shown that NOViSE delivers the required level of realism for training of endoscopic manipulation skills specific to NOTES Conclusions: VR simulation of NOTES procedures can contribute to surgical training and improve the educational experience without putting patients at risk, raising ethical issues or requiring expensive animal or cadaver facilities. In the context of an experimental technique, NOViSE could potentially facilitate NOTES development and contribute to its wider use by keeping practitioners up to date with this novel surgical technique. NOViSE is a first prototype and the initial results indicate that it provides promising foundations for further development