Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase.

Quantitatively assessing the level of readiness of medical technology improves its chance of successfully transfer from research to industry but remains a challenge. As many innovative medical devices are associated with or incorporate software, this article presents a methodology for evaluating the software maturity of a "Software-driven Medical Technology" (SdMT) during the research phase. A technological maturity model is developed by methodologically extracting relevant terms from the ISO/IEC 62304 standard, the main industry standard for medical device software, and results in a list of required software engineering artifacts. This list and the relative weight of the artifacts are used to establish a software maturity score for SdMT and the corresponding assessment questionnaire. The consistency of the model is demonstrated by analyzing the obtained score system relatively with the standard. The maturity score of a SdMT can be assessed during the research phase and depends on the number and importance of the artifacts already present at the time of evaluation.Clinical relevance- The proposed quantitative maturity score can help the medical technology innovation actors (clinicians, researchers and industrials) to better identify, improve and fasten the readiness of technology for clinical investigation and technology transfer.

Obesity impact on the attentional cost for controlling posture.

BACKGROUND: This study investigated the effects of obesity on attentional resources allocated to postural control in seating and unipedal standing. METHODS: Ten non obese adults (BMI = 22.4±1.3, age = 42.4±15.1) and 10 obese adult patients (BMI = 35.2±2.8, age = 46.2±19.6) maintained postural stability on a force platform in two postural tasks (seated and unipedal). The two postural tasks were performed (1) alone and (2) in a dual-task paradigm in combination with an auditory reaction time task (RT). Performing the RT task together with the postural one was supposed to require some attentional resources that allowed estimating the attentional cost of postural control. 4 trials were performed in each condition for a total of 16 trials. FINDINGS: (1) Whereas seated non obese and obese patients exhibited similar centre of foot pressure oscillations (CoP), in the unipedal stance only obese patients strongly increased their CoP sway in comparison to controls. (2) Whatever the postural task, the additional RT task did not affect postural stability. (3) Seated, RT did not differ between the two groups. (4) RT strongly increased between the two postural conditions in the obese patients only, suggesting that body schema and the use of internal models was altered with obesity. INTERPRETATION: Obese patients needed more attentional resources to control postural stability during unipedal stance than non obese participants. This was not the case in a more simple posture such as seating. To reduce the risk of fall as indicated by the critical values of CoP displacement, obese patients must dedicate a strong large part of their attentional resources to postural control, to the detriment of non-postural events. Obese patients were not able to easily perform multitasking as healthy adults do, reflecting weakened psycho-motor abilities.