Smart Insoles for Clinical Research : a Problem-Solving Approach to Deliver Value with Continuous Mobility Assessment

Bringing a drug to market is long and difficult. Studies estimate that the clinical trial process lasts 9 years and costs $1.3B on average. Clinical trials are conducted in multiple phases, with cost and complexity increasing from Phase I to Phase III. Despite the time and capital invested in trials, only 1 in 10 drugs that enter Phase I of a clinical trial will be approved by the FDA.
There is Large medical need to evaluate to treat the physical deterioration of physical status. A growing number of patients with mobility impairments lacks accurate tools to diagnose, monitor expensive evolutive diseases and intervene efficiently.

Gait is the simplest and most actionable biomarker to monitor multiple diseases but vastly underutilized as a biomarker or outcome measure because gait analysis is often not high quality when assessed in the clinic.Clinical gait tests, today, are used to identify mobility disorders, measure the efficacy of a therapeutic treatment. This is done in a controlled setting at sites. However, the technologies or design used present strong limitations. Episodic assessments, sometimes observational, don't generate sufficient sensitive data to demonstrate subtle changes.

The FeetMe solution allows the collection of validated gait data at site with the Insoles, and in the same accurate way in the patients daily life allowing continuous recording of gait data.