The French clinical research organization (CRO), has been selected as a finalist in the 2017 MedStartup awards alongside the health technology company Neogia and partner Bluesleep clinic.
The award is a joint initiative by the Galien Foundation and international development agency Business France to encourage partnerships between French and North American life sciences companies.
The project for which the companies have been nominated centers around Neogia’s connected bracelet, Motio HW, which the company said is able to diagnose and monitors sleep apnea at home by collecting biometrics data.
Kyomed’s role in the project will be to obtain clinical evidence around the device’s efficacy and security. The CRO will also evaluate feedback from patients and medical professionals.
“The most innovative and efficient medical device will not be efficient if it is not used by patients and healthcare professionals,” Daniel Laune, CEO and scientific director at Kyomed told Outsourcing-Pharma.com.
“Today’s medicine involves more and more technologies which require patients’ appropriation,” he added – and this paradigm shift necessitates a change in clinical trial conduct.
As Laune explained, more feedback from patients and medical staff is needed to address real-life challenges. “It is all about placing human at the center of medical innovation,” he said.
“By bringing its ability to evaluate health innovations from both a clinical standpoint and user experience, Kyomed is laying the foundation of the mind change that must take place in the design of health technologies by placing human at the center of it,” Laune said.
Through its partnership with Neogia, Kyomed hopes that this holistic approach will set the benchmark for the future, he said.
The companies are planning to follow-up multicenter trial with the sleep apnea connected wristband in Europe and the US in 2018.
“Being part of this project is for Kyomed an outstanding opportunity to emphasize the importance of considering not only medical benefits but also human and societal aspects related to the use of new health technologies,” added Laune.
US market entry
The awards ceremony, which takes place today, October 26, 2017, in New York, marks Kyomed’s entry into the US market.
To enter the US market, Laune told us the CRO is looking to collaborate with US clinical centers to deploy combined trials as well as establish fee-for-service agreements with big pharma and medtech companies.
For Laune, entering the US market means two things: allowing non-US companies to optimize their US market entry by addressing both clinical and human aspects; and facilitating the entry of US innovations in the European market, “by providing services in the field of clinical trials and evaluation of country-specific human aspects.”
“For a company (US or European), such trials will provide feedbacks from users in each investigated country,” he said. “These real-life data are the key to address each market in the most appropriate way.”