With the launch of QuiO's initial Smartinjector product, the Si One, the company aims to provide the first real-time, connected drug delivery device for injectable therapies. Their Internet of Things (IoT) enabled device and its companion software, which allows medical professionals to monitor adherence and support treatment remotely, looks to offer a long overdue improvement to in-home injection administration technology.
The company was co-founded in early 2014 by CEO Alexander Dahmani, at the time pursuing his Ph.D. in Microbiology and Immunology from Columbia University, and lead engineer Jared Schwartzentruber, himself studying at Columbia's School of Engineering. The pair developed the original functional prototype in Schwartzentruber's bedroom, utilizing a 3D printer than ran continuously for 18 months. QuiO, now based in the Brooklyn Navy Yard and operating out of the New Lab entrepreneurial design and technology center, has come a long way in the time since. Their final prototype device is currently being produced via an FDA-certified development and manufacturing firm, the associated software is finalized pending minor user interface changes, and the company announced last month that they had secured $1.05 million in funding to enable a 2017 release of the Si One device.
The Si One is capable of administering any type of syringe-based medication, and can in fact be cleared to deliver multiple approved injections in the same syringe by virtue of its designation as a General Use Injector. The technology is designed to prevent against the most frequent self-injection mistakes, such as partial dose delivery. Dose administration is monitored automatically and in real-time via the connected QuiO Cloud HIPAA-compliant software platform. Communication and data transmission between the device and the cloud-based software requires no setup, syncing, or additional components, and is conducted over a cellular connection, rather than through Bluetooth pairing. The QuiO Cloud software, meanwhile, provides web-based dashboards for observing individual patient health status and supporting patient populations. Currently, the QuiO Cloud platform consists of a Care Dashboard, for clinicians and pharmacists to directly track patient injection administration, and an Enterprise Dashboard, through which organizations can monitor drug performance, adherence, and outcomes.
Contacted for an exclusive statement regarding the device and its design process, Dahmani told Medgadget:
"We gave ourselves two very important design constraints with our lead Smartinjector device, the Si One. First off, don't change the drug or syringe, because that slows adoption by pharma and prevents payers and providers from being able to deploy it. Secondly, don't burden the patient, because that reduces clinical efficacy and leads to unreliable data collection. All of the competing devices that we've seen so far break one or both of these rules, which is one of the main reasons we haven't seen much traction in the market to-date. We believe the Si One will be the first solution to be deployed at scale because we made it easy for organizations to adopt and even easier for patients to use."
Currently, QuiO is planning a pilot study to identify the extent to which their Smartinjector platform incentivizes and improves adherence for injectable therapies, as well as to quantify improvements in medical outcomes and patient satisfaction. The Si One is anticipated to receive 510(K) clearance as a Class II General Use Injector in 2017.
More information: QuiO…
This post QuiO's Smartinjector Connected Drug Delivery Device Anticipates 2017 Release appeared first on Medgadget.
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