Objective and simultaneous measurement of activity, impulsivity and attention in ADHD
|Funding from Vinnova||SEK 425 000|
|Project duration||June 2017 - August 2018|
|Venture||Swelife and Medtech4Health- Project proposals to improve health|
Purpose and goal
A quality system is developed and CE marking Class 1, completed 2017. A clinical evaluation of the test has received ethics approval and is ongoing. Difficulties with recruitment of study subjects was underestimated and the study is delayed. Sales is ongoing in Germany and contracts have been signed with paying customers. Contact has been established with two research units in England and clinical studies are planned. Work with business strategy has resulted in a clearer brand focus, new product name and graphic expression. Homepage 1.0 ready incl. SEO and translation into 4 languages
Expected results and effects
The Opatus brand has been enhanced by a name change of the product and graphic coordination of app, documentation and website. The company´s value message has been clarified. Business strategy efforts has resulted in contacts and plans for cooperation with two research groups in England and a hospital chain in Germany. Recruitment of subjects has been more difficult than expected and will continue for the rest of 2018. A report is expected to be published in March 2019. We have CE-marked product and comply with the GDPR directives.
Planned approach and implementation
Swedish users often require more validity documents than users from England or Germany. England wishes local reference, a clinic and / or approval of a NHS Foundation Trust Opatus focus is now validating clinical benefits and health economics aspects The CE marking was easier and faster than expected due to the advice of an external consultant. By 2020, new requirements will be introduced resulting in the CE classification being changed from Class I to Class Im. This requires certification through a notified body. A clinical trial is delayed due to an overly optimistic recruitment plan.