Outcome
Accelerated self-certification: Expedited self-certification process to achieve Class ICE status first time and within 6 months from prototype.
Scalability: A scalable QMS system and a fuss-free way to present evidence to notified bodies.
Reduced costs: Successfully met deadlines in an approves market-ready product with minimal costs.
Secured funding:: Secured a further round fo funding and opened up the opportunity to make sales.
Challenges
- Aligning regulatory & commercial strategy
- Being first to market
- Navigating compliance requirements
- Scaling regulatory plan
Potential for non-invasive microcirculation technology to save countless lives
Over the last decade, it has become clear how important assessing the microcirculation function is. Microcirculation is fundamental in delivering oxygen and nutrients to all living tissues in our body. If neglected, complications to microcirculation can lead to cardiovascular and metabolic diseases, such as coronary artery disease, hypertension, and diabetes, to name a few. Therefore, being able to assess complications to microcirculation, monitor the efficacy of treatment, and assess the patient's recovery without the patient undergoing surgery, could save patient morbidity but also expensive care in ICU.
Built on 30 years of clinical research, this start-up venture has developed a novel technology to monitor microcirculation. By assessing microcirculation with non-invasive technology, tailored therapy can be given to patients. This breakthrough technology could enable complications to be detected early on, as well as see if a patient is responding to well to treatment or recovery.
