Periodic Reporting for period 1 - MAMANUCA (Microfluidic Advanced Manufacturing of Ultrasound Contrast Agents)
Período documentado: 2015-02-01 hasta 2015-07-31
Supply chain study - We investigated how the supply chains for current UCAs are constructed in order to identify how our technology can be smoothly introduced using a similar supply and distribution network.
Our results showed current products are distributed through direct sales, with hospitals using a secure webshop to purchase stocks of UCAs. Our survey results mean we will focus on developing our customer network based on direct sales and developing one-to-one relationships with key opinion makers to act as both launching customers and advocates for our product. We believe through their testimonials of the value for our product we will be able to reach a wider audience and bring our product successfully to the market.
Clinical validation - We evaluated which diagnostic area we will carry out or initial clinical validation for and how to proceed with this validation.
As a result of our study we were able to shortlist three key areas where we see great potential in entering the market with our product clinically validated. We focus initially on the diagnostics market as this is a well-developed market; however we see opportunities for the future within the therapeutics market once this sector and our company are both more established. The diagnostic ultrasound sector is very wide and we have selected and initial entry focussed on a selected diagnostic application with back-up applications in place for our route to clinical validation, should our initial path be compromised.
Further, we have mapped the path to a clinically validated bedside production device during our MAManUCA project. Our study has shown that we will need to complete our preclinical testing to define the safe working dose of UCAs created using our bedside production device, as well as creating a working protocol for the use of our bedside production device and the produced UCA that are compatible with the clinical environment. Once this protocol has been discussed with the European medicines agency (EMA), we will proceed to our clinical trials stage.
Usability survey - A successful introduction of our innovative technology requires full understanding of the current working process of the end-user and how to improve it. The usability survey includes understanding current user protocols and defining functional and technical user requirements for our bedside microfluidic platform based on current working.
We surveyed medical professionals in a range of clinical settings including, key opinion makers, leading research clinicians and the more general population of ultrasound users at non-teaching and research hospitals. We believe in looking at both the standard hospital practices as well as the cutting-edge medical research hospitals will ensure that our product fits into the clinical workflow of any ultrasound procedure. To further understand the needs of UCA users we are using our newly launched MicroSphere Creator as an introductory tool. The feedback we have received from leading clinicians and researchers, using this system, has fed directly in to the development steps we are taking with our bedside apparatus.
Certification - Mapping the route to certification and how it will be validated has been a key activity of the work proposed in this project.
Through discussions with regulatory bodies and certification advisors, as well as through our own investigations we have defined the key steps towards the certification level we will need for our bedside microfluidic platform and the best route to obtaining this certification. Our findings have shown that our bedside production device can be considered as a pharmaceutical product, which means to achieve certification we will be assessed and guide by the European medicines agency (EMA), who we are currently in discussions with over our development path.