|Funding from Vinnova||SEK 2 950 000|
|Project duration||January 2016 - December 2017|
Purpose and goal
The project objective was to develop an industrialized version of ICOone, including manufacturing equipment for a lab-scale manufacturing. All the project objectives were met. A new low-cost version of ICOone was developed. The new design has significantly reduced the cost-of-goods. ICOone and the test results, have been shown to several potential customers. We have several ongoing customer discussions regarding the development of a vaccine product and products for other indications. We have recently had a very productive meeting with WHO regarding a vaccine product.
Expected results and effects
A large number of injection molded ICOone devices have been filled with several different types of dry powder formulations, which have been tested using an NGI (Next Generation Impactor) and an HPLC-system. For this purpose, many specialized test methods have been developed and validated. Many of the tested dry powder formulations showed a very good performance, fully comparable to the best inhalation products on the market.
Planned approach and implementation
The development project was planned and executed as an industrial product development project. All the tasks were performed and documented in compliance with the Medical Device Directive and Design Control. A user requirement specification was set up and a project plan defined. In addition to the product development, a risk analysis exercise was carried out and a number of test and analysis methods were developed. The project plan was followed during the whole project. Some equipment and the injection molded parts had a very long delivery time, which made them to be on the critical path.