Periodic Reporting for period 1 - OLDIAS (Online Dialysis Sensor)
Periodo di rendicontazione: 2015-03-01 al 2015-08-31
The main objective of the project is to validate the uremic biomarkers in a clinical research setting by developing a diagnostic medical device in the form of a novel on-line dialysis sensor that offers a unique method for the biomarker detection
• Business plan –preparing a thorough business plan to determine the best commercialization strategy for the technology concerning possible product diversification options. This requires conducting a market study, risk assessment, financial analysis including the need for further investments from private funds (Angel Investors, VCs, and industry partners).
• IPR strategy – by updating the freedom-to-operate study and relying on market information on the most important markets the patent strategy will be finalized. This will feed valuable input to business related activities as IP strategy and commercialization plan are tightly linked by determining the market entry strategy.
• Technological configuration – defining the technical configurations for possible product diversification: 1) high-end MCM monitor, incorporating technology for monitoring all groups of uremic biomarkers, 2) low-end MCM monitor, incorporating technology for monitoring limited/selected groups of uremic biomarkers. The high-end MCM monitors could be applicable during the advanced therapies and in critical situations like patients needing highly personalized treatment or in the Intensive Care Units. Low-end MCM monitors could be utilized during ESRD treatments with standard clinical settings in large patient centres. The evaluation of the market potential, customer segments and commercialization strategy of adding a low-end monitor in the product line and having two configuration options instead of one will be performed under business related activities.
• Business plan –preparing a thorough business plan to determine the best commercialization strategy for the technology concerning possible product diversification options. This requires conducting a market study, risk assessment, financial analysis including the need for further investments from private funds (Angel Investors, VCs, and industry partners).
• IPR strategy – by updating the freedom-to-operate study and relying on market information on the most important markets the patent strategy will be finalized. This will feed valuable input to business related activities as IP strategy and commercialization plan are tightly linked by determining the market entry strategy.
• Technological configuration – defining the technical configurations for possible product diversification: 1) high-end MCM monitor, incorporating technology for monitoring all groups of uremic biomarkers, 2) low-end MCM monitor, incorporating technology for monitoring limited/selected groups of uremic biomarkers. The high-end MCM monitors could be applicable during the advanced therapies and in critical situations like patients needing highly personalized treatment or in the Intensive Care Units. Low-end MCM monitors could be utilized during ESRD treatments with standard clinical settings in large patient centres. The evaluation of the market potential, customer segments and commercialization strategy of adding a low-end monitor in the product line and having two configuration options instead of one will be performed under business related activities.
Overall feasibility study was divided into 3 tasks: business plan development, intellectual property study and technical specification. As business plan development is dependent on updated information from technical specifications and IPR study then these tasks were carried out at the start of the project.
1.1 TECHNICAL SPECIFICATIONS
The task set out to define the technical configurations for possible product diversification: 1) high-end MCM monitor, incorporating technology for monitoring all groups of uremic biomarkers, 2) low-end MCM monitor, incorporating technology for monitoring limited/selected groups of uremic biomarkers
1.2. IPR STUDY
A specialist patent attorney was subcontracted to carry out tasks related to IPR such as the freedom-to-operate study. The objective of the study was to determine the potential limits to the innovation project, but to also give more information about the current state-of-the-art in optical UV methods for monitoring biologic fluids. Based on the IP study suggestions for the IP strategy were made.
1.3. BUSINESS PLAN
Economic feasibility study looked at various aspects of product market fit. Technical feasibility fundamentals gave solid ground for manufacturing cost assessment and thanks to three different capability options and cost options we are able to address three different segments from low and minimum cost to high cost high-end ultra capable sensor. In result it is confirmed that production and sales of three different sensors by OFT is economically feasible.
1.1 TECHNICAL SPECIFICATIONS
The task set out to define the technical configurations for possible product diversification: 1) high-end MCM monitor, incorporating technology for monitoring all groups of uremic biomarkers, 2) low-end MCM monitor, incorporating technology for monitoring limited/selected groups of uremic biomarkers
1.2. IPR STUDY
A specialist patent attorney was subcontracted to carry out tasks related to IPR such as the freedom-to-operate study. The objective of the study was to determine the potential limits to the innovation project, but to also give more information about the current state-of-the-art in optical UV methods for monitoring biologic fluids. Based on the IP study suggestions for the IP strategy were made.
1.3. BUSINESS PLAN
Economic feasibility study looked at various aspects of product market fit. Technical feasibility fundamentals gave solid ground for manufacturing cost assessment and thanks to three different capability options and cost options we are able to address three different segments from low and minimum cost to high cost high-end ultra capable sensor. In result it is confirmed that production and sales of three different sensors by OFT is economically feasible.
Results of Phase 1 project confirm previous expectations about the impact of the project and therefore there are no changes in the objectives nor in the concept and approach. Next steps in product development would highly benefit in terms of time-to-market from Phase 2 project financing and by finding full time expert from field who can maximize product sales and potential.
In conclusion our strategic vision has remained broadly the same, but it has become stronger thanks to the tasks which were carried out. Thanks to technical specification analysis OFT product has now more dynamic capabilities in terms of technology and pricing and that gave us flexibility to reach all price ranges and therefore made it possible to fit into all hemodialysis machines market segments.
In conclusion our strategic vision has remained broadly the same, but it has become stronger thanks to the tasks which were carried out. Thanks to technical specification analysis OFT product has now more dynamic capabilities in terms of technology and pricing and that gave us flexibility to reach all price ranges and therefore made it possible to fit into all hemodialysis machines market segments.