TASK 1 - Validation of customer demand
We have establish a panel of KOLs to provide a steering team for the clinical strategy at an early stage and guide in the design and implementation of the Clinical Investigation. This will help us confirm price point acceptance, our forecasted market size, growth and future market potential.
TASK 2 – Engagement with manufacturing, supply & end user partners
We have gained written agreements from 3D manufacturing partners with the capability to manufacture to our specification and in sufficient volumes as well as packaging and sterilisation equipment provider while considering best value cost of goods development and market penetration
TASK 3- Determine clinical validation & regulatory pathway
We confirmed mechanical, corrosion & fatigue testing standards & develop a road map to complete this testing detailing costs, test centres & duration. We also collated all of the required evidence from the existing published pre-clinical studies & all the mechanical and material testing to fulfil regulatory requirements & achieve CE marking.
TASK 4- Development of an IP and commercialisation strategy
We established freedom to operate with the design by mapping the IP landscape and gained an understanding what we can be protect and integrate into the commercial strategy plan.
TASK 5 Validation of the technical feasibility and cost of getting to TRL 8/9
We explored the technical feasibility to manufacture 100 implants during Phase 2 by confirming the key technical challenges involved in the scale-up manufacturing. We confirmed material costs and developed a project technical plan including Gantt Chart and description of work to get to TRL 8/9.
TASK 6 Risk Analysis
We compiled a risk register detailing technical, commercial and other risks along with mitigation measures.
TASK 7- Development of an elaborated business plan
We produced a business plan incorporating information obtained through the above tasks. This details the necessary levels of investment, resource, distribution channels and key product offering.
