Vertellus Biomaterials firmly believes that a collaborative approach is essential for yielding the best results.
We develop technology partnerships with our customers and all activities are agreed in advance of any work commencing.
The following table summarises the path that is often followed for a typical medical device coating project, the core of our activities. A staged approach is defined with customer agreed goals, timings, deliverables and responsibilities. Costs are also agreed up-front.
|Proof of Concept
||Coated substrate provided for in vitro testing.
||Coated substrates or devices provided for in vitro and pre-clinical testing.
|| Optimised coating process developed, coated samples provided for pre-clinical or clinical testing.
|| Design and build of coating equipment, coating process transferred and validated to customer's manufacturing facility. Marketing approval of coated device.
Of course every customer and application is different so we remain flexible regarding how a project is run. For example, a Proof of Concept / Feasibility Study can often be an either / or option and many customers will want to lead their own sourcing of equipment or process validation. Project phases can also be broken down to provide additional flexibility and to ensure full customer satisfaction before proceeding to the next phase. In this way significant customer risk is reduced. In general, our project work is run according to a fee-based milestone schedule. We do not insist that customers sign up to a licensing agreement from the outset, preferring to enter into such an arrangement when the customer is fully assured of the benefits that PC Technology can bring and it is more meaningful to do so.
Throughout the commercialisation process, Vertellus Biomaterials remains available for consultation and support, particularly regarding regulatory submissions and marketing initiatives. Our technical team is fluent in application development and engineering to deliver turn-key solutions to our customers.
We have longstanding relationships with third parties for the development and execution of biological assays such as protein adhesion and activation, hemocompatibility, bacterial adhesion and inflammatory response. Other test methods that we routinely employ for evaluation of samples include fluorescence microscopy, scanning electron microscopy, atomic force microscopy and infrared spectroscopy/microscopy.