Offering technical and consulting services in all pre-clinical areas of product development.
In analyzing the needs of the medical device, we consider the clinical, scientific, regulatory and engineering perspectives and we also design the characterization and safety tests necessary to properly evaluate the device.
Through our experience in the field of medical devices, we can study and analyze the best way to get our's clients products approved.
In our worldwide network, we have access to groups of doctors and patients, where we can validate, co-create or idealize the product with real users in a real environment, thus allowing the successful introduction in the market of medical-technological innovations.
Product development cycle of medical devices, in areas so diverse as biomaterials, Regulatory requirements and clinical validation.
Literature research, feasibility, design specifications and regulatory assessment
In-house protyping process that ensure the user needs specification is achieved in the design output specifications
The in vitro testing is established to accurately assess whether the design meets the user needs requirements.
We has the knowledge and experience to manage the animal trial process from the protocol writing to testing of the technology through our worldpartner facilities.
We can manage clinical studies as desired by our partners with the objective to generating the data required to achieve global regulatory approval for the technology.
Through our global manufacturing partner relationship we are able to scale-up and produce medical devices under ISO 13485:2003 and ISO 9001:2008 certified facilities.
A great advantage is that it does not need a second surgery and so the patient has no job loss or admission to hospital, facilitates recovery and professional and social integration. There is a reduction in costs for the health system.
The problem of lower urinary tract symptoms (LUTS) and encrustation are the main ones. The short life of this stent means that encrustation will not be a problem, although the LUTS remain.
Think stent symptoms can be quite disabling. A more flexible stent would help, like HydrUStent technology.
The success of HydrUStent technology will be based on No symptoms (LUTS) and no need to remove while still doing its job of draining the kidney.
My reflex response is that a biodegradable stent for kidney transplantation is a gift to the surgeon and the patient.