Quality Assurance (QA) is key to measuring the quality of the components of a product. It is also important that R&D’s experience and critique are transferred to the staff involved in the final Quality Control (QC) of the product.
Bioconnexions Consulting Ltd can review and refine your processes at these critical stages. Our external review and insight can help identify practical issues and highlight steps to mitigate failure.
Based on our experiences of developing a wide range of IVD products, including CE/IVD, Class I, Class II (510k) and Class II (PMA) we can mitigate these issues. We can advise and reflect on the process to be employed for the better development of your products.
Bioconnexions Consulting Ltd has laboratory facilities that allow us to provide a range of services. Proof of concept studies enable us to demonstrate whether the technology (antibody/probe) works in the desired way using predetermined chemistries and instrument platforms. Additionally, biomarker characterization means we can optimise the technology, demonstrating reproducibility across a range of normal and tumour tissues with specific focus on disease of interest. Lastly, through feasibility studies we can demonstrate whether the technology achieves the diagnostic utility in a small scale study sufficient to qualify entering development.
We have access to an extensive range of clinical experts within a wide-range of pathologies who can review results and inform on quality. In summary, we can help refine and improve your current designs to provide better outcomes at less cost and over a shorter time-frame. We can achieve this by:
1. Consulting/interim managagement of your R&D project at your facilities.
2. Conducting research on your behalf at our facilities, transferring knowledge and know-how at the appropriate time.
The same processes enable us to qualify new ideas and create new technologies allowing more effective ideation. Furthermore, we are able to qualify the clinical utility. This means that it is not only effective in the laboratory informing the clinician of relative and actionable data but most importantly it brings benefit to the patient.
Once we have determined the unmet need, qualified the clinical utility and ideated we can assess its commercial potential. Market values are often created through disease incidence, this can lead to wholly underestimated figures and equate to poor market potential for your company. There are many factors to consider in this early phase of a project.
We have guided clients through quite complex diagnostic concepts, identifying unseen issues that should prevent investment in flawed projects. Equally we have experience in creating sound business cases on the basis of having a true understanding of the market.