Bioconnexions Consulting Ltd offers a wide range of business and laboratory services.
Business ServiceBusiness Service
Laboratory ServiceLaboratory Service
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Business ServiceBusiness Service
To provide your product the best chance of success you need a direct channel to your customer, this route to market may be via the internet, distributor or directly. Bioconnexions Consulting Ltd has experience in channel managing distributors across Europe and selling directly globally. For it to be in the right markets you need to be aware of the regulatory requirements and while these vary globally some regulatory approvals are applicable across several regional markets. In addition to these requirements, at launch it is essential that the sales people or distributors are furnished with quality sales and marketing material and that your support services are provided adequate technical and performance data. Equally it is important to launch your product at the appropriate venue to the right audience, with experience of most of the major pathology and cancer meetings we can provide valuable insight. Your market development can be pre-launch or post-launch. Employing initiatives such as ring-studies with KOLs and early adopters can provide you additional data to support your product. In turn producing product advocates in the market at a relatively early stage or raise an existing product’s profile in order to spur growth. With more complex products, including prognostics and theranostics, we can help engage with external quality assurance and proficiency testing schemes globally to help you maintain a quality product within the market.
Commercialization
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We have found that there are several important factors often overlooked when considering the transfer of a project from development to manufacture. The implications may not be realised until later in the products life. While processes and paperwork can be easily created as part of a readiness review, subtle nuances and knowledge can be neglected. Knowledge transfer is critical to make sure that staff in production are equipped to manufacture complex, clinical products.

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.

Manufacture
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VOC allows one to determine important aspects that govern product development. Of these customer needs are possibly the most critical as they define your product requirements. Importantly at this stage the relative product regulatory requirements need to be fed into the process. Once set, a prototype can be developed. This PROTOTYPE allows the subsequent stages of stability to be started. Most importantly one can enter the critical phases of verification and validation. Failure at this stage can lead to extended time lines and escalating costs depending on when the error is identified. The worst case is to launch with a product that the customer can’t use or worse still won’t use.

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.

Development
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We have a wealth of experience in the design and development of hundreds of antibodies and probes for use in IVD tissue-based assays, including some of the world-leading gold-standard antibodies used in immunohistochemistry. Examples include Estrogen Receptor clone 6F11, Progesterone receptor clone 16, CD5 clone 4C7, CD10 clone 56C6, ALK clone 5A4 and Dog-1 clone K9.

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.

Research
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Based on our experience most New Product Development fails due to a company’s inability to determine the unmet need. Through a combination of our own experience and expertise, conducting Voice of Customer (VOC), engaging with our advisors and Key Opinion Leaders (KOLs) we are able to determine and validate the unmet need.

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.

Innovation