As healthcare shifts towards a ‘payment by performance’ paradigm there is greater emphasis on the differences between individual patients and their specific response to a therapeutic. We are now entering a new era referred to as Personalised Medicine.
A key attribute of this field is the development of so called ‘companion diagnostics’; molecular assays that measure levels of proteins, genes or specific mutations in an individual are used to provide information for a therapy specific to that patient's specific condition. As the administration of therapeutics becomes ever more dependant on accurate diagnosis, the importance of diagnostic devices will rise. This presents new challenges and opportunities as parallel development of diagnostic and therapeutic will be required to ensure both receive regulatory clearance following the same Phase III clinical trial.
One of the most exciting and disruptive areas of medical diagnostics is that of DNA sequencing. The potential for emerging technologies to move sequencing from research-only use into clinical applications vastly increases the potential market available to companies active in this area. Developments in 3rd generation sequencing technologies enabling single molecue detection offer potentially lower cost instrumentation but significant scientific challenges remain. This is in addition to new challenges for policy-makers, regulators and healthcare providers who must determine acceptable levels of safety and efficacy as well as the reimbursement means available to pay for the technology.
Those companies who have established a significant market share with existing 2nd generation NGS systems are actively looking to grow margins by reducing production costs of their instruments and consumables while maintaining or improving performance.
Areas of expertise
- High volume consumables
- Automation of lab processes
- Point of care diagnostics
- Usability engineering
- Programme management
- Integration of assay and device
- ISO 13485 programmes
Working with medical clients ranging from early stage start-ups through to world-leading healthcare companies, we have a proven track record in the design and development of laboratory instrumentation and handheld devices. Our front end needs and market analysis offering has helped companies identify new opportunities and determine which products to develop. Deep understanding of complex science and technology allows us to bridge the gap between scientific research and product development. Previous work has also included systems focused on clinical chemistry, haemostasis, immunoassays and molecular diagnostics. More recently, our work has included systems concerned with genomics and proteomics, key enabling technologies for personalised medicine and the devices that enable it.
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