The free eBook has been created as a tool to help organisations identify common areas of concern within any diagnostics development programme and help create a refined development roadmap, ensuring complete end-to-end project visibility and a streamlined route to market.
The Covid 19 pandemic has had a noticeable impact on the MedTech landscape, specifically within the field of diagnostics. As the healthcare sector moves more into a hybrid model of remote and face-to-face consultations, the prevalence of Point of Care (POC) devices is becoming a key part of the delivery model. Many patients are reluctant to visit surgeries and extensive testing causing severe backlogs across laboratories, POC devices provide the first step in the diagnostics pathway, supported by further lab or clinical evaluation, if required. This enables GPs to get timely diagnostic results, often during the patient consultation, helping to accelerate the care pathway and service they provide.
eg technology have noticed an increased sense of urgency within the development process – specifically as new innovations and Covid-related diagnostic devices emerge – leading to further risk of development problems. For many organisations, this adds to the existing pressure on the validation and regulation of diagnostic devices caused by the MDR & forthcoming IVDR. Unless more focus is placed on cost, time to market, patient safety, maintenance of test accuracy, requirements surrounding sustainability and obtaining the relevant certification, many diagnostic innovations will fall down the inevitable gaps in insufficiently managed developments. Within each design and development, more importance will have to be placed on the requirement for bespoke expertise in critical areas, including risk management, regulatory process adherence, device classification, product strategy and clinical evaluation. Outlining the device classification process, refining product strategy and planning ahead will be key to successful developments.
”Failing to identify and address the pitfalls and risks in your programme can cause hefty delays, have a huge financial implication and even put a stop to your development. If speed to market is a focal aspect of your diagnostic development or release of staged funding, full visibility of all potential occurrences will streamline your development pathway. A defined development roadmap which identifies and diagnoses any gaps in your programme should be a priority. The development team will need to consider usability and risk management - incorporating everything from human factors and device design to sustainability, manufacture, bio-compatibility and environmental risks – and factor these elements in to the programme from the start. Then there are the regulatory requirements; these should be integrated in to your programme throughout. There is a lot to think about and many organisations may find the processes involved in even the smallest development programmes challenging. This was the motivation behind our free eBook. Aimed at start-ups and blue-chip organisations alike, the eBook offers practical advice – and even checklists – to help predict problems in any diagnostics development and create a strategy for success. We have also created a supporting Gap Analysis, against which organisations can assess how advanced their development programme is. The eBook and self-assessment are useful tools to gain programme visibility & make sure you’re not missing important considerations in your development programmeLois DixonMarketing Manager, EG Technology
About eg technology
eg technology are a product engineering design and development specialist based in Cambridge. We have extensive experience within the MedTech sector, ranging from microfluidics and diagnostics to surgical instruments and lateral flow. Our engineers are highly skilled in taking devices from concept through to transfer to manufacture. Specialising in electronics, software and mechanical engineering, industrial design, human factors, project management and quality assurance, eg technology is ISO 13485 accredited. We provide our clients with the compliance to standards for safety, quality, risk management and traceability. Our team is able to provide an integrated solution for those who require the expertise to bridge the gap between innovation and a market-ready product.
mOm is a MedTech start-up on a mission to provide global access to high-quality healthcare by providing accessible technology solutions that can operate anywhere in the world. The concept for the mOm incubator came to CEO & Founder, James Roberts, in reaction to the appalling infant mortality statistics in low/middle-income countries. In 2014, he won the Sir James Dyson Global Prize for Innovation for his design. The mOm Incubator is a cost-effective, fold-away and lightweight neonatal incubator offering a safe, thermoregulated environment for neonates. It will help reduce the thousands of newborn deaths that occur every day due to a lack of basic medical equipment.