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There is no denying that the emergence of Covid 19 has changed 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. With patients sometimes reluctant to frequent surgeries and extensive testing causing severe backlogs across laboratories, POC devices provide part of an effective diagnostic solution, potentially saving the NHS Millions in delayed treatment & diagnosis. In fact, BIVDA has stated that 70% of clinical decisions are influenced by the use of an IVD. The POC device provides 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.


With new innovations emerging and a sense of urgency within the development process – specifically with Covid-related diagnostic devices – there is an increased risk of development problems. This will add 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.

Therefore, as diagnostic and POC devices become more prevalent, regulations around these devices have become more stringent. 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. And this must all be factored in to your programme as early as possible. Gone are the days of retrofitting a critical regulatory or usability element on to your design (to be honest, we have never believed in afterthought). Outlining the device classification process, refining product strategy and planning ahead – even if it means planning to fail fast, adapt quickly and optimise effectively – will be key to successful developments.


Failing to identify and address the pitfalls in your programme can cause hefty delays, have a huge financial implication and even put a stop to your development. Why? Because the risks haven’t been factored into your programme from the start. 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 in any development. 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 into the programme from the start. Then there are the regulatory requirements. As mentioned above, these should be integrated into 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. That is why we have put together a free eBook to help identify common areas of concern and create a refined development roadmap for any diagnostics development, to ensure complete end-to-end project visibility and a streamlined route to market.

As well as taking a deeper dive into everything we’ve talked about above, the eBook offers practical advice – and even checklists – to help you predict problems in your diagnostics development and create a strategy for success.


For further information on how eg technology can support your IVD and POC device development, please get in touch.

Via email on, by giving us a call on +44 01223 813184, or by clicking here.