Fast-tracking MedTech innovation in health emergencies
Enabling the rapid deployment of resources to respond to COVID-19
Published on March 30, 2020
MedTech, in its broadest definition, encompasses a wide range of technologies and products used to treat disease and medical conditions. During the ongoing COVID-19 outbreak, we are seeing an unprecedented number of companies of all sizes pivoting to address the need for targeted solutions to aid the fight against the new virus. From the Italian startup using 3D printing to adapt off-the-shelf snorkelling masks for use as respirators, to Dyson, the British engineering firm better known for vacuum cleaners, which is now attempting to produce 15,000 ventilators in a matter of weeks, the COVID-19 pandemic has accelerated innovation in the MedTech to unprecedented speed. However, in an industry where new products can take up to 7 years to reach the market, what is enabling such a rapid deployment of resources to develop a technological response to COVID-19?
Part of the answer lies in regulation. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has published a ‘fast-track’ form for manufacturers working on novel SARS-CoV-2 testing kits for professional use. Although diagnostic devices still require CE-marking, special exemptions from MHRA may authorize manufacturers to supply some non-CE marked devices such a ventilators. Clinical trials related to COVID-19 have also been fast-tracked, with resources dedicated to ensuring priority is given to COVID-19 trials. In the USA, the Food and Drug Administration has also prioritised and supported specific efforts to combat COVID-19, and is using ‘regulatory flexibility’ to fast-track innovation by issuing emergency use authorisations to manufacturers.
Calls to postpone the new Medical Device Regulation (MDR), which was set to come into force on the 26th May 2020, have reached EU policymakers, who are now working on a proposal to adopt a one-year postponement. This would allow medical device manufacturers to prioritise, in the short term, innovation to combat the COVID-19 pandemic.
The other catalyst for rapid innovation is the availability of funding. The EU, through the €164 million European Innovation Council (EIC) Accelerator, has called for applications from SMEs with solutions to help testing, treating and monitoring COVID-19, saying these would be fast-tracked. The Gates Foundation, in partnership with Wellcome and Mastercard, has launched a $125 million COVID-19 Therapeutics Accelerator, aiming to lower the financial and technical barriers for companies developing COVID-19 antivirals. In the UK, University College London has opened a fundraising call (the ‘UCL Coronavirus Response Fund’) with the aim of raising funds to accelerate research into COVID-19 vaccines, monitoring technologies and public health challenges, whilst LifeArc has announced a £10 million funding call to support COVID-19 related innovations.
Overall, the MedTech innovation community is to play a vital part in accelerating and promoting advancements towards diagnosis, treatment and management of COVID-19. From startups to large corporations, from entrepreneurs to healthcare workers, people are pooling knowledge and resources to support the creation of new technologies against the virus. We are already seeing innovation emerging at breath-taking speed around the world, but this is just the start of a global response. New questions will arise as the crisis develops. Innovators will have to deal with daily changes and prepare for the new reality that awaits us after this crisis is passed. In response to the current pandemic, at Oxentia we continue to leverage our networks and expertise in technology commercialisation to foster connections, open new market opportunities, support funding applications and help build resilience for all involved in the MedTech fight against COVID-19.