TECHNOLOGY
new ideas every day to solve the frontline problems. We’ve seen the calls for PPE to be delivered to protect staff and we’ve seen consortiums set up to co-develop ventilators and other lifesaving equipment. There are two clear streams on innovations – those that were (and still are) needed during the immediate pandemic, and those that will only start to be required now as a transition is being made towards a more normal way of life. On this second point, waiting lists are at the highest point since records began, and we urgently need innovative solutions to address the current treatment backlog. The NHS is already in phase 3 of re-
starting routine clinical care, but much more needs to be done to protect the health of staff and patients alike. At Health Enterprise East (HEE) we have seen multiple ideas all centred around this point of providing the same capacity of care, as was delivered pre-COVID, but in a safer manner. Some of these ideas relate to physical devices required to make high-risk procedures safer and thus increase throughput. Other ideas relate to getting information to patients faster in a socially distant manner. While many clinicians are anxious as to what the future may hold and how this might affect their daily duties, all are still as committed to providing the best possible care for their patients as ever.
The challenges and opportunities for innovation
There are several challenges to innovating in general and not least in response to a global pandemic, yet perhaps of the upmost importance is speed. This has caused confusion among innovators; if they are to develop a new tool or medical device to protect, diagnose or treat, how do they undertake the usual well-trodden product development pathway, when this can take five to six years to complete? Put simply, the answer is that they cannot, and COVID-19 innovations need an accelerated development route. This will require streamlined access to funding, as well as exemptions, or fast-tracked regulatory approvals.
In the UK, concessions have already
concept work done, whether this is a health economic assessment, IP and freedom-to- operate searches, or a prototype made. This sets a very high bar as this is a large portion of work to be undertaken by anyone – let alone an NHS staff member who is likely to be also working a highly stressful, full-time job.
been made for medical devices that address an immediate COVID-19 clinical need. Some of these are simple solutions, such as an expedited advice service for all COVID-19 related enquiries by the Medicines and Healthcare Products Regulatory Agency (MHRA). Others are a little more complicated, such as certain exemptions from device regulations during the COVID-19 outbreak.
Exemptions have been made, for example, for ventilators, PPE and COVID-19 testing kits; however, this is not a free pass at a CE mark. Applicants must explain why they have not yet gained CE marking and state when they expect to gain this, as well as other criteria that must also be met, such as providing evidence that the work has been undertaken according to the appropriate ISO standard. In addition to these examples, there are many other flexible policies that the MHRA and other regulatory bodies outside of the UK, such as the FDA, have put in place to ensure medtech innovations are not unduly held up by the normally lengthy regulatory process.
Support for medtech development Another area where medtech innovators may need a helping hand to develop COVID-19 innovations is through funding. While conventional funding programmes are not set up to deal with innovation at such a pace, we are seeing more opportunities becoming available that recognise this. Unfortunately, there is a lack of funding available for proof of concept work in healthcare generally, but more specifically within the NHS. There are funding streams such as the National Institute of Health Research (NIHR) Invention for Innovation (i4i) scheme which includes Product Development Awards (PDA), and the Connect and Challenge Awards. However, there is a need to have some form of proof of
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Medtech Accelerator Support With this in mind, HEE identified a need for a new venture to provide necessary support and financing for NHS-led innovation projects, in order to maximise the potential for success in bringing new life-enhancing technologies to patients. In essence, a fund was necessary to help cross the infamous ‘valley of death’ in early-stage technology development projects. The Medtech Accelerator, led by HEE as a joint venture with New Anglia Local Enterprise Partnerships (LEP), Cambridgeshire & Peterborough Combined Authority, Essex County Council and the Eastern AHSN, was therefore set up to support and finance the early stage development of innovations in the broad area of medical technology (devices, diagnostics, software and eHealth) that meet unmet clinical needs within the NHS. Through this venture, a total of £2 million was made available, granting individual awards of between £15,000 to £125,000. These awards are given to innovation projects that show the potential to create future spin-out companies primarily out of NHS organisations, and are aimed at supporting proof of concept work, which might include IP protection, market analysis, prototype development and testing, clinical evaluation, regulatory support and pilot product production.
Since inception in 2016, the Medtech Accelerator has committed £1.4 million to 13 projects. This track record means that 13 pioneering technologies, originating from within the NHS, in various stages of development, can attribute their success to early support from the scheme. These technologies all have the potential to make a dramatic impact in a wide range of medical fields, including cancer surgery, endoscopy and anaesthesia. The first product, SAFIRA, a regional anaesthesia solution, reached market earlier this year.
COVID-19 specific medtech funding and support
The COVID-19 pandemic is like nothing else to hit the NHS since its formation more than 70 years ago. Who better to understand the urgent unmet clinical needs of the NHS than the frontline NHS staff? HEE is partnered with over 20 NHS Trusts, meaning we receive details of new innovations throughout the year from clinicians and care providers. Since the UK lockdown in March, over 50%
NOVEMBER 2020
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