Charles Lowe, who manages the assessment process for Our Mobile Health, has also reviewed funding proposals for a wide range of EU and UK organisations over the years. In this first article, Charles gives his suggestions on how to maximise your chances of securing the funding you need to take your health app to the next level.
A good idea?
Assessors tend to be older experienced people who know the topic well, so any attempt to dig up an old idea – perhaps one that got short shrift in an earlier funding competition – is likely to be summarily rejected, so don’t bother unless you have a new spin on it. As an example, investment cases for smart homes are old hat, however introducing robotics creates a whole new opportunity.
Harder to deal with are the “cost of failure” proposals which involve automating a process that shouldn’t by rights exist. For example, we know that many hospital doctors refuse to code their own interventions, resulting in hospitals losing substantial NHS tariff income in the UK. Therefore introducing handwriting recognition could actually be a step forwards. However, do we want to take that step, essentially into a cul-de-sac, or encourage direct coding, or even perhaps introduce voice recognition so they could speak it directly and have the precise code agreed verbally? Recognising that such thoughts will swirl around the heads of assessors, perhaps explaining how what looks like a cost of failure may be a step in the right direction, could make all the difference to the attractiveness of the proposal.
Thinking it through
One feature that has become evident recently is that good ideas need to integrate into care pathways: a ‘point solution’ that requires manual input and manual output is alien to a care pathway where data should flow from start to finish, with the patient and clinician. Integrate-ability is therefore almost essential. At the same time, a good idea that transforms a care pathway has ramifications well beyond that part of the pathway covered by your proposal, so do be sure to recognise all the implications and risks of the proposed transformation in your response. A demonstration of this was the Whole System Demonstrator programme where the name rightly recognised the potential impact of adding telecare and telehealth interventions, although by insisting on minimal care pathway change to maintain purity of RCT, the academics ensured very little whole system benefit.
Regulation is becoming increasingly important in the medical technology world, both of data privacy and medical devices. The General Data Protection Regulation (GDPR) comes into force on 25 May 2018 and has wide implications on things like explicit consent and where & how data is stored. For new investment proposals, perhaps the most important, if personal data is being stored and especially if it is sensitive personal data, is to recognise the need to seek professional expertise and include a sum for so doing.
For the medical device regulation, the lowest bar is the safety standard SCCi0129, which the NHS insists all hardware and software used clinically should comply with. This has important requirements like the appointment of a safety officer, the keeping of a log and such like. Far more significant though is the Medical Devices Regulation (MDR) due to come into force in early 2020. This is already replacing the Medical Devices Directive (MDD) as there is no ‘grandfathering’ allowed.
The key thing about this is to recognise that unless you have used good quality management practice specific to the medical device industry from the start of the development and manufacture of your hardware or software, you cannot subsequently receive CE certification; you have to go back and do it all over. This equally applies if your app, say, starts off merely as wellbeing device and then subsequently acquires the characteristics of a medical device by, say, monitoring heartbeat and automatically notifying the user’s clinician of episodes.
A full discussion of what is and what isn’t a medical device – and indeed what will become a medical device under the MDR, which extends both the definition and raises the Class of many categories of device – is well beyond this blog, so thankfully the MHRA has produced an excellent short document summarising the position. They also offer a service to advise on close calls – if your proposal looks to be one such, you really should get it checked by the MHRA before submitting your proposal, and say you have in the proposal, and the result. The worst possible thing is to ignore it as, as a rule of thumb, a cost of about £50k and a delay of 6 months in implementation (though these are only indicative – figures vary widely depending on the device) will result if it subsequently emerges that it is. At the very least, recognise it as a risk.
Answer the question fully
If you have thought through your project proposal fully, you should have decided, for example, on the methodology to use in project management, broken out your work packages, and completed a risk matrix. If you have, then put all this in – skimping for example on the risk matrix, not estimating probability and severity, in order to calculate possible impact, immediately gives the impression of poor potential project management.
Another common practice is the organisation that is so full of its own idea that it wants to repeat it in answer to any question where it can be sort-of fitted. Marks are scored for the right information answering the right question; everything else is wasting an opportunity to put other right information there to score more.
Not using the space provided fully is a dangerous practice as it suggests again that the proposal has not been properly thought through. Likewise if the question asks for the benefits you will receive from the funding and the benefits the taxpayer will receive, don’t merely tell the assessors how wonderful the project will be for you; not detailing why the taxpayer might want to fund it is unforgivable!
There is nothing that irritates an assessor more than a proposal that has obviously not been proofread properly. The immediate conclusion that is (often unconsciously, and perhaps unfairly) drawn is that the proposing organisation will struggle to deliver the project if they cannot even communicate its key features clearly.
There are many potential sources of funding - start by checking out Innovate UK and SBRI to see if there is a relevant competition to enter. Go into every funding application with conviction, and do your utmost to sell your product or service in the most impactful way you can. Knowing and acknowledging the risks shows you understand the market and gives confidence in your commercial acumen. That’s essential to converting an idea into reality.
 This relates to information concerning a data subject's racial or ethnic origin, political opinions, religious beliefs, trade union activities, physical or mental health, sexual life, or details of criminal offences.
 Thus a device that currently meets the MDD requirements though not the MDR ones, would become illegal immediately the MDR comes fully into force.
 Note inclusion of the words “prediction” and “prognosis” in particular, that were not in the MDD definition.