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Proposal Preparation

What type of activities are suitable for this call. For example engineering/development, assembly, clinical trials ?
The intent of the Call is to apply robotics to healthcare needs arising from COVID-19, so the focus should be on where robotics can have actual impact in real healthcare environments. This may involve engineering or product development, all be it on a short time scale, or the re-purposing of existing systems where this has not been tried before. The critical focus on demonstrating the impact of robotics in the context of COVID-19 related need.

Would tele-rehabilitation also be considered relevant?
Yes, if it is specifically related to COVID-19, (e.g. rehabilitation after being long in the ICU) this would be considered as relevant.

Can the robotic solution be linked to the purification of air in retirement homes?
If there is a robotic component involved and it satisfies a current need in connection with COVID-19 this is possible.

You mentioned the emergency call is only for robotics. How about if it’s an AI solution?
DIH-HERO focuses on robotics in healthcare. Some robotics applications strongly rely on AI and it is expected that any proposal will have a robotics element even if the proposal is demonstrating AI technology.

Must SMEs and slightly larger companies be strictly related to healthcare/robotics sector? 
No, but the solution provided should be within the scope of healthcare robotics (see also the major application domains of DIH-HERO).

What are the requirements that have to be met when applying for the COVID-19 call? 
To be eligible for taking part in the Fighting COVID-19 Open Call 2020
within the DIH-HERO project all of the following criteria must be fulfilled:
a. Third parties receiving financial support must be a legal entity, being an SME or a slightly larger company from EU (incl. associated countries) or EEA countries;
b. The proposal must clearly state the relevant clinical demand and the healthcare problem related to COVID-19 to be solved by the intended robotic solution and the added value of the solution;
c. The proposed solution must be an already existing technology that is in the later stages of development and deployable by the healthcare end-users in the fight against COVID-19, quickly;
d. The proposal must fit to the call text;
e. A third party may not receive more than 300k FSTP for the entire action duration;
f. The Proposal must be written in English and submitted via the portal before the deadline;
g. There must be no conflicts of interests with the DIH-HERO consortium partners.
h. Third parties receiving financial support must be financially healthy (they have to sign a declaration of no financial problems).
For further information and requirements please see the Applicant Guide.

Are SMEs or slightly larger companies from the DIH service network eligible for funding in this call? 
Yes, as long as they fulfil the criteria and are not a DIH-HERO core partner. 

Can we submit a proposal with SMEs/partners from one country?
Yes, for this specific call it is possible. In fact only one SME is needed, but if multiple SMEs are involved, they can be from the same country.

Is it preferable – even if not required in this special call – to apply with a cross country partner?
It is not required for this special call to have a cross-border partner as with the other DIH-HERO call and there is no special evaluation criterion for this. Having two (or more) (cross-border) partners can be positive (you may get to a solution faster or have access to a widerange of technology, …) or negative (no travel, difficult coordination, increased integration issues…). Given the short duration of the projects you need to be clear what the added value of multiple partners is and that you have considered precisely how work will be split. This will be critically evaluated in the implementation plan.

Do we need a letter of support from a hospital or end-user and what should be stated in there?
Yes, a letter of support is required to see if there is a clinical need for this particular innovation to support in the fight against COVID-19 and if there is a current demand. It should be signed by a professional to show there is a demand.
Multiple letters of support are not necessary, but also acceptable.

What is the required format for the clinical support letter? Do you provide a template for such letter so we can use it?
We do not provide a template letter. It should be clear from the letter that the hospital is aware of the COVID-19 problem that you want to solve and that your solution is satisfying a current clinical need in connection with COVID-19.

Can a DIH help SMEs to get in touch with healthcare professionals or institutions, in order to assess whether the demand from the market is there, and to acquire a letter of support or for accessing a demonstration side?”
Although in general this is true for example see https://services.dih-hero.eu. However specifically for this call, the time is too short to create new connections. It is expected that in order to complete a demonstration inside four weeks you will need to use an existing connection to a healthcare provider.

Do we need to point out in the call , who is going to benefit from the solution, the name of the hospital or just to present the solution ?
The Call is about demonstrating a working solution that can be generally applied. It is not about supporting a specific hospital. A specific hospital can be mentioned (e.g. through the letter of support), but the solution should be scalable and in principle generally applicable possibly even in multiple healthcare settings.

In the eligibility criteria it is stated that the applicants has to declare that there the company does not face any financial problems’. How can this be done in the application?
You can check your financial capacity yourself by using the H2020 Financial self-check tool at https://ec.europa.eu/research/participants/lfv/lfvSimulation.do 
(The results of this simulation provide only a non-binding indication.)

By signing the declaration of honour you declare that you are currently not facing any financial problems. You can also attach the result page of the simulation as an indication to the declaration of honour.
 

Who should provide the information regarding the financial health only the applicant or contractors you may collaborate with (if any)?
Financial viability information is needed for the applying company and any third party contractors since these need to be named in the proposal. The applicant is responsible for ensuring that any third party is financially viable, for example by supplying a validated PIC number. 
The information is especially needed for the applying company. The applying company is also responsible for the 3rdparty they want to use (if any).

How technical should the proposal be? Should the focus be on the challenge and the concept of the solution or the technological innovation as well?
There must be sufficient technical detail provided so the reviewers can be sure the TRL is high enough to meet the needs of demonstration in a short timescale.

Should the budget structure follow the same rules of H2020?
Yes, the budget structure follows the same rules of H2020. However please note that only the following cost categories are eligible: 
(a) Direct personnel costs 
(b) Direct costs of subcontracting (up to a maximum of 15%)
whereas, 
o subcontracting has to be necessary to implement the action.
o   subcontracting may cover only a limited part of the action.
o   awarding of subcontracts must be done ensuring the best value for money or, if appropriate, the lowest price principle. 
o   any conflict of interests must be avoided.
(c) Other direct costs 
o    travel costs and related subsistence allowances 
o    equipment costs
o    costs of other goods and services
 (d) Indirect costs (25% of direct personnel costs and other direct costs)

An estimated budget template can be found here.

Can costs related to the hardware integration of the robotic system be considered as belonging to the “other goods” category?
If the goods purchased are purchased as consumables and supplies (e.g. raw material) to be integrated and processed in the robotic solution itsself this can be seen as being part of the cost category other direct costs (other goods and services).

Is there a material cost limit?
There is no fixed percentage for material costs. Material should be fully justified and within the total cost of the project. It should be necessary to demonstrate a working solution.

Is ‘marketing and sales’ to be accounted for in the resource planning?
No.

For how long can costs be budgeted? We can deliver within 8 weeks, but costs will last as long as installation is operational.
If the demonstration of a working solution can be done in 8 weeks, all costs for the demonstration should be included. Costs needed for deployment after that, are not needed.

Is it in line with the call rules if the total project cost exceeds the value of 100.000€?
Yes, the total project costs may exceed  €100,000. If the applicant considers to finance the remaining costs from own resources, this is of course also possible and in-kind contributions are encouraged. This should be stated in the proposal.

Where can I find the declaration of honour for the COVID-19 call? 
The declaration of honour for the COVID-19 call can be found here.

Where can I find the declaration of informed consent for data processing for the COVID-19 call?
The declaration of informed consent for data processing for the COVID-19 call can be found here.

Where can I find the statement on legal agreement describing the rights and duties of each party to be negotiated among TD consortium partners?
This statement is included in the online application form.

Where can I find the statement on the announcement for publication? 
This statement is included in the online application form.

In the applicant guide it is stated that “questions for statistical purposes” should be answered. Where can I find them?
The questions for statistical purposes are included in the online application form.

How can we sign up in the platform in order to save our proposal for later?
If you have started the submission process, it is possible to stop and continue later through clicking on the “save and continue later” button right next to the next button. By clicking on save and continue later, you will be redirected to the page where a link is given. You can save this link or have it send to you via email. Through this link you can go back to the place iin the form, where you stopped. The link will be valid 30 days.

What are the weights of each of the evaluation criteria?
Each proposal will be assessed concerning its excellence (weight 30%), impact (weight 40%) and the implementation plan (weight 30%). This is set out in the applicant guide.

Subcontracting

What is the maximum % of budget is for subcontracting or as Third-party?
For this call there is no fixed maximum percentage for subcontracting. In general all subcontracting has to be done according to the rules for subcontracting that apply to Horizon 2020 grants. Subcontracting has to be necessary to implement the action. Subcontracting may cover only a limited part of the action (there is no fixed limit). Awarding of subcontracts must be done ensuring the best value for money or, if appropriate, the lowest price principle.

What are the rules for subcontracting that apply to Horizon 2020 grants? 
Direct costs of subcontracting
whereas, 
o   subcontracting has to be necessary to implement the action.
o   subcontracting may cover only a limited part of the action.
o   awarding of subcontracts must be done ensuring the best value for money or, if appropriate, the lowest price principle. 
o   any conflict of interests must be avoided.
In addition, the subcontracted party may not be part of the consortium or one of the DIH-HERO partners.

Can we subcontract to a party which is not an SME or slightly larger company?
Yes, that is possible. However, please note that the maximum amount that may be subcontracted is 15% of the total budget and that subcontracting must fulfil the following criteria: 
o   subcontracting has to be necessary to implement the action.
o   subcontracting may cover only a limited part of the action.
o   awarding of subcontracts must be done ensuring the best value for money or, if appropriate, the lowest price principle. 
o   any conflict of interests must be avoided.
In addition, the subcontracted party may not be part of the TD or TTE project consortium or one of the DIH-HERO partners.

Project Execution & Reporting

Where does the technology need to be validated? in a clinical environment or a representative environment?
A working solution should be demonstrated in a realistic environment. Your proposal should state clearly how and where the validation will take place.

How can certification and ethical approval for medical devices be handled?
There is insufficient  time to obtain full certification or ethical approval during this project if you do not already have it. You must adhere to local rules for testing, respecting the healthcare and any processes and procedures. Where no product certification exists testing must be fully and directly supervised at all times. It is the responsibility of the applicant to ensure that during testing the product is safe and that the level of safety reflects the testing environment. Clinical supervision and consent will be required for any testing involving patients.

Does TRL refer more to the technology or to the overall product? TRL 9 for a product would mean that the applicant have to go through the certification of the solution and introduction to the market, which could be difficult in the short course of the project.
It should demonstrate a working solution which answers a need. The first demonstrator should be finished in 4 weeks and the whole project should be finished in 8 weeks. So it should be in the later stages of development and be deployable. We are looking to the TRL levels of the whole product. We are not aiming at 8 or 9 but lower TRL levels (no CE certification can be done in this duration). The exact TRL level will vary in each project but should be TRL6/7 or above. The intent of the call is to apply robotics to healthcare needs arising from COVID-19, so the focus should be on where robotics can have actual impact in real healthcare environments.

How is the justification of costs done?
At the end of each project the costs made have to be justified in a final report containing a description of the testing procedure and evidence of outcomes, a description of the test environment and an assessment of the clinical impact of the product. Feedback from the clinical support organisation should also be included.

What are the final deliverables needed to demonstrate the completion of the project?
The project should result in a working solution that can be deployed. There will also be a final report to be submitted at the end of the project to see the end results. This report should contain a description of the testing procedure and evidence of outcomes, a description of the test environment and an assessment of the clinical impact of the product. Feedback from the clinical support organisation should also be included.

How scalable should the proposed solution be. What is the expected timescale for possible scaling?
The project must demonstrate a working solution. There should be evidence of the potential to scale the solution but it is not expected that the solution can be scaled within the 8 weeks.

Other questions

Is it only allowed to attend in the program if we have a concrete idea or is it also allowed to offer our engineering service?
For this COVID-19 call we are looking towards concrete ideas, and actually working demonstrators. For DIH-HERO in general, we are building a digital innovation network for robotic healthcare and an engineering service is very welcome and can be added e.g. to https://services.dih-hero.eu so it can be found by others.

Does the collaboration partner needs to be fixed before the submission deadline or would an LOI from potential partners also be sufficient?
If you want to collaborate, there should be proof of the collaboration in the task descriptions. So the collaboration partner(s) (if any) need to be fixed in the proposal.

Can we also submit a proposal for the post corona phase?
The time frame is to have a working demonstrator in 4 weeks, which helps the COVID-19 fight. If your robotic solution satisfies a current clinical need and it can be realised during the limited timeframe, these solutions are also welcome.
 
Is it possible to collaborate with the USA and/or China ? (considering the applicant will be located in the EU, of course)
Only SMEs and slightly larger companies from the EU (incl. associated countries) and EEA countries are eligible for funding. In addition, the benefit of the solution must be in Europe.

Does the innovation necessarily be applicable or intended for use solely to Europe or also other countries ?
Due to the fact that Horizon 2020 is a European funding programme the benefit of the solution should also be in Europe. Many of the solutions may be most likely also be applicable in other parts of the world, however the primary benefit should be within Europe.

Who owns the project results at the end of the project?
The ownership of the results stays with the applicant not with DIH-HERO.

Making medical devices in this short time is not realistic so I guess this call is more or less for already approved medical devices. So if already having a product fitting the corona situation is this call providing a quick access into hospitals?
This depends on the actions that have to be taken to bring the devices to the hospital. Basically this call is meant to demonstrate a working solution within a realistic environment not for buying robots on a larger scale.

Is it possible to apply for all the calls within DIH-HERO?
Yes, SMEs and slightly larger companies also have the possibility to participate in different DIH-HERO open calls to apply for financial support for technology demonstrators as well as technology transfer experiments during the course of the DIH-HERO innovation action. However, the maximum possible financial support for any SME or slightly larger company is limited to €300,000. In addition, the applicant is not allowed to hand-in multiple proposals for the same purpose also within the different Digital Innovation Hubs Projects Trinity, DIH2 and RIMA. Proposals may be cross-checked in this regard.

Can you submit multiple applications?
Yes, but you cannot get funding for the same purpose twice and the maximum amount that can be received for each third party from the innovation actions is 300k. Furthermore, it should be feasible for the SME to do all the work as promised.

I have already submitted a proposal with our core robotic technology for rehabilitation. How will this proposal be affected by submitting the same technology for a different healthcare application in the COVID-19 call?
You can’t receive funding twice for the same idea. If you now submit and it is not sufficiently different from your previously submitted proposal for the TD call, only one can be funded. The same is true if you submit multiple proposals with the same idea for the same call.

How much funds are available for the COVID-19 call? How much projects can be funded? 
The maximum available budget is €1.000.000. It is difficult to state how many projects will be funded in the end, since this highly depends on the quality of the different proposals and the requested budgets.

Would a transversal technology addition, such as cybersecurity be considered within the call scope? We are observing that most robots out there lag behind in security aspects for real world application.
Any proposal would have to directly address a need related to COVID-19. While this is a generic problem the main goal is to have healthcare robotics impact on current needs.

I have got a question which is not yet addressed here. What can I do?
This list of FAQs will be updated regularly during the further course of the project. If your specific question has not been addressed yet, please contact us directly by sending an email to: dih-healthcare@utwente.nl.