Joint call Healthtech 2021

Contact

Jean-Philippe Arié

Desired goal of the call:

The development and validation of innovative digital health solutions benefiting the national healthcare system (patients, healthcare professionals, and/or payers).
 

Objectives:

Incentivise collaborative R&D projects for improvement of health and care delivery focused on medical evidence, harnessing the opportunities of digital health (mHealth, telemedicine, AI, big data analytics...).

The joint call intends to provide a financial incentive to stakeholders who have an identified technology/product/solution and have to demonstrate its relevance and benefit for human health (the “project”).

Using a flexible approach, stakeholders may apply for funding at any of the three steps below, which can be considered as key R&D milestone towards market access for Health Technologies:
 

• Step 1: evidence of safety and performance (i.e. controlled environment)[1]
• Step 2: evidence of effectiveness (i.e. real-life element),
• Step 3: Health Technology Assessments / proof of value (e.g. calculated financial impact on health, social security, care, or impact of preventative medicine on education and work).

At the end of the project, stakeholders shall be prepared to enter into the next step or to market the solution after step 3. Due to the specificities of the healthtech sector, commercialising the product immediately after the call is not a requirement, however, having a clear path to market is. This could include out-licensing of the technology or fund raising for a further or final phase of clinical evidence in order to produce and/or commercialise a health technology.

The challenges addressed by this joint call are among others described in sections 3.2 “Data analytics, digital tools and digital transformation” and 3.3. “Innovation” of the “European medicines agencies network strategy to 2025” report - accessible here.
 

Call topic:

Use of digital tools and the power of data analytics to improve prevention, diagnosis, monitoring or treatment of health conditions.

Products to be developed through this call must be innovative digital health solutions for human use that (1) are already at prototype stage and (2) are to be regulated by the medical device regulation (MDR)[2] or in-vitro medical device regulation (IVDR)[3]. (Examples: medical software, regulated apps, connected medical devices).

In line with national priorities, consortia will have to align to the following approaches:

• Innovative clinical investigations

Centered on taking the current state of the art in clinical trials and refining their design and implementation though innovative means such as digital tools, smart wearables and sensors, electronic medical record analysis, and other precision medicine approaches. These clinical trials should bring added value to patients.

• Multifactorial intervention strategies

Focused on designing and testing interventions that are not molecular in nature, for example through lifestyle and digital means. The goal is to improve health through innovative, participatory, and personalised intervention strategies, resulting in health-associated impact through interdisciplinary research.
 

Instruments & Consortia:

Consortia are expected to include at least one participating company and one participating research organisation or hospital. An ideal consortium would have as close to an equal contribution between private and public parties as feasible, but at a maximum no party shall bear more than 70 % of the total project costs.

FNR will fund the costs of the accredited research organisations in Luxembourg, up to 700.000€ per project covering all project specific costs.

The Ministry of the Economy will co-finance costs borne by Luxembourg eligible companies up to 700.000€ per project, using the R&D aid scheme. It is expected that projects shall be considered as experimental developments. In this case, maxima co-funding rates are as follows:
Small enterprise: 60%; Medium enterprise: 50%; Large enterprise: 40%.

Costs related to patents and certifications are only eligible for SMEs and will be co-funded up to 50% under the Innovation Aid for SMEs funding scheme.

Project durations are targeted for a 24 to 30 month period, with a 6 month extension to be requested if needed.

Self-funded international consortium partners are permitted to participate in the consortium.
 

Eligibility criteria:

Projects have to be in line with the call topic.
Companies must fulfil the criteria set out in the R&D aid scheme [4].
Research organisations must be accredited by the FNR.

List of eligible research organisations as of 15^th March 2020:

• University of Luxembourg, LIH, LIST, LISER, LNS, CHL, LIROMS, Hellef doheem, CHEM, Cardiolinc, Alzheimer Europe, Rehazenter

 

Evaluation criteria:

1. Relevance (33.3%)

•  project idea; clarity and pertinence of the objectives
•  level of innovation, including advance on state of the art
•  soundness of the research approach and methodology, including the clinical or real-world evidence or technology assessment study,
• likely favourable patient value of the technology
•  due consideration of ethical and regulatory aspects
• ethical and legal governance model for a research data management and storage plan compliant with the required level of data security and privacy that is aligned with

 

2. Implementation: quality and efficiency of the project plan (33.3%)

• coherence and effectiveness of the work plan, including appropriateness of the allocation of tasks and resources
• realistic timing taking into account required authorisations
• realistic timing of patient recruitment, given the patient targeting and recruitment plans
• competences, experience and complementarity of the individual participants, as well as of the consortium and collaboration as a whole
• level of ambition in the collaboration and commitment of the participants in the proposed programme to pool national resources and coordinate their national competences, including a will to recruit on a multi-centre national basis
• appropriateness of the management structures and procedures, quality of the risk management plan and soundness of the risk mitigation plan
• Soundness of data management plan built, when possible or pertinent, on existing data research infrastructures such as ELIXIR

 

3. Impact (33.3%)

• added value of the proposed technology/product/solution in terms of health and current clinical care, as highlighted by the study
• strengthening the competitiveness and growth of involved companies by developing innovations addressing an identified market opportunity
• soundness of the business plan outlining a clear path towards an economic exploitation of the project results
• effectiveness of the proposed measures to exploit and disseminate the project results translated into assets, to communicate the project
• integration of health and disease data, sharing and reuse of data in the health field between researchers, companies and hospitals, while ensuring legal compliance on the use of the data
• laying the foundations of data-intensive digital health approaches for personalised medicine applications in Luxembourg and Europe
• strengthening the position of Luxembourg and the EU in the health technology domain and especially in the digital health domain through increased collaborations between public research, healthcare organisations and industry

 

Call process:

• Stage 1: Short proposal to be submitted as described below.
• Stage 2: full proposal to be sent by each project participant either to the Ministry of the Economy for companies, or to FNR for accredited research organizations. The deliverable of the platform www.research-industry-collaboration.lu will be a technical annex that will be appended to the aid application.

 

Stage 1: 4 May 9am – 30 June 11pm:

Short proposal describing:

• Partners;
• CV of the main investigators;
• Project description;
• Project outcomes.

At the end of stage 1, the Ministry of the Economy, FNR and Luxinnovation (the “Organisers”) will check:

• Eligibility of all parties and co-funding capacity of the company;
• If project description is in line with the call topic;
• If the project objectives are in line with the objectives of the call.

Participants will be invited to proceed to Stage 2, possibly with some recommendations from the organisers.

Stage 2: 5 August 9am – 15 October 11pm:

Full project proposal comprising:

• Draft clinical evaluation (clinical investigation, real-world evidence, technology assessment, protocol, usability study… in line with medical certification strategy);
• Project activities;
• Milestones;
• Timeline;
• Resources;
• Cost;
• Collaboration Agreement (draft ready for signature);
• Intellectual Property;
• Medical certification and commercial path, highlighting the current stages of development of the technology and aim of the project (Step 1, 2 or 3);
• Risk management and quality assurance;
• Proof that the sponsor of the clinical study has entered discussions with an insurance to cover damages resulting from the research and caused to persons participating in this trial.
• GDPR aspects: data flow and ownership, delegations to data processors

Full project proposal will be reviewed by a panel of 4 external reviewers. All consortia having submitted an application at Stage 2 will be invited to a panel review (physical or virtual meeting) end of November. Organisers will participate as observers.  

Projects can start in February 2022.

Clinical investigations to develop and validate digital health solutions (i.e. medical devices), require an approval from the Ministry of Health and / or the CNER. This authorization is a required step in obtaining funding from the Ministry of the Economy and FNR.

The Project(s) selected for financing in this Joint Call will require participants to attend and present a project update at a Joint Annual Technical Monitoring meeting with the two funders, FNR and the Ministry of the Economy, as a condition of the financing.