FAQs
The following are the questions raised by the attendants throughout the webinars held throughout November and December 2021 (Basque Country, Norway, Sweden, International) and the explanations answered by the project partners (PP) and in some cases by the project officer from the European Commission (PO). The literal wording of the responses has been adapted for making reading easier and some questions have been aggregated.
ON THE PROJECT'S CHALLENGE
Q1
On the concept of care used in the Building Blocks, do you define it at a broader EU level or at a national?
(PP) The definition of the building blocks is based on the combination of the needs that we have identified in workshops with professionals and also the in-depth interviews in the three regions of the procurers involved in the project. So, they do not reflect the characteristics of one single country or system, but of the three of them. They do have some differences among them in terms of how the system is structured, and in principle they reflect the characteristics of most of healthcare systems in Europe.
Q2
Has the Carematrix project identified significant differences in silos/white spaces between the buyers’ group (in Sweden, Spain and Norway)?
(PP) No significant differences have been identified.
Q3
What we are talking about now are technical solutions, but this quickly leads us to organisational questions. Do you have any thought about this?
(PP) It is clear that impacts are achieved by involving both technical innovation and organizational aspects. Within the project we focus on technical innovation, however solutions need to take into account organizational aspects, especially since the project involves three different hospital buyers, in three different countries and systems.
Q4
What is the greater challenge, legal (including GDPR) or technical?
The challenge is a combination of clinical, technical, legal and organisational. Taking this into consideration, it means that it is unlikely that addressing/solving single components of these will address the big picture.
Q5
Which clinical specialties are most frequently involved in the care to PMM?
In regard to prevalence Primary Care (Family and Community Medicine and Nursing) would be involved. In regard to incidence Internal Medicine, which takes the role of coordination regarding these patients when other specialties like Cardiology, Pneumology, Endocrinology, Oncology, etc. are involved. Mental Health and Geriatrics should be taken into consideration too, together with the links to social needs that frequently exist in these complex patients.
Q6
Is there a concrete age for PMM considered in the project?
No, all age groups apply.
ON THE PRECOMMERCIAL PROCUREMENT PROCESS
Q7
Is it mandatory to submit RFI in order to be invited for tendering?
(PP) Completion of the questionnaire is voluntary and does not constitute a prerequisite or advantage of any kind for participation in the CareMatrix tender.
Q8
Four barriers are notable/significant, namely:
1). Legal
2). Cloud act (management/interpretation)
3). Medical Devise Regulation (MDR)
4). Health & Care Organisational maturity
(PP) The PCP&PPI instruments are a way of addressing these barriers, not only for suppliers but also for buyers to increase understanding on how these solutions should/would be designed. Furthermore, these instruments allow the buyers group to better understanding different types of legal aspects, and their (actual) boundaries. It is in the interest of the European commission for these projects to bring value, meaning that (i) relevant solutions are developed as well as (ii) being able to provide necessary feedback on legal barriers currently preventing relevant solutions being implemented.
Q9
Is purchase of the solution at the end of the project a joint purchase from all the partners or up to the buyers in the various organisations?
(PP) Up to the buyers in the various organisations.
Q10
In case there are already solutions in the market, will they be taken out of the future tender? / How is purchase of development weighted against existing solutions?
(PP) Although relevant solutions (addressing parts of the challenge) might be available the Carematrix project is seeking a comprehensive one, and the EU are clear that what´s expected of the project is TRL 6-7.
Q11
As there are many stakeholders involved (patients, nursing homes, etc.), who will own the solution? Will the hospital be the owner and manage this or is it the patient?
(PP) The buyer is the procurer in each country (depending on the case, a hospital, an entire healthcare system, etc.) and the owner of the intellectual property of the solution is the company. Regarding the buyer of the solution, this will be solved differently in the different partner countries.
In Norway for example and generally speaking there is a divided purchasing structure where the municipalities buy for themselves, the GPs buy for themselves, and the hospitals buy for themselves. When it comes to the specific solution within the Carematrix project, the buyer in the specific case of Norway will probably be the hospital, and then we have to find a model where the other organisations in Norway can be included in the solution. Among the patients, the group of patients with multimorbidity need most resources, both in the special health service and in the municipalities. So even though there is a complex organisation in Norway, there is a great need to try to find solutions for this patient group. With good solutions, both the specialist health service and the municipal health service will be interested.
In the Basque Country-Spain, on the other hand, there is a comprehensive healthcare service where there is a single buyer. There are differences in how this is organised in different countries in Europe.
On the offer side, consortia may emerge in such projects, but it remains to be seen the way the market will respond to this process, whether it will be one supplier or whether it is more consortium building. Initially it seems that a consortium building might be what it takes to succeed.
Q12
As there are many stakeholders involved (patients, nursing homes, etc.), who will own the solution? Will the hospital be the owner and manage this or is it the patient?
(PP) There are boards that will work on this, and it is the buyers who make the final decision, but there will be international experts end-users who will give advice.
Q13
The common testing under real world conditions; is real world evidence collection also a big part of the activity, or how do we foresee the evidence collection on impact of this integrated solution?
- (PO) Cooperating in the framework of PCP gives the possibility to test the tool that you are developing in the real-world conditions. And that is because the consortium of procurers, the buyers’ group themselves, are regional authorities and hospitals that have access to the real-world conditions.
- (PP) In the Carematrix project we are speaking more specifically about real world conditions or environments in phase 3 of the process. The possible products and solutions will be evaluated, with actual end users, whoever they might be. Depending on the type of solutions they may be health care staff, they may be the patients themselves, or they may even the informal carers surrounding the patient. Those concrete evaluations will be a big part of the overall evaluation that will be done on that phase of the project.
Q14
Will proof of concept take place in all three countries?
(PP) It will take place in all three countries but will probably be divided so that one looks at different things in different places.
Q15
The number of contracts in the different phases, is it in one country (Norway for example) or is it in all the partner countries together?
(PP) All the partner countries together.
Q16
On block 4 (continuity of care and proactive) it is mentioned that a proactive health care system monitors health status and intervenes in a proactive manner. This sounds very much like software for a medical device system, that will be subject to regulations and perhaps also to medical device certification in Europe. How much these regulatory processes have been planned in this project?
(PP) It is the vendor´s side who is responsible for regulatory compliance, not the buyers. See anyway answer to next question.
Q17
Decision support - Software that requires some certification, will that be a part of this project?
(PP) We are very interested in tools that can aid decision support. We do not expect this to be completed during the project period, but you will receive support from the project´s consortium in these processes. In phase 2, the development phase, regulatory issues will be addressed, as we see necessary to hold a discussion on regulatory issues (it is early to say whether it will be a class 1 or 2 Medical device, for example). We have ways we can work with this within the framework of evaluations, but that is only limited to the evaluation situation, and not a certification.
Q18
This is a pre-commercialization procurement. In case there are integration needs, what is the expected time frame for the development of the final solution?
(PP) Broadly speaking, there will be 3 phases in the process: the Open Market Consultation, in which, on the one side there will be interaction at the very beginning in terms of understanding what the challenges and possible solutions are. The second phase will be about refining those possible solutions, and in the third phase will be about integrating those solutions and reaching to the final solution that will be purchased. It is therefore an iterative process, as any other PCP. You can see below the general scheme:
Since integrations are often handled by the operational IT care departments (and not the project) we can not promise that they will be fully integrated as part of the evaluation in phase 3.. We will not know that until we have selected solutions ahead of phase 3, as focus of phase 3 is efficient and fair evaluations (in isolated clinical environments/scenarios, simulation, real world testing, etc.)
Q19
Since the certification is a quite time-consuming process, that might not fit with this project’s timeline, how do you balance then implementing a product that someone already has in the new solution, being this is a procurement?
(PP) There is nothing anticipated beforehand at this stage, as that could be one of the challenges along the process. We as project partners do not know yet whether there is already a solution that could be modified, or a comprehensive new solution should be put in place.
ON THE TOOLS/SOLUTIONS
Q20
What are some early requirements on addressing patients living with multimorbidity (PMM) challenges?
(PP) The building blocks and use cases describe a wide net of needs and challenges and point at possible solutions (you can read thoroughly on the available documents). Solutions targeting single needs and challenges are relevant and can be involved in the project too. Described solutions with a wider scope (that is covering more building blocks and a larger share of Integrated care) will be significantly more relevant and highly rated to the project.
Q21
We are working on a solution involving early diagnostics of cognitive impairment/dementia. This can be perceived as a silo in itself but involves a number of components, and its (correct) diagnosis is key for the proper management of other diagnosis. What are the terms for us to be involved in the project considering our intervention area?
(PP) Speaking of integrated care, you could certainly emphasise the integration of care processes, but this as well could mean the integration of different technical solutions, and that relates of course to interoperability challenges (both organisational and technical). This is a key factor on what the EU is looking for with these different types of projects: a larger emphasis on interoperability between solutions and between systems and processes.
Q22
In seeking different solutions which might be provided by different vendors, who is responsible for the integration and interoperability of those solutions?
In case a single vendor is not able to answer to the identified challenges in a comprehensive way, we encourage companies to collaborate in a joint proposal, covering more of the building blocks and proposing a more comprehensive solution. Carematrix offer tools for matchmaking with other vendors through the website and throughout the OMC period.
It is up to the collaborating companies to design a joint, integrated solution for submission in the Carematrix tender process.
The goal at the end of phase 3 is to have 2-3 solution interoperable and able to be integrated within the characteristics of the three regions and procurers involved and, by extension, to any other system in Europe.
Q23
Use case 5 - Have you considered increasing the health competence of the patient in this project?
(PP) It is important that there are solutions that help the patient and relatives so that they can take a more active part in the follow-up at home. Please see Use Case 5 Supporting empowerment and self-management by people living with multimorbidity and their carers, including early detection of complications and signs of deterioration.
Q24
How and when will solutions be evaluated on the basis of patient's needs? Is that something that falls on the procurers?
(PP) The best solution will come from an iterative process of dialogue between the procurers and the vendors. Assessing the personal impact achieved by different solutions is a component of the evaluations that will be done throughout the 3 phases of the procurement process. There will have individuals from the 3 procuring regions working in the different types of evaluation panels or groups.
Q25
What are the project's partners and European Commission's project officer's thoughts on scalability of the possible solution to the rest of Europe?
(PO) From a European perspective the approach is that the solution to be developed in the framework of this procurement will extend the duration of the project and that will then be replicated at the European level. We are still at the pre commercial procurement phase and although there is not a commitment, there could be opportunities in the future either from the European level or at national level, both, where the solution could be further replicated and expanded at a commercial level.
(PP) Reading the background material from the European Commission you will see a lot of references to the usage of standards or impacts on trying to promote interoperability with these types of solutions. So, in the context of scalability interested companies can expect that there will be a lot of references to the usage of stablished standards in these types of requirements that will be put forth as well. That means that companies will not only have access to the health care providers or buyers that are part of this project, but also a larger group of European buyers, looking for these types of solutions.
OPEN MARKET Consultation
Find out more about this significant next step in Stage 0 of the project and how to participate.