Frequently asked questions

This section covers all the questions that we were asked during the OMC. It will be updated regularly with answers to your questions.

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47
The ideal consortium, what kind of capabilities should it ideally include? 100% digital/tech? 50% digital/tech and 50% clinical? 80% digital/tech and 20% clinical? What capabilities should clinical “companies have?”

There are no restrictions on the composition of the consortium, however, it is recommendable to build a Consortium that represents a multi-disciplinary approach and broad areas of expertise.

46
Are there specific actions for Long QT syndrome?

See use cases. Suppliers are free to add valuable solutions outside the use cases.

45
What peculiarities do these pre-tender events have in which it is possible to dialogue with the client network?

In preparation for the PCP Call for Tenders, an Open Market Consultation (OMC) will take place from June to August 2021. This OMC will consist of events but also other activities such as the OMC questionnaire, where suppliers can ask for improvements or clarifications and make suggestions or comments on the planned procurement. The buyers’ group will collect and analyse your feedback, and inform the tender preparation accordingly.

All answers to questions asked by suppliers will be published on the INCAREHEART website. There will be no bilateral interaction allowed between a specific supplier and the buyers group. Questions occurring any time after the OMC event can be send to suppliers@incareheart.EU. Answers will be published in the FAQ section of the project website.

43
Will the participating consortium have a coordinator? If yes, what are the differences in terms of commitment between partners and coordinators?

It is required for joint tenders that:

  • each member of the group of tenderers assumes joint and several liability for the performance of the contract;
  • the group of tenderers must mandate one of them with the power to sign the Framework Agreement and specific contracts provided in their name and on their behalf (“Lead Contractor”).

To meet these requirements, each of the members of a group of tenderers except the Lead Contractor must provide with the tender an originally signed power of attorney conforming to the template that will be provided.”

42
Is the Call for Tender already open and what are the deadlines?

The call for tender is expected to be open between November 2021 and April 2022.

41
If a company has a solution already available that could be adapted to specific needs can it be proposed or does it have to be an ex novo development process?

To the knowledge of the Buyers Group, no solution presently covers 100% of the INCAREHEART challenge. Existing solutions can be part of the sought-for INCAREHEART systems. However, it should be well-justified that even though these solutions/modules/functionalities are already developed, they will be customized to meet INCAREHEART requirements.

40
Do you already have an indication of which homecare devices should be integrated into the home solution to monitor the CHF patient?

No, the Buyers Group is open to devices fulfilling regulatory and quality standards.

39
CE Marks? What Medical Devices certification (I guess class IIa or IIb)?

The PCP process involves only testing the solution for usability and usefulness by users, but not certification. If the solution uses device or scales to measure clinical parameters, they must already be validated.

38
Is it necessary to ensure interoperability with the Information Systems of all procurers?

Yes.