- What is Nightingale?
- Industry – how to get involved
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Can I read Q+As from the OMC meetings?
Yes. The Nightingale open market consultation meetings generated lively discussion. Here you can read each question and answer that was raised during the breakout sessions.
When will the official tender be released?
We will put the tender on the EU website ‘TED’ in November 2017.
What is the timeline of the Nightingale project?
The project started on 1 November 2016 and will last for four years. In the first year of the project the tender specifications will be developed and ‘fine-tuned’ based on the outcomes of the dialogue with industry in the Open Market Consultation.
What is the Open Market Consultation, will industry have to disclose their technology?
Our Open Market Consultation (OMC) meetings took place in March and April 2017 where we initiated a dialogue with all interested parties. In these meetings we explained the clinical need (why do we need such an advanced remote monitoring system?) as well as the European Commission Pre-Commercial Procurement process and answered any additional questions.
The Nightingale open market consultation meetings generated lively discussion. Here you can read each question and answer that was raised during the breakout sessions.
If we share our current technology development with the Nightingale consortium will this remain confidential?
Yes. We will not share confidential information regarding your technology with any competitors or other outside parties.
In addition, the Nightingale team will do everything in their power to be fully transparent in sharing details about the desired monitoring solution with all interested parties. As a result, no R&D developer will be disadvantaged by possessing less information.
We are a medical device company, why should we join Nightingale?
You will have the opportunity to work with highly motivated and experienced professionals from prestigious European University Medical Centres. They can advise you regarding the development and help to improve your product.
Your final product is more likely to be accepted in the medical community than if you had tried to create the solution by yourself. Your products will have undergone validation in extensive bench testing and field tests in human volunteers and patients at much reduced cost. Finally, the European Commission subsidises your innovative product development via the consortium under the Pre-commercial Procurement (PCP) scheme.
Which vital signs should our solution be able to monitor?
At the very least your solution should be able measure heart rate, respiratory rate, skin temperature and movement/position in a 3D space. Measurement of arterial blood oxygen saturation and an indicator of circulatory status is highly desirable.
Does every vital sign need to be monitored continuously, or can some signs be measured intermittently?
Continuous vital signs monitoring suggests beat to beat heart rate and breath by breath respiratory rate. However, from a monitoring perspective the optimal update rate of the monitored variables depends on the nature of the clinical situation that needs to be recognised. For example, transmitting the current value of skin temperature once every second would not provide useful information to caregivers.
Considering the need for a very robust system with an extremely low false alarm rate; and given the typical time course of patient deterioration we consider an update rate of one full set of ‘validated’ vital signs data every two minutes to be acceptable.
Why would you want a wireless sensor with embedded artificial intelligence?
Patient monitoring is an extremely important element of health care. Patients on wards and patients recently discharged home from the hospital, however, are still poorly monitored. We realise that transmitting and presenting real-time vital signs data from multiple patients simultaneously to a very busy nurse will result in information overload; and believe that by pre-processing and analysing the various vital signs in context and in relation with each other the specificity of the system can be enhanced and false alarm rates decreased.
We are not a medical device company, but we do have experience with artificial intelligence and monitoring big data, can we register our interest?
Yes. The consortium hospitals and clinicians realise that the medical device industry and artificial intelligence/machine learning companies inhabit quite different worlds (at least until very recently). We encourage companies that are considering joining Nightingale to explore the possibility of creating a consortium to deliver the solution and make sure that all necessary know-how is in place to design our envisioned ‘smart’ remote monitoring system. The most up to date list of interested parties willing to make their interest known to other parties can be obtained by emailing email@example.com.
Are hospitals are willing to pay for such technology? What is the business case for you and what is the business case for us?
There is a growing trend for third party payers not to pay for costly re-admissions or even complications that are seen to be the result of sub-optimal care. The ‘Value-Based Healthcare’ movement proposes to pay for good patient outcomes, rather than for procedures or admissions. If continuous vital signs monitoring can prevent costly re-admissions to intensive care (in hospitalised patients) or readmissions from home to the hospital (in recently discharged patients), the business case is immediately obvious, because even one day in hospital is more costly than the total cost of monitoring.
If the system can be shown to actually save lives, the cost savings to society become huge. Even in patients who do need intensive care treatment or re-admission to the hospital, a system that allows early detection of deterioration may still save money by allowing the patient to be readmitted earlier and in a much better physical condition, which will reduce the subsequent number of days in hospital.
What are the benefits for my company if we decide to join Nightingale?
Companies that have been selected to join Nightingale will see direct and intense involvement from clinicians and nurses in five top level academic hospitals. They will provide a clinical test bed for your product in multiple European hospitals and would be very eager to implement the technology once it is deemed market-ready. In addition, the European Commission will subsidise your development of the solution through the consortium hospitals using the PCP scheme.
What about the competition? Is it the case that we will always have at least one competitor within this project?
Yes. The European Commission demands that the development of the solution follows a funnel-shaped competitive model. This means that several companies may enter Phase 1 to develop and propose a solution design. The total budget for Phase 1 is € 150,000.
For Phase 2 (prototype development) the available budget is €2,400,000. We envision that a minimum of four companies will enter Phase 2. In Phase 3 a pre-market prototype must be developed by industry which will be tested in the consortium hospitals. For Phase 3 the available budget is €1,200,000, which will be divided between two or three finalists.