Periodic Reporting for period 1 - NIGHTINGALE (Connecting Patients and Carers using wearable sensor technology)
Reporting period: 2016-11-01 to 2017-06-30
The Nightingale project unites 5 academic partners; University Medical Centre Utrecht, the Netherlands; Karolinska Hospital, Stockholm, Sweden; University Hospitals Leuven, Belgium; University College London Hospitals, United Kingdom; and University Clinics, Aachen, Germany. Together, they wish to create a system that connects patients and their carers (doctors, nurses and informal carers). A system that shares important vital signs, but also nurse and patient-entered data on well-being, symptoms and signs. Even in the best hospitals, patients today can still die unnoticed on general wards, for lack of appropriate monitoring, while in the home situation there is no structured vital signs monitoring at all. This can be remedied with the envisioned Nightingale solution, wearable wireless vital signs monitoring combined with intelligent analysis software and bi-directional communication
The Nightingale consortium partners organised two ‘Open Market Consultation” meetings with industry in March and April 2017. The response from industry was very high (in all, more than one hundred European companies have now expressed an interest in bidding for the tender). Companies varied in size and expertise: larger medical device companies indicated to have all the required know-how available, although some were also interested in collaborating with innovative start-ups. Many small to medium enterprises (SMEs), for example makers of wearable sensors, data analytics companies and telecommunications firms, explicitly requested support from the Nightingale consortium to help find suitable partners with appropriate complementary expertise to form consortia that can successfully bid on the tender. During these market consultation sessions we have explained the challenge, and responded to questions from industry at multiple roundtable sessions. On the Nightingale website (www.nightingale-h2020.eu) all questions made known to us to date have been answered to the best of our knowledge. Important recurring themes were:
• can you better specify the intended target conditions and patient groups, possibly in clinical use cases?
• can you commit already to purchasing and hospital-wide implementation of our system in your hospitals, once it becomes available?
• do you really need continuous vital signs monitoring in the home care situation? Would you be willing to compromise for the home care monitoring and accept intermittent vital signs monitoring?
• what is the business case? Who will pay for the system?
• do you insist on disposable single-use devices, or should the sensors be reusable?
• ‘’Willingness to Pay’: what would you consider the acceptable cost for continuously monitoring one patient for one week? Do you have a maximum price in mind?
• home monitoring of vital signs is new and vast, unexplored territory: in your view, who will continually observe all these data? For example, do you foresee development of ‘medical call centres’ to take care of this?
• how will you divide/reallocate responsibilities between the hospital and primary care?
• do you realize that implementation of the Nightingale solution across the care continuum (hospital-rehabilitation-general practice- home) might require major system redesign?
• how will you address the many known interoperability issues, in particular ‘vendor lock-in’ with the current hospital EMRs?
These market consultation sessions have given the Nightingale consortium partners extremely valuable feedback, which we have now taken into account when drafting the documents for the tender package, planned for public release in the fall of 2017.
Next steps - We will organize a face-to-face ‘matchmaking’ event in September 2017 to assist industry in finding the right partners to bid collaboratively (as a consortium) on the Nightingale tender. Around the same time, EC experts will help us to fine-tune the tender package and PCP contract templates. We expect to receive a large number of bids and will review all of them in January 2018; thereafter we will select 8 - 10 companies/consortia to enter PCP Phase 1 (three months) to develop a detailed work plan and prototype system (on paper). We will use a transparent system of award criteria to select a minimum of four best solution designs; these companies are invited to enter PCP Phase 2 and be given 12 months to complete a first working prototype system.
During this phase, we will provide industry with feedback using a process called ‘Value Sensitive Design’, in which we will elicit views on functionality, usability, as well as user demands and concerns from all stakeholders, including patients and carers. To test sensors and data transmission, we will recruit human volunteers; to determine the performance of the decision support elements in the systems, we will use annotated historical patient data. For the final PCP Phase 3, a minimum of two companies will be selected using a similar rigorous and transparent process. At the end of the project we intend to test the systems in limited numbers of patients at each of the Nightingale academic hospitals.
Public Procurement of Innovation - When the Nightingale project is completed, we expect several systems to have been approved for clinical use and be available on the market. This would be the ideal time to perform one or more large scale clinical trials to determine the efficacy and societal benefits of the solution. Here the European Commission can assist via its PPI (Public Procurement of Innovation) scheme, by subsidizing early adopters of innovative technology for (part of) the costs of implementing the new system in clinical practice.